Candidiasis
Conditions
Keywords
Ecalta, Eraxis, Candida, Candidemia, Systemic Candidiasis, ICU, Intensive Care Unit, Critical Care Unit
Brief summary
The purpose of this study is to describe the real world effectiveness of anidulafungin in clinical practice in a large Liver Unit in the United Kingdom.
Detailed description
All subjects that have been treated with Anidulafungin according to its licence during the period of July 2009 and September 2010 will be included.
Interventions
DRUGanidulafungin
A single 200 mg loading dose should be administered on Day 1, followed by 100 mg daily thereafter.
Sponsors
Pfizer
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No
Inclusion criteria
* Subjects who have been prescribed anidulafungin between 1st July 2009 and 30th September 2010. Patients admitted to specialist liver unit wards and the Liver Intensive Therapy Unit during this period
Exclusion criteria
* Patients who participated in any interventional clinical trial during this episode of sepsis. Patients who received anidulafungin for infection prophylaxis
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With Favorable Outcome | Day 28 post-treatment | Favorable outcome was defined as favorable clinical response and documented or presumed microbial eradication (two negative follow-up blood cultures for bloodstream infections or a successful clinical response without follow-up cultures for other infections). Favorable clinical response was defined as clinical resolution of signs and symptoms of infection and no need to change or add to antifungal therapy, or transition to oral antifungal to complete therapy. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants Who Received 100 mg Dose on Day 2 | Day 2 | — |
| Percentage of Participants With Unfavorable Outcome | Day 28 post-treatment | Unfavorable outcome was defined as the need to change to another antifungal agent because of lack of clinical response or death due to the antifungal infection or microbiologic persistence of the fungus or superinfection with a new Candida, Aspergillus or other fungal strain occurring at least 3 days and up to 14 days of anidulafungin therapy, or a lack of follow up data about clinical and microbiologic responses at the end of anidulafungin therapy. |
| Percentage of Participants Who Died Due to All Causes | Baseline up to Day 28 post-treatment | Death due to all causes included death attributable to fungal infection, death unrelated to fungal infection and death due to multiple causes. |
| Percentage of Participants With Death Attributable to Fungal Infection | Baseline up to Day 28 post-treatment | — |
| Percentage of Participants With Death Unrelated to Fungal Infection | Baseline up to Day 28 post-treatment | — |
| Percentage of Participants With Favorable Clinical Response | Day 28 post-treatment | Favorable clinical response was defined as clinical resolution of signs and symptoms of infection and no need to change or add to antifungal therapy, or transition to oral antifungal to complete therapy. |
| Percentage of Participants With Lack of Clinical Response | Day 28 post-treatment | Favorable clinical response was defined as clinical resolution of signs and symptoms of infection and no need to change or add to antifungal therapy, or transition to oral antifungal to complete therapy. |
| Percentage of Participants Requiring Change or Additional Antifungal Therapy | Baseline up to Day 28 post-treatment | Lower limit of confidence interval was reported as 0 if the same was calculated as less than 0 by standard calculations (outside the valid range of 0 to 100). |
| Percentage of Participants With Oral Antifungal Started to Complete Therapy | Baseline up to Day 28 post-treatment | — |
| Percentage of Participants With Documented Eradication of Infecting Species | Baseline | Documented microbial eradication was defined as 2 negative follow-up blood cultures for bloodstream infections. |
| Percentage of Participants With Resolution of Signs of Infection According to Ultrasound Scan Results | Baseline up to Day 28 post-treatment | An ultrasound scan was performed and the resultant scan was reviewed for the presence of the infection as per investigator's discretion. |
| Percentage of Participants With Resolution of Signs of Infection According to Computerized Tomography (CT) Scan Results | Baseline up to Day 28 post-treatment | A CT scan was performed and the resultant scan was reviewed for the presence of the infection as per investigator's discretion. |
| Percentage of Participants With Abnormal Results for Liver Function at Initiation of Drug Therapy | Baseline | Percentage of participants with abnormal liver function results were based on 4 liver function variables- bilirubin, aspartate transaminase, alkaline phosphatase and gamma glutamyl transferase. Normal reference ranges of these variables are: plasma bilirubin: 3-17 micromoles/L or 2.5-10 mg/L for adults; aspartate transaminase: 6-34 International Units/Liter (IU/L) for females and 8-40 IU/L for males; alkaline phosphatase: 5-38 IU/L for females and 10-50 IU/L for males; gamma glutamyl transferase: 7-32 IU/L for females and 11-50 IU/L for males. Upper limit of confidence interval was reported as 100 if the same was calculated as greater than 100 by standard calculations (outside the valid range of 0 to 100). |
| Percentage of Participants With Abnormal Results for Liver Function at End of Drug Therapy | Day 28 post-treatment | Percentage of participants with abnormal liver function results were based on 4 liver function variables- bilirubin, aspartate transaminase, alkaline phosphatase and gamma glutamyl transferase. Normal reference ranges of these variables are: plasma bilirubin: 3-17 micromoles/L or 2.5-10 mg/L for adults; aspartate transaminase: 6-34 IU/L for females and 8-40 IU/L for males; alkaline phosphatase: 5-38 IU/L for females and 10-50 IU/L for males; gamma glutamyl transferase: 7-32 IU/L for females and 11-50 IU/L for males. |
| Percentage of Participants With Liver Function Test Results at Least Twice the Baseline Value During Period of Drug Therapy | Baseline up to Day 28 post-treatment | Percentage of participants with liver function test results at least twice the baseline value during period of drug therapy was calculated for the liver function variables, bilirubin, aspartate transaminase, alkaline phosphatase and gamma glutamyl transferase. |
| Percentage of Participants With Creatinine Clearance at Least Twice the Baseline Value During Period of Drug Therapy | Baseline up to Day 28 post-treatment | — |
| Percentage of Participants Admitted to Liver Intensive Therapy Unit (LITU) | Baseline | — |
| Duration of Stay at Liver Intensive Therapy Unit (LITU) | Baseline up to Day 28 post-treatment | — |
| Percentage of Participants With Absolute Neutrophil Count Less Than 500 Per Cubic Millimeter (/mm^3) and Greater Than or Equal to 500 /mm^3 | Baseline | Lower limit of confidence interval was reported as 0 if the same was calculated as less than 0 and upper limit of confidence interval was reported as 100 if the same was calculated as greater than 100, by standard calculations (outside the valid range of 0 to 100). |
| Percentage of Participants With Concomitant Bacterial or Viral Infection | Baseline | Upper limit of confidence interval was reported as 100 if the same was calculated as greater than 100 by standard calculations (outside the valid range of 0 to 100). |
| Percentage of Participants Prescribed With Systemic Antifungal Within 30 Days Before Study Start | Baseline | Lower limit of confidence interval was reported as 0 if the same was calculated as less than 0 by standard calculations (outside the valid range of 0 to 100). |
| Dose Changes for Immunosuppressant Drugs | Baseline up to Day 28 post-treatment | — |
| Percentage of Participants With Probable or Proven Fungal Infection at the Initiation of Drug Therapy | Baseline | — |
| Percentage of Participants With Documented Body Temperature Above 38.0 Degree Celsius or Below 36.0 Degree Celsius Within 24 Hour Period Prior to Initiation of Drug Therapy | Baseline | Lower limit of confidence interval was reported as 0 if the same was calculated as less than 0 and upper limit of confidence interval was reported as 100 if the same was calculated as greater than 100, by standard calculations (outside the valid range of 0 to 100). |
| Percentage of Participants With Systolic Blood Pressure More Than 2 Standard Deviations Below the Mean for Age Recorded Within 24 Hour Period Prior to Initiation of Drug Therapy | Baseline | Lower limit of confidence interval was reported as 0 if the same was calculated as less than 0 by standard calculations (outside the valid range of 0 to 100). |
| Number of Participants With Infection Sites as Per Microbiological Analysis | Baseline | Infection sites included blood, chest, urinary tract, intra-abdominal, bile duct, liver, kidney, mouth and esophagus. |
| Number of Participants With Infection Sites as Per Ultrasound Scan and Computerized Tomography (CT) Scan | Baseline | — |
| Infecting Organisms by Species | Baseline up to Day 14 post-treatment | — |
| Percentage of Participants With Prior Colonization With Candida by Species | Baseline | Lower limit of confidence interval was reported as 0 if the same was calculated as less than 0 by standard calculations (outside the valid range of 0 to 100). |
| Percentage of Participants With Prior Colonization With Candida by Colonization Index | Baseline | — |
| Percentage of Participants With Other Prior Fungal Infection by Species and Colonization Index | Baseline | — |
| Number of Participants Who Received Water-based and Ethanol-based Formulation | Baseline | — |
| Percentage of Participants Who Received Water-based and Ethanol-based Formulation | Baseline | — |
| Percentage of Participants Who Received 200 mg Loading Dose | Day 1 | — |
| Percentage of Participants Who Received 200 mg Dose on Day 1 and 100 mg for All Subsequent Doses | Baseline up to Day 28 post-treatment | — |
| Duration of Anidulafungin Therapy | Baseline | — |
| Number of Serious Adverse Events (SAEs) | Baseline up to Day 28 post-treatment | Any untoward medical occurrence in a participant who received study treatment was considered an adverse event (AE) without regard to possibility of causal relationship. An AE resulting in any of the following outcomes, or deemed to be significant for any other reason, was considered to be a SAE: death; initial or prolonged inpatient hospitalization; a life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. |
| Percentage of Participants With One or More Drug-related Serious Adverse Events (SAEs) | Baseline up to Day 28 post-treatment | — |
| Number of Participants With Different Types of Drug-related Serious Adverse Events | Baseline up to Day 28 post-treatment | — |
| Number of Participants With Other Dosing Patterns | Baseline up to Day 28 post-treatment | The other dosing patterns for anidulafungin included any dosing pattern different from 200 mg loading dose on Day 1 followed by 100 mg doses subsequently starting from Day 2. |
Countries
United Kingdom
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Anidulafungin Anidulafungin (Ecalta) 200 milligram (mg) intravenous infusion on the first day followed by 100 mg intravenous infusion once daily as per investigator's discretion. | 50 |
| Total | 50 |
Baseline characteristics
| Characteristic | Anidulafungin |
|---|---|
| Age, Customized | 50.5 years INTER_QUARTILE_RANGE 16.4 |
| Duration of antibiotic course | 16.00 days |
| Duration of antiviral courses | NA days |
| Number of participants with concomitant antibiotics prescribed 0 antibiotic | 4 participants |
| Number of participants with concomitant antibiotics prescribed 1 antibiotic | 8 participants |
| Number of participants with concomitant antibiotics prescribed 2 antibiotics | 22 participants |
| Number of participants with concomitant antibiotics prescribed 3 antibiotics | 8 participants |
| Number of participants with concomitant antibiotics prescribed 4 antibiotics | 7 participants |
| Number of participants with concomitant antibiotics prescribed 5 antibiotics | 1 participants |
| Number of participants with C-reactive protein (CRP) levels Greater than or equal to 5 mg/L | 44 participants |
| Number of participants with C-reactive protein (CRP) levels Less than 5 mg/liter (mg/L) | 2 participants |
| Number of participants with C-reactive protein (CRP) levels Not done | 4 participants |
| Number of participants with disease severity score | NA participants |
| Number of participants with International Normalized Ratio (INR) results 0.8 to 1.6 | 32 participants |
| Number of participants with International Normalized Ratio (INR) results Greater than 1.6 | 18 participants |
| Number of participants with International Normalized Ratio (INR) results Less than 0.8 | 0 participants |
| Number of participants with markers of illness severity Central line of admission | 25 participants |
| Number of participants with markers of illness severity Intubated on admission | 15 participants |
| Number of participants with markers of illness severity Major surgery | 37 participants |
| Number of participants with markers of illness severity Renal failure | 31 participants |
| Number of participants with markers of illness severity Total parenteral nutrition | 26 participants |
| Number of participants with markers of illness severity Upper gastrointestinal (GI) bleed | 21 participants |
| Number of participants with relevant co-morbidities Diabetes | 18 participants |
| Number of participants with relevant co-morbidities Hepatitis C | 5 participants |
| Number of participants with relevant co-morbidities History of alcohol abuse | 19 participants |
| Number of participants with relevant co-morbidities Malignancy | 12 participants |
| Number of participants with relevant co-morbidities Other | 37 participants |
| Number of participants with total white cell count 4 to 11 * 10^9/Liter | 3 participants |
| Number of participants with total white cell count Greater than 11 * 10^9/Liter | 39 participants |
| Number of participants with total white cell count Less than 4 * 10^9/Liter | 8 participants |
| Number of participants with underlying liver disease Acute liver disease | 1 participants |
| Number of participants with underlying liver disease Chronic and acute liver disease | 3 participants |
| Number of participants with underlying liver disease Chronic liver disease | 8 participants |
| Number of participants with underlying liver disease Hepatopancreaticobiliary disease | 12 participants |
| Number of participants with underlying liver disease Hepatopancreaticobiliary disease, pancreatitis | 3 participants |
| Number of participants with underlying liver disease Liver laceration | 1 participants |
| Number of participants with underlying liver disease Liver transplant | 4 participants |
| Number of participants with underlying liver disease Liver transplant, acute liver disease | 3 participants |
| Number of participants with underlying liver disease Liver transplant, acute liver disease, failure | 1 participants |
| Number of participants with underlying liver disease Liver transplant, acute liver failure | 1 participants |
| Number of participants with underlying liver disease Liver transplant, chronic disease, acute failure | 1 participants |
| Number of participants with underlying liver disease Liver transplant, chronic disease, pancreatitis | 1 participants |
| Number of participants with underlying liver disease Liver transplant, chronic liver disease | 11 participants |
| Number of participants with urea levels 3.3 to 6.7 mmol/L | 15 participants |
| Number of participants with urea levels Greater than 6.7 mmol/L | 34 participants |
| Number of participants with urea levels Less than 3.3 millimole/Liter (mmol/L) | 1 participants |
| Overall duration of hospital stay | 86.46 days |
| Percentage of participants prescribed with antiviral courses Aciclovir | 2 percentage of participants |
| Percentage of participants prescribed with antiviral courses Ganciclovir | 6 percentage of participants |
| Percentage of participants prescribed with antiviral courses Oseltamivir | 2 percentage of participants |
| Percentage of participants prescribed with antiviral courses Valganciclovir | 20 percentage of participants |
| Percentage of participants prescribed with concomitant antibiotics Amikacin | 22 percentage of participants |
| Percentage of participants prescribed with concomitant antibiotics Ciprofloxacin | 2 percentage of participants |
| Percentage of participants prescribed with concomitant antibiotics Clarithromycin | 2 percentage of participants |
| Percentage of participants prescribed with concomitant antibiotics Colistin | 4 percentage of participants |
| Percentage of participants prescribed with concomitant antibiotics Co-trimoxazole | 8 percentage of participants |
| Percentage of participants prescribed with concomitant antibiotics Erythromycin | 4 percentage of participants |
| Percentage of participants prescribed with concomitant antibiotics Gentamicin | 4 percentage of participants |
| Percentage of participants prescribed with concomitant antibiotics Linezolid | 28 percentage of participants |
| Percentage of participants prescribed with concomitant antibiotics Metronidazole | 4 percentage of participants |
| Percentage of participants prescribed with concomitant antibiotics Tazocin | 34 percentage of participants |
| Percentage of participants prescribed with concomitant antibiotics Vancomycin | 38 percentage of participants |
| Percentage of participants prescribed with concomitant systemic antifungals Amphotericin | 2 percentage of participants |
| Percentage of participants prescribed with concomitant systemic antifungals Fluconazole | 12 percentage of participants |
| Percentage of participants prescribed with immunosuppressant drugs Azathioprine | 2 percentage of participants |
| Percentage of participants prescribed with immunosuppressant drugs Ciclosporin | 2 percentage of participants |
| Percentage of participants prescribed with immunosuppressant drugs Methylprednisolone | 2 percentage of participants |
| Percentage of participants prescribed with immunosuppressant drugs Prednisolone | 44 percentage of participants |
| Percentage of participants prescribed with immunosuppressant drugs Tacrolimus or tacrolimus modified release (MR) | 50 percentage of participants |
| Percentage of participants with creatinine clearance outside normal range | NA percentage of participants |
| Percentage of participants with elective or emergency hospital admission Elective admission | 72 percentage of participants |
| Percentage of participants with elective or emergency hospital admission Emergency admission | 28 percentage of participants |
| Percentage of participants with Model for End-Stage Liver Disease (MELD) score 10 to 19 | 13 percentage of participants |
| Percentage of participants with Model for End-Stage Liver Disease (MELD) score 20 to 29 | 37 percentage of participants |
| Percentage of participants with Model for End-Stage Liver Disease (MELD) score 30 to 39 | 37 percentage of participants |
| Percentage of participants with Model for End-Stage Liver Disease (MELD) score Greater than or equal to 40 | 7 percentage of participants |
| Percentage of participants with Model for End-Stage Liver Disease (MELD) score Less than 10 | 7 percentage of participants |
| Sex: Female, Male Female | 20 Participants |
| Sex: Female, Male Male | 30 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 50 |
| serious Total, serious adverse events | 5 / 50 |
Outcome results
Primary
Percentage of Participants With Favorable Outcome
Favorable outcome was defined as favorable clinical response and documented or presumed microbial eradication (two negative follow-up blood cultures for bloodstream infections or a successful clinical response without follow-up cultures for other infections). Favorable clinical response was defined as clinical resolution of signs and symptoms of infection and no need to change or add to antifungal therapy, or transition to oral antifungal to complete therapy.
Time frame: Day 28 post-treatment
Population: Full analysis set included all participants who met the defined eligibility criteria. Here, 'N' (number of participants analyzed) is signifying those participants who were evaluable for this measure.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Anidulafungin | Percentage of Participants With Favorable Outcome | 76.1 percentage of participants |
Secondary
Dose Changes for Immunosuppressant Drugs
Time frame: Baseline up to Day 28 post-treatment
Population: Data was not analyzed as the study was retrospective and data for dose change for immunosuppressant drugs was not available.
Secondary
Duration of Anidulafungin Therapy
Time frame: Baseline
Population: Full analysis set included all participants who met the defined eligibility criteria.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Anidulafungin | Duration of Anidulafungin Therapy | 17.96 days | Standard Deviation 11.04 |
Secondary
Duration of Stay at Liver Intensive Therapy Unit (LITU)
Time frame: Baseline up to Day 28 post-treatment
Population: Full analysis set included all participants who met the defined eligibility criteria. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Anidulafungin | Duration of Stay at Liver Intensive Therapy Unit (LITU) | 29.38 days |
Secondary
Infecting Organisms by Species
Time frame: Baseline up to Day 14 post-treatment
Population: Full analysis set included all participants who met the defined eligibility criteria.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Anidulafungin | Infecting Organisms by Species | Hemagglutinin 1 Neuraminidase 1 (H1N1)- swine flu | 3 participants |
| Anidulafungin | Infecting Organisms by Species | Candida tropicalis | 1 participants |
| Anidulafungin | Infecting Organisms by Species | Fusarium dimerum | 1 participants |
| Anidulafungin | Infecting Organisms by Species | Candida albicans | 17 participants |
| Anidulafungin | Infecting Organisms by Species | Candida glabrata | 17 participants |
| Anidulafungin | Infecting Organisms by Species | Candida guilliermondii | 3 participants |
| Anidulafungin | Infecting Organisms by Species | Candida krusei | 2 participants |
| Anidulafungin | Infecting Organisms by Species | Candida parapsilosis | 3 participants |
| Anidulafungin | Infecting Organisms by Species | Candida species (spp) | 16 participants |
| Anidulafungin | Infecting Organisms by Species | Candida spp (non Candida albicans) | 1 participants |
| Anidulafungin | Infecting Organisms by Species | Saccharomyces cerevisiae | 2 participants |
| Anidulafungin | Infecting Organisms by Species | Yeast | 2 participants |
| Anidulafungin | Infecting Organisms by Species | Adenovirus | 1 participants |
| Anidulafungin | Infecting Organisms by Species | Citrobacter | 2 participants |
| Anidulafungin | Infecting Organisms by Species | Clostridium difficile | 3 participants |
| Anidulafungin | Infecting Organisms by Species | Cytomegalovirus (CMV) | 9 participants |
| Anidulafungin | Infecting Organisms by Species | Escherichia coli | 5 participants |
| Anidulafungin | Infecting Organisms by Species | Escherichia faecalis | 4 participants |
| Anidulafungin | Infecting Organisms by Species | Escherichia faecium | 4 participants |
| Anidulafungin | Infecting Organisms by Species | Epstein-Barr virus (EBV) | 3 participants |
| Anidulafungin | Infecting Organisms by Species | Elizabeth meningoseptica cum chrysobacterium | 1 participants |
| Anidulafungin | Infecting Organisms by Species | Enterobacter cloacae | 1 participants |
| Anidulafungin | Infecting Organisms by Species | Enterobacter spp | 3 participants |
| Anidulafungin | Infecting Organisms by Species | Herpes simplex virus type 1 | 2 participants |
| Anidulafungin | Infecting Organisms by Species | Klebsiella oxytoca | 1 participants |
| Anidulafungin | Infecting Organisms by Species | Klebsiella pneumonia | 1 participants |
| Anidulafungin | Infecting Organisms by Species | Klebsiella spp | 4 participants |
| Anidulafungin | Infecting Organisms by Species | Methicillin-resistent Staphylococcus aureus | 1 participants |
| Anidulafungin | Infecting Organisms by Species | Pneumocystic jiroveci | 1 participants |
| Anidulafungin | Infecting Organisms by Species | Pseudomonas spp | 5 participants |
| Anidulafungin | Infecting Organisms by Species | Respiratory syncytial virus | 1 participants |
| Anidulafungin | Infecting Organisms by Species | Rhinovirus | 1 participants |
| Anidulafungin | Infecting Organisms by Species | Staphylococcus aureus | 3 participants |
| Anidulafungin | Infecting Organisms by Species | Staphylococcus capitis | 1 participants |
| Anidulafungin | Infecting Organisms by Species | Stenotrophomonas maltophilia | 1 participants |
| Anidulafungin | Infecting Organisms by Species | Stenotrophomonas spp | 3 participants |
| Anidulafungin | Infecting Organisms by Species | Vancomycin-resistant enterococcus | 7 participants |
| Anidulafungin | Infecting Organisms by Species | Pseudomonas aeruginosa | 1 participants |
| Anidulafungin | Infecting Organisms by Species | Staphylococcus epidermidis | 1 participants |
Secondary
Number of Participants Who Received Water-based and Ethanol-based Formulation
Time frame: Baseline
Population: Full analysis set included all participants who met the defined eligibility criteria.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Anidulafungin | Number of Participants Who Received Water-based and Ethanol-based Formulation | Water based formulation | 16 participants |
| Anidulafungin | Number of Participants Who Received Water-based and Ethanol-based Formulation | Ethanol based formulation | 34 participants |
Secondary
Number of Participants With Different Types of Drug-related Serious Adverse Events
Time frame: Baseline up to Day 28 post-treatment
Population: Full analysis set included all participants who met the defined eligibility criteria.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Anidulafungin | Number of Participants With Different Types of Drug-related Serious Adverse Events | 0 participants |
Secondary
Number of Participants With Infection Sites as Per Microbiological Analysis
Infection sites included blood, chest, urinary tract, intra-abdominal, bile duct, liver, kidney, mouth and esophagus.
Time frame: Baseline
Population: Full analysis set included all participants who met the defined eligibility criteria.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Anidulafungin | Number of Participants With Infection Sites as Per Microbiological Analysis | Blood only | 4 participants |
| Anidulafungin | Number of Participants With Infection Sites as Per Microbiological Analysis | Blood and chest | 1 participants |
| Anidulafungin | Number of Participants With Infection Sites as Per Microbiological Analysis | Blood and urinary tract | 2 participants |
| Anidulafungin | Number of Participants With Infection Sites as Per Microbiological Analysis | Chest only | 3 participants |
| Anidulafungin | Number of Participants With Infection Sites as Per Microbiological Analysis | Intra-abdominal | 13 participants |
| Anidulafungin | Number of Participants With Infection Sites as Per Microbiological Analysis | Intra-abdominal and bile duct | 3 participants |
| Anidulafungin | Number of Participants With Infection Sites as Per Microbiological Analysis | Intra-abdominal and blood | 4 participants |
| Anidulafungin | Number of Participants With Infection Sites as Per Microbiological Analysis | Intra-abdominal, chest and liver | 1 participants |
| Anidulafungin | Number of Participants With Infection Sites as Per Microbiological Analysis | Intra-abdominal and kidney | 1 participants |
| Anidulafungin | Number of Participants With Infection Sites as Per Microbiological Analysis | Intra-abdominal and liver | 2 participants |
| Anidulafungin | Number of Participants With Infection Sites as Per Microbiological Analysis | Liver only | 1 participants |
| Anidulafungin | Number of Participants With Infection Sites as Per Microbiological Analysis | Liver and urinary tract | 1 participants |
| Anidulafungin | Number of Participants With Infection Sites as Per Microbiological Analysis | Esophagus and mouth | 1 participants |
| Anidulafungin | Number of Participants With Infection Sites as Per Microbiological Analysis | Urinary tract and chest | 1 participants |
| Anidulafungin | Number of Participants With Infection Sites as Per Microbiological Analysis | Urinary tract and esophagus | 1 participants |
Secondary
Number of Participants With Infection Sites as Per Ultrasound Scan and Computerized Tomography (CT) Scan
Time frame: Baseline
Population: Data was not analyzed as the study was retrospective and data for infection site as per ultrasound and CT scan was not available.
Secondary
Number of Participants With Other Dosing Patterns
The other dosing patterns for anidulafungin included any dosing pattern different from 200 mg loading dose on Day 1 followed by 100 mg doses subsequently starting from Day 2.
Time frame: Baseline up to Day 28 post-treatment
Population: Full analysis set included all participants who met the defined eligibility criteria.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Anidulafungin | Number of Participants With Other Dosing Patterns | 0 participants |
Secondary
Number of Serious Adverse Events (SAEs)
Any untoward medical occurrence in a participant who received study treatment was considered an adverse event (AE) without regard to possibility of causal relationship. An AE resulting in any of the following outcomes, or deemed to be significant for any other reason, was considered to be a SAE: death; initial or prolonged inpatient hospitalization; a life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.
Time frame: Baseline up to Day 28 post-treatment
Population: Full analysis set included all participants who met the defined eligibility criteria.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Anidulafungin | Number of Serious Adverse Events (SAEs) | 5 events |
Secondary
Percentage of Participants Admitted to Liver Intensive Therapy Unit (LITU)
Time frame: Baseline
Population: Full analysis set included all participants who met the defined eligibility criteria.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Anidulafungin | Percentage of Participants Admitted to Liver Intensive Therapy Unit (LITU) | 78.0 percentage of participants |
Secondary
Percentage of Participants Prescribed With Systemic Antifungal Within 30 Days Before Study Start
Lower limit of confidence interval was reported as 0 if the same was calculated as less than 0 by standard calculations (outside the valid range of 0 to 100).
Time frame: Baseline
Population: Full analysis set included all participants who met the defined eligibility criteria.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Anidulafungin | Percentage of Participants Prescribed With Systemic Antifungal Within 30 Days Before Study Start | Amphotericin | 4.0 percentage of participants |
| Anidulafungin | Percentage of Participants Prescribed With Systemic Antifungal Within 30 Days Before Study Start | Caspofungin | 4.0 percentage of participants |
| Anidulafungin | Percentage of Participants Prescribed With Systemic Antifungal Within 30 Days Before Study Start | Fluconazole | 70.0 percentage of participants |
Secondary
Percentage of Participants Requiring Change or Additional Antifungal Therapy
Lower limit of confidence interval was reported as 0 if the same was calculated as less than 0 by standard calculations (outside the valid range of 0 to 100).
Time frame: Baseline up to Day 28 post-treatment
Population: Full analysis set included all participants who met the defined eligibility criteria.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Anidulafungin | Percentage of Participants Requiring Change or Additional Antifungal Therapy | Due to all reasons | 16.0 percentage of participants |
| Anidulafungin | Percentage of Participants Requiring Change or Additional Antifungal Therapy | Due to lack of clinical response | 4.0 percentage of participants |
| Anidulafungin | Percentage of Participants Requiring Change or Additional Antifungal Therapy | Due to adverse event | 0.0 percentage of participants |
Secondary
Percentage of Participants Who Died Due to All Causes
Death due to all causes included death attributable to fungal infection, death unrelated to fungal infection and death due to multiple causes.
Time frame: Baseline up to Day 28 post-treatment
Population: Full analysis set included all participants who met the defined eligibility criteria.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Anidulafungin | Percentage of Participants Who Died Due to All Causes | 38.0 percentage of participants |
Secondary
Percentage of Participants Who Received 100 mg Dose on Day 2
Time frame: Day 2
Population: Full analysis set included all participants who met the defined eligibility criteria.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Anidulafungin | Percentage of Participants Who Received 100 mg Dose on Day 2 | 100.0 percentage of participants |
Secondary
Percentage of Participants Who Received 200 mg Dose on Day 1 and 100 mg for All Subsequent Doses
Time frame: Baseline up to Day 28 post-treatment
Population: Full analysis set included all participants who met the defined eligibility criteria.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Anidulafungin | Percentage of Participants Who Received 200 mg Dose on Day 1 and 100 mg for All Subsequent Doses | 100.0 percentage of participants |
Secondary
Percentage of Participants Who Received 200 mg Loading Dose
Time frame: Day 1
Population: Full analysis set included all participants who met the defined eligibility criteria.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Anidulafungin | Percentage of Participants Who Received 200 mg Loading Dose | 100.0 percentage of participants |
Secondary
Percentage of Participants Who Received Water-based and Ethanol-based Formulation
Time frame: Baseline
Population: Full analysis set included all participants who met the defined eligibility criteria.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Anidulafungin | Percentage of Participants Who Received Water-based and Ethanol-based Formulation | Water based formulation | 32.0 percentage of participants |
| Anidulafungin | Percentage of Participants Who Received Water-based and Ethanol-based Formulation | Ethanol based formulation | 68.0 percentage of participants |
Secondary
Percentage of Participants With Abnormal Results for Liver Function at End of Drug Therapy
Percentage of participants with abnormal liver function results were based on 4 liver function variables- bilirubin, aspartate transaminase, alkaline phosphatase and gamma glutamyl transferase. Normal reference ranges of these variables are: plasma bilirubin: 3-17 micromoles/L or 2.5-10 mg/L for adults; aspartate transaminase: 6-34 IU/L for females and 8-40 IU/L for males; alkaline phosphatase: 5-38 IU/L for females and 10-50 IU/L for males; gamma glutamyl transferase: 7-32 IU/L for females and 11-50 IU/L for males.
Time frame: Day 28 post-treatment
Population: Full analysis set included all participants who met the defined eligibility criteria.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Anidulafungin | Percentage of Participants With Abnormal Results for Liver Function at End of Drug Therapy | 74.0 percentage of participants |
Secondary
Percentage of Participants With Abnormal Results for Liver Function at Initiation of Drug Therapy
Percentage of participants with abnormal liver function results were based on 4 liver function variables- bilirubin, aspartate transaminase, alkaline phosphatase and gamma glutamyl transferase. Normal reference ranges of these variables are: plasma bilirubin: 3-17 micromoles/L or 2.5-10 mg/L for adults; aspartate transaminase: 6-34 International Units/Liter (IU/L) for females and 8-40 IU/L for males; alkaline phosphatase: 5-38 IU/L for females and 10-50 IU/L for males; gamma glutamyl transferase: 7-32 IU/L for females and 11-50 IU/L for males. Upper limit of confidence interval was reported as 100 if the same was calculated as greater than 100 by standard calculations (outside the valid range of 0 to 100).
Time frame: Baseline
Population: Full analysis set included all participants who met the defined eligibility criteria.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Anidulafungin | Percentage of Participants With Abnormal Results for Liver Function at Initiation of Drug Therapy | 98.0 percentage of participants |
Secondary
Percentage of Participants With Absolute Neutrophil Count Less Than 500 Per Cubic Millimeter (/mm^3) and Greater Than or Equal to 500 /mm^3
Lower limit of confidence interval was reported as 0 if the same was calculated as less than 0 and upper limit of confidence interval was reported as 100 if the same was calculated as greater than 100, by standard calculations (outside the valid range of 0 to 100).
Time frame: Baseline
Population: Full analysis set included all participants who met the defined eligibility criteria.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Anidulafungin | Percentage of Participants With Absolute Neutrophil Count Less Than 500 Per Cubic Millimeter (/mm^3) and Greater Than or Equal to 500 /mm^3 | Less than 500/mm^3 | 2.0 percentage of participants |
| Anidulafungin | Percentage of Participants With Absolute Neutrophil Count Less Than 500 Per Cubic Millimeter (/mm^3) and Greater Than or Equal to 500 /mm^3 | Greater than or equal to 500/mm^3 | 98.0 percentage of participants |
Secondary
Percentage of Participants With Concomitant Bacterial or Viral Infection
Upper limit of confidence interval was reported as 100 if the same was calculated as greater than 100 by standard calculations (outside the valid range of 0 to 100).
Time frame: Baseline
Population: Full analysis set included all participants who met the defined eligibility criteria.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Anidulafungin | Percentage of Participants With Concomitant Bacterial or Viral Infection | Bacterial infection | 96.0 percentage of participants |
| Anidulafungin | Percentage of Participants With Concomitant Bacterial or Viral Infection | Viral infection | 46.0 percentage of participants |
Secondary
Percentage of Participants With Creatinine Clearance at Least Twice the Baseline Value During Period of Drug Therapy
Time frame: Baseline up to Day 28 post-treatment
Population: Data was not analyzed as the study was retrospective and data for creatinine clearance was not available for the participants.
Secondary
Percentage of Participants With Death Attributable to Fungal Infection
Time frame: Baseline up to Day 28 post-treatment
Population: Full analysis set included all participants who met the defined eligibility criteria.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Anidulafungin | Percentage of Participants With Death Attributable to Fungal Infection | 0 percentage of participants |
Secondary
Percentage of Participants With Death Unrelated to Fungal Infection
Time frame: Baseline up to Day 28 post-treatment
Population: Full analysis set included all participants who met the defined eligibility criteria.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Anidulafungin | Percentage of Participants With Death Unrelated to Fungal Infection | 36.0 percentage of participants |
Secondary
Percentage of Participants With Documented Body Temperature Above 38.0 Degree Celsius or Below 36.0 Degree Celsius Within 24 Hour Period Prior to Initiation of Drug Therapy
Lower limit of confidence interval was reported as 0 if the same was calculated as less than 0 and upper limit of confidence interval was reported as 100 if the same was calculated as greater than 100, by standard calculations (outside the valid range of 0 to 100).
Time frame: Baseline
Population: Full analysis set included all participants who met the defined eligibility criteria.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Anidulafungin | Percentage of Participants With Documented Body Temperature Above 38.0 Degree Celsius or Below 36.0 Degree Celsius Within 24 Hour Period Prior to Initiation of Drug Therapy | Above 38.0 degree Celsius | 98.0 percentage of participants |
| Anidulafungin | Percentage of Participants With Documented Body Temperature Above 38.0 Degree Celsius or Below 36.0 Degree Celsius Within 24 Hour Period Prior to Initiation of Drug Therapy | Below 36.0 degree Celsius | 2.0 percentage of participants |
Secondary
Percentage of Participants With Documented Eradication of Infecting Species
Documented microbial eradication was defined as 2 negative follow-up blood cultures for bloodstream infections.
Time frame: Baseline
Population: Data was not analyzed as the study was retrospective and data for eradication of candida infection was not documented in the participants' medical notes.
Secondary
Percentage of Participants With Favorable Clinical Response
Favorable clinical response was defined as clinical resolution of signs and symptoms of infection and no need to change or add to antifungal therapy, or transition to oral antifungal to complete therapy.
Time frame: Day 28 post-treatment
Population: Full analysis set included all participants who met the defined eligibility criteria. Here, 'N' (number of participants analyzed) is signifying those participants who were evaluable for this measure.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Anidulafungin | Percentage of Participants With Favorable Clinical Response | 80.4 percentage of participants |
Secondary
Percentage of Participants With Lack of Clinical Response
Favorable clinical response was defined as clinical resolution of signs and symptoms of infection and no need to change or add to antifungal therapy, or transition to oral antifungal to complete therapy.
Time frame: Day 28 post-treatment
Population: Full analysis set included all participants who met the defined eligibility criteria. Here, 'N' (number of participants analyzed) is signifying those participants who were evaluable for this measure.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Anidulafungin | Percentage of Participants With Lack of Clinical Response | 19.6 percentage of participants |
Secondary
Percentage of Participants With Liver Function Test Results at Least Twice the Baseline Value During Period of Drug Therapy
Percentage of participants with liver function test results at least twice the baseline value during period of drug therapy was calculated for the liver function variables, bilirubin, aspartate transaminase, alkaline phosphatase and gamma glutamyl transferase.
Time frame: Baseline up to Day 28 post-treatment
Population: Full analysis set included all participants who met the defined eligibility criteria.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Anidulafungin | Percentage of Participants With Liver Function Test Results at Least Twice the Baseline Value During Period of Drug Therapy | Bilirubin test | 24.0 percentage of participants |
| Anidulafungin | Percentage of Participants With Liver Function Test Results at Least Twice the Baseline Value During Period of Drug Therapy | Aspartate transaminase test | 40.0 percentage of participants |
| Anidulafungin | Percentage of Participants With Liver Function Test Results at Least Twice the Baseline Value During Period of Drug Therapy | Alkaline phosphatase test | 34.0 percentage of participants |
| Anidulafungin | Percentage of Participants With Liver Function Test Results at Least Twice the Baseline Value During Period of Drug Therapy | Gamma glutamyl transferase test | 36.0 percentage of participants |
Secondary
Percentage of Participants With One or More Drug-related Serious Adverse Events (SAEs)
Time frame: Baseline up to Day 28 post-treatment
Population: Full analysis set included all participants who met the defined eligibility criteria.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Anidulafungin | Percentage of Participants With One or More Drug-related Serious Adverse Events (SAEs) | 0 percentage of participants |
Secondary
Percentage of Participants With Oral Antifungal Started to Complete Therapy
Time frame: Baseline up to Day 28 post-treatment
Population: Full analysis set included all participants who met the defined eligibility criteria.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Anidulafungin | Percentage of Participants With Oral Antifungal Started to Complete Therapy | 32.0 percentage of participants |
Secondary
Percentage of Participants With Other Prior Fungal Infection by Species and Colonization Index
Time frame: Baseline
Population: Full analysis set included all participants who met the defined eligibility criteria.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Anidulafungin | Percentage of Participants With Other Prior Fungal Infection by Species and Colonization Index | 0 percentage of participants |
Secondary
Percentage of Participants With Prior Colonization With Candida by Colonization Index
Time frame: Baseline
Population: Data for prior colonization by colonization index was not analyzed as the study was retrospective and colonization index was not recorded for the participants.
Secondary
Percentage of Participants With Prior Colonization With Candida by Species
Lower limit of confidence interval was reported as 0 if the same was calculated as less than 0 by standard calculations (outside the valid range of 0 to 100).
Time frame: Baseline
Population: Full analysis set included all participants who met the defined eligibility criteria.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Anidulafungin | Percentage of Participants With Prior Colonization With Candida by Species | Candida albicans | 16.0 percentage of participants |
| Anidulafungin | Percentage of Participants With Prior Colonization With Candida by Species | Candida glabrata | 10.0 percentage of participants |
| Anidulafungin | Percentage of Participants With Prior Colonization With Candida by Species | Candida guilliermondii | 2.0 percentage of participants |
| Anidulafungin | Percentage of Participants With Prior Colonization With Candida by Species | Candida spp | 12.0 percentage of participants |
| Anidulafungin | Percentage of Participants With Prior Colonization With Candida by Species | Candida tropicalis | 2.0 percentage of participants |
| Anidulafungin | Percentage of Participants With Prior Colonization With Candida by Species | Candida species unknown | 6.0 percentage of participants |
Secondary
Percentage of Participants With Probable or Proven Fungal Infection at the Initiation of Drug Therapy
Time frame: Baseline
Population: Full analysis set included all participants who met the defined eligibility criteria.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Anidulafungin | Percentage of Participants With Probable or Proven Fungal Infection at the Initiation of Drug Therapy | Probable fungal infection | 28.0 percentage of participants |
| Anidulafungin | Percentage of Participants With Probable or Proven Fungal Infection at the Initiation of Drug Therapy | Proven fungal infection | 72.0 percentage of participants |
Secondary
Percentage of Participants With Resolution of Signs of Infection According to Computerized Tomography (CT) Scan Results
A CT scan was performed and the resultant scan was reviewed for the presence of the infection as per investigator's discretion.
Time frame: Baseline up to Day 28 post-treatment
Population: Full analysis set included all participants who met the defined eligibility criteria.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Anidulafungin | Percentage of Participants With Resolution of Signs of Infection According to Computerized Tomography (CT) Scan Results | 68.0 percentage of participants |
Secondary
Percentage of Participants With Resolution of Signs of Infection According to Ultrasound Scan Results
An ultrasound scan was performed and the resultant scan was reviewed for the presence of the infection as per investigator's discretion.
Time frame: Baseline up to Day 28 post-treatment
Population: Full analysis set included all participants who met the defined eligibility criteria.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Anidulafungin | Percentage of Participants With Resolution of Signs of Infection According to Ultrasound Scan Results | 80.0 percentage of participants |
Secondary
Percentage of Participants With Systolic Blood Pressure More Than 2 Standard Deviations Below the Mean for Age Recorded Within 24 Hour Period Prior to Initiation of Drug Therapy
Lower limit of confidence interval was reported as 0 if the same was calculated as less than 0 by standard calculations (outside the valid range of 0 to 100).
Time frame: Baseline
Population: Full analysis set included all participants who met the defined eligibility criteria.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Anidulafungin | Percentage of Participants With Systolic Blood Pressure More Than 2 Standard Deviations Below the Mean for Age Recorded Within 24 Hour Period Prior to Initiation of Drug Therapy | 4.0 percentage of participants |
Secondary
Percentage of Participants With Unfavorable Outcome
Unfavorable outcome was defined as the need to change to another antifungal agent because of lack of clinical response or death due to the antifungal infection or microbiologic persistence of the fungus or superinfection with a new Candida, Aspergillus or other fungal strain occurring at least 3 days and up to 14 days of anidulafungin therapy, or a lack of follow up data about clinical and microbiologic responses at the end of anidulafungin therapy.
Time frame: Day 28 post-treatment
Population: Full analysis set included all participants who met the defined eligibility criteria. Here, 'N' (number of participants analyzed) is signifying those participants who were evaluable for this measure.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Anidulafungin | Percentage of Participants With Unfavorable Outcome | 23.9 percentage of participants |