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| ID | Type | Description | Link |
|---|---|---|---|
| PF-03910960 |
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The purpose of this study is to determine whether or not the Investigational Study Drug anidulafungin is safe and effective in the treatment of a fungal infection, candidemia, in Asian subjects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Open | Other | This is an open-label, multi-center, non-comparative 12 week study evaluating the efficacy and safety of anidulafungin in subjects with candidemia. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Anidulafungin | Drug | Eligible subjects will be initiated on a single loading dose of 200 mg IV anidulafungin, followed by 100 mg IV anidulafungin once daily for a minimum of 5 days but not more than 42 days. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Subjects With Global Response of Success at End of Treatment | Number of subjects with clinician assessed global response of success; defined as cure (resolution of signs and symptoms of Candida infection) or improvement (significant but incomplete resolution of signs and symptoms of Candida infection) on the clinical response in conjunction with eradication (follow up negative culture result for Candida species [spp]) or presumed eradication (follow up culture was not available and clinical outcome defined as success) on the microbiological response. | End of treatment (EOT) = Day 5 up to Day 42 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Subjects With Global Response of Success at Endpoints | Number of subjects with clinician assessed global response of success. Defined as cure or improvement (cure/improvement): cure=resolution of signs and symptoms of Candida infection; improvement=significant but incomplete resolution of signs and symptoms of Candida infection on the clinical response in conjunction with eradication or presumed eradication (erad/presumed erad): erad=follow up negative culture result for Candida spp; presumed erad=follow up culture was not available and clinical outcome defined as success on the microbiological response. |
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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 | Ahmedabad | Gujarat | 380 054 | India | ||
| 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. | |
| 31280481 | Derived |
| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
Not provided
Approximately 100 eligible subjects from 22 centers were planned to be enrolled. However, due to slow enrollment, 46 subjects were screened and 43 subjects were assigned to treatment.
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| ID | Title | Description |
|---|---|---|
| FG000 | Anidulafungin | Single 200 milligram (mg) intravenous (IV) dose of anidulafungin, followed by anidulafungin 100 mg IV once daily (QD) for a minimum of 5 days but not more than 42 days. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Anidulafungin | Single 200 milligram (mg) intravenous (IV) dose of anidulafungin, followed by anidulafungin 100 mg IV once daily (QD) for a minimum of 5 days but not more than 42 days. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Number |
| 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 | Number of Subjects With Global Response of Success at End of Treatment | Number of subjects with clinician assessed global response of success; defined as cure (resolution of signs and symptoms of Candida infection) or improvement (significant but incomplete resolution of signs and symptoms of Candida infection) on the clinical response in conjunction with eradication (follow up negative culture result for Candida species [spp]) or presumed eradication (follow up culture was not available and clinical outcome defined as success) on the microbiological response. | Modified Intent to Treat (MITT): includes all Full Analysis Set (FAS) subjects (received at least 1 dose of study treatment) with confirmed, documented diagnosis of candidemia and had received the initial loading dose of study treatment. | Posted | Number | participants | End of treatment (EOT) = Day 5 up to Day 42 |
|
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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 | Single 200 milligram (mg) intravenous (IV) dose of anidulafungin, followed by anidulafungin 100 mg IV once daily (QD) for a minimum of 5 days but not more than 42 days. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cardiac failure congestive | Cardiac disorders | MedDRA (12.0) | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Leukopenia | Blood and lymphatic system disorders | MedDRA (12.0) | Systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Pfizer ClinicalTrials.gov Call Center | Pfizer, Inc. | 1-800-718-1021 | ClinicalTrials.govCallCenter@pfizer.com |
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| ID | Term |
|---|---|
| D058387 | Candidemia |
| ID | Term |
|---|---|
| D058365 | Candidiasis, Invasive |
| D002177 | Candidiasis |
| D009181 | Mycoses |
| D001423 | Bacterial Infections and Mycoses |
Not provided
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| ID | Term |
|---|---|
| D000077612 | Anidulafungin |
| ID | Term |
|---|---|
| D054714 | Echinocandins |
| D010456 | Peptides, Cyclic |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
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| End of intravenous treatment (EOIT), end of Week 2 after EOT (2 Wks post EOT), end of Week 6 after EOT (6 Wks post EOT), at end of 12 weeks after baseline (12 Wks post baseline) |
| Number of Subjects With Clinical Response of Success at Endpoints | Number of subjects with clinician assessed clinical response (CR) of success. Defined as cure or improvement (cure/improvement): cure=resolution of signs and symptoms of Candida infection; improvement=significant but incomplete resolution of signs and symptoms of Candida infection on the clinical response. | EOIT, EOT (Day 5 up to Day 42), 2 Wks post EOT, 6 Wks post EOT, 12 Wks post baseline |
| Number of Subjects With Microbiological Response of Success at Endpoints | Number of subjects with clinician assessed microbiological response (MR) of success. Defined as eradication or presumed eradication (erad/presumed erad): erad=follow up negative culture result for Candida spp; presumed eradication=follow up culture was not available and clinical outcome defined as success on the microbiological response. | EOIT, EOT (Day 5 up to Day 42), 2 Wks post EOT, 6 Wks post EOT, 12 Wks post baseline |
| Time to Death From Any Cause | Time to death (median survival time in days) from any cause; time to death includes the first day (Day 1) of study drug (baseline and Day 1 allowed to occur on same day). EOT visit could occur anytime from Day 5 through Day 42; if a subject terminated early, the timeframe "at end of 12 weeks after baseline" could occur in the follow-up period (6 Wks post EOT or Week 12 post EOT). | Baseline through end of 12 weeks after baseline |
| Time to Death Due to Candidemia | Time to death (median survival time in days) due to candidemia; time to death includes the first day (Day 1) of study drug (baseline and Day 1 allowed to occur on same day). EOT visit could occur anytime from Day 5 through Day 42; if a subject terminated early, the timeframe "at end of 12 weeks after baseline" could occur in the follow-up period (6 Wks post EOT or Week 12 post EOT). | Baseline through end of 12 weeks after baseline |
| Absolute Values for β-D-glucan Assay Results at Endpoints in Relation to Clinical Response Status of Success or Status of Failure at End of All Treatment | Absolute values for β-D-glucan (range 0 to 6000 picograms per milliliter [pg/mL]) summarized at all timeframe endpoints by subject's at end of all treatment clinical response status of success (Success at EOT) or failure (Failure at EOT) and as combined status of all subjects (All at EOT). Success: cure (resolution of signs and symptoms of Candida infection) or improvement (significant but incomplete resolution of signs and symptoms); failure: no significant improvement in signs and symptoms or death due to Candida infection; subjects must have received at least 3 doses of anidulafungin. | Baseline, Day 3, Day 5, Day 7, EOT (Day 5 up to Day 42) |
| Change From Baseline for β-D-glucan Assay Results at Endpoints in Relation to Clinical Response Status of Success or Status of Failure at End of All Treatment | Change from baseline for β-D-glucan (range 0 to 6000 pg/mL) summarized at endpoints by subject's at end of all treatment clinical response status of Success at EOT or Failure at EOT and as combined status of All at EOT. Success=cure (resolution of signs, symptoms of Candida infection) or improvement (significant but incomplete resolution of signs, symptoms); failure=no significant improvement or death due to Candida infection; subject must have received at least 3 doses of anidulafungin. Percent change calculated as ([mean value of β-D-glucan at observation-baseline value]/baseline value*100). | Baseline, Day 3, Day 5, Day 7, EOT (Day 5 up to Day 42) |
| Absolute Values for β-D-glucan Assay Results at Endpoints in Relation to Microbiological Response Status of Success or Status of Failure at End of All Treatment | Absolute values for β-D-glucan (range 0 to 6000 pg/mL) summarized at timeframe endpoints by subject's at end of all treatment microbiological response status of Success at EOT or Failure at EOT and as combined status of All at EOT. Success: eradication (follow up negative culture for Candida spp) or presumed eradication (follow up culture was not available and clinical outcome defined as success); failure: persistence (follow up culture was positive for at least 1 baseline Candida spp) or presumed persistence (follow up culture was not available and clinical outcome was defined as failure). | Baseline, Day 3, Day 5, Day 7, EOT (Day 5 up to Day 42) |
| Change From Baseline for β-D-glucan Assay Results at Endpoints in Relation to Microbiological Response of Status of Success or Status of Failure at EOT | Change from baseline in β-D-glucan (range 0 to 6000 pg/mL) summarized at endpoints and by subject's EOT microbiological response status of Success at EOT or Failure at EOT and as combined status of All at EOT. Success=eradication (negative culture Candida spp or presumed eradication (culture not available, clinical outcome defined as success); failure=persistence (culture positive for at least 1 baseline Candida spp) or presumed persistence (culture not available, clinical outcome defined as failure). Percent change=([mean value of β-D-glucan at observation-baseline value]/baseline value*100). | Baseline, Day 3, Day 5, Day 7, EOT (Day 5 up to Day 42) |
| Number of Subjects With Global Response of Success at EOT in Relation to Subject Subgroups | Number of subjects with clinician assessed global response of success at EOT (clinical=cure, improvement, microbiological=eradication, presumed eradication) in relation to subject subgroups (subject may be represented in >1 subgroup). Subgroups: Neutropenic status (absolute neutrophil count [ANC in cubic millimeters [cmm]); baseline pathogen; previous surgery (any surgery, abdominal surgery); organ transplantation (kidney, liver, heart); elderly; renal insufficiency (calculated creatinine clearance [CCC] in milliliters per minute [mL/min]); central venous catheter; receiving chemotherapy.](streamdown:incomplete-link) | EOT (Day 5 up to Day 42) |
| Bangalore |
| Karnataka |
| 560034 |
| India |
| Pfizer Investigational Site | Mumbai | Maharashtra | 400 022 | India |
| Pfizer Investigational Site | Ludhiana | Punjab | 141 001 | India |
| Pfizer Investigational Site | Noida | Uttar Pradesh | 201301 | India |
| Pfizer Investigational Site | Legaspi Village, Makati City | 1200 | Philippines |
| Pfizer Investigational Site | Banqiao District | Taipei | 220 | Taiwan |
| Pfizer Investigational Site | Taichung | 404 | Taiwan |
| Pfizer Investigational Site | Tainan | 704 | Taiwan |
| Pfizer Investigational Site | Taipei | 100 | Taiwan |
| Pfizer Investigational Site | Pathumwan | Bangkok | 10330 | Thailand |
| Pfizer Investigational Site | Amphoe Mueang | Changwat Khon Kaen | 40002 | Thailand |
| Pfizer Investigational Site | Amphoe Mueang | Chiang Mai | 50200 | Thailand |
| Sganga G, Wang M, Capparella MR, Tawadrous M, Yan JL, Aram JA, Montravers P. Evaluation of anidulafungin in the treatment of intra-abdominal candidiasis: a pooled analysis of patient-level data from 5 prospective studies. Eur J Clin Microbiol Infect Dis. 2019 Oct;38(10):1849-1856. doi: 10.1007/s10096-019-03617-9. Epub 2019 Jul 6. |
| 28597967 | Derived | 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. |
| 23676114 | Derived | Mootsikapun P, Hsueh PR, Talwar D, Co VM, Rajadhyaksha V, Ong ML. Intravenous anidulafungin followed optionally by oral voriconazole for the treatment of candidemia in Asian patients: results from an open-label Phase III trial. BMC Infect Dis. 2013 May 15;13:219. doi: 10.1186/1471-2334-13-219. |
| Lost to Follow-up |
|
| Withdrawal by Subject |
|
| Other |
|
| participants |
|
| Age Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
Single 200 milligram (mg) intravenous (IV) dose of anidulafungin, followed by anidulafungin 100 mg IV once daily (QD) for a minimum of 5 days but not more than 42 days.
|
|
|
| Secondary | Number of Subjects With Global Response of Success at Endpoints | Number of subjects with clinician assessed global response of success. Defined as cure or improvement (cure/improvement): cure=resolution of signs and symptoms of Candida infection; improvement=significant but incomplete resolution of signs and symptoms of Candida infection on the clinical response in conjunction with eradication or presumed eradication (erad/presumed erad): erad=follow up negative culture result for Candida spp; presumed erad=follow up culture was not available and clinical outcome defined as success on the microbiological response. | MITT; EOT visit could occur anytime from Day 5 through Day 42; if a subject terminated early, the timeframe "at end of 12 weeks after baseline" could occur in the follow-up period (6 Wks post EOT or Week 12 post EOT). | Posted | Number | participants | End of intravenous treatment (EOIT), end of Week 2 after EOT (2 Wks post EOT), end of Week 6 after EOT (6 Wks post EOT), at end of 12 weeks after baseline (12 Wks post baseline) |
|
|
|
|
| Secondary | Number of Subjects With Clinical Response of Success at Endpoints | Number of subjects with clinician assessed clinical response (CR) of success. Defined as cure or improvement (cure/improvement): cure=resolution of signs and symptoms of Candida infection; improvement=significant but incomplete resolution of signs and symptoms of Candida infection on the clinical response. | MITT. EOT visit could occur anytime from Day 5 through Day 42; if a subject terminated early, the timeframe "at end of 12 weeks after baseline" could occur in the follow-up period (6 Wks post EOT or Week 12 post EOT). | Posted | Number | participants | EOIT, EOT (Day 5 up to Day 42), 2 Wks post EOT, 6 Wks post EOT, 12 Wks post baseline |
|
|
|
|
| Secondary | Number of Subjects With Microbiological Response of Success at Endpoints | Number of subjects with clinician assessed microbiological response (MR) of success. Defined as eradication or presumed eradication (erad/presumed erad): erad=follow up negative culture result for Candida spp; presumed eradication=follow up culture was not available and clinical outcome defined as success on the microbiological response. | MITT. EOT visit could occur anytime from Day 5 through Day 42; if a subject terminated early, the timeframe "at end of 12 weeks after baseline" could occur in the follow-up period (6 Wks post EOT or Week 12 post EOT). | Posted | Number | participants | EOIT, EOT (Day 5 up to Day 42), 2 Wks post EOT, 6 Wks post EOT, 12 Wks post baseline |
|
|
|
|
| Secondary | Time to Death From Any Cause | Time to death (median survival time in days) from any cause; time to death includes the first day (Day 1) of study drug (baseline and Day 1 allowed to occur on same day). EOT visit could occur anytime from Day 5 through Day 42; if a subject terminated early, the timeframe "at end of 12 weeks after baseline" could occur in the follow-up period (6 Wks post EOT or Week 12 post EOT). | MITT; time to death (median survival time in days) based on Kaplan-Meier method if estimable. Data not summarized by median survival time as planned as median time is not estimable; < 50% of subjects died out of the analyzable population. | Posted | Median | Full Range | days | Baseline through end of 12 weeks after baseline |
|
|
| Secondary | Time to Death Due to Candidemia | Time to death (median survival time in days) due to candidemia; time to death includes the first day (Day 1) of study drug (baseline and Day 1 allowed to occur on same day). EOT visit could occur anytime from Day 5 through Day 42; if a subject terminated early, the timeframe "at end of 12 weeks after baseline" could occur in the follow-up period (6 Wks post EOT or Week 12 post EOT). | MITT; time to death (median survival time in days) based on Kaplan-Meier method if estimable. Data not summarized by median survival time as planned as median time is not estimable; no subjects died due to candidemia out of the analyzable population. | Posted | Median | Full Range | days | Baseline through end of 12 weeks after baseline |
|
|
| Secondary | Absolute Values for β-D-glucan Assay Results at Endpoints in Relation to Clinical Response Status of Success or Status of Failure at End of All Treatment | Absolute values for β-D-glucan (range 0 to 6000 picograms per milliliter [pg/mL]) summarized at all timeframe endpoints by subject's at end of all treatment clinical response status of success (Success at EOT) or failure (Failure at EOT) and as combined status of all subjects (All at EOT). Success: cure (resolution of signs and symptoms of Candida infection) or improvement (significant but incomplete resolution of signs and symptoms); failure: no significant improvement in signs and symptoms or death due to Candida infection; subjects must have received at least 3 doses of anidulafungin. | MITT; (n)=number of subjects with analyzable data at observation; summary includes only subjects who completed visit; missing or indeterminate CR treated as failures. Failures were carried forward for subjects who withdrew prematurely from study with a documented failure. "All" category includes all subjects with success or failure at EOT. | Posted | Mean | Standard Deviation | pg/mL | Baseline, Day 3, Day 5, Day 7, EOT (Day 5 up to Day 42) |
|
|
|
| Secondary | Change From Baseline for β-D-glucan Assay Results at Endpoints in Relation to Clinical Response Status of Success or Status of Failure at End of All Treatment | Change from baseline for β-D-glucan (range 0 to 6000 pg/mL) summarized at endpoints by subject's at end of all treatment clinical response status of Success at EOT or Failure at EOT and as combined status of All at EOT. Success=cure (resolution of signs, symptoms of Candida infection) or improvement (significant but incomplete resolution of signs, symptoms); failure=no significant improvement or death due to Candida infection; subject must have received at least 3 doses of anidulafungin. Percent change calculated as ([mean value of β-D-glucan at observation-baseline value]/baseline value*100). | MITT; (n)=number of subjects with analyzable data at observation; summary includes only subjects who completed visit; missing or indeterminate CR treated as failures. Failures were carried forward for subjects who withdrew prematurely from study with a documented failure. "All" category includes all subjects with success or failure at EOT. | Posted | Mean | Standard Deviation | percent change | Baseline, Day 3, Day 5, Day 7, EOT (Day 5 up to Day 42) |
|
|
|
| Secondary | Absolute Values for β-D-glucan Assay Results at Endpoints in Relation to Microbiological Response Status of Success or Status of Failure at End of All Treatment | Absolute values for β-D-glucan (range 0 to 6000 pg/mL) summarized at timeframe endpoints by subject's at end of all treatment microbiological response status of Success at EOT or Failure at EOT and as combined status of All at EOT. Success: eradication (follow up negative culture for Candida spp) or presumed eradication (follow up culture was not available and clinical outcome defined as success); failure: persistence (follow up culture was positive for at least 1 baseline Candida spp) or presumed persistence (follow up culture was not available and clinical outcome was defined as failure). | MITT; (n)=number of subjects with analyzable data at observation; summary includes only subjects who completed visit; missing microbiological responses treated as failures. Failures carried forward for subjects who withdrew prematurely from study with documented failure. "All" category includes all subjects with success or failure at EOT. | Posted | Mean | Standard Deviation | pg/mL | Baseline, Day 3, Day 5, Day 7, EOT (Day 5 up to Day 42) |
|
|
|
| Secondary | Change From Baseline for β-D-glucan Assay Results at Endpoints in Relation to Microbiological Response of Status of Success or Status of Failure at EOT | Change from baseline in β-D-glucan (range 0 to 6000 pg/mL) summarized at endpoints and by subject's EOT microbiological response status of Success at EOT or Failure at EOT and as combined status of All at EOT. Success=eradication (negative culture Candida spp or presumed eradication (culture not available, clinical outcome defined as success); failure=persistence (culture positive for at least 1 baseline Candida spp) or presumed persistence (culture not available, clinical outcome defined as failure). Percent change=([mean value of β-D-glucan at observation-baseline value]/baseline value*100). | MITT; (n)=number of subjects with analyzable data at observation; summary includes only subjects who completed visit; missing microbiological responses treated as failures. Failures carried forward for subjects who withdrew prematurely from study with documented failure. "All" category includes all subjects with success or failure at EOT. | Posted | Mean | Standard Deviation | percent change | Baseline, Day 3, Day 5, Day 7, EOT (Day 5 up to Day 42) |
|
|
|
| Secondary | Number of Subjects With Global Response of Success at EOT in Relation to Subject Subgroups | Number of subjects with clinician assessed global response of success at EOT (clinical=cure, improvement, microbiological=eradication, presumed eradication) in relation to subject subgroups (subject may be represented in >1 subgroup). Subgroups: Neutropenic status (absolute neutrophil count [ANC in cubic millimeters [cmm]); baseline pathogen; previous surgery (any surgery, abdominal surgery); organ transplantation (kidney, liver, heart); elderly; renal insufficiency (calculated creatinine clearance [CCC] in milliliters per minute [mL/min]); central venous catheter; receiving chemotherapy.](streamdown:incomplete-link) | MITT. May have >1 baseline pathogen; previous surgery=any surgery (includes abdominal surgery) within 1 month prior to baseline (PTB); chemotherapy for solid cell tumors or hematological malignancies at baseline or within 3 months PTB; central venous catheter (CVC) up to 1 month PTB; (n)=subjects per subgroup with analyzable data at observation. | Posted | Number | participants | EOT (Day 5 up to Day 42) |
|
|
|
|
| 16 |
| 43 |
| 30 |
| 43 |
| Cardio-respiratory arrest | Cardiac disorders | MedDRA (12.0) | Systematic Assessment |
|
| Myocardial infarction | Cardiac disorders | MedDRA (12.0) | Systematic Assessment |
|
| Upper gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA (12.0) | Systematic Assessment |
|
| Chills | General disorders | MedDRA (12.0) | Systematic Assessment |
|
| Pyrexia | General disorders | MedDRA (12.0) | Systematic Assessment |
|
| Bacteraemia | Infections and infestations | MedDRA (12.0) | Systematic Assessment |
|
| Pneumonia | Infections and infestations | MedDRA (12.0) | Systematic Assessment |
|
| Septic shock | Infections and infestations | MedDRA (12.0) | Systematic Assessment |
|
| Systemic candida | Infections and infestations | MedDRA (12.0) | Systematic Assessment |
|
| Hypernatraemia | Metabolism and nutrition disorders | MedDRA (12.0) | Systematic Assessment |
|
| Hypoglycaemia | Metabolism and nutrition disorders | MedDRA (12.0) | Systematic Assessment |
|
| Bile duct cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (12.0) | Systematic Assessment |
|
| Gastric cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (12.0) | Systematic Assessment |
|
| Hepatic neoplasm malignant | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (12.0) | Systematic Assessment |
|
| Lung neoplasm malignant | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (12.0) | Systematic Assessment |
|
| Pancreatic carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (12.0) | Systematic Assessment |
|
| Cerebrovascular accident | Nervous system disorders | MedDRA (12.0) | Systematic Assessment |
|
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA (12.0) | Systematic Assessment |
|
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA (12.0) | Systematic Assessment |
|
| Hypotension | Vascular disorders | MedDRA (12.0) | Systematic Assessment |
|
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA (12.0) | Systematic Assessment |
|
| Acute coronary syndrome | Cardiac disorders | MedDRA (12.0) | Systematic Assessment |
|
| Cardiac failure congestive | Cardiac disorders | MedDRA (12.0) | Systematic Assessment |
|
| Tachycardia | Cardiac disorders | MedDRA (12.0) | Systematic Assessment |
|
| Asthenopia | Eye disorders | MedDRA (12.0) | Systematic Assessment |
|
| Conjunctivitis | Eye disorders | MedDRA (12.0) | Systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | MedDRA (12.0) | Systematic Assessment |
|
| Ascites | Gastrointestinal disorders | MedDRA (12.0) | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA (12.0) | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA (12.0) | Systematic Assessment |
|
| Flatulence | Gastrointestinal disorders | MedDRA (12.0) | Systematic Assessment |
|
| Ileus | Gastrointestinal disorders | MedDRA (12.0) | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA (12.0) | Systematic Assessment |
|
| Peritonitis | Gastrointestinal disorders | MedDRA (12.0) | Systematic Assessment |
|
| Upper gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA (12.0) | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA (12.0) | Systematic Assessment |
|
| Chest discomfort | General disorders | MedDRA (12.0) | Systematic Assessment |
|
| Chest pain | General disorders | MedDRA (12.0) | Systematic Assessment |
|
| Oedema peripheral | General disorders | MedDRA (12.0) | Systematic Assessment |
|
| Pain | General disorders | MedDRA (12.0) | Systematic Assessment |
|
| Pitting oedema | General disorders | MedDRA (12.0) | Systematic Assessment |
|
| Pyrexia | General disorders | MedDRA (12.0) | Systematic Assessment |
|
| Thirst | General disorders | MedDRA (12.0) | Systematic Assessment |
|
| Jaundice | Hepatobiliary disorders | MedDRA (12.0) | Systematic Assessment |
|
| Drug hypersensitivity | Immune system disorders | MedDRA (12.0) | Systematic Assessment |
|
| Abscess limb | Infections and infestations | MedDRA (12.0) | Systematic Assessment |
|
| Acarodermatitis | Infections and infestations | MedDRA (12.0) | Systematic Assessment |
|
| Bacteraemia | Infections and infestations | MedDRA (12.0) | Systematic Assessment |
|
| Bacterial sepsis | Infections and infestations | MedDRA (12.0) | Systematic Assessment |
|
| Cellulitis | Infections and infestations | MedDRA (12.0) | Systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRA (12.0) | Systematic Assessment |
|
| Nosocomial infection | Infections and infestations | MedDRA (12.0) | Systematic Assessment |
|
| Oral candidiasis | Infections and infestations | MedDRA (12.0) | Systematic Assessment |
|
| Pneumonia | Infections and infestations | MedDRA (12.0) | Systematic Assessment |
|
| Sepsis | Infections and infestations | MedDRA (12.0) | Systematic Assessment |
|
| Systemic candida | Infections and infestations | MedDRA (12.0) | Systematic Assessment |
|
| Urosepsis | Infections and infestations | MedDRA (12.0) | Systematic Assessment |
|
| ECG signs of myocardial ischaemia | Investigations | MedDRA (12.0) | Systematic Assessment |
|
| Transaminases increased | Investigations | MedDRA (12.0) | Systematic Assessment |
|
| Cachexia | Metabolism and nutrition disorders | MedDRA (12.0) | Systematic Assessment |
|
| Dehydration | Metabolism and nutrition disorders | MedDRA (12.0) | Systematic Assessment |
|
| Fluid overload | Metabolism and nutrition disorders | MedDRA (12.0) | Systematic Assessment |
|
| Hyperammonaemia | Metabolism and nutrition disorders | MedDRA (12.0) | Systematic Assessment |
|
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA (12.0) | Systematic Assessment |
|
| Hyperkalaemia | Metabolism and nutrition disorders | MedDRA (12.0) | Systematic Assessment |
|
| Hypernatraemia | Metabolism and nutrition disorders | MedDRA (12.0) | Systematic Assessment |
|
| Hypocalcaemia | Metabolism and nutrition disorders | MedDRA (12.0) | Systematic Assessment |
|
| Hypoglycaemia | Metabolism and nutrition disorders | MedDRA (12.0) | Systematic Assessment |
|
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA (12.0) | Systematic Assessment |
|
| Hypophosphataemia | Metabolism and nutrition disorders | MedDRA (12.0) | Systematic Assessment |
|
| Metabolic acidosis | Metabolism and nutrition disorders | MedDRA (12.0) | Systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA (12.0) | Systematic Assessment |
|
| Flank pain | Musculoskeletal and connective tissue disorders | MedDRA (12.0) | Systematic Assessment |
|
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA (12.0) | Systematic Assessment |
|
| Gastric cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (12.0) | Systematic Assessment |
|
| Convulsion | Nervous system disorders | MedDRA (12.0) | Systematic Assessment |
|
| Depressed level of consciousness | Nervous system disorders | MedDRA (12.0) | Systematic Assessment |
|
| Hepatic encephalopathy | Nervous system disorders | MedDRA (12.0) | Systematic Assessment |
|
| Somnolence | Nervous system disorders | MedDRA (12.0) | Systematic Assessment |
|
| Anxiety | Psychiatric disorders | MedDRA (12.0) | Systematic Assessment |
|
| Confusional state | Psychiatric disorders | MedDRA (12.0) | Systematic Assessment |
|
| Delirium | Psychiatric disorders | MedDRA (12.0) | Systematic Assessment |
|
| Depression | Psychiatric disorders | MedDRA (12.0) | Systematic Assessment |
|
| Insomnia | Psychiatric disorders | MedDRA (12.0) | Systematic Assessment |
|
| Azotaemia | Renal and urinary disorders | MedDRA (12.0) | Systematic Assessment |
|
| Haematuria | Renal and urinary disorders | MedDRA (12.0) | Systematic Assessment |
|
| Hydronephrosis | Renal and urinary disorders | MedDRA (12.0) | Systematic Assessment |
|
| Renal failure acute | Renal and urinary disorders | MedDRA (12.0) | Systematic Assessment |
|
| Bronchospasm | Respiratory, thoracic and mediastinal disorders | MedDRA (12.0) | Systematic Assessment |
|
| Choking | Respiratory, thoracic and mediastinal disorders | MedDRA (12.0) | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA (12.0) | Systematic Assessment |
|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA (12.0) | Systematic Assessment |
|
| Hypercapnia | Respiratory, thoracic and mediastinal disorders | MedDRA (12.0) | Systematic Assessment |
|
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA (12.0) | Systematic Assessment |
|
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA (12.0) | Systematic Assessment |
|
| Respiratory tract haemorrhage | Respiratory, thoracic and mediastinal disorders | MedDRA (12.0) | Systematic Assessment |
|
| Wheezing | Respiratory, thoracic and mediastinal disorders | MedDRA (12.0) | Systematic Assessment |
|
| Drug eruption | Skin and subcutaneous tissue disorders | MedDRA (12.0) | Systematic Assessment |
|
| Dry skin | Skin and subcutaneous tissue disorders | MedDRA (12.0) | Systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | MedDRA (12.0) | Systematic Assessment |
|
| Rash pruritic | Skin and subcutaneous tissue disorders | MedDRA (12.0) | Systematic Assessment |
|
| Deep vein thrombosis | Vascular disorders | MedDRA (12.0) | Systematic Assessment |
|
| Hypertension | Vascular disorders | MedDRA (12.0) | Systematic Assessment |
|
| Hypotension | Vascular disorders | MedDRA (12.0) | Systematic Assessment |
|
| Thrombophlebitis | Vascular disorders | MedDRA (12.0) | Systematic Assessment |
|
Pfizer has the right to review disclosures, requesting a delay of < 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), < 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
| D007239 |
| Infections |
| D000072742 | Invasive Fungal Infections |
| D016469 | Fungemia |
| D018805 | Sepsis |
| D018746 | Systemic Inflammatory Response Syndrome |
| D007249 | Inflammation |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| Title | Measurements |
|---|---|
|
| 12 Wks post baseline |
|
| 2-sided exact Clopper-Pearson (percent) |
| 82.8 |
| 95 |
| 64.2 |
| 94.2 |
| No |
| Superiority or Other |
| 6 Wks post EOT | 2-sided exact Clopper-Pearson (percent) | 89.5 | 95 | 66.9 | 98.7 | No | Superiority or Other |
| 12 Wks post baseline | 2-sided exact Clopper-Pearson (percent) | 72.7 | 95 | 49.8 | 89.3 | No | Superiority or Other |
| Title | Measurements |
|---|---|
|
| EOT: success (cure/improvement) |
|
| EOT: cure |
|
| EOT: improvement |
|
| 2 Wks post EOT: success (cure/improvement) |
|
| 2 Wks post EOT: cure |
|
| 2 Wks post EOT: improvement |
|
| 6 Wks post EOT: success (cure/improvement) |
|
| 6 Wks post EOT: cure |
|
| 6 Wks post EOT: improvement |
|
| 12 Wks post baseline: success (cure/improvement) |
|
| 12 Wks post baseline: cure |
|
| 12 Wks post baseline: improvement |
|
| 2-sided exact Clopper-Pearson (percent) |
| 94.1 |
| 95 |
| 80.3 |
| 99.3 |
| No |
| Superiority or Other |
| 2 Wks post EOT: success (cure/improvement) | 2-sided exact Clopper-Pearson (percent) | 92.9 | 95 | 76.5 | 99.1 | No | Superiority or Other |
| 6 Wks post EOT: success (cure/improvement) | 2-sided exact Clopper-Pearson (percent) | 94.4 | 95 | 72.7 | 99.9 | No | Superiority or Other |
| 12 Wks post baseline: success (cure/improvement) | 2-sided exact Clopper-Pearson (percent) | 85.0 | 95 | 62.1 | 96.8 | No | Superiority or Other |
| Title | Measurements |
|---|---|
|
| EOT: success (erad/presumed erad) |
|
| EOT: erad |
|
| EOT: presumed erad |
|
| 2 Wks post EOT: success (erad/presumed erad) |
|
| 2 Wks post EOT: erad |
|
| 2 Wks post EOT: presumed erad |
|
| 6 Wks post EOT: success (erad/presumed erad) |
|
| 6 Wks post EOT: erad |
|
| 6 Wks post EOT: presumed erad |
|
| 12 Wks post baseline: success (erad/presumed erad) |
|
| 12 Wks post baseline: erad |
|
| 12 Wks post baseline: presumed erad |
|
| 2-sided exact Clopper-Pearson (percent) |
| 97.1 |
| 95 |
| 85.1 |
| 99.9 |
| No |
| Superiority or Other |
| 2 Wks post EOT: success (erad/presumed erad) | 2-sided exact Clopper-Pearson (percent) | 86.2 | 95 | 68.3 | 96.1 | No | Superiority or Other |
| 6 Wks post EOT: success (erad/presumed erad) | 2-sided exact Clopper-Pearson (percent) | 94.4 | 95 | 72.7 | 99.9 | No | Superiority or Other |
| 12 Wks post baseline: success (erad/presumed erad) | 2-sided exact Clopper-Pearson (percent) | 84.2 | 95 | 60.4 | 96.6 | No | Superiority or Other |
|
| Success at EOT: Day 3 β-D-glucan (n=32) |
|
| Failure at EOT: Day 3 β-D-glucan (n=4) |
|
| All at EOT: Day 3 β-D-glucan (n=36) |
|
| Success at EOT: Day 5 β-D-glucan (n=29) |
|
| Failure at EOT: Day 5 β-D-glucan (n=6) |
|
| All at EOT: Day 5 β-D-glucan (n=35) |
|
| Success at EOT: Day 7 β-D-glucan (n=24) |
|
| Failure at EOT: Day 7 β-D-glucan (n=4) |
|
| All at EOT: Day 7 β-D-glucan (n=28) |
|
| Success at EOT: EOT β-D-glucan (n=28) |
|
| Failure at EOT: EOT β-D-glucan (n=3) |
|
| All at EOT: EOT β-D-glucan (n=31) |
|
|
| Success at EOT: Day 5 β-D-glucan (n=27) |
|
| Failure at EOT: Day 5 β-D-glucan (n=6) |
|
| All at EOT: Day 5 β-D-glucan (n=33) |
|
| Success at EOT: Day 7 β-D-glucan (n=23) |
|
| Failure at EOT: Day 7 β-D-glucan (n=4) |
|
| All at EOT: Day 7 β-D-glucan (n=27) |
|
| Success at EOT: EOT β-D-glucan (n=27) |
|
| Failure at EOT: EOT β-D-glucan (n=3) |
|
| All at EOT: EOT β-D-glucan (n=30) |
|
|
| Success at EOT: Day 3 β-D-glucan (n=32) |
|
| Failure at EOT: Day 3 β-D-glucan (n=4) |
|
| All at EOT: Day 3 β-D-glucan (n=36) |
|
| Success at EOT: Day 5 β-D-glucan (n=29) |
|
| Failure at EOT: Day 5 β-D-glucan (n=6) |
|
| All at EOT: Day 5 β-D-glucan (n=35) |
|
| Success at EOT: Day 7 β-D-glucan (n=24) |
|
| Failure at EOT: Day 7 β-D-glucan (n=4) |
|
| All at EOT: Day 7 β-D-glucan (n=28) |
|
| Success at EOT: EOT β-D-glucan (n=31) |
|
| All at EOT: EOT β-D-glucan (n=31) |
|
|
| Success at EOT: Day 5 β-D-glucan (n=27) |
|
| Failure at EOT: Day 5 β-D-glucan (n=6) |
|
| All at EOT: Day 5 β-D-glucan (n=33) |
|
| Success at EOT: Day 7 β-D-glucan (n=23) |
|
| Failure at EOT: Day 7 β-D-glucan (n=4) |
|
| All at EOT: Day 7 β-D-glucan (n=27) |
|
| Success at EOT: EOT β-D-glucan (n=30) |
|
| All at EOT: Day 7 β-D-glucan (n=30) |
|
| Title | Measurements |
|---|---|
|
| Baseline pathogen: Candida glabrata (n=6) |
|
| Baseline pathogen: Candida parapsilosis (n=4) |
|
| Baseline pathogen: Candida rugosa (n=1) |
|
| Baseline pathogen: Candida tropicalis (n=18) |
|
| Previous surgery: Any surgery (n=13) |
|
| Previous surgery: Abdominal surgery (n=8) |
|
| Elderly: Age ≥ 65 years (n=17) |
|
| Renal insufficiency (CCC < 30 mL/min) (n=11) |
|
| Use of Central venous catheter = Yes (n=21) |
|
| Receiving chemotherapy = Yes (n=7) |
|
| 2-sided exact Clopper-Pearson (percent) |
| 75.7 |
| 95 |
| 58.8 |
| 88.2 |
| No |
| Superiority or Other |
| Baseline pathogen: Candida albicans | 2-sided exact Clopper-Pearson (percent) | 71.4 | 95 | 41.9 | 91.6 | No | Superiority or Other |
| Baseline pathogen: Candida glabrata | 2-sided exact Clopper-Pearson (percent) | 66.7 | 95 | 22.3 | 95.7 | No | Superiority or Other |
| Baseline pathogen: Candida parapsilosis | 2-sided exact Clopper-Pearson (percent) | 100.0 | 95 | 39.8 | 100.0 | No | Superiority or Other |
| Baseline pathogen: Candida rugosa | 2-sided exact Clopper-Pearson (percent) | 100.0 | 95 | 2.5 | 100.0 | No | Superiority or Other |
| Baseline pathogen: Candida tropicalis | 2-sided exact Clopper-Pearson (percent) | 72.2 | 95 | 46.5 | 90.3 | No | Superiority or Other |
| Previous surgery: Any surgery | 2-sided exact Clopper-Pearson (percent) | 84.6 | 95 | 54.6 | 98.1 | No | Superiority or Other |
| Previous surgery: Abdominal surgery | 2-sided exact Clopper-Pearson (percent) | 87.5 | 95 | 47.3 | 99.7 | No | Superiority or Other |
| Elderly: Age ≥ 65 years | 2-sided exact Clopper-Pearson (percent) | 58.8 | 95 | 32.9 | 81.6 | No | Superiority or Other |
| Renal insufficiency (CCC < 30 mL/min) | 2-sided exact Clopper-Pearson (percent) | 54.5 | 95 | 23.4 | 83.3 | No | Superiority or Other |
| Use of Central venous catheter = Yes | 2-sided exact Clopper-Pearson (percent) | 81.0 | 95 | 58.1 | 94.6 | No | Superiority or Other |
| Receiving chemotherapy = Yes | 2-sided exact Clopper-Pearson (percent) | 71.4 | 95 | 29.0 | 96.3 | No | Superiority or Other |