Trial Outcomes & Findings for Early Clinical Experience With Anidulafungin In Patients With Liver Disease In The United Kingdom (NCT NCT01202253)
NCT ID: NCT01202253
Last Updated: 2014-04-16
Results Overview
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.
COMPLETED
50 participants
Day 28 post-treatment
2014-04-16
Participant Flow
Participant milestones
| Measure |
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.
|
|---|---|
|
Overall Study
STARTED
|
50
|
|
Overall Study
COMPLETED
|
50
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Early Clinical Experience With Anidulafungin In Patients With Liver Disease In The United Kingdom
Baseline characteristics by cohort
| Measure |
Anidulafungin
n=50 Participants
Anidulafungin (Ecalta) 200 milligram (mg) intravenous infusion on the first day followed by 100 mg intravenous infusion once daily as per investigator's discretion.
|
|---|---|
|
Age, Customized
|
50.5 years
INTER_QUARTILE_RANGE 16.4 • n=5 Participants
|
|
Sex: Female, Male
Female
|
20 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
30 Participants
n=5 Participants
|
|
Percentage of participants with elective or emergency hospital admission
Elective admission
|
72 percentage of participants
n=5 Participants
|
|
Percentage of participants with elective or emergency hospital admission
Emergency admission
|
28 percentage of participants
n=5 Participants
|
|
Overall duration of hospital stay
|
86.46 days
n=5 Participants
|
|
Number of participants with underlying liver disease
Acute liver disease
|
1 participants
n=5 Participants
|
|
Number of participants with underlying liver disease
Chronic liver disease
|
8 participants
n=5 Participants
|
|
Number of participants with underlying liver disease
Chronic and acute liver disease
|
3 participants
n=5 Participants
|
|
Number of participants with underlying liver disease
Hepatopancreaticobiliary disease
|
12 participants
n=5 Participants
|
|
Number of participants with underlying liver disease
Hepatopancreaticobiliary disease, pancreatitis
|
3 participants
n=5 Participants
|
|
Number of participants with underlying liver disease
Liver transplant
|
4 participants
n=5 Participants
|
|
Number of participants with underlying liver disease
Liver transplant, acute liver disease
|
3 participants
n=5 Participants
|
|
Number of participants with underlying liver disease
Liver transplant, acute liver failure
|
1 participants
n=5 Participants
|
|
Number of participants with underlying liver disease
Liver transplant, acute liver disease, failure
|
1 participants
n=5 Participants
|
|
Number of participants with underlying liver disease
Liver transplant, chronic liver disease
|
11 participants
n=5 Participants
|
|
Number of participants with underlying liver disease
Liver transplant, chronic disease, acute failure
|
1 participants
n=5 Participants
|
|
Number of participants with underlying liver disease
Liver transplant, chronic disease, pancreatitis
|
1 participants
n=5 Participants
|
|
Number of participants with underlying liver disease
Liver laceration
|
1 participants
n=5 Participants
|
|
Number of participants with relevant co-morbidities
History of alcohol abuse
|
19 participants
n=5 Participants
|
|
Number of participants with relevant co-morbidities
Diabetes
|
18 participants
n=5 Participants
|
|
Number of participants with relevant co-morbidities
Hepatitis C
|
5 participants
n=5 Participants
|
|
Number of participants with relevant co-morbidities
Malignancy
|
12 participants
n=5 Participants
|
|
Number of participants with relevant co-morbidities
Other
|
37 participants
n=5 Participants
|
|
Number of participants with markers of illness severity
Upper gastrointestinal (GI) bleed
|
21 participants
n=5 Participants
|
|
Number of participants with markers of illness severity
Central line of admission
|
25 participants
n=5 Participants
|
|
Number of participants with markers of illness severity
Total parenteral nutrition
|
26 participants
n=5 Participants
|
|
Number of participants with markers of illness severity
Intubated on admission
|
15 participants
n=5 Participants
|
|
Number of participants with markers of illness severity
Major surgery
|
37 participants
n=5 Participants
|
|
Number of participants with markers of illness severity
Renal failure
|
31 participants
n=5 Participants
|
|
Percentage of participants with Model for End-Stage Liver Disease (MELD) score
Less than 10
|
7 percentage of participants
n=5 Participants
|
|
Percentage of participants with Model for End-Stage Liver Disease (MELD) score
10 to 19
|
13 percentage of participants
n=5 Participants
|
|
Percentage of participants with Model for End-Stage Liver Disease (MELD) score
20 to 29
|
37 percentage of participants
n=5 Participants
|
|
Percentage of participants with Model for End-Stage Liver Disease (MELD) score
30 to 39
|
37 percentage of participants
n=5 Participants
|
|
Percentage of participants with Model for End-Stage Liver Disease (MELD) score
Greater than or equal to 40
|
7 percentage of participants
n=5 Participants
|
|
Number of participants with disease severity score
|
NA participants
n=5 Participants
|
|
Number of participants with total white cell count
Less than 4 * 10^9/Liter
|
8 participants
n=5 Participants
|
|
Number of participants with total white cell count
4 to 11 * 10^9/Liter
|
3 participants
n=5 Participants
|
|
Number of participants with total white cell count
Greater than 11 * 10^9/Liter
|
39 participants
n=5 Participants
|
|
Number of participants with International Normalized Ratio (INR) results
Less than 0.8
|
0 participants
n=5 Participants
|
|
Number of participants with International Normalized Ratio (INR) results
0.8 to 1.6
|
32 participants
n=5 Participants
|
|
Number of participants with International Normalized Ratio (INR) results
Greater than 1.6
|
18 participants
n=5 Participants
|
|
Number of participants with C-reactive protein (CRP) levels
Less than 5 mg/liter (mg/L)
|
2 participants
n=5 Participants
|
|
Number of participants with C-reactive protein (CRP) levels
Greater than or equal to 5 mg/L
|
44 participants
n=5 Participants
|
|
Number of participants with C-reactive protein (CRP) levels
Not done
|
4 participants
n=5 Participants
|
|
Number of participants with urea levels
Less than 3.3 millimole/Liter (mmol/L)
|
1 participants
n=5 Participants
|
|
Number of participants with urea levels
3.3 to 6.7 mmol/L
|
15 participants
n=5 Participants
|
|
Number of participants with urea levels
Greater than 6.7 mmol/L
|
34 participants
n=5 Participants
|
|
Percentage of participants with creatinine clearance outside normal range
|
NA percentage of participants
n=5 Participants
|
|
Percentage of participants prescribed with immunosuppressant drugs
Azathioprine
|
2 percentage of participants
n=5 Participants
|
|
Percentage of participants prescribed with immunosuppressant drugs
Ciclosporin
|
2 percentage of participants
n=5 Participants
|
|
Percentage of participants prescribed with immunosuppressant drugs
Methylprednisolone
|
2 percentage of participants
n=5 Participants
|
|
Percentage of participants prescribed with immunosuppressant drugs
Prednisolone
|
44 percentage of participants
n=5 Participants
|
|
Percentage of participants prescribed with immunosuppressant drugs
Tacrolimus or tacrolimus modified release (MR)
|
50 percentage of participants
n=5 Participants
|
|
Percentage of participants prescribed with concomitant systemic antifungals
Amphotericin
|
2 percentage of participants
n=5 Participants
|
|
Percentage of participants prescribed with concomitant systemic antifungals
Fluconazole
|
12 percentage of participants
n=5 Participants
|
|
Percentage of participants prescribed with concomitant antibiotics
Amikacin
|
22 percentage of participants
n=5 Participants
|
|
Percentage of participants prescribed with concomitant antibiotics
Ciprofloxacin
|
2 percentage of participants
n=5 Participants
|
|
Percentage of participants prescribed with concomitant antibiotics
Clarithromycin
|
2 percentage of participants
n=5 Participants
|
|
Percentage of participants prescribed with concomitant antibiotics
Colistin
|
4 percentage of participants
n=5 Participants
|
|
Percentage of participants prescribed with concomitant antibiotics
Co-trimoxazole
|
8 percentage of participants
n=5 Participants
|
|
Percentage of participants prescribed with concomitant antibiotics
Erythromycin
|
4 percentage of participants
n=5 Participants
|
|
Percentage of participants prescribed with concomitant antibiotics
Gentamicin
|
4 percentage of participants
n=5 Participants
|
|
Percentage of participants prescribed with concomitant antibiotics
Linezolid
|
28 percentage of participants
n=5 Participants
|
|
Percentage of participants prescribed with concomitant antibiotics
Metronidazole
|
4 percentage of participants
n=5 Participants
|
|
Percentage of participants prescribed with concomitant antibiotics
Tazocin
|
34 percentage of participants
n=5 Participants
|
|
Percentage of participants prescribed with concomitant antibiotics
Vancomycin
|
38 percentage of participants
n=5 Participants
|
|
Number of participants with concomitant antibiotics prescribed
0 antibiotic
|
4 participants
n=5 Participants
|
|
Number of participants with concomitant antibiotics prescribed
1 antibiotic
|
8 participants
n=5 Participants
|
|
Number of participants with concomitant antibiotics prescribed
2 antibiotics
|
22 participants
n=5 Participants
|
|
Number of participants with concomitant antibiotics prescribed
3 antibiotics
|
8 participants
n=5 Participants
|
|
Number of participants with concomitant antibiotics prescribed
4 antibiotics
|
7 participants
n=5 Participants
|
|
Number of participants with concomitant antibiotics prescribed
5 antibiotics
|
1 participants
n=5 Participants
|
|
Duration of antibiotic course
|
16.00 days
n=5 Participants
|
|
Percentage of participants prescribed with antiviral courses
Aciclovir
|
2 percentage of participants
n=5 Participants
|
|
Percentage of participants prescribed with antiviral courses
Ganciclovir
|
6 percentage of participants
n=5 Participants
|
|
Percentage of participants prescribed with antiviral courses
Oseltamivir
|
2 percentage of participants
n=5 Participants
|
|
Percentage of participants prescribed with antiviral courses
Valganciclovir
|
20 percentage of participants
n=5 Participants
|
|
Duration of antiviral courses
|
NA days
n=5 Participants
|
PRIMARY outcome
Timeframe: Day 28 post-treatmentPopulation: 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.
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.
Outcome measures
| Measure |
Anidulafungin
n=46 Participants
Anidulafungin (Ecalta) 200 milligram (mg) intravenous infusion on the first day followed by 100 mg intravenous infusion once daily as per investigator's discretion.
|
|---|---|
|
Percentage of Participants With Favorable Outcome
|
76.1 percentage of participants
Interval 64.3 to 87.9
|
SECONDARY outcome
Timeframe: Day 28 post-treatmentPopulation: 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.
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.
Outcome measures
| Measure |
Anidulafungin
n=46 Participants
Anidulafungin (Ecalta) 200 milligram (mg) intravenous infusion on the first day followed by 100 mg intravenous infusion once daily as per investigator's discretion.
|
|---|---|
|
Percentage of Participants With Unfavorable Outcome
|
23.9 percentage of participants
Interval 12.1 to 35.7
|
SECONDARY outcome
Timeframe: Baseline up to Day 28 post-treatmentPopulation: Full analysis set included all participants who met the defined eligibility criteria.
Death due to all causes included death attributable to fungal infection, death unrelated to fungal infection and death due to multiple causes.
Outcome measures
| Measure |
Anidulafungin
n=50 Participants
Anidulafungin (Ecalta) 200 milligram (mg) intravenous infusion on the first day followed by 100 mg intravenous infusion once daily as per investigator's discretion.
|
|---|---|
|
Percentage of Participants Who Died Due to All Causes
|
38.0 percentage of participants
Interval 24.5 to 51.5
|
SECONDARY outcome
Timeframe: Baseline up to Day 28 post-treatmentPopulation: Full analysis set included all participants who met the defined eligibility criteria.
Outcome measures
| Measure |
Anidulafungin
n=50 Participants
Anidulafungin (Ecalta) 200 milligram (mg) intravenous infusion on the first day followed by 100 mg intravenous infusion once daily as per investigator's discretion.
|
|---|---|
|
Percentage of Participants With Death Attributable to Fungal Infection
|
0 percentage of participants
Interval 0.0 to 0.0
|
SECONDARY outcome
Timeframe: Baseline up to Day 28 post-treatmentPopulation: Full analysis set included all participants who met the defined eligibility criteria.
Outcome measures
| Measure |
Anidulafungin
n=50 Participants
Anidulafungin (Ecalta) 200 milligram (mg) intravenous infusion on the first day followed by 100 mg intravenous infusion once daily as per investigator's discretion.
|
|---|---|
|
Percentage of Participants With Death Unrelated to Fungal Infection
|
36.0 percentage of participants
Interval 22.7 to 49.3
|
SECONDARY outcome
Timeframe: Day 28 post-treatmentPopulation: 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.
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.
Outcome measures
| Measure |
Anidulafungin
n=46 Participants
Anidulafungin (Ecalta) 200 milligram (mg) intravenous infusion on the first day followed by 100 mg intravenous infusion once daily as per investigator's discretion.
|
|---|---|
|
Percentage of Participants With Favorable Clinical Response
|
80.4 percentage of participants
Interval 69.4 to 91.4
|
SECONDARY outcome
Timeframe: Day 28 post-treatmentPopulation: 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.
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.
Outcome measures
| Measure |
Anidulafungin
n=46 Participants
Anidulafungin (Ecalta) 200 milligram (mg) intravenous infusion on the first day followed by 100 mg intravenous infusion once daily as per investigator's discretion.
|
|---|---|
|
Percentage of Participants With Lack of Clinical Response
|
19.6 percentage of participants
Interval 8.6 to 30.6
|
SECONDARY outcome
Timeframe: Baseline up to Day 28 post-treatmentPopulation: Full analysis set included all participants who met the defined eligibility criteria.
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).
Outcome measures
| Measure |
Anidulafungin
n=50 Participants
Anidulafungin (Ecalta) 200 milligram (mg) intravenous infusion on the first day followed by 100 mg intravenous infusion once daily as per investigator's discretion.
|
|---|---|
|
Percentage of Participants Requiring Change or Additional Antifungal Therapy
Due to all reasons
|
16.0 percentage of participants
Interval 5.8 to 26.2
|
|
Percentage of Participants Requiring Change or Additional Antifungal Therapy
Due to lack of clinical response
|
4.0 percentage of participants
Interval 0.0 to 9.4
|
|
Percentage of Participants Requiring Change or Additional Antifungal Therapy
Due to adverse event
|
0.0 percentage of participants
Interval 0.0 to 0.0
|
SECONDARY outcome
Timeframe: Baseline up to Day 28 post-treatmentPopulation: Full analysis set included all participants who met the defined eligibility criteria.
Outcome measures
| Measure |
Anidulafungin
n=50 Participants
Anidulafungin (Ecalta) 200 milligram (mg) intravenous infusion on the first day followed by 100 mg intravenous infusion once daily as per investigator's discretion.
|
|---|---|
|
Percentage of Participants With Oral Antifungal Started to Complete Therapy
|
32.0 percentage of participants
Interval 19.1 to 44.9
|
SECONDARY outcome
Timeframe: BaselinePopulation: Data was not analyzed as the study was retrospective and data for eradication of candida infection was not documented in the participants' medical notes.
Documented microbial eradication was defined as 2 negative follow-up blood cultures for bloodstream infections.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline up to Day 28 post-treatmentPopulation: Full analysis set included all participants who met the defined eligibility criteria.
An ultrasound scan was performed and the resultant scan was reviewed for the presence of the infection as per investigator's discretion.
Outcome measures
| Measure |
Anidulafungin
n=50 Participants
Anidulafungin (Ecalta) 200 milligram (mg) intravenous infusion on the first day followed by 100 mg intravenous infusion once daily as per investigator's discretion.
|
|---|---|
|
Percentage of Participants With Resolution of Signs of Infection According to Ultrasound Scan Results
|
80.0 percentage of participants
Interval 68.9 to 91.1
|
SECONDARY outcome
Timeframe: Baseline up to Day 28 post-treatmentPopulation: Full analysis set included all participants who met the defined eligibility criteria.
A CT scan was performed and the resultant scan was reviewed for the presence of the infection as per investigator's discretion.
Outcome measures
| Measure |
Anidulafungin
n=50 Participants
Anidulafungin (Ecalta) 200 milligram (mg) intravenous infusion on the first day followed by 100 mg intravenous infusion once daily as per investigator's discretion.
|
|---|---|
|
Percentage of Participants With Resolution of Signs of Infection According to Computerized Tomography (CT) Scan Results
|
68.0 percentage of participants
Interval 55.1 to 80.9
|
SECONDARY outcome
Timeframe: BaselinePopulation: Full analysis set included all participants who met the defined eligibility criteria.
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).
Outcome measures
| Measure |
Anidulafungin
n=50 Participants
Anidulafungin (Ecalta) 200 milligram (mg) intravenous infusion on the first day followed by 100 mg intravenous infusion once daily as per investigator's discretion.
|
|---|---|
|
Percentage of Participants With Abnormal Results for Liver Function at Initiation of Drug Therapy
|
98.0 percentage of participants
Interval 94.1 to 100.0
|
SECONDARY outcome
Timeframe: Day 28 post-treatmentPopulation: Full analysis set included all participants who met the defined eligibility criteria.
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.
Outcome measures
| Measure |
Anidulafungin
n=50 Participants
Anidulafungin (Ecalta) 200 milligram (mg) intravenous infusion on the first day followed by 100 mg intravenous infusion once daily as per investigator's discretion.
|
|---|---|
|
Percentage of Participants With Abnormal Results for Liver Function at End of Drug Therapy
|
74.0 percentage of participants
Interval 61.8 to 86.3
|
SECONDARY outcome
Timeframe: Baseline up to Day 28 post-treatmentPopulation: Full analysis set included all participants who met the defined eligibility criteria.
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.
Outcome measures
| Measure |
Anidulafungin
n=50 Participants
Anidulafungin (Ecalta) 200 milligram (mg) intravenous infusion on the first day followed by 100 mg intravenous infusion once daily as per investigator's discretion.
|
|---|---|
|
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
Interval 12.2 to 35.8
|
|
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
Interval 26.4 to 53.6
|
|
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
Interval 20.9 to 47.1
|
|
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
Interval 22.7 to 49.3
|
SECONDARY outcome
Timeframe: Baseline up to Day 28 post-treatmentPopulation: Data was not analyzed as the study was retrospective and data for creatinine clearance was not available for the participants.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: BaselinePopulation: Full analysis set included all participants who met the defined eligibility criteria.
Outcome measures
| Measure |
Anidulafungin
n=50 Participants
Anidulafungin (Ecalta) 200 milligram (mg) intravenous infusion on the first day followed by 100 mg intravenous infusion once daily as per investigator's discretion.
|
|---|---|
|
Percentage of Participants Admitted to Liver Intensive Therapy Unit (LITU)
|
78.0 percentage of participants
Interval 66.5 to 89.5
|
SECONDARY outcome
Timeframe: Baseline up to Day 28 post-treatmentPopulation: 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.
Outcome measures
| Measure |
Anidulafungin
n=39 Participants
Anidulafungin (Ecalta) 200 milligram (mg) intravenous infusion on the first day followed by 100 mg intravenous infusion once daily as per investigator's discretion.
|
|---|---|
|
Duration of Stay at Liver Intensive Therapy Unit (LITU)
|
29.38 days
Interval 7.0 to 38.0
|
SECONDARY outcome
Timeframe: BaselinePopulation: Full analysis set included all participants who met the defined eligibility criteria.
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).
Outcome measures
| Measure |
Anidulafungin
n=50 Participants
Anidulafungin (Ecalta) 200 milligram (mg) intravenous infusion on the first day followed by 100 mg intravenous infusion once daily as per investigator's discretion.
|
|---|---|
|
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
Interval 0.0 to 5.9
|
|
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
Interval 94.1 to 100.0
|
SECONDARY outcome
Timeframe: BaselinePopulation: Full analysis set included all participants who met the defined eligibility criteria.
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).
Outcome measures
| Measure |
Anidulafungin
n=50 Participants
Anidulafungin (Ecalta) 200 milligram (mg) intravenous infusion on the first day followed by 100 mg intravenous infusion once daily as per investigator's discretion.
|
|---|---|
|
Percentage of Participants With Concomitant Bacterial or Viral Infection
Bacterial infection
|
96.0 percentage of participants
Interval 90.6 to 100.0
|
|
Percentage of Participants With Concomitant Bacterial or Viral Infection
Viral infection
|
46.0 percentage of participants
Interval 32.2 to 59.8
|
SECONDARY outcome
Timeframe: BaselinePopulation: Full analysis set included all participants who met the defined eligibility criteria.
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).
Outcome measures
| Measure |
Anidulafungin
n=50 Participants
Anidulafungin (Ecalta) 200 milligram (mg) intravenous infusion on the first day followed by 100 mg intravenous infusion once daily as per investigator's discretion.
|
|---|---|
|
Percentage of Participants Prescribed With Systemic Antifungal Within 30 Days Before Study Start
Amphotericin
|
4.0 percentage of participants
Interval 0.0 to 9.4
|
|
Percentage of Participants Prescribed With Systemic Antifungal Within 30 Days Before Study Start
Caspofungin
|
4.0 percentage of participants
Interval 0.0 to 9.4
|
|
Percentage of Participants Prescribed With Systemic Antifungal Within 30 Days Before Study Start
Fluconazole
|
70.0 percentage of participants
Interval 57.3 to 82.7
|
SECONDARY outcome
Timeframe: Baseline up to Day 28 post-treatmentPopulation: Data was not analyzed as the study was retrospective and data for dose change for immunosuppressant drugs was not available.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: BaselinePopulation: Full analysis set included all participants who met the defined eligibility criteria.
Outcome measures
| Measure |
Anidulafungin
n=50 Participants
Anidulafungin (Ecalta) 200 milligram (mg) intravenous infusion on the first day followed by 100 mg intravenous infusion once daily as per investigator's discretion.
|
|---|---|
|
Percentage of Participants With Probable or Proven Fungal Infection at the Initiation of Drug Therapy
Probable fungal infection
|
28.0 percentage of participants
Interval 15.6 to 40.4
|
|
Percentage of Participants With Probable or Proven Fungal Infection at the Initiation of Drug Therapy
Proven fungal infection
|
72.0 percentage of participants
Interval 59.6 to 84.4
|
SECONDARY outcome
Timeframe: BaselinePopulation: Full analysis set included all participants who met the defined eligibility criteria.
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).
Outcome measures
| Measure |
Anidulafungin
n=50 Participants
Anidulafungin (Ecalta) 200 milligram (mg) intravenous infusion on the first day followed by 100 mg intravenous infusion once daily as per investigator's discretion.
|
|---|---|
|
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
Interval 94.1 to 100.0
|
|
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
Interval 0.0 to 5.9
|
SECONDARY outcome
Timeframe: BaselinePopulation: Full analysis set included all participants who met the defined eligibility criteria.
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).
Outcome measures
| Measure |
Anidulafungin
n=50 Participants
Anidulafungin (Ecalta) 200 milligram (mg) intravenous infusion on the first day followed by 100 mg intravenous infusion once daily as per investigator's discretion.
|
|---|---|
|
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
Interval 0.0 to 9.4
|
SECONDARY outcome
Timeframe: BaselinePopulation: Full analysis set included all participants who met the defined eligibility criteria.
Infection sites included blood, chest, urinary tract, intra-abdominal, bile duct, liver, kidney, mouth and esophagus.
Outcome measures
| Measure |
Anidulafungin
n=50 Participants
Anidulafungin (Ecalta) 200 milligram (mg) intravenous infusion on the first day followed by 100 mg intravenous infusion once daily as per investigator's discretion.
|
|---|---|
|
Number of Participants With Infection Sites as Per Microbiological Analysis
Blood only
|
4 participants
|
|
Number of Participants With Infection Sites as Per Microbiological Analysis
Blood and chest
|
1 participants
|
|
Number of Participants With Infection Sites as Per Microbiological Analysis
Blood and urinary tract
|
2 participants
|
|
Number of Participants With Infection Sites as Per Microbiological Analysis
Chest only
|
3 participants
|
|
Number of Participants With Infection Sites as Per Microbiological Analysis
Intra-abdominal
|
13 participants
|
|
Number of Participants With Infection Sites as Per Microbiological Analysis
Intra-abdominal and bile duct
|
3 participants
|
|
Number of Participants With Infection Sites as Per Microbiological Analysis
Intra-abdominal and blood
|
4 participants
|
|
Number of Participants With Infection Sites as Per Microbiological Analysis
Intra-abdominal, chest and liver
|
1 participants
|
|
Number of Participants With Infection Sites as Per Microbiological Analysis
Intra-abdominal and kidney
|
1 participants
|
|
Number of Participants With Infection Sites as Per Microbiological Analysis
Intra-abdominal and liver
|
2 participants
|
|
Number of Participants With Infection Sites as Per Microbiological Analysis
Liver only
|
1 participants
|
|
Number of Participants With Infection Sites as Per Microbiological Analysis
Liver and urinary tract
|
1 participants
|
|
Number of Participants With Infection Sites as Per Microbiological Analysis
Esophagus and mouth
|
1 participants
|
|
Number of Participants With Infection Sites as Per Microbiological Analysis
Urinary tract and chest
|
1 participants
|
|
Number of Participants With Infection Sites as Per Microbiological Analysis
Urinary tract and esophagus
|
1 participants
|
SECONDARY outcome
Timeframe: BaselinePopulation: Data was not analyzed as the study was retrospective and data for infection site as per ultrasound and CT scan was not available.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline up to Day 14 post-treatmentPopulation: Full analysis set included all participants who met the defined eligibility criteria.
Outcome measures
| Measure |
Anidulafungin
n=50 Participants
Anidulafungin (Ecalta) 200 milligram (mg) intravenous infusion on the first day followed by 100 mg intravenous infusion once daily as per investigator's discretion.
|
|---|---|
|
Infecting Organisms by Species
Candida albicans
|
17 participants
|
|
Infecting Organisms by Species
Candida glabrata
|
17 participants
|
|
Infecting Organisms by Species
Candida guilliermondii
|
3 participants
|
|
Infecting Organisms by Species
Candida krusei
|
2 participants
|
|
Infecting Organisms by Species
Candida parapsilosis
|
3 participants
|
|
Infecting Organisms by Species
Candida species (spp)
|
16 participants
|
|
Infecting Organisms by Species
Candida spp (non Candida albicans)
|
1 participants
|
|
Infecting Organisms by Species
Candida tropicalis
|
1 participants
|
|
Infecting Organisms by Species
Fusarium dimerum
|
1 participants
|
|
Infecting Organisms by Species
Saccharomyces cerevisiae
|
2 participants
|
|
Infecting Organisms by Species
Yeast
|
2 participants
|
|
Infecting Organisms by Species
Adenovirus
|
1 participants
|
|
Infecting Organisms by Species
Citrobacter
|
2 participants
|
|
Infecting Organisms by Species
Clostridium difficile
|
3 participants
|
|
Infecting Organisms by Species
Cytomegalovirus (CMV)
|
9 participants
|
|
Infecting Organisms by Species
Escherichia coli
|
5 participants
|
|
Infecting Organisms by Species
Escherichia faecalis
|
4 participants
|
|
Infecting Organisms by Species
Escherichia faecium
|
4 participants
|
|
Infecting Organisms by Species
Epstein-Barr virus (EBV)
|
3 participants
|
|
Infecting Organisms by Species
Elizabeth meningoseptica cum chrysobacterium
|
1 participants
|
|
Infecting Organisms by Species
Enterobacter cloacae
|
1 participants
|
|
Infecting Organisms by Species
Enterobacter spp
|
3 participants
|
|
Infecting Organisms by Species
Hemagglutinin 1 Neuraminidase 1 (H1N1)- swine flu
|
3 participants
|
|
Infecting Organisms by Species
Herpes simplex virus type 1
|
2 participants
|
|
Infecting Organisms by Species
Klebsiella oxytoca
|
1 participants
|
|
Infecting Organisms by Species
Klebsiella pneumonia
|
1 participants
|
|
Infecting Organisms by Species
Klebsiella spp
|
4 participants
|
|
Infecting Organisms by Species
Methicillin-resistent Staphylococcus aureus
|
1 participants
|
|
Infecting Organisms by Species
Pneumocystic jiroveci
|
1 participants
|
|
Infecting Organisms by Species
Pseudomonas spp
|
5 participants
|
|
Infecting Organisms by Species
Respiratory syncytial virus
|
1 participants
|
|
Infecting Organisms by Species
Rhinovirus
|
1 participants
|
|
Infecting Organisms by Species
Staphylococcus aureus
|
3 participants
|
|
Infecting Organisms by Species
Staphylococcus capitis
|
1 participants
|
|
Infecting Organisms by Species
Stenotrophomonas maltophilia
|
1 participants
|
|
Infecting Organisms by Species
Stenotrophomonas spp
|
3 participants
|
|
Infecting Organisms by Species
Vancomycin-resistant enterococcus
|
7 participants
|
|
Infecting Organisms by Species
Pseudomonas aeruginosa
|
1 participants
|
|
Infecting Organisms by Species
Staphylococcus epidermidis
|
1 participants
|
SECONDARY outcome
Timeframe: BaselinePopulation: Full analysis set included all participants who met the defined eligibility criteria.
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).
Outcome measures
| Measure |
Anidulafungin
n=50 Participants
Anidulafungin (Ecalta) 200 milligram (mg) intravenous infusion on the first day followed by 100 mg intravenous infusion once daily as per investigator's discretion.
|
|---|---|
|
Percentage of Participants With Prior Colonization With Candida by Species
Candida albicans
|
16.0 percentage of participants
Interval 5.8 to 26.2
|
|
Percentage of Participants With Prior Colonization With Candida by Species
Candida glabrata
|
10.0 percentage of participants
Interval 1.7 to 18.3
|
|
Percentage of Participants With Prior Colonization With Candida by Species
Candida guilliermondii
|
2.0 percentage of participants
Interval 0.0 to 5.9
|
|
Percentage of Participants With Prior Colonization With Candida by Species
Candida spp
|
12.0 percentage of participants
Interval 3.0 to 21.0
|
|
Percentage of Participants With Prior Colonization With Candida by Species
Candida tropicalis
|
2.0 percentage of participants
Interval 0.0 to 5.9
|
|
Percentage of Participants With Prior Colonization With Candida by Species
Candida species unknown
|
6.0 percentage of participants
Interval 0.0 to 12.6
|
SECONDARY outcome
Timeframe: BaselinePopulation: Data for prior colonization by colonization index was not analyzed as the study was retrospective and colonization index was not recorded for the participants.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: BaselinePopulation: Full analysis set included all participants who met the defined eligibility criteria.
Outcome measures
| Measure |
Anidulafungin
n=50 Participants
Anidulafungin (Ecalta) 200 milligram (mg) intravenous infusion on the first day followed by 100 mg intravenous infusion once daily as per investigator's discretion.
|
|---|---|
|
Percentage of Participants With Other Prior Fungal Infection by Species and Colonization Index
|
0 percentage of participants
|
SECONDARY outcome
Timeframe: BaselinePopulation: Full analysis set included all participants who met the defined eligibility criteria.
Outcome measures
| Measure |
Anidulafungin
n=50 Participants
Anidulafungin (Ecalta) 200 milligram (mg) intravenous infusion on the first day followed by 100 mg intravenous infusion once daily as per investigator's discretion.
|
|---|---|
|
Number of Participants Who Received Water-based and Ethanol-based Formulation
Water based formulation
|
16 participants
|
|
Number of Participants Who Received Water-based and Ethanol-based Formulation
Ethanol based formulation
|
34 participants
|
SECONDARY outcome
Timeframe: BaselinePopulation: Full analysis set included all participants who met the defined eligibility criteria.
Outcome measures
| Measure |
Anidulafungin
n=50 Participants
Anidulafungin (Ecalta) 200 milligram (mg) intravenous infusion on the first day followed by 100 mg intravenous infusion once daily as per investigator's discretion.
|
|---|---|
|
Percentage of Participants Who Received Water-based and Ethanol-based Formulation
Water based formulation
|
32.0 percentage of participants
Interval 19.1 to 44.9
|
|
Percentage of Participants Who Received Water-based and Ethanol-based Formulation
Ethanol based formulation
|
68.0 percentage of participants
Interval 55.1 to 80.9
|
SECONDARY outcome
Timeframe: Day 1Population: Full analysis set included all participants who met the defined eligibility criteria.
Outcome measures
| Measure |
Anidulafungin
n=50 Participants
Anidulafungin (Ecalta) 200 milligram (mg) intravenous infusion on the first day followed by 100 mg intravenous infusion once daily as per investigator's discretion.
|
|---|---|
|
Percentage of Participants Who Received 200 mg Loading Dose
|
100.0 percentage of participants
Interval 100.0 to 100.0
|
SECONDARY outcome
Timeframe: Day 2Population: Full analysis set included all participants who met the defined eligibility criteria.
Outcome measures
| Measure |
Anidulafungin
n=50 Participants
Anidulafungin (Ecalta) 200 milligram (mg) intravenous infusion on the first day followed by 100 mg intravenous infusion once daily as per investigator's discretion.
|
|---|---|
|
Percentage of Participants Who Received 100 mg Dose on Day 2
|
100.0 percentage of participants
Interval 100.0 to 100.0
|
SECONDARY outcome
Timeframe: Baseline up to Day 28 post-treatmentPopulation: Full analysis set included all participants who met the defined eligibility criteria.
Outcome measures
| Measure |
Anidulafungin
n=50 Participants
Anidulafungin (Ecalta) 200 milligram (mg) intravenous infusion on the first day followed by 100 mg intravenous infusion once daily as per investigator's discretion.
|
|---|---|
|
Percentage of Participants Who Received 200 mg Dose on Day 1 and 100 mg for All Subsequent Doses
|
100.0 percentage of participants
Interval 100.0 to 100.0
|
SECONDARY outcome
Timeframe: Baseline up to Day 28 post-treatmentPopulation: Full analysis set included all participants who met the defined eligibility criteria.
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.
Outcome measures
| Measure |
Anidulafungin
n=50 Participants
Anidulafungin (Ecalta) 200 milligram (mg) intravenous infusion on the first day followed by 100 mg intravenous infusion once daily as per investigator's discretion.
|
|---|---|
|
Number of Participants With Other Dosing Patterns
|
0 participants
|
SECONDARY outcome
Timeframe: BaselinePopulation: Full analysis set included all participants who met the defined eligibility criteria.
Outcome measures
| Measure |
Anidulafungin
n=50 Participants
Anidulafungin (Ecalta) 200 milligram (mg) intravenous infusion on the first day followed by 100 mg intravenous infusion once daily as per investigator's discretion.
|
|---|---|
|
Duration of Anidulafungin Therapy
|
17.96 days
Standard Deviation 11.04
|
SECONDARY outcome
Timeframe: Baseline up to Day 28 post-treatmentPopulation: Full analysis set included all participants who met the defined eligibility criteria.
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.
Outcome measures
| Measure |
Anidulafungin
n=50 Participants
Anidulafungin (Ecalta) 200 milligram (mg) intravenous infusion on the first day followed by 100 mg intravenous infusion once daily as per investigator's discretion.
|
|---|---|
|
Number of Serious Adverse Events (SAEs)
|
5 events
|
SECONDARY outcome
Timeframe: Baseline up to Day 28 post-treatmentPopulation: Full analysis set included all participants who met the defined eligibility criteria.
Outcome measures
| Measure |
Anidulafungin
n=50 Participants
Anidulafungin (Ecalta) 200 milligram (mg) intravenous infusion on the first day followed by 100 mg intravenous infusion once daily as per investigator's discretion.
|
|---|---|
|
Percentage of Participants With One or More Drug-related Serious Adverse Events (SAEs)
|
0 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline up to Day 28 post-treatmentPopulation: Full analysis set included all participants who met the defined eligibility criteria.
Outcome measures
| Measure |
Anidulafungin
n=50 Participants
Anidulafungin (Ecalta) 200 milligram (mg) intravenous infusion on the first day followed by 100 mg intravenous infusion once daily as per investigator's discretion.
|
|---|---|
|
Number of Participants With Different Types of Drug-related Serious Adverse Events
|
0 participants
|
Adverse Events
Anidulafungin
Serious adverse events
| Measure |
Anidulafungin
n=50 participants at risk
Anidulafungin (Ecalta) 200 milligram (mg) intravenous infusion on the first day followed by 100 mg intravenous infusion once daily as per investigator's discretion.
|
|---|---|
|
General disorders
New Candida parapsilosis infection
|
2.0%
1/50
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
General disorders
Breakthrough Candida glabrata infection
|
4.0%
2/50
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
General disorders
Breakthrough Candida parapsilosis infection
|
2.0%
1/50
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
General disorders
Continuing Candida glabrata infection
|
2.0%
1/50
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
- Publication restrictions are in place
Restriction type: OTHER