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The study was prematurely terminated on May 18, 2012 due to slow enrollment. The study was not terminate due to any safety issues or concerns.
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Anidulafungin Arm | Experimental | Subjects were randomized 2:1 (anidulafungin:caspofunin). |
|
| Caspofungin Arm | Experimental | Subjects were randomized 2:1 (anidulafungin:caspofunin). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Active Anidulafungin | Drug | Subjects in this arm will receive active anidulafungin and placebo caspofungin |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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). | Day 10 up to Day 42 |
| Measure | Description | Time Frame |
|---|---|---|
| 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). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pfizer Investigational Site | Sarajevo | 71000 | Bosnia and Herzegovina | |||
| Pfizer Investigational Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33891293 | Derived | De Rosa FG, Busca A, Capparella MR, Yan JL, Aram JA. Invasive Candidiasis in Patients with Solid Tumors Treated with Anidulafungin: A Post Hoc Analysis of Efficacy and Safety of Six Pooled Studies. Clin Drug Investig. 2021 Jun;41(6):539-548. doi: 10.1007/s40261-021-01024-7. Epub 2021 Apr 23. | |
| 28597967 | Derived |
| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | Anidulafungin | Participants received anidulafungin (100 milligrams [mg]) followed by matched placebo-caspofungin once daily (QD) or participants received matched placebo-caspofungin followed by active anidulafungin (100 mg) QD. Anidulafungin loading dose on Day 1 was 200 mg. Study treatments given either entirely as intravenous (IV) therapy or if protocol-specified criteria met, as sequential IV (at least 10 days) then oral antifungal therapy (14 days). Dosage of antifungal therapy (fluconazole or voriconazole tablets) determined by the Investigator. A maximum of 42 days of IV study treatment and a maximum of 14 days of oral study treatment allowed. Thus, participants may have received up to a maximum of 56 days of study therapy. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Active Caspofungin | Drug | Subjects in this arm will receive active caspofungin and placebo anidulafungin |
|
| 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). | 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). | 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]). | 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]). | 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]). | 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]). | 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. | 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. | 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. | 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. | Baseline up to Day 56 |
| Time to Death | Time to death defined as: date of death minus first treatment date plus 1. | 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 | Baseline up to 6 weeks post treatment |
| Grenoble |
| 38043 |
| France |
| Pfizer Investigational Site | Strasbourg | 67098 | France |
| Pfizer Investigational Site | Bologna | 40138 | Italy |
| Pfizer Investigational Site | Roma | 00133 | Italy |
| Pfizer Investigational Site | Gdansk | 80-952 | Poland |
| Pfizer Investigational Site | Warsaw | 02-776 | Poland |
| Pfizer Investigational Site | Wroclaw | 50-367 | Poland |
| Pfizer Investigational Site | Moscow | 115478 | Russia |
| Pfizer Investigational Site | Košice | 04190 | Slovakia |
| Kontoyiannis DP, Bassetti M, Nucci M, Capparella MR, Yan JL, Aram J, Hogan PA. Anidulafungin for the treatment of candidaemia caused by Candida parapsilosis: Analysis of pooled data from six prospective clinical studies. Mycoses. 2017 Oct;60(10):663-667. doi: 10.1111/myc.12641. Epub 2017 Jun 9. |
| 28459966 | Derived | Kullberg BJ, Vasquez J, Mootsikapun P, Nucci M, Paiva JA, Garbino J, Yan JL, Aram J, Capparella MR, Conte U, Schlamm H, Swanson R, Herbrecht R. Efficacy of anidulafungin in 539 patients with invasive candidiasis: a patient-level pooled analysis of six clinical trials. J Antimicrob Chemother. 2017 Aug 1;72(8):2368-2377. doi: 10.1093/jac/dkx116. |
| FG001 | Caspofungin | Participants received caspofungin (35, 50, or 70 mg depending on participant's weight, baseline liver function, or receipt of an interacting drug) followed by matched placebo-anidulafungin QD or participants received matched placebo-anidulafungin followed by active caspofungin (35, 50, or 70 mg) QD. Caspofungin loading dose on Day 1 was 70 mg. Study treatments given either entirely as IV therapy or if protocol-specified criteria met, as sequential IV (at least 10 days) then oral antifungal therapy (14 days). Dosage of antifungal therapy (fluconazole or voriconazole tablets) determined by the Investigator. A maximum of 42 days of IV study treatment and a maximum of 14 days of oral study treatment allowed. Thus, participants may have received up to a maximum of 56 days of study therapy. |
| COMPLETED |
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| NOT COMPLETED |
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|
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| ID | Title | Description |
|---|---|---|
| BG000 | Anidulafungin | Participants received anidulafungin (100 milligrams [mg]) followed by matched placebo-caspofungin once daily (QD) or participants received matched placebo-caspofungin followed by active anidulafungin (100 mg) QD. Anidulafungin loading dose on Day 1 was 200 mg. Study treatments given either entirely as intravenous (IV) therapy or if protocol-specified criteria met, as sequential IV (at least 10 days) then oral antifungal therapy (14 days). Dosage of antifungal therapy (fluconazole or voriconazole tablets) determined by the Investigator. A maximum of 42 days of IV study treatment and a maximum of 14 days of oral study treatment allowed. Thus, participants may have received up to a maximum of 56 days of study therapy. |
| BG001 | Caspofungin | Participants received caspofungin (35, 50, or 70 mg depending on participant's weight, baseline liver function, or receipt of an interacting drug) followed by matched placebo-anidulafungin QD or participants received matched placebo-anidulafungin followed by active caspofungin (35, 50, or 70 mg) QD. Caspofungin loading dose on Day 1 was 70 mg. Study treatments given either entirely as IV therapy or if protocol-specified criteria met, as sequential IV (at least 10 days) then oral antifungal therapy (14 days). Dosage of antifungal therapy (fluconazole or voriconazole tablets) determined by the Investigator. A maximum of 42 days of IV study treatment and a maximum of 14 days of oral study treatment allowed. Thus, participants may have received up to a maximum of 56 days of study therapy. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | |||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Number | participants |
| |||||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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). | Modified Intent to Treat (MITT) Population: participants who received at least 1 dose of study medication and had positive culture for Candida sp isolated from cultures obtained from a normally sterile site within 96 hours prior to treatment initiation. A global response of failure at EOIVT was carried forward programmatically to subsequent visits. | Posted | Number | participants | Day 10 up to Day 42 |
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| Secondary | 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). | MITT Population; A global response of failure at EOT was carried forward programmatically to all subsequent visits. | Posted | Number | participants | Day 14 up to Day 56 |
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| Secondary | 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). | MITT Population; subset of participants who, according to the investigator, completed therapy and participants with global response of failure at EOIVT or EOT. A global response of failure at the 2-week and 6-week visits carried forward programmatically to all subsequent visits. Number of participants analyzed (N): participants with evaluable data. | Posted | Number | participants | 2 weeks post treatment |
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| Secondary | 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). | MITT Population; subset of participants who, according to the investigator, completed therapy and participants with global response of failure at EOIVT or EOT. A global response of failure at the 2-week and 6-week visits carried forward programmatically to all subsequent visits. Number of participants analyzed (N): participants with evaluable data. | Posted | Number | participants | 6 weeks post treatment |
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| Secondary | 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]). | MITT Population; subset of participants with clinical cure or improvement and microbiological eradication or presumed eradication. A global response of failure at EOIVT was carried forward programmatically to all subsequent visits. | Posted | Number | participants | Day 10 up to Day 42 |
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| Secondary | 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]). | MITT Population; subset of participants with clinical cure or improvement and microbiological eradication or presumed eradication. A global response of failure at EOT was carried forward programmatically to all subsequent visits. | Posted | Number | participants | Day 14 up to Day 56 |
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| Secondary | 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]). | MITT Population; subset of participants with clinical cure or improvement and microbiological eradication or presumed eradication; Number of participants analyzed (N): participants with evaluable data a specified time point | Posted | Number | participants | 2 weeks post treatment |
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| Secondary | 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]). | MITT Population; subset of participants with clinical cure or improvement and microbiological eradication or presumed eradication; Number of participants analyzed (N): participants with evaluable data a specified time point | Posted | Number | participants | 6 weeks post treatment |
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| Secondary | 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. | MITT Population; Number of participants analyzed (N): participants with evaluable data | Posted | Number | participants | Day 10 |
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| Secondary | 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. | MITT Population | Posted | Number | participants | 2 and 6 weeks post treatment |
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| Secondary | 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. | MITT Population | Posted | Number | participants | 2 and 6 weeks post treatment |
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| Secondary | 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. | MITT Population; subset of participants who had a positive blood culture for Candida sp. on Day 1 of treatment. No participant in the Caspofungin treatment arm had a positive blood culture for Candida sp. on Day 1 of treatment. | Posted | Median | Full Range | days | Baseline up to Day 56 |
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| Secondary | Time to Death | Time to death defined as: date of death minus first treatment date plus 1. | Safety Population;subset of participants who died | Posted | Median | Full Range | days | Day 1 up to Day 98 |
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| Secondary | 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 | Safety Population | Posted | Number | participants | Baseline up to 6 weeks post treatment |
|
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All-causality events reported. The same event may appear as both an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Anidulafungin | Participants received anidulafungin (100 milligrams [mg]) followed by matched placebo-caspofungin once daily (QD) or participants received matched placebo-caspofungin followed by active anidulafungin (100 mg) QD. Anidulafungin loading dose on Day 1 was 200 mg. Study treatments given either entirely as intravenous (IV) therapy or if protocol-specified criteria met, as sequential IV (at least 10 days) then oral antifungal therapy (14 days). Dosage of antifungal therapy (fluconazole or voriconazole tablets) determined by the Investigator. A maximum of 42 days of IV study treatment and a maximum of 14 days of oral study treatment allowed. Thus, participants may have received up to a maximum of 56 days of study therapy. | 5 | 15 | 14 | 15 | ||
| EG001 | Caspofungin | Participants received caspofungin (35, 50, or 70 mg depending on participant's weight, baseline liver function, or receipt of an interacting drug) followed by matched placebo-anidulafungin QD or participants received matched placebo-anidulafungin followed by active caspofungin (35, 50, or 70 mg) QD. Caspofungin loading dose on Day 1 was 70 mg. Study treatments given either entirely as IV therapy or if protocol-specified criteria met, as sequential IV (at least 10 days) then oral antifungal therapy (14 days). Dosage of antifungal therapy (fluconazole or voriconazole tablets) determined by the Investigator. A maximum of 42 days of IV study treatment and a maximum of 14 days of oral study treatment allowed. Thus, participants may have received up to a maximum of 56 days of study therapy. | 4 | 6 | 5 | 6 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Drug ineffective | General disorders | MedDRA v15.0 | Non-systematic Assessment |
| |
| Multi-organ failure | General disorders | MedDRA v15.0 | Non-systematic Assessment |
| |
| hepatotoxicity | Hepatobiliary disorders | MedDRA v15.0 | Non-systematic Assessment |
| |
| Candidiasis | Infections and infestations | MedDRA v15.0 | Non-systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA v15.0 | Non-systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA v15.0 | Non-systematic Assessment |
| |
| Septic shock | Infections and infestations | MedDRA v15.0 | Non-systematic Assessment |
| |
| Acute leukaemia | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v15.0 | Non-systematic Assessment |
| |
| Acute lymphocytic leukaemia | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v15.0 | Non-systematic Assessment |
| |
| Leukaemia | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v15.0 | Non-systematic Assessment |
| |
| Lymphoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v15.0 | Non-systematic Assessment |
| |
| Respiratory distress | Respiratory, thoracic and mediastinal disorders | MedDRA v15.0 | Non-systematic Assessment |
| |
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA v15.0 | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA v15.0 | Non-systematic Assessment |
| |
| Lymphadenopathy | Blood and lymphatic system disorders | MedDRA v15.0 | Non-systematic Assessment |
| |
| Lymphopenia | Blood and lymphatic system disorders | MedDRA v15.0 | Non-systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA v15.0 | Non-systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA v15.0 | Non-systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | MedDRA v15.0 | Non-systematic Assessment |
| |
| Bradycardia | Cardiac disorders | MedDRA v15.0 | Non-systematic Assessment |
| |
| Supraventricular tachycardia | Cardiac disorders | MedDRA v15.0 | Non-systematic Assessment |
| |
| Tachycardia | Cardiac disorders | MedDRA v15.0 | Non-systematic Assessment |
| |
| Colour blindness acquired | Eye disorders | MedDRA v15.0 | Non-systematic Assessment |
| |
| Conjunctivitis | Eye disorders | MedDRA v15.0 | Non-systematic Assessment |
| |
| Phosphenes | Eye disorders | MedDRA v15.0 | Non-systematic Assessment |
| |
| Retinal exudates | Eye disorders | MedDRA v15.0 | Non-systematic Assessment |
| |
| Retinal haemorrhage | Eye disorders | MedDRA v15.0 | Non-systematic Assessment |
| |
| Visual brightness | Eye disorders | MedDRA v15.0 | Non-systematic Assessment |
| |
| Abdominal distension | Gastrointestinal disorders | MedDRA v15.0 | Non-systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA v15.0 | Non-systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA v15.0 | Non-systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA v15.0 | Non-systematic Assessment |
| |
| Dry mouth | Gastrointestinal disorders | MedDRA v15.0 | Non-systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA v15.0 | Non-systematic Assessment |
| |
| Gingival disorder | Gastrointestinal disorders | MedDRA v15.0 | Non-systematic Assessment |
| |
| Melaena | Gastrointestinal disorders | MedDRA v15.0 | Non-systematic Assessment |
| |
| Mouth haemorrhage | Gastrointestinal disorders | MedDRA v15.0 | Non-systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA v15.0 | Non-systematic Assessment |
| |
| Stomatitis | Gastrointestinal disorders | MedDRA v15.0 | Non-systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA v15.0 | Non-systematic Assessment |
| |
| Asthenia | General disorders | MedDRA v15.0 | Non-systematic Assessment |
| |
| Catheter site inflammation | General disorders | MedDRA v15.0 | Non-systematic Assessment |
| |
| Chills | General disorders | MedDRA v15.0 | Non-systematic Assessment |
| |
| General physical health deterioration | General disorders | MedDRA v15.0 | Non-systematic Assessment |
| |
| Generalised oedema | General disorders | MedDRA v15.0 | Non-systematic Assessment |
| |
| Malaise | General disorders | MedDRA v15.0 | Non-systematic Assessment |
| |
| Mucosal inflammation | General disorders | MedDRA v15.0 | Non-systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA v15.0 | Non-systematic Assessment |
| |
| Pain | General disorders | MedDRA v15.0 | Non-systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA v15.0 | Non-systematic Assessment |
| |
| Hyperbilirubinaemia | Hepatobiliary disorders | MedDRA v15.0 | Non-systematic Assessment |
| |
| Aspergillosis | Infections and infestations | MedDRA v15.0 | Non-systematic Assessment |
| |
| Bronchopneumonia | Infections and infestations | MedDRA v15.0 | Non-systematic Assessment |
| |
| Enterococcal bacteraemia | Infections and infestations | MedDRA v15.0 | Non-systematic Assessment |
| |
| Enterococcal infection | Infections and infestations | MedDRA v15.0 | Non-systematic Assessment |
| |
| Escherichia bacteraemia | Infections and infestations | MedDRA v15.0 | Non-systematic Assessment |
| |
| Furuncle | Infections and infestations | MedDRA v15.0 | Non-systematic Assessment |
| |
| Klebsiella bacteraemia | Infections and infestations | MedDRA v15.0 | Non-systematic Assessment |
| |
| Oral fungal infection | Infections and infestations | MedDRA v15.0 | Non-systematic Assessment |
| |
| Oral herpes | Infections and infestations | MedDRA v15.0 | Non-systematic Assessment |
| |
| Postoperative wound infection | Infections and infestations | MedDRA v15.0 | Non-systematic Assessment |
| |
| Pseudomonas infection | Infections and infestations | MedDRA v15.0 | Non-systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA v15.0 | Non-systematic Assessment |
| |
| Staphylococcal bacteraemia | Infections and infestations | MedDRA v15.0 | Non-systematic Assessment |
| |
| Streptococcal bacteraemia | Infections and infestations | MedDRA v15.0 | Non-systematic Assessment |
| |
| Urinary tract infection enterococcal | Infections and infestations | MedDRA v15.0 | Non-systematic Assessment |
| |
| Eschar | Injury, poisoning and procedural complications | MedDRA v15.0 | Non-systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA v15.0 | Non-systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MedDRA v15.0 | Non-systematic Assessment |
| |
| Bacterial test positive | Investigations | MedDRA v15.0 | Non-systematic Assessment |
| |
| Blood alkaline phosphatase increased | Investigations | MedDRA v15.0 | Non-systematic Assessment |
| |
| Blood bilirubin increased | Investigations | MedDRA v15.0 | Non-systematic Assessment |
| |
| Blood creatine increased | Investigations | MedDRA v15.0 | Non-systematic Assessment |
| |
| Blood creatinine increased | Investigations | MedDRA v15.0 | Non-systematic Assessment |
| |
| Blood lactate dehydrogenase increased | Investigations | MedDRA v15.0 | Non-systematic Assessment |
| |
| Blood urea increased | Investigations | MedDRA v15.0 | Non-systematic Assessment |
| |
| Breath sounds abnormal | Investigations | MedDRA v15.0 | Non-systematic Assessment |
| |
| Fungal test positive | Investigations | MedDRA v15.0 | Non-systematic Assessment |
| |
| Gamma-glutamyltransferase increased | Investigations | MedDRA v15.0 | Non-systematic Assessment |
| |
| Weight increased | Investigations | MedDRA v15.0 | Non-systematic Assessment |
| |
| Hyperkalaemia | Metabolism and nutrition disorders | MedDRA v15.0 | Non-systematic Assessment |
| |
| Hypoalbuminaemia | Metabolism and nutrition disorders | MedDRA v15.0 | Non-systematic Assessment |
| |
| Hypocalcaemia | Metabolism and nutrition disorders | MedDRA v15.0 | Non-systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA v15.0 | Non-systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA v15.0 | Non-systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA v15.0 | Non-systematic Assessment |
| |
| Soft tissue necrosis | Musculoskeletal and connective tissue disorders | MedDRA v15.0 | Non-systematic Assessment |
| |
| Coma | Nervous system disorders | MedDRA v15.0 | Non-systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA v15.0 | Non-systematic Assessment |
| |
| Somnolence | Nervous system disorders | MedDRA v15.0 | Non-systematic Assessment |
| |
| Tremor | Nervous system disorders | MedDRA v15.0 | Non-systematic Assessment |
| |
| Agitation | Psychiatric disorders | MedDRA v15.0 | Non-systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA v15.0 | Non-systematic Assessment |
| |
| Confusional state | Psychiatric disorders | MedDRA v15.0 | Non-systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA v15.0 | Non-systematic Assessment |
| |
| Anuria | Renal and urinary disorders | MedDRA v15.0 | Non-systematic Assessment |
| |
| Costovertebral angle tenderness | Renal and urinary disorders | MedDRA v15.0 | Non-systematic Assessment |
| |
| Haematuria | Renal and urinary disorders | MedDRA v15.0 | Non-systematic Assessment |
| |
| Renal failure | Renal and urinary disorders | MedDRA v15.0 | Non-systematic Assessment |
| |
| Urinary retention | Renal and urinary disorders | MedDRA v15.0 | Non-systematic Assessment |
| |
| Acute pulmonary oedema | Respiratory, thoracic and mediastinal disorders | MedDRA v15.0 | Non-systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA v15.0 | Non-systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA v15.0 | Non-systematic Assessment |
| |
| Hypoventilation | Respiratory, thoracic and mediastinal disorders | MedDRA v15.0 | Non-systematic Assessment |
| |
| Hypoxia | Respiratory, thoracic and mediastinal disorders | MedDRA v15.0 | Non-systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA v15.0 | Non-systematic Assessment |
| |
| Pulmonary congestion | Respiratory, thoracic and mediastinal disorders | MedDRA v15.0 | Non-systematic Assessment |
| |
| Rales | Respiratory, thoracic and mediastinal disorders | MedDRA v15.0 | Non-systematic Assessment |
| |
| Decubitus ulcer | Skin and subcutaneous tissue disorders | MedDRA v15.0 | Non-systematic Assessment |
| |
| Generalised erythema | Skin and subcutaneous tissue disorders | MedDRA v15.0 | Non-systematic Assessment |
| |
| Papule | Skin and subcutaneous tissue disorders | MedDRA v15.0 | Non-systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA v15.0 | Non-systematic Assessment |
| |
| Purpura | Skin and subcutaneous tissue disorders | MedDRA v15.0 | Non-systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA v15.0 | Non-systematic Assessment |
| |
| Rash generalised | Skin and subcutaneous tissue disorders | MedDRA v15.0 | Non-systematic Assessment |
| |
| Rash maculo-papular | Skin and subcutaneous tissue disorders | MedDRA v15.0 | Non-systematic Assessment |
| |
| Toxic skin eruption | Skin and subcutaneous tissue disorders | MedDRA v15.0 | Non-systematic Assessment |
| |
| Haematoma | Vascular disorders | MedDRA v15.0 | Non-systematic Assessment |
| |
| Hyperaemia | Vascular disorders | MedDRA v15.0 | Non-systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA v15.0 | Non-systematic Assessment |
| |
| Palatal disorder | Gastrointestinal disorders | MedDRA v15.0 | Non-systematic Assessment |
| |
| Feeding disorder | Metabolism and nutrition disorders | MedDRA v15.0 | Non-systematic Assessment |
|
Study prematurely terminated due to slow enrollment, not due to safety issues. Meaningful interpretation and comparison of treatment outcomes with caspofungin was difficult due to low number of participants (n=3) with confirmed Candida infection.
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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Pfizer ClinicalTrials.gov Call Center | Pfizer, Inc. | 1-800-718-1021 | ClinicalTrials.gov_Inquiries@pfizer.com |
| ID | Term |
|---|---|
| D016469 | Fungemia |
| D009503 | Neutropenia |
| D002177 | Candidiasis |
| D058365 | Candidiasis, Invasive |
| C536972 | Torulopsis |
| D058387 | Candidemia |
| D009181 | Mycoses |
| ID | Term |
|---|---|
| D000072742 | Invasive Fungal Infections |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
| D018805 | Sepsis |
| D018746 | Systemic Inflammatory Response Syndrome |
| D007249 | Inflammation |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D000380 | Agranulocytosis |
| D007970 | Leukopenia |
| D000095542 | Cytopenia |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007960 | Leukocyte Disorders |
Not provided
Not provided
| Title | Measurements |
|---|---|
|
| greater than or equal to (≥) 65 years |
|
| Male |
|
| Indeterminate |
|
| OG001 | Caspofungin | Participants received caspofungin (35, 50, or 70 mg depending on participant's weight, baseline liver function, or receipt of an interacting drug) followed by matched placebo-anidulafungin QD or participants received matched placebo-anidulafungin followed by active caspofungin (35, 50, or 70 mg) QD. Caspofungin loading dose on Day 1 was 70 mg. Study treatments given either entirely as IV therapy or if protocol-specified criteria met, as sequential IV (at least 10 days) then oral antifungal therapy (14 days). Dosage of antifungal therapy (fluconazole or voriconazole tablets) determined by the Investigator. A maximum of 42 days of IV study treatment and a maximum of 14 days of oral study treatment allowed. Thus, participants may have received up to a maximum of 56 days of study therapy. |
|
|
|
| OG001 | Caspofungin | Participants received caspofungin (35, 50, or 70 mg depending on participant's weight, baseline liver function, or receipt of an interacting drug) followed by matched placebo-anidulafungin QD or participants received matched placebo-anidulafungin followed by active caspofungin (35, 50, or 70 mg) QD. Caspofungin loading dose on Day 1 was 70 mg. Study treatments given either entirely as IV therapy or if protocol-specified criteria met, as sequential IV (at least 10 days) then oral antifungal therapy (14 days). Dosage of antifungal therapy (fluconazole or voriconazole tablets) determined by the Investigator. A maximum of 42 days of IV study treatment and a maximum of 14 days of oral study treatment allowed. Thus, participants may have received up to a maximum of 56 days of study therapy. |
|
|
|
| OG001 | Caspofungin | Participants received caspofungin (35, 50, or 70 mg depending on participant's weight, baseline liver function, or receipt of an interacting drug) followed by matched placebo-anidulafungin QD or participants received matched placebo-anidulafungin followed by active caspofungin (35, 50, or 70 mg) QD. Caspofungin loading dose on Day 1 was 70 mg. Study treatments given either entirely as IV therapy or if protocol-specified criteria met, as sequential IV (at least 10 days) then oral antifungal therapy (14 days). Dosage of antifungal therapy (fluconazole or voriconazole tablets) determined by the Investigator. A maximum of 42 days of IV study treatment and a maximum of 14 days of oral study treatment allowed. Thus, participants may have received up to a maximum of 56 days of study therapy. |
|
|
|
|
|
|
|
|
|
|
|
Participants received caspofungin (35, 50, or 70 mg depending on participant's weight, baseline liver function, or receipt of an interacting drug) followed by matched placebo-anidulafungin QD or participants received matched placebo-anidulafungin followed by active caspofungin (35, 50, or 70 mg) QD. Caspofungin loading dose on Day 1 was 70 mg. Study treatments given either entirely as IV therapy or if protocol-specified criteria met, as sequential IV (at least 10 days) then oral antifungal therapy (14 days). Dosage of antifungal therapy (fluconazole or voriconazole tablets) determined by the Investigator. A maximum of 42 days of IV study treatment and a maximum of 14 days of oral study treatment allowed. Thus, participants may have received up to a maximum of 56 days of study therapy.
|
|
|
|
|
|
|
| Units | Counts |
|---|
| Participants |
|
|
|
|
|
|