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To evaluate the efficacy and safety of anidulafungin in the treatment of systemic fungal infections in intensive care and critical care unit patients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment Group | Experimental | Option to treat with oral azole therapy following treatment with anidulafungin |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Anidulafungin | Drug | Anidulafungin Intravenous Administration |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Global Treatment Response Success at End of Treatment | Global response based on combination of clinical and microbiological outcomes; success defined as clinical response of cure (resolution of signs and symptoms of Candida infection) or improvement (significant, but incomplete resolution of signs and symptoms of Candida infection) in conjunction with microbiological eradication (follow-up culture negative for Candida species) or presumed eradication (follow-up culture not available and clinical response of success). | End of Treatment (Day 14 to Day 56) |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Global Response Success at End of Intravenous Treatment (EOIVT) | Global response based on combination of clinical and microbiological outcomes; success defined as clinical response of cure (resolution of signs and symptoms of Candida infection) or improvement (significant, but incomplete resolution of signs and symptoms of Candida infection) in conjunction with microbiological eradication (follow-up culture negative for Candida species) or presumed eradication (follow-up culture not available and clinical response of success). |
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Inclusion Criteria:
ICU patients with a diagnosis of documented candidemia or invasive candidiasis and belonging to one or more of the following specific populations:
Exclusion Criteria:
Patients with poor venous access that would preclude IV drug delivery or multiple blood draws.
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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 | Vienna | A-1090 | Austria | |||
| 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
Two-hundred twenty one (221) participants were screened; 5 participants were screen failures who did not receive study medication.
Adult specific participants were recruited from intensive care unit (ICU) populations.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Anidulafungin | Anidulafungin: 200 milligrams (mg) Day 1, 100 mg once daily from Day 2 (minimum of 9 days, maximum of 41 days). After Day 10 option to treat with oral azole therapy (voriconazole or fluconazole) at a dose determined by local clinical practice up to a maximum of 56 days from Day 1. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
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| Fluconazole |
| Drug |
Oral Administration of Fluconazole |
|
| Voriconazole | Drug | Oral Administration of Voriconazole |
|
| EOIVT (Day 10 up to Day 42) |
| Percentage of Participants With Global Response Success at 2 Weeks After End of Treatment | Global response based on combination of clinical and microbiological outcomes; success defined as clinical response of cure (resolution of signs and symptoms of Candida infection) or improvement (significant, but incomplete resolution of signs and symptoms of Candida infection) in conjunction with microbiological eradication (follow-up culture negative for Candida species) or presumed eradication (follow-up culture not available and clinical response of success). | 2 weeks after End of Treatment (Day 14 + 14 up to Day 56 + 14) |
| Percentage of Participants With Global Response Success 6 Weeks After End of Treatment | Global response based on combination of clinical and microbiological outcomes; success defined as clinical response of cure (resolution of signs and symptoms of Candida infection) or improvement (significant, but incomplete resolution of signs and symptoms of Candida infection) in conjunction with microbiological eradication (follow-up culture negative for Candida species) or presumed eradication (follow-up culture not available and clinical response of success). | 6 weeks after End of Treatment (Day 14 + 42 up to Day 56 + 42) |
| Time to First Negative Blood Culture | Negative blood culture defined as first negative culture that was not followed by a positive culture within the next 3 days (or 4 days if negative culture was observed on or after Day 10) from start of study medication until end of intravenous treatment (EOIVT). Time to first negative culture includes the first day of study medication. | Day 1 up to Day 42 |
| Day 90 Survival | Percentage of participants known or assumed to be alive on Day 90. | Day 90 |
| Time to Successful Intensive Care Unit (ICU) Discharge | Time from start of study medication to successful ICU discharge (by end of treatment [EOT]), defined as being alive on the day after the EOT visit, not being in the ICU on the day after the EOT visit, and being classed as a global treatment success at EOT. | Day 1 up to Day 56 |
| Brussels |
| 1090 |
| Belgium |
| Pfizer Investigational Site | Brussels | B-1070 | Belgium |
| Pfizer Investigational Site | Ghent | 9000 | Belgium |
| Pfizer Investigational Site | Leuven | 3000 | Belgium |
| Pfizer Investigational Site | Liège | B-4000 | Belgium |
| Pfizer Investigational Site | Yvoir | 5530 | Belgium |
| Pfizer Investigational Site | Hamilton | Ontario | L8N 3Z5 | Canada |
| Pfizer Investigational Site | Hamilton | Ontario | L8N 4A6 | Canada |
| Pfizer Investigational Site | Québec | Quebec | G1R 2J6 | Canada |
| Pfizer Investigational Site | Brno | 656 91 | Czechia |
| Pfizer Investigational Site | Ostrava | 708 52 | Czechia |
| Pfizer Investigational Site | Prague | 100 34 | Czechia |
| Pfizer Investigational Site | Koebenhavn OE | 2100 | Denmark |
| Pfizer Investigational Site | Odense C | 5000 | Denmark |
| Pfizer Investigational Site | Amiens | France | 80054 | France |
| Pfizer Investigational Site | Bordeaux | France | 33076 | France |
| Pfizer Investigational Site | Clichy | France | 92110 | France |
| Pfizer Investigational Site | Lyon | France | 69433 | France |
| Pfizer Investigational Site | Marseille | France | 13385 | France |
| Pfizer Investigational Site | Montpellier | France | 34295 | France |
| Pfizer Investigational Site | Paris | France | 75877 | France |
| Pfizer Investigational Site | Villejuif | 94804 | France |
| Pfizer Investigational Site | Berlin | 10117 | Germany |
| Pfizer Investigational Site | Freiburg im Breisgau | 79106 | Germany |
| Pfizer Investigational Site | Wuppertal | 42283 | Germany |
| Pfizer Investigational Site | Kifissia | Athens | 14561 | Greece |
| Pfizer Investigational Site | Haidari | Attica | 12462 | Greece |
| Pfizer Investigational Site | Budapest | 1106 | Hungary |
| Pfizer Investigational Site | Budapest | 1125 | Hungary |
| Pfizer Investigational Site | Pisa | 56124 | Italy |
| Pfizer Investigational Site | Roma | 00161 | Italy |
| Pfizer Investigational Site | Roma | 00168 | Italy |
| Pfizer Investigational Site | Torino | 10143 | Italy |
| Pfizer Investigational Site | Udine | 33100 | Italy |
| Pfizer Investigational Site | Ede | 6716 RP | Netherlands |
| Pfizer Investigational Site | Rotterdam | 3083 AN | Netherlands |
| Pfizer Investigational Site | Krakow | 31-501 | Poland |
| Pfizer Investigational Site | Lodz | 90-153 | Poland |
| Pfizer Investigational Site | Coimbra | 3040-853 | Portugal |
| Pfizer Investigational Site | Lisbon | 1349-019 | Portugal |
| Pfizer Investigational Site | Porto | 4200-072 | Portugal |
| Pfizer Investigational Site | Porto | 4200-319 | Portugal |
| Pfizer Investigational Site | Iași | Iaşi | 700111 | Romania |
| Pfizer Investigational Site | Bucharest | 022328 | Romania |
| Pfizer Investigational Site | Moscow | 115478 | Russia |
| Pfizer Investigational Site | Moscow | 121552 | Russia |
| Pfizer Investigational Site | Moscow | 125167 | Russia |
| Pfizer Investigational Site | Saint Petersburg | 191015 | Russia |
| Pfizer Investigational Site | Saint Petersburg | 194291 | Russia |
| Pfizer Investigational Site | Bratislava | 033 10 | Slovakia |
| Pfizer Investigational Site | Bratislava | 851 07 | Slovakia |
| Pfizer Investigational Site | Košice | 041 66 | Slovakia |
| Pfizer Investigational Site | Görükle | Bursa | 16045 | Turkey (Türkiye) |
| Pfizer Investigational Site | Ankara | 06100 | Turkey (Türkiye) |
| Pfizer Investigational Site | Trabzon | 61080 | Turkey (Türkiye) |
| Pfizer Investigational Site | Dnipropetrovsk | 49600 | Ukraine |
| Pfizer Investigational Site | Donetsk | 84003 | Ukraine |
| Pfizer Investigational Site | Leeds | West Yorkshire | LS1 3EX | United Kingdom |
| Pfizer Investigational Site | Liverpool | L7 8XP | United Kingdom |
| Pfizer Investigational Site | London | SE5 9RS | United Kingdom |
| 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. |
| COMPLETED |
|
| NOT COMPLETED |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Anidulafungin | Anidulafungin: 200 milligrams (mg) Day 1, 100 mg once daily from Day 2 (minimum of 9 days, maximum of 41 days). After Day 10 option to treat with oral azole therapy (voriconazole or fluconazole) at a dose determined by local clinical practice up to a maximum of 56 days from Day 1. |
| 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 | Percentage of Participants With Global Treatment Response Success at End of Treatment | Global response based on combination of clinical and microbiological outcomes; success defined as clinical response of cure (resolution of signs and symptoms of Candida infection) or improvement (significant, but incomplete resolution of signs and symptoms of Candida infection) in conjunction with microbiological eradication (follow-up culture negative for Candida species) or presumed eradication (follow-up culture not available and clinical response of success). | Modified Intent-To-Treat (MITT) analysis set: all participants in the ITT population with confirmed diagnosis of candidemia or invasive candidiasis, documented within 96 hours prior to initiation of study treatment or 48 hours after commencing treatment. N excludes participants with missing or unknown global responses. | Posted | Number | 95% Confidence Interval | percentage of participants | End of Treatment (Day 14 to Day 56) |
|
|
| |||||||||||||||||||||||||
| Secondary | Percentage of Participants With Global Response Success at End of Intravenous Treatment (EOIVT) | Global response based on combination of clinical and microbiological outcomes; success defined as clinical response of cure (resolution of signs and symptoms of Candida infection) or improvement (significant, but incomplete resolution of signs and symptoms of Candida infection) in conjunction with microbiological eradication (follow-up culture negative for Candida species) or presumed eradication (follow-up culture not available and clinical response of success). | MITT; N excludes participants with missing or unknown global responses. | Posted | Number | 95% Confidence Interval | percentage of participants | EOIVT (Day 10 up to Day 42) |
|
| ||||||||||||||||||||||||||
| Secondary | Percentage of Participants With Global Response Success at 2 Weeks After End of Treatment | Global response based on combination of clinical and microbiological outcomes; success defined as clinical response of cure (resolution of signs and symptoms of Candida infection) or improvement (significant, but incomplete resolution of signs and symptoms of Candida infection) in conjunction with microbiological eradication (follow-up culture negative for Candida species) or presumed eradication (follow-up culture not available and clinical response of success). | MITT; N excludes participants with missing or unknown global responses. | Posted | Number | 95% Confidence Interval | percentage of participants | 2 weeks after End of Treatment (Day 14 + 14 up to Day 56 + 14) |
|
| ||||||||||||||||||||||||||
| Secondary | Percentage of Participants With Global Response Success 6 Weeks After End of Treatment | Global response based on combination of clinical and microbiological outcomes; success defined as clinical response of cure (resolution of signs and symptoms of Candida infection) or improvement (significant, but incomplete resolution of signs and symptoms of Candida infection) in conjunction with microbiological eradication (follow-up culture negative for Candida species) or presumed eradication (follow-up culture not available and clinical response of success). | MITT; N excludes participants with missing or unknown global responses. | Posted | Number | 95% Confidence Interval | percentage of participants | 6 weeks after End of Treatment (Day 14 + 42 up to Day 56 + 42) |
|
| ||||||||||||||||||||||||||
| Secondary | Time to First Negative Blood Culture | Negative blood culture defined as first negative culture that was not followed by a positive culture within the next 3 days (or 4 days if negative culture was observed on or after Day 10) from start of study medication until end of intravenous treatment (EOIVT). Time to first negative culture includes the first day of study medication. | MITT. N = participants who received a minimum of 3 days of dosing with anidulafungin, excluding participants who experienced invasive candidiasis either at baseline or while on anidulafungin and participants who did not have a first negative blood culture by EOIVT. | Posted | Mean | 95% Confidence Interval | days | Day 1 up to Day 42 |
|
| ||||||||||||||||||||||||||
| Secondary | Day 90 Survival | Percentage of participants known or assumed to be alive on Day 90. | MITT | Posted | Number | 95% Confidence Interval | percentage of participants | Day 90 |
|
| ||||||||||||||||||||||||||
| Secondary | Time to Successful Intensive Care Unit (ICU) Discharge | Time from start of study medication to successful ICU discharge (by end of treatment [EOT]), defined as being alive on the day after the EOT visit, not being in the ICU on the day after the EOT visit, and being classed as a global treatment success at EOT. | MITT. N = participants who had a successful ICU discharge. | Posted | Mean | 95% Confidence Interval | days | Day 1 up to Day 56 |
|
|
Not provided
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Anidulafungin | Anidulafungin: 200 milligrams (mg) Day 1, 100 mg once daily from Day 2 (minimum of 9 days, maximum of 41 days). After Day 10 option to treat with oral azole therapy (voriconazole or fluconazole) at a dose determined by local clinical practice up to a maximum of 56 days from Day 1. | 107 | 216 | 78 | 216 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Cardiac arrest | Cardiac disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Cardiac failure | Cardiac disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Cardiac failure acute | Cardiac disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Cardio-respiratory arrest | Cardiac disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Cardiopulmonary failure | Cardiac disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Cardiovascular disorder | Cardiac disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Myocardial infarction | Cardiac disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Tachycardia | Cardiac disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Gastrointestinal obstruction | Gastrointestinal disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Haematemesis | Gastrointestinal disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Ileus paralytic | Gastrointestinal disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Intestinal ischaemia | Gastrointestinal disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Intestinal obstruction | Gastrointestinal disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Pancreatic fistula | Gastrointestinal disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Pancreatic necrosis | Gastrointestinal disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Peritonitis | Gastrointestinal disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Rectal haemorrhage | Gastrointestinal disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Stress ulcer | Gastrointestinal disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Upper gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Chills | General disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Death | General disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Disease progression | General disorders | MedDRA 13.1 | Systematic Assessment |
| |
| General physical health deterioration | General disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Infusion related reaction | General disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Multi-organ disorder | General disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Multi-organ failure | General disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Sudden death | General disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Haemobilia | Hepatobiliary disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Hepatic failure | Hepatobiliary disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Hepatic haemorrhage | Hepatobiliary disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Pneumobilia | Hepatobiliary disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Abdominal abscess | Infections and infestations | MedDRA 13.1 | Systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA 13.1 | Systematic Assessment |
| |
| Fungaemia | Infections and infestations | MedDRA 13.1 | Systematic Assessment |
| |
| Lung infection pseudomonal | Infections and infestations | MedDRA 13.1 | Systematic Assessment |
| |
| Nosocomial infection | Infections and infestations | MedDRA 13.1 | Systematic Assessment |
| |
| Pancreas infection | Infections and infestations | MedDRA 13.1 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 13.1 | Systematic Assessment |
| |
| Post procedural infection | Infections and infestations | MedDRA 13.1 | Systematic Assessment |
| |
| Pseudomonal bacteraemia | Infections and infestations | MedDRA 13.1 | Systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA 13.1 | Systematic Assessment |
| |
| Septic embolus | Infections and infestations | MedDRA 13.1 | Systematic Assessment |
| |
| Septic shock | Infections and infestations | MedDRA 13.1 | Systematic Assessment |
| |
| Staphylococcal bacteraemia | Infections and infestations | MedDRA 13.1 | Systematic Assessment |
| |
| Urosepsis | Infections and infestations | MedDRA 13.1 | Systematic Assessment |
| |
| Graft thrombosis | Injury, poisoning and procedural complications | MedDRA 13.1 | Systematic Assessment |
| |
| Procedural complication | Injury, poisoning and procedural complications | MedDRA 13.1 | Systematic Assessment |
| |
| Vascular pseudoaneurysm | Injury, poisoning and procedural complications | MedDRA 13.1 | Systematic Assessment |
| |
| Wound dehiscence | Injury, poisoning and procedural complications | MedDRA 13.1 | Systematic Assessment |
| |
| Body temperature increased | Investigations | MedDRA 13.1 | Systematic Assessment |
| |
| International normalised ratio increased | Investigations | MedDRA 13.1 | Systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Acute myeloid leukaemia | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 13.1 | Systematic Assessment |
| |
| Bone neoplasm malignant | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 13.1 | Systematic Assessment |
| |
| Lymphoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 13.1 | Systematic Assessment |
| |
| Metastasis | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 13.1 | Systematic Assessment |
| |
| Oesophageal carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 13.1 | Systematic Assessment |
| |
| Pancreatic carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 13.1 | Systematic Assessment |
| |
| Cerebral ischaemia | Nervous system disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Convulsion | Nervous system disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Hemiparesis | Nervous system disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Nervous system disorder | Nervous system disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Neurological symptom | Nervous system disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Polyneuropathy | Nervous system disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Somnolence | Nervous system disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Renal failure | Renal and urinary disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Renal failure acute | Renal and urinary disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Urinary bladder haemorrhage | Renal and urinary disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Acute respiratory distress syndrome | Respiratory, thoracic and mediastinal disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Acute respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Bronchospasm | Respiratory, thoracic and mediastinal disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Hypoxia | Respiratory, thoracic and mediastinal disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Pneumothorax | Respiratory, thoracic and mediastinal disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Pulmonary oedema | Respiratory, thoracic and mediastinal disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Respiratory distress | Respiratory, thoracic and mediastinal disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Erythema | Skin and subcutaneous tissue disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Abdominal operation | Surgical and medical procedures | MedDRA 13.1 | Systematic Assessment |
| |
| Amputation revision | Surgical and medical procedures | MedDRA 13.1 | Systematic Assessment |
| |
| Debridement | Surgical and medical procedures | MedDRA 13.1 | Systematic Assessment |
| |
| Circulatory collapse | Vascular disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Haemorrhage | Vascular disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Shock | Vascular disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Shock haemorrhagic | Vascular disorders | MedDRA 13.1 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Tachycardia | Cardiac disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA 13.1 | Systematic Assessment |
|
In a change to the protocol, time to first negative blood/tissue culture will only concern time to first negative blood culture. Lack of regular tissue sampling meant that analysis of time to first tissue culture could not be meaningfully performed.
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 |
|---|---|
| D058365 | Candidiasis, Invasive |
| C536972 | Torulopsis |
| D058387 | Candidemia |
| C536777 | Systemic candidiasis |
| ID | Term |
|---|---|
| D002177 | Candidiasis |
| D009181 | Mycoses |
| D001423 | Bacterial Infections and Mycoses |
| 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 |
Not provided
Not provided
| ID | Term |
|---|---|
| D000077612 | Anidulafungin |
| D015725 | Fluconazole |
| D065819 | Voriconazole |
| ID | Term |
|---|---|
| D054714 | Echinocandins |
| D010456 | Peptides, Cyclic |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D014230 | Triazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
Not provided
Not provided
| Title | Measurements |
|---|---|
|
| ≥ 65 years |
|
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| Title | Denominators | Categories | ||||
|---|---|---|---|---|---|---|
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