Primary Clostridium Difficile Infection, Recurrent Clostridium Difficile Infection
Conditions
Keywords
Clostridium difficile, FMT, Fecal Microbiota Transfer
Brief summary
Patients with microbiota alterations developed after being exposed to antibiotics are especially susceptible to Clostridioides difficile infections (CDI). The incidence and severity of CDI has increased in recent years and CDI recurrences (r-CDI) due to the appearance of new episodes in patients with a previous cured CDI, represent a serious and complex clinical issue. Although antibiotics are the recommended therapy for the first episode of CDI, treatment with oral vancomycin and/or metronidazole often results in significant treatment failure. In addition, the treatment of r-CDI is not adequately standardized, and although the most widely used treatment is the administration of fidaxomicin and bezlotoxumab, its efficacy in patients who already have r-CDI is not proven. In the late years, Fecal Microbiota Transfer (FMT) has emerged as the preferred non-pharmacological treatment to manage CDI with multiple recurrences and recent clinical trials have evaluated its potential efficacy and safety in the treatment of patients with primary CD infection. The objective of this study is to assess the efficacy and safety of the MBK-01 medication, consisting of heterologous lyophilized fecal microbiota capsules coming from healthy donors in comparison to the treatment with fidaxomicin, in 92 patients with primary or r-CDI.
Detailed description
This is a Phase III, multicenter, controlled and open label clinical trial in which patients who suffered an episode of Clostridioides difficile infection (either the first episode or subsequent recurrences) will be randomly assigned (1:1) to one of the following arms: * Fidaxomicin * MBK-01 (heterologous lyophilized fecal microbiota) Objective: To assess the efficacy of FMT with capsules of lyophilized fecal microbiota (MBK-01), compared to the control (fidaxomicin) at 8 weeks after the start of the treatment. Also, assess the safety of MBK-01 and the quality of life of patients participating in the study. Follow up: participants will return for clinic visits at 72 hours, week 3 and week 8 after the start of the treatment, and will receive follow-up phone calls at month 3 and month 6 after the start of the treatment. Stool samples will be collected from participants for further studies at time 0 and week 8 after the start of the treatment. Study Outcomes are detailed in the specific section of this website. Rationale: The transferred microbiota restores the recipient's intestinal microbiota by reintroducing bacterial taxa that were absent or in low proportion in the recipient before the FMT. This supports the expansion of the recipient's own commensal microbiota and re-establishing a microbiota community with a high biodiversity. Donors: All donors are screened to ensure they meet the strict requirements necessary to maintain the safety of the MBK-01. Justification: The treatment of Clostridioides difficile infections (CDI) with antibiotics is usually effective for acute symptoms, but after the initial treatment, the probability of recurrence at 8 weeks ranges from 10-20 % of cases, and once a patient has a recurrence, the probability of further recurrences increases up to 40-65 %. In recent years, Fecal Microbiota Transfer (FMT) has emerged as the preferred non-pharmacological treatment to manage CDI with multiple recurrences and recent clinical trials have evaluated its potential efficacy and safety in the treatment of patients with primary CD infection. Although antibiotics are the recommended therapy for the first episode of CDI, treatment with oral vancomycin and/or metronidazole often results in significant treatment failure, with recurrences occurring in up to 30-40% of patients. Furthermore, antibiotic treatment does not correct deficiencies in the intestinal microbiota that facilitate CD infection and is associated with the risk of the emergence of antibiotic-resistant bacteria. Moreover, the treatment of recurrences is not adequately standardized. In recent years, although the most widely used alternatives have been fidaxomicin and bezlotoxumab, their efficacy in patients who already suffer from r-CDI is not proven. The administration of the FMT through oral capsules, although it is not standardized, has proven to be effective in the restoration of intestinal microbiota of patients with r-CDI. In addition, the use of lyophilized formulas facilitates the concentration of bacteria and further optimizes the donors' sample and reduces the amount of capsules that the patient has to ingest.
Interventions
BIOLOGICALMBK-01
A single dose of 4 capsules of MBK-01 (heterologous lyophilized fecal microbiota coming from healthy donors) orally.
DRUGFidaxomicin
Oral administration of 200mg/12 hours of fidaxomicin for 10 days.
Sponsors
Mikrobiomik Healthcare Company S.L.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Patients of both genders, over 18 years. 2. Patients that undergo an episode of CD infection (either the first episode or subsequent recurrences). 3. Presence of an episode of diarrhea defined as ≥3 stools/24 hours, at the beginning of the episode. 4. Confirmation of the presence of CD toxin A and/or B in faeces, by a direct toxin detection test or by the PCR technique for the detection of toxin/s producing genes, at the start of the episode that is going to be treated in the clinical trial (the toxin test must be positive within 7 days prior to the enrolment of the patient in the trial).
Exclusion criteria
1. Previous faecal microbiota transfer. 2. Transplanted patients, except those with a solid organ transplant of more than 2 years, with good organ function. 3. Absolute neutrophil count \<500 cells /μL at the time of the enrollment in the study. 4. Pregnancy, breastfeeding, or pregnancy intentions over the course of the study. 5. Active treatment with bile acid sequestrants (for instance: cholestyramine). 6. Positive patients for the human immunodeficiency virus (HIV) except those with lymphocytes T CD4 count \> 200 cells/μL and viral load less than 20 copies. 7. Swallowing dysfunction or no oral motor coordination. 8. Patient admitted in an intensive care unit or expected to be admitted in an intensive care unit due to serious illness. 9. History of significant medical conditions that, in the opinion of the investigator, would not allow an adequate evaluation or follow-up of the patient.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Global Absence of Diarrhea Due to Clostridiodes Difficile 8 Weeks After the Start of the Treatment | 8 weeks after the start of the treatment | Number of patients who showed recurrence of at least one Episode of Diarrhea (3 or More Stools/24 Hours) 8 Weeks After the Start of the Treatment. Recurrence is understood as the reappearance of clinical manifestations of a new episode of CDI that re-occurs within 8 weeks after the onset of symptoms of a previous episode that was resolved. |
| Absence of Diarrhea: Number of Episodes of Diarrhea (3 or More Stools/24 Hours) 72 Hours After the Start of the Treatment | 72 hours after the start of the treatment | Diarrhea resolution: \<3 stools/24 hours for at least 2 consecutive days after the end of the treatment. |
| Absence of Diarrhea: Number of Episodes of Diarrhea (3 or More Stools/24 Hours) 3 Weeks After the Start of the Treatment | 3 weeks after the start of the treatment | Diarrhea resolution: \<3 stools/24 hours for at least 2 consecutive days after the end of the treatment. |
| Absence of Diarrhea: Number of Episodes of Diarrhea (3 or More Stools/24 Hours) 3 Months After the Start of the Treatment | 3 months after the start of the treatment | Diarrhea resolution: \<3 stools/24 hours for at least 2 consecutive days after the end of the treatment. |
| Absence of Diarrhea: Number of Episodes of Diarrhea (3 or More Stools/24 Hours) 6 Months After the Start of the Treatment | 6 months after the start of the treatment | Diarrhea resolution: \<3 stools/24 hours for at least 2 consecutive days after the end of the treatment. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Adverse Events Per Randomisation Group | Up to 6 months after the start of the treatment | Number of Adverse Events per randomisation group since baseline. |
| Type of Adverse Events Per Ramdomisation Group | Up to 6 months after the start of the treatment | Type of Adverse Events per ramdomisation group since baseline. |
| Number of Serious Adverse Events Per Ramdomisation Group | Up to 6 months after the start of the treatment | Number of Serious Adverse Events per ramdomisation group since baseline. |
| Type of Serious Adverse Events Per Ramdomisation Group | Up to 6 months after the start of the treatment | Type of Serious Adverse Events per ramdomisation group since baseline. |
| Adverse Events Related to the Treatment | Up to 6 months after the start of the treatment | Adverse Events related to the treatment since baseline. |
| Duration of Hospitalisation | Up to 8 weeks after the start of the treatment | Time, in days, that the patient remains in the hospital as a result of CDI (but not necessarily indicating a recurrence of diarrhea due to CDI). |
| Adverse Events Related to the CDI | Up to 6 months after the start of the treatment | Adverse Events related to the CDI since baseline. |
| Mortality Associated With CDI | Up to 6 months after the start of the treatment | Percentage of patients that die due to CDI after a defined period of time from the beginning of the treatment. |
| Intensive Care Unit Admissions (ICU) | Up to 6 months after the start of the treatment | Percentage of patients admitted in the ICU after a defined period of time from the beginning of the treatment. |
| Adverse Events of Special Interest | Up to 6 months after the start of the treatment | Adverse Events of special interest since baseline. |
| SF36 Questionnaire (The Short Form-36 Health Survey) to Evaluate the Quality of Life | Day 0, 8 weeks and 6 months after the start of the treatment | For each dimension (physical functioning, role limits-physical, bodily pain, general health, vitality, social functioning, role limits-emotional, mental health), the scale ranges from 0 (the worst health status for that dimension) to 100 (the best health status). |
| Adverse Event Seriousness | Up to 6 months after the start of the treatment | Adverse Event Seriousness since baseline. |
| Good/Bad Progress of the Patient | Up to 72 hours after the start of the treatment | A bad progress of the patient is defined as the detection 48-72 hours after the start of the treatment (MBK-01 or Fidaxomicin) of: A worsening of the diarrhea episode (at least one stool more than at baseline, baseline being understood as the time of the start of the study treatment (fidaxomicin or MBK01)). And, at least, one of the following factors: * Increase in C-reactive protein (CRP) value (\> 5 % of the baseline value). * Increase in white blood cell count (\> 5 % of the baseline value). * Progression to sepsis: hypotension or organ failure with no other apparent cause. |
| Time to Recurrence Depending on Randomisation Groups | Up to 6 months after the start of the treatment | Recurrence: Reappearance of clinical manifestations of a new CDI episode in a patient with an CDI episode treated and cured in the previous 8 weeks. |
| Duration of Treatment | Up to 10 days | Duration in days of the treatment. |
| Overall Survival | Up to 6 months after the start of the treatment | Percentage of patients that are still alive after a defined period of time from the beginning of the treatment. |
Countries
Spain
Participant flow
Recruitment details
First patient was recruited on 29th October 2021. Last patient was recruited on 15th November 2023. Patients were recruited in the study sites.
Pre-assignment details
One selected patient was excluded before randomisation because of screening failure.
Participants by arm
| Arm | Count |
|---|---|
| MBK-01 Participants will receive MBK-01 capsules of fecal microbiota coming from healthy donors (45 patients).
MBK-01: A single dose of 4 capsules of MBK-01 (heterologous lyophilized fecal microbiota coming from healthy donors) orally. | 45 |
| Fidaxomicin Participants will receive Fidaxomicin (47 patients). Dificlir: Oral administration of 200mg/12 hours of fidaxomicin for 10 days. | 47 |
| Total | 92 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 7 | 11 |
| Overall Study | Clinical condition | 1 | 0 |
| Overall Study | Death | 1 | 1 |
| Overall Study | Forbidden medication | 9 | 5 |
| Overall Study | Lack of Efficacy | 0 | 2 |
| Overall Study | Lost to Follow-up | 0 | 1 |
| Overall Study | Physician Decision | 1 | 1 |
| Overall Study | Protocol Violation | 1 | 0 |
| Overall Study | SAE and sepsis | 1 | 0 |
| Overall Study | Transfer to another hospital | 0 | 1 |
| Overall Study | Withdrawal by Subject | 1 | 0 |
Baseline characteristics
| Characteristic | Fidaxomicin | Total | MBK-01 |
|---|---|---|---|
| Age, Continuous | 65.26 years STANDARD_DEVIATION 14.65 | 65.24 years STANDARD_DEVIATION 15.88 | 65.22 years STANDARD_DEVIATION 17.24 |
| Clostridioides difficile infection episode Primary episode | 28 Participants | 53 Participants | 25 Participants |
| Clostridioides difficile infection episode Recurrent episode | 19 Participants | 39 Participants | 20 Participants |
| Declared outcome of health | 3.65 units on a scale STANDARD_DEVIATION 0.97 | 3.69 units on a scale STANDARD_DEVIATION 0.99 | 3.74 units on a scale STANDARD_DEVIATION 1.01 |
| Duration of antibiotic treatment | 3.21 days STANDARD_DEVIATION 1.15 | 3.08 days STANDARD_DEVIATION 1.41 | 2.96 days STANDARD_DEVIATION 1.72 |
| Medical history: number of pretreatments | 2.51 pretreatments STANDARD_DEVIATION 2.34 | 2.38 pretreatments STANDARD_DEVIATION 2.3 | 2.33 pretreatments STANDARD_DEVIATION 2 |
| Medical history: number of previous pathologies | 6.62 previous pathologies STANDARD_DEVIATION 4.33 | 7.27 previous pathologies STANDARD_DEVIATION 4.58 | 7.96 previous pathologies STANDARD_DEVIATION 4.79 |
| Previous antibiotic treatment Previous antibiotic No | 18 Participants | 40 Participants | 22 Participants |
| Previous antibiotic treatment Previous antibiotic Yes | 29 Participants | 52 Participants | 23 Participants |
| Previous antibiotic treatment Pre-washing out No | 0 Participants | 0 Participants | 0 Participants |
| Previous antibiotic treatment Pre-washing out Yes | 29 Participants | 52 Participants | 23 Participants |
| Proton pump inhibitor treatment No | 19 Participants | 38 Participants | 19 Participants |
| Proton pump inhibitor treatment Yes | 28 Participants | 54 Participants | 26 Participants |
| Race/Ethnicity, Customized Amerindian | 0 Participants | 1 Participants | 1 Participants |
| Race/Ethnicity, Customized Asian | 1 Participants | 1 Participants | 0 Participants |
| Race/Ethnicity, Customized Caucasian | 45 Participants | 89 Participants | 44 Participants |
| Race/Ethnicity, Customized Other | 1 Participants | 1 Participants | 0 Participants |
| Region of Enrollment Spain | 47 participants | 92 participants | 45 participants |
| Sex: Female, Male Female | 30 Participants | 60 Participants | 30 Participants |
| Sex: Female, Male Male | 17 Participants | 32 Participants | 15 Participants |
| SF36 Questionnaire (The Short Form-36 Health Survey) to Evaluate the Quality of Life Bodily pain | 57.25 units on a scale STANDARD_DEVIATION 29.07 | 55.18 units on a scale STANDARD_DEVIATION 29.35 | 52.91 units on a scale STANDARD_DEVIATION 29.84 |
| SF36 Questionnaire (The Short Form-36 Health Survey) to Evaluate the Quality of Life Emotional role | 68.30 units on a scale STANDARD_DEVIATION 32.18 | 63.51 units on a scale STANDARD_DEVIATION 35.7 | 58.13 units on a scale STANDARD_DEVIATION 38.98 |
| SF36 Questionnaire (The Short Form-36 Health Survey) to Evaluate the Quality of Life General health | 54.85 units on a scale STANDARD_DEVIATION 20.62 | 54.98 units on a scale STANDARD_DEVIATION 18.9 | 55.13 units on a scale STANDARD_DEVIATION 17.07 |
| SF36 Questionnaire (The Short Form-36 Health Survey) to Evaluate the Quality of Life Mental health | 56.06 units on a scale STANDARD_DEVIATION 17.17 | 55.40 units on a scale STANDARD_DEVIATION 16.97 | 54.64 units on a scale STANDARD_DEVIATION 16.93 |
| SF36 Questionnaire (The Short Form-36 Health Survey) to Evaluate the Quality of Life Physical function | 57.07 units on a scale STANDARD_DEVIATION 33.71 | 56.99 units on a scale STANDARD_DEVIATION 34.57 | 56.90 units on a scale STANDARD_DEVIATION 35.9 |
| SF36 Questionnaire (The Short Form-36 Health Survey) to Evaluate the Quality of Life Physical role | 36.55 units on a scale STANDARD_DEVIATION 32.81 | 35.90 units on a scale STANDARD_DEVIATION 32.96 | 33.48 units on a scale STANDARD_DEVIATION 33.44 |
| SF36 Questionnaire (The Short Form-36 Health Survey) to Evaluate the Quality of Life Social function | 63.77 units on a scale STANDARD_DEVIATION 19.02 | 64.39 units on a scale STANDARD_DEVIATION 17.36 | 65.08 units on a scale STANDARD_DEVIATION 15.53 |
| SF36 Questionnaire (The Short Form-36 Health Survey) to Evaluate the Quality of Life Vitality | 35.69 units on a scale STANDARD_DEVIATION 18.56 | 37.02 units on a scale STANDARD_DEVIATION 15.74 | 38.33 units on a scale STANDARD_DEVIATION 11.75 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 1 / 45 | 1 / 47 |
| other Total, other adverse events | 36 / 45 | 38 / 47 |
| serious Total, serious adverse events | 9 / 45 | 4 / 47 |
Outcome results
Primary
Absence of Diarrhea: Number of Episodes of Diarrhea (3 or More Stools/24 Hours) 3 Months After the Start of the Treatment
Diarrhea resolution: \<3 stools/24 hours for at least 2 consecutive days after the end of the treatment.
Time frame: 3 months after the start of the treatment
Population: For the analysis of recurrences, there are 77 patients evaluable. The remaining patients were excluded from this analysis due to different reasons.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| MBK-01 | Absence of Diarrhea: Number of Episodes of Diarrhea (3 or More Stools/24 Hours) 3 Months After the Start of the Treatment | 4 Participants |
| Fidaxomicin | Absence of Diarrhea: Number of Episodes of Diarrhea (3 or More Stools/24 Hours) 3 Months After the Start of the Treatment | 9 Participants |
Primary
Absence of Diarrhea: Number of Episodes of Diarrhea (3 or More Stools/24 Hours) 3 Weeks After the Start of the Treatment
Diarrhea resolution: \<3 stools/24 hours for at least 2 consecutive days after the end of the treatment.
Time frame: 3 weeks after the start of the treatment
Population: For the analysis of recurrences, there are 77 patients evaluable. The remaining patients were excluded from this analysis due to different reasons.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| MBK-01 | Absence of Diarrhea: Number of Episodes of Diarrhea (3 or More Stools/24 Hours) 3 Weeks After the Start of the Treatment | 2 Participants |
| Fidaxomicin | Absence of Diarrhea: Number of Episodes of Diarrhea (3 or More Stools/24 Hours) 3 Weeks After the Start of the Treatment | 2 Participants |
Primary
Absence of Diarrhea: Number of Episodes of Diarrhea (3 or More Stools/24 Hours) 6 Months After the Start of the Treatment
Diarrhea resolution: \<3 stools/24 hours for at least 2 consecutive days after the end of the treatment.
Time frame: 6 months after the start of the treatment
Population: For the analysis of recurrences, there are 77 patients evaluable. The remaining patients were excluded from this analysis due to different reasons.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| MBK-01 | Absence of Diarrhea: Number of Episodes of Diarrhea (3 or More Stools/24 Hours) 6 Months After the Start of the Treatment | 4 Participants |
| Fidaxomicin | Absence of Diarrhea: Number of Episodes of Diarrhea (3 or More Stools/24 Hours) 6 Months After the Start of the Treatment | 9 Participants |
Primary
Absence of Diarrhea: Number of Episodes of Diarrhea (3 or More Stools/24 Hours) 72 Hours After the Start of the Treatment
Diarrhea resolution: \<3 stools/24 hours for at least 2 consecutive days after the end of the treatment.
Time frame: 72 hours after the start of the treatment
Population: For the analysis of recurrences, there are 77 patients evaluable. The remaining patients were excluded from this analysis due to different reasons.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| MBK-01 | Absence of Diarrhea: Number of Episodes of Diarrhea (3 or More Stools/24 Hours) 72 Hours After the Start of the Treatment | 1 Participants |
| Fidaxomicin | Absence of Diarrhea: Number of Episodes of Diarrhea (3 or More Stools/24 Hours) 72 Hours After the Start of the Treatment | 0 Participants |
Primary
Global Absence of Diarrhea Due to Clostridiodes Difficile 8 Weeks After the Start of the Treatment
Number of patients who showed recurrence of at least one Episode of Diarrhea (3 or More Stools/24 Hours) 8 Weeks After the Start of the Treatment. Recurrence is understood as the reappearance of clinical manifestations of a new episode of CDI that re-occurs within 8 weeks after the onset of symptoms of a previous episode that was resolved.
Time frame: 8 weeks after the start of the treatment
Population: For the analysis of recurrences, there are 77 patients evaluable. The remaining patients were excluded from this analysis due to different reasons.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| MBK-01 | Global Absence of Diarrhea Due to Clostridiodes Difficile 8 Weeks After the Start of the Treatment | 4 Participants |
| Fidaxomicin | Global Absence of Diarrhea Due to Clostridiodes Difficile 8 Weeks After the Start of the Treatment | 9 Participants |
p-value: 0.22897.79% CI: [0.54, 10.624]Regression, Logistic
Secondary
Adverse Event Seriousness
Adverse Event Seriousness since baseline.
Time frame: Up to 6 months after the start of the treatment
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| MBK-01 | Adverse Event Seriousness | Moderate | 17 Number of Adverse Events |
| MBK-01 | Adverse Event Seriousness | Life threatening | 0 Number of Adverse Events |
| MBK-01 | Adverse Event Seriousness | Severe | 1 Number of Adverse Events |
| MBK-01 | Adverse Event Seriousness | Death | 1 Number of Adverse Events |
| MBK-01 | Adverse Event Seriousness | Mild | 70 Number of Adverse Events |
| Fidaxomicin | Adverse Event Seriousness | Death | 0 Number of Adverse Events |
| Fidaxomicin | Adverse Event Seriousness | Mild | 77 Number of Adverse Events |
| Fidaxomicin | Adverse Event Seriousness | Moderate | 22 Number of Adverse Events |
| Fidaxomicin | Adverse Event Seriousness | Severe | 4 Number of Adverse Events |
| Fidaxomicin | Adverse Event Seriousness | Life threatening | 0 Number of Adverse Events |
Secondary
Adverse Events of Special Interest
Adverse Events of special interest since baseline.
Time frame: Up to 6 months after the start of the treatment
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| MBK-01 | Adverse Events of Special Interest | Prostatitis | 1 Number of AEs |
| MBK-01 | Adverse Events of Special Interest | Flatulence | 1 Number of AEs |
| MBK-01 | Adverse Events of Special Interest | Migraine | 1 Number of AEs |
| MBK-01 | Adverse Events of Special Interest | Vomiting | 4 Number of AEs |
| MBK-01 | Adverse Events of Special Interest | Diarrhoea | 17 Number of AEs |
| MBK-01 | Adverse Events of Special Interest | Irritable bowel syndrome | 0 Number of AEs |
| MBK-01 | Adverse Events of Special Interest | Cystitis | 0 Number of AEs |
| MBK-01 | Adverse Events of Special Interest | Perineal abscess | 1 Number of AEs |
| MBK-01 | Adverse Events of Special Interest | Constipation | 1 Number of AEs |
| MBK-01 | Adverse Events of Special Interest | Influenza | 1 Number of AEs |
| MBK-01 | Adverse Events of Special Interest | Colitis ulcerative | 1 Number of AEs |
| MBK-01 | Adverse Events of Special Interest | Pyrexia | 3 Number of AEs |
| MBK-01 | Adverse Events of Special Interest | Clostridium test positive | 1 Number of AEs |
| MBK-01 | Adverse Events of Special Interest | Inflammatory bowel disease | 0 Number of AEs |
| MBK-01 | Adverse Events of Special Interest | Clostridium difficile infection | 3 Number of AEs |
| MBK-01 | Adverse Events of Special Interest | Pain | 3 Number of AEs |
| MBK-01 | Adverse Events of Special Interest | Clostridium difficile colitis | 0 Number of AEs |
| MBK-01 | Adverse Events of Special Interest | Headache | 2 Number of AEs |
| MBK-01 | Adverse Events of Special Interest | Urinary tract infection | 1 Number of AEs |
| MBK-01 | Adverse Events of Special Interest | C-reactive protein increased | 13 Number of AEs |
| MBK-01 | Adverse Events of Special Interest | Haemorrhoids | 1 Number of AEs |
| MBK-01 | Adverse Events of Special Interest | Abdominal pain upper | 1 Number of AEs |
| MBK-01 | Adverse Events of Special Interest | Nausea | 3 Number of AEs |
| MBK-01 | Adverse Events of Special Interest | Abdominal pain | 4 Number of AEs |
| MBK-01 | Adverse Events of Special Interest | Abdominal discomfort | 0 Number of AEs |
| MBK-01 | Adverse Events of Special Interest | Gastroenteritis | 1 Number of AEs |
| MBK-01 | Adverse Events of Special Interest | COVID-19 | 0 Number of AEs |
| MBK-01 | Adverse Events of Special Interest | Fatigue | 0 Number of AEs |
| Fidaxomicin | Adverse Events of Special Interest | Abdominal pain | 3 Number of AEs |
| Fidaxomicin | Adverse Events of Special Interest | Vomiting | 2 Number of AEs |
| Fidaxomicin | Adverse Events of Special Interest | Urinary tract infection | 0 Number of AEs |
| Fidaxomicin | Adverse Events of Special Interest | Pyrexia | 2 Number of AEs |
| Fidaxomicin | Adverse Events of Special Interest | Prostatitis | 0 Number of AEs |
| Fidaxomicin | Adverse Events of Special Interest | Perineal abscess | 0 Number of AEs |
| Fidaxomicin | Adverse Events of Special Interest | Pain | 1 Number of AEs |
| Fidaxomicin | Adverse Events of Special Interest | Nausea | 3 Number of AEs |
| Fidaxomicin | Adverse Events of Special Interest | Migraine | 0 Number of AEs |
| Fidaxomicin | Adverse Events of Special Interest | Irritable bowel syndrome | 1 Number of AEs |
| Fidaxomicin | Adverse Events of Special Interest | Influenza | 0 Number of AEs |
| Fidaxomicin | Adverse Events of Special Interest | Inflammatory bowel disease | 1 Number of AEs |
| Fidaxomicin | Adverse Events of Special Interest | Headache | 3 Number of AEs |
| Fidaxomicin | Adverse Events of Special Interest | Haemorrhoids | 0 Number of AEs |
| Fidaxomicin | Adverse Events of Special Interest | Gastroenteritis | 0 Number of AEs |
| Fidaxomicin | Adverse Events of Special Interest | Flatulence | 3 Number of AEs |
| Fidaxomicin | Adverse Events of Special Interest | Fatigue | 1 Number of AEs |
| Fidaxomicin | Adverse Events of Special Interest | Diarrhoea | 26 Number of AEs |
| Fidaxomicin | Adverse Events of Special Interest | Cystitis | 1 Number of AEs |
| Fidaxomicin | Adverse Events of Special Interest | Constipation | 2 Number of AEs |
| Fidaxomicin | Adverse Events of Special Interest | Colitis ulcerative | 0 Number of AEs |
| Fidaxomicin | Adverse Events of Special Interest | Clostridium test positive | 0 Number of AEs |
| Fidaxomicin | Adverse Events of Special Interest | Clostridium difficile infection | 4 Number of AEs |
| Fidaxomicin | Adverse Events of Special Interest | Clostridium difficile colitis | 1 Number of AEs |
| Fidaxomicin | Adverse Events of Special Interest | COVID-19 | 1 Number of AEs |
| Fidaxomicin | Adverse Events of Special Interest | C-reactive protein increased | 5 Number of AEs |
| Fidaxomicin | Adverse Events of Special Interest | Abdominal pain upper | 1 Number of AEs |
| Fidaxomicin | Adverse Events of Special Interest | Abdominal discomfort | 2 Number of AEs |
Secondary
Adverse Events Related to the CDI
Adverse Events related to the CDI since baseline.
Time frame: Up to 6 months after the start of the treatment
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| MBK-01 | Adverse Events Related to the CDI | Diarrhea | 17 Number of Adverse Events |
| MBK-01 | Adverse Events Related to the CDI | Positive Clostridium test | 1 Number of Adverse Events |
| MBK-01 | Adverse Events Related to the CDI | Clostridium difficile infection | 3 Number of Adverse Events |
| MBK-01 | Adverse Events Related to the CDI | Total of Adverse Events related to the CDI | 21 Number of Adverse Events |
| MBK-01 | Adverse Events Related to the CDI | Clostridium difficile colitis | 0 Number of Adverse Events |
| Fidaxomicin | Adverse Events Related to the CDI | Total of Adverse Events related to the CDI | 33 Number of Adverse Events |
| Fidaxomicin | Adverse Events Related to the CDI | Clostridium difficile colitis | 1 Number of Adverse Events |
| Fidaxomicin | Adverse Events Related to the CDI | Diarrhea | 28 Number of Adverse Events |
| Fidaxomicin | Adverse Events Related to the CDI | Clostridium difficile infection | 4 Number of Adverse Events |
| Fidaxomicin | Adverse Events Related to the CDI | Positive Clostridium test | 0 Number of Adverse Events |
Secondary
Adverse Events Related to the Treatment
Adverse Events related to the treatment since baseline.
Time frame: Up to 6 months after the start of the treatment
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| MBK-01 | Adverse Events Related to the Treatment | 1 Number of Adverse Events |
| Fidaxomicin | Adverse Events Related to the Treatment | 3 Number of Adverse Events |
Secondary
Duration of Hospitalisation
Time, in days, that the patient remains in the hospital as a result of CDI (but not necessarily indicating a recurrence of diarrhea due to CDI).
Time frame: Up to 8 weeks after the start of the treatment
Population: Out of all partipants analyzed, only 14 in the MBK-01 group and 6 in the fidaxomicin group where hospitalised due to CDI. No participant received both treatments in any case.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| MBK-01 | Duration of Hospitalisation | 6.50 days |
| Fidaxomicin | Duration of Hospitalisation | 5.50 days |
Secondary
Duration of Treatment
Duration in days of the treatment.
Time frame: Up to 10 days
Population: There are 46 evaluable patients in the Fidaxomicin group because 1 patient assigned to fidaxomicin was transferred to another hospital before first administration of the treatment. No patient received both treatments under any circumstances.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| MBK-01 | Duration of Treatment | 1.0 days |
| Fidaxomicin | Duration of Treatment | 10.0 days |
Secondary
Good/Bad Progress of the Patient
A bad progress of the patient is defined as the detection 48-72 hours after the start of the treatment (MBK-01 or Fidaxomicin) of: A worsening of the diarrhea episode (at least one stool more than at baseline, baseline being understood as the time of the start of the study treatment (fidaxomicin or MBK01)). And, at least, one of the following factors: * Increase in C-reactive protein (CRP) value (\> 5 % of the baseline value). * Increase in white blood cell count (\> 5 % of the baseline value). * Progression to sepsis: hypotension or organ failure with no other apparent cause.
Time frame: Up to 72 hours after the start of the treatment
Population: The analysis is carried out on ITT population, excluding patients with no data related to this outcome
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| MBK-01 | Good/Bad Progress of the Patient | Good progress | 43 Participants |
| MBK-01 | Good/Bad Progress of the Patient | Bad progress | 0 Participants |
| MBK-01 | Good/Bad Progress of the Patient | Worsening of the diarrhea episode | 2 Participants |
| MBK-01 | Good/Bad Progress of the Patient | Increase in CRP value | 3 Participants |
| MBK-01 | Good/Bad Progress of the Patient | Increase in white blood cell count | 7 Participants |
| MBK-01 | Good/Bad Progress of the Patient | Progression to sepsis | 0 Participants |
| Fidaxomicin | Good/Bad Progress of the Patient | Increase in white blood cell count | 8 Participants |
| Fidaxomicin | Good/Bad Progress of the Patient | Good progress | 44 Participants |
| Fidaxomicin | Good/Bad Progress of the Patient | Increase in CRP value | 3 Participants |
| Fidaxomicin | Good/Bad Progress of the Patient | Bad progress | 1 Participants |
| Fidaxomicin | Good/Bad Progress of the Patient | Progression to sepsis | 0 Participants |
| Fidaxomicin | Good/Bad Progress of the Patient | Worsening of the diarrhea episode | 1 Participants |
Comparison: Alpha value used: 0.0221
Secondary
Intensive Care Unit Admissions (ICU)
Percentage of patients admitted in the ICU after a defined period of time from the beginning of the treatment.
Time frame: Up to 6 months after the start of the treatment
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| MBK-01 | Intensive Care Unit Admissions (ICU) | 0 Participants |
| Fidaxomicin | Intensive Care Unit Admissions (ICU) | 0 Participants |
Secondary
Mortality Associated With CDI
Percentage of patients that die due to CDI after a defined period of time from the beginning of the treatment.
Time frame: Up to 6 months after the start of the treatment
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| MBK-01 | Mortality Associated With CDI | 0 Participants |
| Fidaxomicin | Mortality Associated With CDI | 0 Participants |
Secondary
Number of Adverse Events Per Randomisation Group
Number of Adverse Events per randomisation group since baseline.
Time frame: Up to 6 months after the start of the treatment
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| MBK-01 | Number of Adverse Events Per Randomisation Group | 89 Number of Adverse Events |
| Fidaxomicin | Number of Adverse Events Per Randomisation Group | 103 Number of Adverse Events |
Secondary
Number of Serious Adverse Events Per Ramdomisation Group
Number of Serious Adverse Events per ramdomisation group since baseline.
Time frame: Up to 6 months after the start of the treatment
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| MBK-01 | Number of Serious Adverse Events Per Ramdomisation Group | 11 Number of Serious Adverse Events |
| Fidaxomicin | Number of Serious Adverse Events Per Ramdomisation Group | 5 Number of Serious Adverse Events |
Secondary
Overall Survival
Percentage of patients that are still alive after a defined period of time from the beginning of the treatment.
Time frame: Up to 6 months after the start of the treatment
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| MBK-01 | Overall Survival | 44 Participants |
| Fidaxomicin | Overall Survival | 46 Participants |
p-value: 0.9Regression, Cox
Secondary
SF36 Questionnaire (The Short Form-36 Health Survey) to Evaluate the Quality of Life
For each dimension (physical functioning, role limits-physical, bodily pain, general health, vitality, social functioning, role limits-emotional, mental health), the scale ranges from 0 (the worst health status for that dimension) to 100 (the best health status).
Time frame: Day 0, 8 weeks and 6 months after the start of the treatment
Population: In addition to the lack of some data by different reasons through the study (i.e. dropout due to the use of forbidden medication), not all the patients completed all the visits.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| MBK-01 | SF36 Questionnaire (The Short Form-36 Health Survey) to Evaluate the Quality of Life | General health (day 0) | 55.13 score on a scale | Standard Deviation 17.07 |
| MBK-01 | SF36 Questionnaire (The Short Form-36 Health Survey) to Evaluate the Quality of Life | Physical Function (8 weeks) | 68.5 score on a scale | Standard Deviation 30.6 |
| MBK-01 | SF36 Questionnaire (The Short Form-36 Health Survey) to Evaluate the Quality of Life | Physical Function (6 months) | 77.5 score on a scale | Standard Deviation 27.01 |
| MBK-01 | SF36 Questionnaire (The Short Form-36 Health Survey) to Evaluate the Quality of Life | Bodily pain (day 0) | 52.91 score on a scale | Standard Deviation 29.84 |
| MBK-01 | SF36 Questionnaire (The Short Form-36 Health Survey) to Evaluate the Quality of Life | Bodily pain (8 weeks) | 35.19 score on a scale | Standard Deviation 29.19 |
| MBK-01 | SF36 Questionnaire (The Short Form-36 Health Survey) to Evaluate the Quality of Life | Bodily pain (6 months) | 35.19 score on a scale | Standard Deviation 33.78 |
| MBK-01 | SF36 Questionnaire (The Short Form-36 Health Survey) to Evaluate the Quality of Life | Physical Function (day 0) | 56.9 score on a scale | Standard Deviation 35.9 |
| MBK-01 | SF36 Questionnaire (The Short Form-36 Health Survey) to Evaluate the Quality of Life | General health (8 weeks) | 47.18 score on a scale | Standard Deviation 18.04 |
| MBK-01 | SF36 Questionnaire (The Short Form-36 Health Survey) to Evaluate the Quality of Life | General health (6 months) | 41.03 score on a scale | Standard Deviation 15.5 |
| MBK-01 | SF36 Questionnaire (The Short Form-36 Health Survey) to Evaluate the Quality of Life | Vitality (day 0) | 38.1 score on a scale | Standard Deviation 11.52 |
| MBK-01 | SF36 Questionnaire (The Short Form-36 Health Survey) to Evaluate the Quality of Life | Vitality (8 weeks) | 36.39 score on a scale | Standard Deviation 17.02 |
| MBK-01 | SF36 Questionnaire (The Short Form-36 Health Survey) to Evaluate the Quality of Life | Vitality (6 months) | 35.42 score on a scale | Standard Deviation 7.22 |
| MBK-01 | SF36 Questionnaire (The Short Form-36 Health Survey) to Evaluate the Quality of Life | Social role (day 0) | 65.08 score on a scale | Standard Deviation 15.53 |
| MBK-01 | SF36 Questionnaire (The Short Form-36 Health Survey) to Evaluate the Quality of Life | Social role (8 weeks) | 63.33 score on a scale | Standard Deviation 14.78 |
| MBK-01 | SF36 Questionnaire (The Short Form-36 Health Survey) to Evaluate the Quality of Life | Social role (6 months) | 59.72 score on a scale | Standard Deviation 11.14 |
| MBK-01 | SF36 Questionnaire (The Short Form-36 Health Survey) to Evaluate the Quality of Life | Emotional role (day 0) | 59.13 score on a scale | Standard Deviation 39.04 |
| MBK-01 | SF36 Questionnaire (The Short Form-36 Health Survey) to Evaluate the Quality of Life | Emotional role (8 weeks) | 82.78 score on a scale | Standard Deviation 25.7 |
| MBK-01 | SF36 Questionnaire (The Short Form-36 Health Survey) to Evaluate the Quality of Life | Emotional role (6 months) | 86.11 score on a scale | Standard Deviation 22.29 |
| MBK-01 | SF36 Questionnaire (The Short Form-36 Health Survey) to Evaluate the Quality of Life | Mental health (day 0) | 55.27 score on a scale | Standard Deviation 16.92 |
| MBK-01 | SF36 Questionnaire (The Short Form-36 Health Survey) to Evaluate the Quality of Life | Mental health (8 weeks) | 60 score on a scale | Standard Deviation 16.42 |
| MBK-01 | SF36 Questionnaire (The Short Form-36 Health Survey) to Evaluate the Quality of Life | Mental health (6 months) | 63.69 score on a scale | Standard Deviation 11.97 |
| MBK-01 | SF36 Questionnaire (The Short Form-36 Health Survey) to Evaluate the Quality of Life | Physical Role (day 0) | 33.48 score on a scale | Standard Deviation 33.44 |
| MBK-01 | SF36 Questionnaire (The Short Form-36 Health Survey) to Evaluate the Quality of Life | Physical Role (8 weeks) | 69.17 score on a scale | Standard Deviation 35.84 |
| MBK-01 | SF36 Questionnaire (The Short Form-36 Health Survey) to Evaluate the Quality of Life | Physical Role (6 months) | 72.92 score on a scale | Standard Deviation 29.95 |
| Fidaxomicin | SF36 Questionnaire (The Short Form-36 Health Survey) to Evaluate the Quality of Life | Physical Role (8 weeks) | 57.46 score on a scale | Standard Deviation 30.64 |
| Fidaxomicin | SF36 Questionnaire (The Short Form-36 Health Survey) to Evaluate the Quality of Life | Physical Function (day 0) | 57.07 score on a scale | Standard Deviation 33.71 |
| Fidaxomicin | SF36 Questionnaire (The Short Form-36 Health Survey) to Evaluate the Quality of Life | Social role (day 0) | 63.77 score on a scale | Standard Deviation 19.02 |
| Fidaxomicin | SF36 Questionnaire (The Short Form-36 Health Survey) to Evaluate the Quality of Life | Physical Function (8 weeks) | 62.58 score on a scale | Standard Deviation 30.44 |
| Fidaxomicin | SF36 Questionnaire (The Short Form-36 Health Survey) to Evaluate the Quality of Life | Mental health (day 0) | 56.06 score on a scale | Standard Deviation 17.17 |
| Fidaxomicin | SF36 Questionnaire (The Short Form-36 Health Survey) to Evaluate the Quality of Life | Physical Function (6 months) | 77.73 score on a scale | Standard Deviation 27.14 |
| Fidaxomicin | SF36 Questionnaire (The Short Form-36 Health Survey) to Evaluate the Quality of Life | Social role (8 weeks) | 63.44 score on a scale | Standard Deviation 11.72 |
| Fidaxomicin | SF36 Questionnaire (The Short Form-36 Health Survey) to Evaluate the Quality of Life | Bodily pain (day 0) | 57.25 score on a scale | Standard Deviation 29.07 |
| Fidaxomicin | SF36 Questionnaire (The Short Form-36 Health Survey) to Evaluate the Quality of Life | Physical Role (day 0) | 36.55 score on a scale | Standard Deviation 32.81 |
| Fidaxomicin | SF36 Questionnaire (The Short Form-36 Health Survey) to Evaluate the Quality of Life | Bodily pain (8 weeks) | 40.5 score on a scale | Standard Deviation 28.33 |
| Fidaxomicin | SF36 Questionnaire (The Short Form-36 Health Survey) to Evaluate the Quality of Life | Social role (6 months) | 69.7 score on a scale | Standard Deviation 10.05 |
| Fidaxomicin | SF36 Questionnaire (The Short Form-36 Health Survey) to Evaluate the Quality of Life | Bodily pain (6 months) | 27.27 score on a scale | Standard Deviation 28.27 |
| Fidaxomicin | SF36 Questionnaire (The Short Form-36 Health Survey) to Evaluate the Quality of Life | Mental health (8 weeks) | 57.83 score on a scale | Standard Deviation 13.84 |
| Fidaxomicin | SF36 Questionnaire (The Short Form-36 Health Survey) to Evaluate the Quality of Life | General health (day 0) | 54.85 score on a scale | Standard Deviation 20.62 |
| Fidaxomicin | SF36 Questionnaire (The Short Form-36 Health Survey) to Evaluate the Quality of Life | Emotional role (day 0) | 68.3 score on a scale | Standard Deviation 32.18 |
| Fidaxomicin | SF36 Questionnaire (The Short Form-36 Health Survey) to Evaluate the Quality of Life | General health (8 weeks) | 49.13 score on a scale | Standard Deviation 17.5 |
| Fidaxomicin | SF36 Questionnaire (The Short Form-36 Health Survey) to Evaluate the Quality of Life | Physical Role (6 months) | 74.43 score on a scale | Standard Deviation 34.51 |
| Fidaxomicin | SF36 Questionnaire (The Short Form-36 Health Survey) to Evaluate the Quality of Life | General health (6 months) | 38.46 score on a scale | Standard Deviation 16.14 |
| Fidaxomicin | SF36 Questionnaire (The Short Form-36 Health Survey) to Evaluate the Quality of Life | Emotional role (8 weeks) | 70.43 score on a scale | Standard Deviation 28.04 |
| Fidaxomicin | SF36 Questionnaire (The Short Form-36 Health Survey) to Evaluate the Quality of Life | Vitality (day 0) | 35.69 score on a scale | Standard Deviation 18.56 |
| Fidaxomicin | SF36 Questionnaire (The Short Form-36 Health Survey) to Evaluate the Quality of Life | Mental health (6 months) | 62.34 score on a scale | Standard Deviation 12.81 |
| Fidaxomicin | SF36 Questionnaire (The Short Form-36 Health Survey) to Evaluate the Quality of Life | Vitality (8 weeks) | 40.86 score on a scale | Standard Deviation 11.85 |
| Fidaxomicin | SF36 Questionnaire (The Short Form-36 Health Survey) to Evaluate the Quality of Life | Emotional role (6 months) | 84.09 score on a scale | Standard Deviation 20.57 |
| Fidaxomicin | SF36 Questionnaire (The Short Form-36 Health Survey) to Evaluate the Quality of Life | Vitality (6 months) | 36.36 score on a scale | Standard Deviation 8.56 |
Comparison: For each area of the SF-36 questionnaire, a mixed ANOVA for the effect of Group, Visit, and interaction effect of Group x Visit was performed. alpha = 0.0221.p-value: 0.749ANOVA
Comparison: For each area of the SF-36 questionnaire, a mixed ANOVA for the effect of Group, Visit, and interaction effect of Group x Visit was performed. alpha = 0.0221.p-value: 0.62ANOVA
Comparison: For each area of the SF-36 questionnaire, a mixed ANOVA for the effect of Group, Visit, and interaction effect of Group x Visit was performed. alpha = 0.0221.p-value: 0.16ANOVA
Comparison: For each area of the SF-36 questionnaire, a mixed ANOVA for the effect of Group, Visit, and interaction effect of Group x Visit was performed. alpha = 0.0221.p-value: 0.614ANOVA
Comparison: For each area of the SF-36 questionnaire, a mixed ANOVA for the effect of Group, Visit, and interaction effect of Group x Visit was performed. alpha = 0.0221.p-value: 0.007ANOVA
Comparison: For each area of the SF-36 questionnaire, a mixed ANOVA for the effect of Group, Visit, and interaction effect of Group x Visit was performed. alpha = 0.0221.p-value: 0.718ANOVA
Comparison: For each area of the SF-36 questionnaire, a mixed ANOVA for the effect of Group, Visit, and interaction effect of Group x Visit was performed. alpha = 0.0221.p-value: 0.494ANOVA
Comparison: For each area of the SF-36 questionnaire, a mixed ANOVA for the effect of Group, Visit, and interaction effect of Group x Visit was performed. alpha = 0.0221.p-value: 0.339ANOVA
Comparison: For each area of the SF-36 questionnaire, a mixed ANOVA for the effect of Group, Visit, and interaction effect of Group x Visit was performed. alpha = 0.0221.p-value: 0.38ANOVA
Comparison: For each area of the SF-36 questionnaire, a mixed ANOVA for the effect of Group, Visit, and interaction effect of Group x Visit was performed. alpha = 0.0221.p-value: 0.79ANOVA
Comparison: For each area of the SF-36 questionnaire, a mixed ANOVA for the effect of Group, Visit, and interaction effect of Group x Visit was performed. alpha = 0.0221.p-value: 0.498ANOVA
Comparison: For each area of the SF-36 questionnaire, a mixed ANOVA for the effect of Group, Visit, and interaction effect of Group x Visit was performed. alpha = 0.0221.p-value: 0.023ANOVA
Comparison: For each area of the SF-36 questionnaire, a mixed ANOVA for the effect of Group, Visit, and interaction effect of Group x Visit was performed. alpha = 0.0221.p-value: 0.553ANOVA
Comparison: For each area of the SF-36 questionnaire, a mixed ANOVA for the effect of Group, Visit, and interaction effect of Group x Visit was performed. alpha = 0.0221.p-value: 0.718ANOVA
Comparison: For each area of the SF-36 questionnaire, a mixed ANOVA for the effect of Group, Visit, and interaction effect of Group x Visit was performed. alpha = 0.0221.p-value: 0.574ANOVA
Comparison: For each area of the SF-36 questionnaire, a mixed ANOVA for the effect of Group, Visit, and interaction effect of Group x Visit was performed. alpha = 0.0221.p-value: 0.49ANOVA
Comparison: For each area of the SF-36 questionnaire, a mixed ANOVA for the effect of Group, Visit, and interaction effect of Group x Visit was performed. alpha = 0.0221.p-value: 0.032ANOVA
Comparison: For each area of the SF-36 questionnaire, a mixed ANOVA for the effect of Group, Visit, and interaction effect of Group x Visit was performed. alpha = 0.0221.p-value: 0.145ANOVA
Comparison: For each area of the SF-36 questionnaire, a mixed ANOVA for the effect of Group, Visit, and interaction effect of Group x Visit was performed. alpha = 0.0221.p-value: 0.467ANOVA
Comparison: For each area of the SF-36 questionnaire, a mixed ANOVA for the effect of Group, Visit, and interaction effect of Group x Visit was performed. alpha = 0.0221.p-value: 0.1ANOVA
Comparison: For each area of the SF-36 questionnaire, a mixed ANOVA for the effect of Group, Visit, and interaction effect of Group x Visit was performed. alpha = 0.0221.p-value: 0.89ANOVA
Comparison: For each area of the SF-36 questionnaire, a mixed ANOVA for the effect of Group, Visit, and interaction effect of Group x Visit was performed. alpha = 0.0221.p-value: 0.742ANOVA
Comparison: For each area of the SF-36 questionnaire, a mixed ANOVA for the effect of Group, Visit, and interaction effect of Group x Visit was performed. alpha = 0.0221.p-value: <0.001ANOVA
Comparison: For each area of the SF-36 questionnaire, a mixed ANOVA for the effect of Group, Visit, and interaction effect of Group x Visit was performed. alpha = 0.0221.p-value: 0.089ANOVA
Secondary
Time to Recurrence Depending on Randomisation Groups
Recurrence: Reappearance of clinical manifestations of a new CDI episode in a patient with an CDI episode treated and cured in the previous 8 weeks.
Time frame: Up to 6 months after the start of the treatment
Population: For the analysis of time to recurrence, there were 77 evaluable participants (37 in MBK-01 and 40 in fidaxomicin group). The reasons for non-evaluable were:~MBK-01:~* Non-evaluable (n=8)~* Death (n=1)~* Forbidden medication (n=2)~* Investigator decision (n=1)~* Adverse event (n=3)~* Informed consent withdrawal (n=1)~Fidaxomicin:~* Non-evaluable (n=7):~* Death (n=1)~* Forbidden medication (n=2)~* Investigator decision (n=1)~* Adverse event (n=2)~* Transfer to other hospital (n=1)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| MBK-01 | Time to Recurrence Depending on Randomisation Groups | 24.70 weeks | Standard Error 1.34 |
| Fidaxomicin | Time to Recurrence Depending on Randomisation Groups | 22.40 weeks | Standard Error 1.53 |
p-value: 0.3Regression, Cox
Secondary
Type of Adverse Events Per Ramdomisation Group
Type of Adverse Events per ramdomisation group since baseline.
Time frame: Up to 6 months after the start of the treatment
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| MBK-01 | Type of Adverse Events Per Ramdomisation Group | Investigations: cardiac murmur | 1 Number of Adverse Events |
| MBK-01 | Type of Adverse Events Per Ramdomisation Group | Investigations: Clostridium test positive | 1 Number of Adverse Events |
| MBK-01 | Type of Adverse Events Per Ramdomisation Group | Investigations: C-reactive protein increased | 13 Number of Adverse Events |
| MBK-01 | Type of Adverse Events Per Ramdomisation Group | Investigations: international normalised ratio increased | 0 Number of Adverse Events |
| MBK-01 | Type of Adverse Events Per Ramdomisation Group | Investigations: white blood cell count increased | 0 Number of Adverse Events |
| MBK-01 | Type of Adverse Events Per Ramdomisation Group | Metabolism and nutrition disorders: folate deficiency | 0 Number of Adverse Events |
| MBK-01 | Type of Adverse Events Per Ramdomisation Group | Metabolism and nutrition disorders: hypokalaemia | 0 Number of Adverse Events |
| MBK-01 | Type of Adverse Events Per Ramdomisation Group | Metabolism and nutrition disorders: hyponatraemia | 0 Number of Adverse Events |
| MBK-01 | Type of Adverse Events Per Ramdomisation Group | Metabolism and nutrition disorders: vitamin B12 deficiency | 0 Number of Adverse Events |
| MBK-01 | Type of Adverse Events Per Ramdomisation Group | Metabolism and nutrition disorders: vitamin D deficiency | 0 Number of Adverse Events |
| MBK-01 | Type of Adverse Events Per Ramdomisation Group | Musculoskeletal and connective tissue disorders: back pain | 1 Number of Adverse Events |
| MBK-01 | Type of Adverse Events Per Ramdomisation Group | Musculoskeletal and connective tissue disorders: musculoskeletal chest pain | 0 Number of Adverse Events |
| MBK-01 | Type of Adverse Events Per Ramdomisation Group | Nervous system disorders: dizziness | 0 Number of Adverse Events |
| MBK-01 | Type of Adverse Events Per Ramdomisation Group | Nervous system disorders: headache | 3 Number of Adverse Events |
| MBK-01 | Type of Adverse Events Per Ramdomisation Group | Nervous system disorders: migraine | 1 Number of Adverse Events |
| MBK-01 | Type of Adverse Events Per Ramdomisation Group | Psychiatric disorders: agitation | 1 Number of Adverse Events |
| MBK-01 | Type of Adverse Events Per Ramdomisation Group | Psychiatric disorders: insomnia | 0 Number of Adverse Events |
| MBK-01 | Type of Adverse Events Per Ramdomisation Group | Psychiatric disorders: mixed anxiety and depressive disorder | 0 Number of Adverse Events |
| MBK-01 | Type of Adverse Events Per Ramdomisation Group | Renal and urinary disorders: microalbuminuria | 0 Number of Adverse Events |
| MBK-01 | Type of Adverse Events Per Ramdomisation Group | Renal and urinary disorders: oliguria | 1 Number of Adverse Events |
| MBK-01 | Type of Adverse Events Per Ramdomisation Group | Reproductive system and breast disorders: prostatitis | 1 Number of Adverse Events |
| MBK-01 | Type of Adverse Events Per Ramdomisation Group | Respiratory, thoracic and mediastinal disorders: catarrh | 1 Number of Adverse Events |
| MBK-01 | Type of Adverse Events Per Ramdomisation Group | Skin and subcutaneous tissue disorders: angioedema | 0 Number of Adverse Events |
| MBK-01 | Type of Adverse Events Per Ramdomisation Group | Skin and subcutaneous tissue disorders: hidradenitis | 0 Number of Adverse Events |
| MBK-01 | Type of Adverse Events Per Ramdomisation Group | Skin and subcutaneous tissue disorders: pruritus | 0 Number of Adverse Events |
| MBK-01 | Type of Adverse Events Per Ramdomisation Group | Skin and subcutaneous tissue disorders: toxic skin eruption | 0 Number of Adverse Events |
| MBK-01 | Type of Adverse Events Per Ramdomisation Group | Skin and subcutaneous tissue disorders: vascular purpura | 0 Number of Adverse Events |
| MBK-01 | Type of Adverse Events Per Ramdomisation Group | Surgical and medical procedures: prophylaxis | 1 Number of Adverse Events |
| MBK-01 | Type of Adverse Events Per Ramdomisation Group | Surgical and medical procedures: tooth extraction | 0 Number of Adverse Events |
| MBK-01 | Type of Adverse Events Per Ramdomisation Group | Vascular disorders: hot flush | 0 Number of Adverse Events |
| MBK-01 | Type of Adverse Events Per Ramdomisation Group | Vascular disorders: hypertensive crisis | 1 Number of Adverse Events |
| MBK-01 | Type of Adverse Events Per Ramdomisation Group | Blood and lymphatic system disorders: anaemia | 1 Number of Adverse Events |
| MBK-01 | Type of Adverse Events Per Ramdomisation Group | Blood and lymphatic system disorders: iron deficiency anaemia | 0 Number of Adverse Events |
| MBK-01 | Type of Adverse Events Per Ramdomisation Group | Blood and lymphatic system disorders: leukocytosis | 1 Number of Adverse Events |
| MBK-01 | Type of Adverse Events Per Ramdomisation Group | Cardiac disorders: cardiac failure | 0 Number of Adverse Events |
| MBK-01 | Type of Adverse Events Per Ramdomisation Group | Ear and labyrinth disorders: vertigo | 1 Number of Adverse Events |
| MBK-01 | Type of Adverse Events Per Ramdomisation Group | Gastrointestinal disorders: abdominal discomfort | 1 Number of Adverse Events |
| MBK-01 | Type of Adverse Events Per Ramdomisation Group | Gastrointestinal disorders: abdominal pain | 4 Number of Adverse Events |
| MBK-01 | Type of Adverse Events Per Ramdomisation Group | Gastrointestinal disorders: abdominal pain lower | 0 Number of Adverse Events |
| MBK-01 | Type of Adverse Events Per Ramdomisation Group | Gastrointestinal disorders: abdominal pain upper | 1 Number of Adverse Events |
| MBK-01 | Type of Adverse Events Per Ramdomisation Group | Gastrointestinal disorders: colitis ulcerative | 1 Number of Adverse Events |
| MBK-01 | Type of Adverse Events Per Ramdomisation Group | Gastrointestinal disorders: constipation | 1 Number of Adverse Events |
| MBK-01 | Type of Adverse Events Per Ramdomisation Group | Gastrointestinal disorders: dental discomfort | 1 Number of Adverse Events |
| MBK-01 | Type of Adverse Events Per Ramdomisation Group | Gastrointestinal disorders: diarrhea | 17 Number of Adverse Events |
| MBK-01 | Type of Adverse Events Per Ramdomisation Group | Gastrointestinal disorders: erosive duodenitis | 0 Number of Adverse Events |
| MBK-01 | Type of Adverse Events Per Ramdomisation Group | Gastrointestinal disorders: flatulence | 2 Number of Adverse Events |
| MBK-01 | Type of Adverse Events Per Ramdomisation Group | Gastrointestinal disorders: gastrointestinal sounds abnormal | 0 Number of Adverse Events |
| MBK-01 | Type of Adverse Events Per Ramdomisation Group | Gastrointestinal disorders: gastrooesophageal reflux disease | 0 Number of Adverse Events |
| MBK-01 | Type of Adverse Events Per Ramdomisation Group | Gastrointestinal disorders: haemorroids | 2 Number of Adverse Events |
| MBK-01 | Type of Adverse Events Per Ramdomisation Group | Gastrointestinal disorders: irritable bowel syndrome | 0 Number of Adverse Events |
| MBK-01 | Type of Adverse Events Per Ramdomisation Group | Gastrointestinal disorders: nausea | 3 Number of Adverse Events |
| MBK-01 | Type of Adverse Events Per Ramdomisation Group | Gastrointestinal disorders: odynophagia | 1 Number of Adverse Events |
| MBK-01 | Type of Adverse Events Per Ramdomisation Group | Gastrointestinal disorders: reflux gastritis | 1 Number of Adverse Events |
| MBK-01 | Type of Adverse Events Per Ramdomisation Group | Gastrointestinal disorders: vomiting | 4 Number of Adverse Events |
| MBK-01 | Type of Adverse Events Per Ramdomisation Group | General disorders and administration site conditions: fatigue | 0 Number of Adverse Events |
| MBK-01 | Type of Adverse Events Per Ramdomisation Group | General disorders and administration site conditions: medical device site reaction | 0 Number of Adverse Events |
| MBK-01 | Type of Adverse Events Per Ramdomisation Group | General disorders and administration site conditions: pain | 3 Number of Adverse Events |
| MBK-01 | Type of Adverse Events Per Ramdomisation Group | General disorders and administration site conditions: polyp | 0 Number of Adverse Events |
| MBK-01 | Type of Adverse Events Per Ramdomisation Group | General disorders and administration site conditions: pyrexia | 3 Number of Adverse Events |
| MBK-01 | Type of Adverse Events Per Ramdomisation Group | Infections and infestations: Clostridium difficile colitis | 0 Number of Adverse Events |
| MBK-01 | Type of Adverse Events Per Ramdomisation Group | Infections and infestations: Clostridium difficile infection | 2 Number of Adverse Events |
| MBK-01 | Type of Adverse Events Per Ramdomisation Group | Infections and infestations: COVID-19 | 1 Number of Adverse Events |
| MBK-01 | Type of Adverse Events Per Ramdomisation Group | Infections and infestations: cystitis | 1 Number of Adverse Events |
| MBK-01 | Type of Adverse Events Per Ramdomisation Group | Infections and infestations: Escherichia urinary tract infection | 0 Number of Adverse Events |
| MBK-01 | Type of Adverse Events Per Ramdomisation Group | Infections and infestations: gastroenteritis | 3 Number of Adverse Events |
| MBK-01 | Type of Adverse Events Per Ramdomisation Group | Infections and infestations: influenza | 1 Number of Adverse Events |
| MBK-01 | Type of Adverse Events Per Ramdomisation Group | Infections and infestations: oral candidiasis | 1 Number of Adverse Events |
| MBK-01 | Type of Adverse Events Per Ramdomisation Group | Infections and infestations: perineal abscess | 1 Number of Adverse Events |
| MBK-01 | Type of Adverse Events Per Ramdomisation Group | Infections and infestations: pneumonia | 0 Number of Adverse Events |
| MBK-01 | Type of Adverse Events Per Ramdomisation Group | Infections and infestations: respiratory tract infection | 0 Number of Adverse Events |
| MBK-01 | Type of Adverse Events Per Ramdomisation Group | Infections and infestations: urinary tract infection | 3 Number of Adverse Events |
| MBK-01 | Type of Adverse Events Per Ramdomisation Group | Injury, poisoning and procedural complications: fall | 1 Number of Adverse Events |
| MBK-01 | Type of Adverse Events Per Ramdomisation Group | Injury, poisoning and procedural complications: spinal fracture | 0 Number of Adverse Events |
| MBK-01 | Type of Adverse Events Per Ramdomisation Group | Injury, poisoning and procedural complications: synovial rupture | 1 Number of Adverse Events |
| MBK-01 | Type of Adverse Events Per Ramdomisation Group | Investigations: blood creatinine increased | 0 Number of Adverse Events |
| Fidaxomicin | Type of Adverse Events Per Ramdomisation Group | Infections and infestations: oral candidiasis | 0 Number of Adverse Events |
| Fidaxomicin | Type of Adverse Events Per Ramdomisation Group | Gastrointestinal disorders: abdominal pain lower | 1 Number of Adverse Events |
| Fidaxomicin | Type of Adverse Events Per Ramdomisation Group | Investigations: Clostridium test positive | 0 Number of Adverse Events |
| Fidaxomicin | Type of Adverse Events Per Ramdomisation Group | General disorders and administration site conditions: polyp | 1 Number of Adverse Events |
| Fidaxomicin | Type of Adverse Events Per Ramdomisation Group | Investigations: C-reactive protein increased | 7 Number of Adverse Events |
| Fidaxomicin | Type of Adverse Events Per Ramdomisation Group | Gastrointestinal disorders: abdominal pain upper | 1 Number of Adverse Events |
| Fidaxomicin | Type of Adverse Events Per Ramdomisation Group | Investigations: international normalised ratio increased | 1 Number of Adverse Events |
| Fidaxomicin | Type of Adverse Events Per Ramdomisation Group | Injury, poisoning and procedural complications: fall | 0 Number of Adverse Events |
| Fidaxomicin | Type of Adverse Events Per Ramdomisation Group | Investigations: white blood cell count increased | 2 Number of Adverse Events |
| Fidaxomicin | Type of Adverse Events Per Ramdomisation Group | Gastrointestinal disorders: colitis ulcerative | 0 Number of Adverse Events |
| Fidaxomicin | Type of Adverse Events Per Ramdomisation Group | Metabolism and nutrition disorders: folate deficiency | 1 Number of Adverse Events |
| Fidaxomicin | Type of Adverse Events Per Ramdomisation Group | General disorders and administration site conditions: pyrexia | 2 Number of Adverse Events |
| Fidaxomicin | Type of Adverse Events Per Ramdomisation Group | Metabolism and nutrition disorders: hypokalaemia | 1 Number of Adverse Events |
| Fidaxomicin | Type of Adverse Events Per Ramdomisation Group | Gastrointestinal disorders: constipation | 2 Number of Adverse Events |
| Fidaxomicin | Type of Adverse Events Per Ramdomisation Group | Metabolism and nutrition disorders: hyponatraemia | 1 Number of Adverse Events |
| Fidaxomicin | Type of Adverse Events Per Ramdomisation Group | Infections and infestations: perineal abscess | 0 Number of Adverse Events |
| Fidaxomicin | Type of Adverse Events Per Ramdomisation Group | Metabolism and nutrition disorders: vitamin B12 deficiency | 1 Number of Adverse Events |
| Fidaxomicin | Type of Adverse Events Per Ramdomisation Group | Gastrointestinal disorders: dental discomfort | 0 Number of Adverse Events |
| Fidaxomicin | Type of Adverse Events Per Ramdomisation Group | Metabolism and nutrition disorders: vitamin D deficiency | 1 Number of Adverse Events |
| Fidaxomicin | Type of Adverse Events Per Ramdomisation Group | Infections and infestations: Clostridium difficile colitis | 1 Number of Adverse Events |
| Fidaxomicin | Type of Adverse Events Per Ramdomisation Group | Musculoskeletal and connective tissue disorders: back pain | 1 Number of Adverse Events |
| Fidaxomicin | Type of Adverse Events Per Ramdomisation Group | Gastrointestinal disorders: diarrhea | 27 Number of Adverse Events |
| Fidaxomicin | Type of Adverse Events Per Ramdomisation Group | Musculoskeletal and connective tissue disorders: musculoskeletal chest pain | 1 Number of Adverse Events |
| Fidaxomicin | Type of Adverse Events Per Ramdomisation Group | Investigations: cardiac murmur | 0 Number of Adverse Events |
| Fidaxomicin | Type of Adverse Events Per Ramdomisation Group | Nervous system disorders: dizziness | 1 Number of Adverse Events |
| Fidaxomicin | Type of Adverse Events Per Ramdomisation Group | Gastrointestinal disorders: erosive duodenitis | 1 Number of Adverse Events |
| Fidaxomicin | Type of Adverse Events Per Ramdomisation Group | Nervous system disorders: headache | 4 Number of Adverse Events |
| Fidaxomicin | Type of Adverse Events Per Ramdomisation Group | Infections and infestations: Clostridium difficile infection | 3 Number of Adverse Events |
| Fidaxomicin | Type of Adverse Events Per Ramdomisation Group | Nervous system disorders: migraine | 0 Number of Adverse Events |
| Fidaxomicin | Type of Adverse Events Per Ramdomisation Group | Gastrointestinal disorders: flatulence | 4 Number of Adverse Events |
| Fidaxomicin | Type of Adverse Events Per Ramdomisation Group | Psychiatric disorders: agitation | 0 Number of Adverse Events |
| Fidaxomicin | Type of Adverse Events Per Ramdomisation Group | Infections and infestations: pneumonia | 1 Number of Adverse Events |
| Fidaxomicin | Type of Adverse Events Per Ramdomisation Group | Psychiatric disorders: insomnia | 1 Number of Adverse Events |
| Fidaxomicin | Type of Adverse Events Per Ramdomisation Group | Gastrointestinal disorders: gastrointestinal sounds abnormal | 1 Number of Adverse Events |
| Fidaxomicin | Type of Adverse Events Per Ramdomisation Group | Psychiatric disorders: mixed anxiety and depressive disorder | 1 Number of Adverse Events |
| Fidaxomicin | Type of Adverse Events Per Ramdomisation Group | Infections and infestations: COVID-19 | 1 Number of Adverse Events |
| Fidaxomicin | Type of Adverse Events Per Ramdomisation Group | Renal and urinary disorders: microalbuminuria | 1 Number of Adverse Events |
| Fidaxomicin | Type of Adverse Events Per Ramdomisation Group | Gastrointestinal disorders: gastrooesophageal reflux disease | 1 Number of Adverse Events |
| Fidaxomicin | Type of Adverse Events Per Ramdomisation Group | Renal and urinary disorders: oliguria | 0 Number of Adverse Events |
| Fidaxomicin | Type of Adverse Events Per Ramdomisation Group | Injury, poisoning and procedural complications: spinal fracture | 1 Number of Adverse Events |
| Fidaxomicin | Type of Adverse Events Per Ramdomisation Group | Reproductive system and breast disorders: prostatitis | 0 Number of Adverse Events |
| Fidaxomicin | Type of Adverse Events Per Ramdomisation Group | Gastrointestinal disorders: haemorroids | 1 Number of Adverse Events |
| Fidaxomicin | Type of Adverse Events Per Ramdomisation Group | Respiratory, thoracic and mediastinal disorders: catarrh | 0 Number of Adverse Events |
| Fidaxomicin | Type of Adverse Events Per Ramdomisation Group | Infections and infestations: cystitis | 1 Number of Adverse Events |
| Fidaxomicin | Type of Adverse Events Per Ramdomisation Group | Skin and subcutaneous tissue disorders: angioedema | 1 Number of Adverse Events |
| Fidaxomicin | Type of Adverse Events Per Ramdomisation Group | Gastrointestinal disorders: irritable bowel syndrome | 1 Number of Adverse Events |
| Fidaxomicin | Type of Adverse Events Per Ramdomisation Group | Skin and subcutaneous tissue disorders: hidradenitis | 1 Number of Adverse Events |
| Fidaxomicin | Type of Adverse Events Per Ramdomisation Group | Infections and infestations: respiratory tract infection | 1 Number of Adverse Events |
| Fidaxomicin | Type of Adverse Events Per Ramdomisation Group | Skin and subcutaneous tissue disorders: pruritus | 1 Number of Adverse Events |
| Fidaxomicin | Type of Adverse Events Per Ramdomisation Group | Gastrointestinal disorders: nausea | 3 Number of Adverse Events |
| Fidaxomicin | Type of Adverse Events Per Ramdomisation Group | Skin and subcutaneous tissue disorders: toxic skin eruption | 1 Number of Adverse Events |
| Fidaxomicin | Type of Adverse Events Per Ramdomisation Group | Infections and infestations: Escherichia urinary tract infection | 1 Number of Adverse Events |
| Fidaxomicin | Type of Adverse Events Per Ramdomisation Group | Skin and subcutaneous tissue disorders: vascular purpura | 1 Number of Adverse Events |
| Fidaxomicin | Type of Adverse Events Per Ramdomisation Group | Gastrointestinal disorders: odynophagia | 0 Number of Adverse Events |
| Fidaxomicin | Type of Adverse Events Per Ramdomisation Group | Surgical and medical procedures: prophylaxis | 0 Number of Adverse Events |
| Fidaxomicin | Type of Adverse Events Per Ramdomisation Group | Investigations: blood creatinine increased | 1 Number of Adverse Events |
| Fidaxomicin | Type of Adverse Events Per Ramdomisation Group | Surgical and medical procedures: tooth extraction | 1 Number of Adverse Events |
| Fidaxomicin | Type of Adverse Events Per Ramdomisation Group | Gastrointestinal disorders: reflux gastritis | 0 Number of Adverse Events |
| Fidaxomicin | Type of Adverse Events Per Ramdomisation Group | Vascular disorders: hot flush | 1 Number of Adverse Events |
| Fidaxomicin | Type of Adverse Events Per Ramdomisation Group | Infections and infestations: gastroenteritis | 0 Number of Adverse Events |
| Fidaxomicin | Type of Adverse Events Per Ramdomisation Group | Vascular disorders: hypertensive crisis | 0 Number of Adverse Events |
| Fidaxomicin | Type of Adverse Events Per Ramdomisation Group | Gastrointestinal disorders: vomiting | 2 Number of Adverse Events |
| Fidaxomicin | Type of Adverse Events Per Ramdomisation Group | Blood and lymphatic system disorders: anaemia | 0 Number of Adverse Events |
| Fidaxomicin | Type of Adverse Events Per Ramdomisation Group | Infections and infestations: urinary tract infection | 2 Number of Adverse Events |
| Fidaxomicin | Type of Adverse Events Per Ramdomisation Group | Blood and lymphatic system disorders: iron deficiency anaemia | 1 Number of Adverse Events |
| Fidaxomicin | Type of Adverse Events Per Ramdomisation Group | General disorders and administration site conditions: fatigue | 1 Number of Adverse Events |
| Fidaxomicin | Type of Adverse Events Per Ramdomisation Group | Blood and lymphatic system disorders: leukocytosis | 0 Number of Adverse Events |
| Fidaxomicin | Type of Adverse Events Per Ramdomisation Group | Infections and infestations: influenza | 0 Number of Adverse Events |
| Fidaxomicin | Type of Adverse Events Per Ramdomisation Group | Cardiac disorders: cardiac failure | 1 Number of Adverse Events |
| Fidaxomicin | Type of Adverse Events Per Ramdomisation Group | General disorders and administration site conditions: medical device site reaction | 1 Number of Adverse Events |
| Fidaxomicin | Type of Adverse Events Per Ramdomisation Group | Ear and labyrinth disorders: vertigo | 0 Number of Adverse Events |
| Fidaxomicin | Type of Adverse Events Per Ramdomisation Group | Injury, poisoning and procedural complications: synovial rupture | 0 Number of Adverse Events |
| Fidaxomicin | Type of Adverse Events Per Ramdomisation Group | Gastrointestinal disorders: abdominal discomfort | 2 Number of Adverse Events |
| Fidaxomicin | Type of Adverse Events Per Ramdomisation Group | General disorders and administration site conditions: pain | 1 Number of Adverse Events |
| Fidaxomicin | Type of Adverse Events Per Ramdomisation Group | Gastrointestinal disorders: abdominal pain | 3 Number of Adverse Events |
Secondary
Type of Serious Adverse Events Per Ramdomisation Group
Type of Serious Adverse Events per ramdomisation group since baseline.
Time frame: Up to 6 months after the start of the treatment
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| MBK-01 | Type of Serious Adverse Events Per Ramdomisation Group | Gastrointestinal disorders: intra-abdominal fluid collection | 1 Number of Serious Adverse Events |
| MBK-01 | Type of Serious Adverse Events Per Ramdomisation Group | Infections and infestations: necrotising fasciitis | 1 Number of Serious Adverse Events |
| MBK-01 | Type of Serious Adverse Events Per Ramdomisation Group | Gastrointestinal disorders: colitis ulcerative | 1 Number of Serious Adverse Events |
| MBK-01 | Type of Serious Adverse Events Per Ramdomisation Group | Infections and infestations: pneumonia | 1 Number of Serious Adverse Events |
| MBK-01 | Type of Serious Adverse Events Per Ramdomisation Group | Gastrointestinal disorders: rectal haemorrhage | 0 Number of Serious Adverse Events |
| MBK-01 | Type of Serious Adverse Events Per Ramdomisation Group | Infections and infestations: pyelonephritis acute | 1 Number of Serious Adverse Events |
| MBK-01 | Type of Serious Adverse Events Per Ramdomisation Group | Gastrointestinal disorders: inflammatory bowel disease | 0 Number of Serious Adverse Events |
| MBK-01 | Type of Serious Adverse Events Per Ramdomisation Group | Infections and infestations: sepsis | 1 Number of Serious Adverse Events |
| MBK-01 | Type of Serious Adverse Events Per Ramdomisation Group | Infections and infestations: anal abscess | 1 Number of Serious Adverse Events |
| MBK-01 | Type of Serious Adverse Events Per Ramdomisation Group | Neoplasms, benign, malignant and unspecified (incl cysts and polyps): renal cancer | 1 Number of Serious Adverse Events |
| MBK-01 | Type of Serious Adverse Events Per Ramdomisation Group | Gastrointestinal disorders: diarrhea | 0 Number of Serious Adverse Events |
| MBK-01 | Type of Serious Adverse Events Per Ramdomisation Group | Respiratory, thoracic and mediastinal disorders: acute respiratory distress syndrome | 0 Number of Serious Adverse Events |
| MBK-01 | Type of Serious Adverse Events Per Ramdomisation Group | Infections and infestations: Clostridium difficile infection | 1 Number of Serious Adverse Events |
| MBK-01 | Type of Serious Adverse Events Per Ramdomisation Group | Respiratory, thoracic and mediastinal disorders: acute respiratory failure | 1 Number of Serious Adverse Events |
| MBK-01 | Type of Serious Adverse Events Per Ramdomisation Group | Cardiac disorders: cardiac failure | 1 Number of Serious Adverse Events |
| Fidaxomicin | Type of Serious Adverse Events Per Ramdomisation Group | Respiratory, thoracic and mediastinal disorders: acute respiratory failure | 0 Number of Serious Adverse Events |
| Fidaxomicin | Type of Serious Adverse Events Per Ramdomisation Group | Cardiac disorders: cardiac failure | 0 Number of Serious Adverse Events |
| Fidaxomicin | Type of Serious Adverse Events Per Ramdomisation Group | Gastrointestinal disorders: colitis ulcerative | 0 Number of Serious Adverse Events |
| Fidaxomicin | Type of Serious Adverse Events Per Ramdomisation Group | Gastrointestinal disorders: diarrhea | 1 Number of Serious Adverse Events |
| Fidaxomicin | Type of Serious Adverse Events Per Ramdomisation Group | Gastrointestinal disorders: inflammatory bowel disease | 1 Number of Serious Adverse Events |
| Fidaxomicin | Type of Serious Adverse Events Per Ramdomisation Group | Gastrointestinal disorders: intra-abdominal fluid collection | 0 Number of Serious Adverse Events |
| Fidaxomicin | Type of Serious Adverse Events Per Ramdomisation Group | Gastrointestinal disorders: rectal haemorrhage | 1 Number of Serious Adverse Events |
| Fidaxomicin | Type of Serious Adverse Events Per Ramdomisation Group | Infections and infestations: anal abscess | 0 Number of Serious Adverse Events |
| Fidaxomicin | Type of Serious Adverse Events Per Ramdomisation Group | Infections and infestations: Clostridium difficile infection | 1 Number of Serious Adverse Events |
| Fidaxomicin | Type of Serious Adverse Events Per Ramdomisation Group | Infections and infestations: necrotising fasciitis | 0 Number of Serious Adverse Events |
| Fidaxomicin | Type of Serious Adverse Events Per Ramdomisation Group | Infections and infestations: pneumonia | 0 Number of Serious Adverse Events |
| Fidaxomicin | Type of Serious Adverse Events Per Ramdomisation Group | Infections and infestations: pyelonephritis acute | 0 Number of Serious Adverse Events |
| Fidaxomicin | Type of Serious Adverse Events Per Ramdomisation Group | Infections and infestations: sepsis | 0 Number of Serious Adverse Events |
| Fidaxomicin | Type of Serious Adverse Events Per Ramdomisation Group | Neoplasms, benign, malignant and unspecified (incl cysts and polyps): renal cancer | 0 Number of Serious Adverse Events |
| Fidaxomicin | Type of Serious Adverse Events Per Ramdomisation Group | Respiratory, thoracic and mediastinal disorders: acute respiratory distress syndrome | 1 Number of Serious Adverse Events |