Clostridioides Difficile Infection
Conditions
Keywords
CMTS0929, Clostridioides difficile infection, efficacy, safety
Brief summary
This is a prospective, open-label, single-arm study to explore the safety and the efficacy of CMTS0929 for patients with Clostridioides difficile infection (CDI).
Detailed description
At least 12 subjects who meet all the inclusion criteria but do not meet any exclusion criteria will be enrolled in this study. Data of demographic characteristics and clinical data will be collected. After treatment, they will enter the follow-up period for safety and efficacy evaluation.
Interventions
BIOLOGICALCMTS0929
CMTS0929 is defined as suspension from washed microbiota.
Sponsors
The Second Hospital of Nanjing Medical University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Eligible subjects will receive treatment with CMTS0929. They will be administered one unit of the liquid via colonic transendoscopic enteral tube (cTET) for three consecutive days.
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
Subjects must meet all of the following inclusion criteria to enter the study: 1. At the time of informed consent, the age is between 18 and 75 years old (inclusive), including both males and non - pregnant, non - lactating females. 2. At the time of screening, meet the diagnostic criteria for Clostridioides difficile infection: a)There is a medical record proving a confirmed CDI before screening (laboratory tests show positive results for Clostridioides difficile or its toxins): positive results in Clostridioides difficile toxin detection (determined by EIAs) or colonoscopy indicating pseudomembranous colitis; or positive GDH with negative toxin results, along with obvious predisposing factors and diarrhea. b)Have an episode of CDI - related diarrhea, that is, having at least 3 bowel movements per day for at least two consecutive days and the stools are unformed (Bristol Stool Form Scale score of 6 - 7). 3. The subject or their legal representative provides informed consent, fully understands the purpose of the study, can communicate well with the researcher, and can understand and comply with all the requirements of this study.
Exclusion criteria
Subjects meeting any of the following
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The safety of CMTS0929 | Four-week | The incidence of treatment-related adverse events (AE) assessed by CTCAE, Version 5.0: The severity of AE was graded as mild (grade 1), moderate (grade 2), severe/disabling (grade 3), life threatening (grade 4), and death (grade 5). All AE were divided in definitely, probably and possibly related to treatment. The treatment-related AE we focused on included microbiota-related AEs (e.g., infection, diarrhea, abdominal pain, etc.) and route of delivery related AEs (e.g., nausea, vomiting, etc.) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The complete response rate of CDI-related diarrhea | Four-week, Eight-week | Having no diarrhea for at least two consecutive days (with normal stool consistency (Bristol Stool Form Scale score ≤ 5) and 1-2 bowel movements per day). |
| The ultra-early complete response rate of CDI-related diarrhea | One-week post treatment | Having no diarrhea for at least two consecutive days (with normal stool consistency (Bristol Stool Form Scale score ≤ 5) and 1-2 bowel movements per day). |
| The early complete response rate of CDI-related diarrhea | Two-week post treatment | Having no diarrhea for at least two consecutive days (with normal stool consistency (Bristol Stool Form Scale score ≤ 5) and 1-2 bowel movements per day). |
| The safety of CMTS0929 | Immediately, One-week, Two-week, Eight-week, Twenty four-week | The incidence of treatment-related adverse events (AE) assessed by CTCAE, Version 5.0: The severity of AE was graded as mild (grade 1), moderate (grade 2), severe/disabling (grade 3), life threatening (grade 4), and death (grade 5). All AE were divided in definitely, probably and possibly related to treatment. The treatment-related AE we focused on included microbiota-related AEs (e.g., infection, diarrhea, abdominal pain, etc.) and route of delivery related AEs (e.g., nausea, vomiting, etc.) |
| The recurrence rate of CDI-related diarrhea | Four-week, Six-week, Eight-week, Twenty four-week | After the disappearance of CDI-related diarrhea, the recurrence of CDI-related diarrhea occurs, and the detection of Clostridioides difficile toxins is positive (judged by glutamate dehydrogenase \[GDH\] and enzyme immunoassays \[EIAs\]). |
| The major disease progression rate of CDI | Twenty four-week | Progression to severe CDI (SCDI)/severe complicated CDI (ScCDI) (defined as high fever ≥ 38.5°C, white blood cell count \> 15×10⁹/L, increased serum creatinine \[\> 50% higher than the baseline level\], hypotension, septic shock, increased serum lactate \[\> 2.2 mmol/L\], intestinal obstruction, toxic megacolon, intestinal perforation, or any fulminant course \[i.e., the patient's condition deteriorates rapidly, or requires treatment in the intensive care unit (ICU), or is complicated by organ failure\]), death, emergency colectomy, receiving ≥ 2 courses of fecal microbiota transplantation (FMT)/washed microbiota transplantation (WMT) or other forms of approved or investigational salvage therapy, or early withdrawal from the study or loss to follow-up) |
| The salvage/replacement treatment rate of CDI | Immediately, One-week, Two-week, Four-week, Eight-week, Twenty four-week | The salvage/replacement treatments include receiving approved or investigational anti-infective treatment, toxin-neutralizing treatment, other FMT/WMT outside the protocol, and emergency, hospitalization, ICU or surgical treatment due to CDI-related diarrhea, etc. |
| The non-response rate of CDI-related diarrhea | Two-week, Four-week, Six-week, Eight-week post treatment | Having at least 3 bowel movements per day for at least two consecutive days and the stools are unformed (Bristol Stool Form Scale score of 6-7), and further anti-CDI treatment is required. |
Countries
China
Contacts
Primary ContactFaming Zhang, PhD
Backup ContactBota Cui, MD
Outcome results
None listed