A Phase 3 interventional study of Active Anidulafungin and Active Caspofungin in Fungemia, Neutropenia and Candidiasis, sponsored by Pfizer. Terminated at 10 sites in 6 countries. Open to participants aged 16 Years and older. Per ClinicalTrials.gov, last updated 2012-12-20.
Sponsored by Pfizer · Phase 3, Interventional, and Treatment
The purpose of this study is to gather information on the use of anidulafungin for the treatment of Candida infection in patients with an abnormal immune system. It is expected that anidulafungin will be at least as safe and as effective as the comparator drug, caspofungin.
27 studies on the registry are indexed under Fungemia; 3 are open to participants now.
This study's enrollment of 21 is below the median of 248 across 16 interventional studies indexed under Fungemia.
Browse Fungemia studies →Pfizer is the lead sponsor of 3,323 studies on the registry; 145 are open to participants now.
Of its 597 completed or terminated interventional studies of FDA-regulated products, 391 (65%) have results posted.
Counted across the registry records on this site, refreshed daily.
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Exclusion Criteria:
Subjects were randomized 2:1 (anidulafungin:caspofunin).
Drug: Active Anidulafungin
Subjects were randomized 2:1 (anidulafungin:caspofunin).
Drug: Active Caspofungin
Subjects in this arm will receive active anidulafungin and placebo caspofungin
Subjects in this arm will receive active caspofungin and placebo anidulafungin
Global Response at End of Intravenous Treatment (EOIVT)
Participant counts of global response of success, failure, or indeterminate. Success: clinical response of cure (no signs, symptoms \[s/s\] of Candida) or improvement (significant, incomplete resolution of s/s) and microbiological response of eradication (follow-up \[f/u\] culture negative) or presumed eradication (f/u culture not available and clinical success). Failure: clinical response of failure (greater than or equal to \[≥3\] doses study medication and no significant improvement of s/s or death due to Candida) and/or unsuccessful microbiological response of persistent(positive culture any Candida species \[sp\]), new infection or relapse at f/u. Indeterminate: clinical and/or microbiological response of indeterminate (evaluation could not be made due to withdrawal from study prior to assessment of cure or failure) and there was neither clinical response of failure nor unsuccessful microbiological response (persistence or new infection or relapse).
Time frame: Day 10 up to Day 42
Global Response at End of Treatment (EOT)
Participant counts of global response of success, failure, or indeterminate. Success: clinical response of cure (no s/s of Candida) or improvement (significant, incomplete resolution of s/s) and microbiological response of eradication (f/u culture negative) or presumed eradication (f/u culture not available and clinical success). Failure: clinical response of failure (≥3 doses study medication and no significant improvement of s/s or death due to Candida) and/or unsuccessful microbiological response of persistent (positive culture any Candida sp), new infection or relapse at f/u. Indeterminate: clinical and/or microbiological response of indeterminate (evaluation could not be made due to withdrawal from study prior to assessment of cure or failure) and there was neither clinical response of failure nor unsuccessful microbiological response (persistence or new infection or relapse).
Time frame: Day 14 up to Day 56
Global Response at 2-Week Follow-Up Visit
Participant counts of global response of success, failure, or indeterminate. Success: clinical response of cure (no s/s of Candida) or improvement (significant, incomplete resolution of s/s) and microbiological response of eradication (f/u culture negative) or presumed eradication (f/u culture not available and clinical success). Failure: clinical response of failure (≥3 doses study medication and no significant improvement of s/s or death due to Candida) and/or unsuccessful microbiological response of persistent (positive culture any Candida sp), new infection or relapse at f/u. Indeterminate: clinical and/or microbiological response of indeterminate (evaluation could not be made due to withdrawal from study prior to assessment of cure or failure) and there was neither clinical response of failure nor unsuccessful microbiological response (persistence or new infection or relapse).
Time frame: 2 weeks post treatment
Global Response at 6-Week Follow-Up Visit
Participant counts of global response of success, failure, or indeterminate. Success: clinical response of cure (no s/s of Candida) or improvement (significant, incomplete resolution of s/s) and microbiological response of eradication (f/u culture negative) or presumed eradication (f/u culture not available and clinical success). Failure: clinical response of failure (≥3 doses study medication and no significant improvement of s/s or death due to Candida) and/or unsuccessful microbiological response of persistent (positive culture any Candida sp), new infection or relapse at f/u. Indeterminate: clinical and/or microbiological response of indeterminate (evaluation could not be made due to withdrawal from study prior to assessment of cure or failure) and there was neither clinical response of failure nor unsuccessful microbiological response (persistence or new infection or relapse).
Time frame: 6 weeks post treatment
Response Based on Clinical Cure and Microbiological Success at EOIVT
Participant counts of clinical cure (no s/s of Candida) and microbiological success (eradication \[f/u culture negative\] or presumed eradication \[f/u culture not available and a clinical response of cure\]).
Time frame: Day 10 up to Day 42
Response Based on Clinical Cure and Microbiological Success at EOT
Participant counts of clinical cure (no s/s of Candida) and microbiological success (eradication \[f/u culture negative\] or presumed eradication \[f/u culture not available and a clinical response of cure\]).
Time frame: Day 14 up to Day 56
Response Based on Clinical Cure and Microbiological Success at 2-Week Follow-Up Visit
Participant counts of clinical cure (no s/s of Candida) and microbiological success (eradication \[f/u culture negative\] or presumed eradication \[f/u culture not available and a clinical response of cure\]).
Time frame: 2 weeks post treatment
Response Based on Clinical Cure and Microbiological Success at 6-Week Follow-Up Visit
Participant counts of clinical cure (no s/s of Candida) and microbiological success (eradication \[f/u culture negative\] or presumed eradication \[f/u culture not available and a clinical response of cure\]).
Time frame: 6 weeks post treatment
Clinical Response at Day 10
Participant counts of clinical response categorized as success, failure, or indeterminate. Success: no s/s of Candida (cure) or significant but incomplete resolution of s/s of Candida; no additional systemic or oral antifungal treatment required (improvement). Failure: worsening of s/s of the Candida infection. Indeterminate: evaluation could not be made due to withdrawal from study prior to assessment of cure or failure. Participants who received fewer than 3 doses of study medication were assigned a clinical efficacy response of indeterminate.
Time frame: Day 10
Number of Participants With Recurrence
Participant counts of microbiologic response of recurrence defined as any baseline Candida sp isolated following eradication, or culture data were not available for participants with a clinical response of failure after a previous response of success. Clinical failure defined as ≥3 doses study medication and no significant improvement of s/s or death due to Candida. Clinical success is resolution of s/s and no additional antifungal treatment needed.
Time frame: 2 and 6 weeks post treatment
Number of Participants With New Infections
Participant counts of microbiologic response of new infection defined as clinical failure with emergence of new Candida sp not identified at baseline at the original site of infection or at a distant site of infection. Clinical failure defined as ≥3 doses study medication and no significant improvement of s/s or death due to Candida.
Time frame: 2 and 6 weeks post treatment
Time to First Negative Blood Culture for Candida Species
A participant had a negative blood culture, if having determined the day of the first negative blood culture, the subsequent blood culture was also negative, or if positive, the interval between the cultures was at least 2 days. For participants whose blood culture went from positive to negative, the time to negative blood culture defined as: date of first negative blood culture minus first treatment date plus 1.
Time frame: Baseline up to Day 56
Time to Death
Time to death defined as: date of death minus first treatment date plus 1.
Time frame: Day 1 up to Day 98
All-Cause Mortality
All-cause mortality during study therapy and at follow-up visits reported as unique deaths at EOIVT, end of oral treatment (EOT-oral), 2 Week Follow-Up and 6 Week Follow-Up
Time frame: Baseline up to 6 weeks post treatment
| Milestone | Anidulafungin | Caspofungin |
|---|---|---|
| Started | 15 | 6 |
| Completed | 10 | 2 |
| Not completed | 5 | 4 |
| Withdrew: Death | 5 | 4 |
Participant counts of global response of success, failure, or indeterminate. Success: clinical response of cure (no signs, symptoms \[s/s\] of Candida) or improvement (significant, incomplete resolution of s/s) and microbiological response of eradication (follow-up \[f/u\] culture negative) or presumed eradication (f/u culture not available and clinical success). Failure: clinical response of failure (greater than or equal to \[≥3\] doses study medication and no significant improvement of s/s or death due to Candida) and/or unsuccessful microbiological response of persistent(positive culture any Candida species \[sp\]), new infection or relapse at f/u. Indeterminate: clinical and/or microbiological response of indeterminate (evaluation could not be made due to withdrawal from study prior to assessment of cure or failure) and there was neither clinical response of failure nor unsuccessful microbiological response (persistence or new infection or relapse).
| participants | Anidulafungin | Caspofungin |
|---|---|---|
| Success | 8 | 3 |
| Failure | 3 | 0 |
| Indeterminate | 0 | 0 |
Participant counts of global response of success, failure, or indeterminate. Success: clinical response of cure (no s/s of Candida) or improvement (significant, incomplete resolution of s/s) and microbiological response of eradication (f/u culture negative) or presumed eradication (f/u culture not available and clinical success). Failure: clinical response of failure (≥3 doses study medication and no significant improvement of s/s or death due to Candida) and/or unsuccessful microbiological response of persistent (positive culture any Candida sp), new infection or relapse at f/u. Indeterminate: clinical and/or microbiological response of indeterminate (evaluation could not be made due to withdrawal from study prior to assessment of cure or failure) and there was neither clinical response of failure nor unsuccessful microbiological response (persistence or new infection or relapse).
| participants | Anidulafungin | Caspofungin |
|---|---|---|
| Success | 8 | 3 |
| Failure | 3 | 0 |
| Indeterminate | 0 | 0 |
Participant counts of global response of success, failure, or indeterminate. Success: clinical response of cure (no s/s of Candida) or improvement (significant, incomplete resolution of s/s) and microbiological response of eradication (f/u culture negative) or presumed eradication (f/u culture not available and clinical success). Failure: clinical response of failure (≥3 doses study medication and no significant improvement of s/s or death due to Candida) and/or unsuccessful microbiological response of persistent (positive culture any Candida sp), new infection or relapse at f/u. Indeterminate: clinical and/or microbiological response of indeterminate (evaluation could not be made due to withdrawal from study prior to assessment of cure or failure) and there was neither clinical response of failure nor unsuccessful microbiological response (persistence or new infection or relapse).
| participants | Anidulafungin | Caspofungin |
|---|---|---|
| Success | 6 | 1 |
| Failure | 3 | 0 |
| Indeterminate | 0 | 0 |
Participant counts of global response of success, failure, or indeterminate. Success: clinical response of cure (no s/s of Candida) or improvement (significant, incomplete resolution of s/s) and microbiological response of eradication (f/u culture negative) or presumed eradication (f/u culture not available and clinical success). Failure: clinical response of failure (≥3 doses study medication and no significant improvement of s/s or death due to Candida) and/or unsuccessful microbiological response of persistent (positive culture any Candida sp), new infection or relapse at f/u. Indeterminate: clinical and/or microbiological response of indeterminate (evaluation could not be made due to withdrawal from study prior to assessment of cure or failure) and there was neither clinical response of failure nor unsuccessful microbiological response (persistence or new infection or relapse).
| participants | Anidulafungin | Caspofungin |
|---|---|---|
| Success | 5 | 1 |
| Failure | 4 | 0 |
| Indeterminate | 0 | 0 |
Participant counts of clinical cure (no s/s of Candida) and microbiological success (eradication \[f/u culture negative\] or presumed eradication \[f/u culture not available and a clinical response of cure\]).
| participants | Anidulafungin | Caspofungin |
|---|---|---|
| Response Based on Clinical Cure and Microbiological Success at EOIVT | 7 | 2 |
Participant counts of clinical cure (no s/s of Candida) and microbiological success (eradication \[f/u culture negative\] or presumed eradication \[f/u culture not available and a clinical response of cure\]).
| participants | Anidulafungin | Caspofungin |
|---|---|---|
| Response Based on Clinical Cure and Microbiological Success at EOT | 6 | 3 |
Participant counts of clinical cure (no s/s of Candida) and microbiological success (eradication \[f/u culture negative\] or presumed eradication \[f/u culture not available and a clinical response of cure\]).
| participants | Anidulafungin | Caspofungin |
|---|---|---|
| Response Based on Clinical Cure and Microbiological Success at 2-Week Follow-Up Visit | 4 | 1 |
Participant counts of clinical cure (no s/s of Candida) and microbiological success (eradication \[f/u culture negative\] or presumed eradication \[f/u culture not available and a clinical response of cure\]).
| participants | Anidulafungin | Caspofungin |
|---|---|---|
| Response Based on Clinical Cure and Microbiological Success at 6-Week Follow-Up Visit | 6 | 1 |
Participant counts of clinical response categorized as success, failure, or indeterminate. Success: no s/s of Candida (cure) or significant but incomplete resolution of s/s of Candida; no additional systemic or oral antifungal treatment required (improvement). Failure: worsening of s/s of the Candida infection. Indeterminate: evaluation could not be made due to withdrawal from study prior to assessment of cure or failure. Participants who received fewer than 3 doses of study medication were assigned a clinical efficacy response of indeterminate.
| participants | Anidulafungin | Caspofungin |
|---|---|---|
| Success | 7 | 3 |
| Failure | 0 | 0 |
| Indeterminate | 2 | 0 |
Participant counts of microbiologic response of recurrence defined as any baseline Candida sp isolated following eradication, or culture data were not available for participants with a clinical response of failure after a previous response of success. Clinical failure defined as ≥3 doses study medication and no significant improvement of s/s or death due to Candida. Clinical success is resolution of s/s and no additional antifungal treatment needed.
| participants | Anidulafungin | Caspofungin |
|---|---|---|
| 2 Weeks post treatment | 0 | 0 |
| 6 Weeks post treatment | 0 | 0 |
Participant counts of microbiologic response of new infection defined as clinical failure with emergence of new Candida sp not identified at baseline at the original site of infection or at a distant site of infection. Clinical failure defined as ≥3 doses study medication and no significant improvement of s/s or death due to Candida.
| participants | Anidulafungin | Caspofungin |
|---|---|---|
| 2 weeks post treatment | 0 | 0 |
| 6 weeks post treatment | 0 | 0 |
A participant had a negative blood culture, if having determined the day of the first negative blood culture, the subsequent blood culture was also negative, or if positive, the interval between the cultures was at least 2 days. For participants whose blood culture went from positive to negative, the time to negative blood culture defined as: date of first negative blood culture minus first treatment date plus 1.
| days | Anidulafungin |
|---|---|
| Time to First Negative Blood Culture for Candida Species | 2.0 (2 to 5) |
Time to death defined as: date of death minus first treatment date plus 1.
| days | Anidulafungin | Caspofungin |
|---|---|---|
| Time to Death | 34.0 (5 to 36) | 15.5 (3 to 41) |
All-cause mortality during study therapy and at follow-up visits reported as unique deaths at EOIVT, end of oral treatment (EOT-oral), 2 Week Follow-Up and 6 Week Follow-Up
| participants | Anidulafungin | Caspofungin |
|---|---|---|
| at EOIVT | 1 | 1 |
| at EOT - oral | 1 | 0 |
| at 2 Week Follow-Up Visit | 1 | 3 |
| at 6 Week Follow-Up Visit | 2 | 0 |
Non-serious events are listed at a 2% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Anidulafungin | — | 5/15 (33.3%) | 14/15 (93.3%) |
| Caspofungin | — | 4/6 (66.7%) | 5/6 (83.3%) |
| Event | Anidulafungin | Caspofungin |
|---|---|---|
| SepsisInfections and infestations | 0/15 | 2/6 |
| Multi-organ failureGeneral disorders | 0/15 | 1/6 |
| hepatotoxicityHepatobiliary disorders | 0/15 | 1/6 |
| Septic shockInfections and infestations | 0/15 | 1/6 |
| Acute lymphocytic leukaemiaNeoplasms benign, malignant and unspecified (incl cysts and polyps) | 0/15 | 1/6 |
| LymphomaNeoplasms benign, malignant and unspecified (incl cysts and polyps) | 0/15 | 1/6 |
| Drug ineffectiveGeneral disorders | 1/15 | 0/6 |
| CandidiasisInfections and infestations | 1/15 | 0/6 |
| PneumoniaInfections and infestations | 1/15 | 0/6 |
| Acute leukaemiaNeoplasms benign, malignant and unspecified (incl cysts and polyps) | 1/15 | 0/6 |
| Event | Anidulafungin | Caspofungin |
|---|---|---|
| PyrexiaGeneral disorders | 6/15 | 1/6 |
| NauseaGastrointestinal disorders | 5/15 | 1/6 |
| Gamma-glutamyltransferase increasedInvestigations | 1/15 | 2/6 |
| Abdominal painGastrointestinal disorders | 3/15 | 0/6 |
| Blood alkaline phosphatase increasedInvestigations | 3/15 | 1/6 |
| DyspnoeaRespiratory, thoracic and mediastinal disorders | 3/15 | 0/6 |
| Pleural effusionRespiratory, thoracic and mediastinal disorders | 3/15 | 0/6 |
| RalesRespiratory, thoracic and mediastinal disorders | 3/15 | 1/6 |
| AnaemiaBlood and lymphatic system disorders | 1/15 | 1/6 |
| Colour blindness acquiredEye disorders | 0/15 | 1/6 |
| Age, Customized(participants) | Anidulafungin | Caspofungin | Total |
|---|---|---|---|
| 18 to 44 years | 2 | 2 | 4 |
| 45 to 64 years | 9 | 2 | 11 |
| greater than or equal to (≥) 65 years | 4 | 2 | 6 |
| Sex: Female, Male(Participants) | Anidulafungin | Caspofungin | Total |
|---|---|---|---|
| Female | 6 | 3 | 9 |
| Male | 9 | 3 | 12 |
This study is terminated, as verified in Nov 2012. You cannot join it, but the record below documents what was studied.
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