Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
To collect and summarize information on the diagnosis, management, and clinical and mycological outcomes of patients with systemic fungal infections in order to better understand the effectiveness of antifungals in the treatment of Systemic Fungal Infections (SFI) in India.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| voriconazole | Drug | Patients must have received (in the Intensive Care Unit [ICU] at study entry) at least 1 day therapy with systemic antifungal agent for treatment of a proven or suspected fungal infection. The decision regarding choice of antifungal agent would lie with the treating physician and will necessarily precede and be independent of the decision to enroll a patient into the study. |
| Measure | Description | Time Frame |
|---|---|---|
| Diagnosis of Systemic Fungal Infection (SFI) | Evidence of clinical signs and symptoms of systemic fungal infection including: fever, hypotension, or radiological or microbiological evidence, as assessed by the investigator. | Up to 9 months |
| Management of SFI: Choice of Treatment | Number of participants treated with each antifungal therapy. Each participant may have recieved 1 or more treatments as deemed clinically necessary by the investigator. | Up to 9 months |
| Management of SFI: Reason for Selection of Antifungal Agent | Number of participants with reason for investigator's selection of particular antifungal therapy. | Up to 9 months |
| Total Daily Dose for Selected Antifungal Agent | Up to 9 months | |
| Number of Participants With Clinical Outcomes. | Clinical outcomes, as assessed by the investigator, defined as: Cured: clinical signs and symptoms of fungal infection absent. Improved: clinical signs and symptoms of fungal infection improved. Stable: no change in overall clinical findings, compared with previous reporting period. Deteriorated: clinical signs and symptoms of fungal infection worsened (including death). Indeterminate; clinical signs and symptoms of fungal infection were insufficient to make an evaluation. | Up to 9 months |
| Number of Participants With Mycological Outcomes | Mycological outcome of persistence (continued presence of fungi on microbiology despite therapy), eradication (absence of fungi after therapy ), or unknown (results are not available/not known) as assessed by the Investigator/Physician. |
| Measure | Description | Time Frame |
|---|---|---|
| Concomitant Medications | Up to 9 months | |
| Median Duration of Antifungal Therapy | Up to 9 months | |
| Medication Administration |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
A database of outcomes in patients with proven or probable Systemic Fungal Infections (SFI) treated with antifungals in 5 centers across India.
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pfizer Investigational Site | Pune | Maharashtra | 411 001 | India | ||
| Pfizer Investigational Site |
Not provided
| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Voriconazole Antifungal Treatment | Systemic antifungals were administered based on approved prescribing documents and were adjusted solely according to medical and therapeutic necessity. The choice of systemic antifungal agent was dependent on the investigators decision and was independent of enrollment into the study. |
| FG001 | Other Antifungal Treatment | Systemic antifungals were administered based on approved prescribing documents and were adjusted solely according to medical and therapeutic necessity. The choice of systemic antifungal agent was dependent on the investigators decision and was independent of enrollment into the study. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Entire Study Population | Systemic antifungals were administered based on approved prescribing documents and were adjusted solely according to medical and therapeutic necessity. The choice of systemic antifungal agent was dependent on the investigators decision and was independent of enrollment into the study |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of 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 | Diagnosis of Systemic Fungal Infection (SFI) | Evidence of clinical signs and symptoms of systemic fungal infection including: fever, hypotension, or radiological or microbiological evidence, as assessed by the investigator. | Full analysis set (FAS) = all enrolled participants who received at least one dose of antifungal therapy. n = number of participants who had microbiological assessments performed. SOT = start of treatment, EOT = end of treatment | Posted | Number | Participants | Up to 9 months |
|
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 | Therapy for Systemic Fungal Infections | Systemic antifungals were administered based on approved prescribing documents and were adjusted solely according to medical and therapeutic necessity. The choice of systemic antifungal agent was dependent on the investigators decision and was independent of enrollment into the study |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pancreatitis | Gastrointestinal disorders | MedDRA v12.1 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Vomiting | Gastrointestinal disorders | MedDRA v12.1 | Systematic Assessment |
Primary and Secondary outcome measured were arbitrarily defined as they were not defined in the protocol.
This study was terminated prematurely due to slow recruitment rate leading to a small (23) number of subjects analyzed.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Pfizer ClinicalTrials.gov Call Center | Pfizer, Inc. | 1-800-718-1021 | ClinicalTrials.gov_Inquiries@pfizer.com |
Not provided
| ID | Term |
|---|---|
| D065819 | Voriconazole |
| ID | Term |
|---|---|
| D014230 | Triazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
|
| Up to 9 months |
Participants who received medication by IV or oral administration, reported by total number of participants receiving IV and total number of participants receiving oral administation (overall), and by total number of participants receiving voriconazole only by IV or oral administration. |
| Up to 9 months |
| Pune |
| Maharashtra |
| 411004 |
| India |
| Pfizer Investigational Site | New Delhi | New Delhi | 110 076 | India |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
|
|
| Primary | Management of SFI: Choice of Treatment | Number of participants treated with each antifungal therapy. Each participant may have recieved 1 or more treatments as deemed clinically necessary by the investigator. | FAS. | Posted | Number | Participants | Up to 9 months |
|
|
|
| Primary | Management of SFI: Reason for Selection of Antifungal Agent | Number of participants with reason for investigator's selection of particular antifungal therapy. | FAS. Data were not analyzed. | Posted | Number | Participants | Up to 9 months |
|
|
| Primary | Total Daily Dose for Selected Antifungal Agent | FAS. Data were not analyzed. | Posted | Number | mg | Up to 9 months |
|
|
| Primary | Number of Participants With Clinical Outcomes. | Clinical outcomes, as assessed by the investigator, defined as: Cured: clinical signs and symptoms of fungal infection absent. Improved: clinical signs and symptoms of fungal infection improved. Stable: no change in overall clinical findings, compared with previous reporting period. Deteriorated: clinical signs and symptoms of fungal infection worsened (including death). Indeterminate; clinical signs and symptoms of fungal infection were insufficient to make an evaluation. | FAS. | Posted | Number | Participants | Up to 9 months |
|
|
|
| Primary | Number of Participants With Mycological Outcomes | Mycological outcome of persistence (continued presence of fungi on microbiology despite therapy), eradication (absence of fungi after therapy ), or unknown (results are not available/not known) as assessed by the Investigator/Physician. | FAS. | Posted | Number | Participants | Up to 9 months |
|
|
|
| Secondary | Concomitant Medications | FAS. | Posted | Number | Participants | Up to 9 months |
|
|
|
| Secondary | Median Duration of Antifungal Therapy | FAS. | Posted | Median | Full Range | Days | Up to 9 months |
|
|
|
| Secondary | Medication Administration | Participants who received medication by IV or oral administration, reported by total number of participants receiving IV and total number of participants receiving oral administation (overall), and by total number of participants receiving voriconazole only by IV or oral administration. | FAS. | Posted | Number | Participants | Up to 9 months |
|
|
|
| 5 |
| 23 |
| 3 |
| 23 |
| Multi-organ failure | General disorders | MedDRA v12.1 | Systematic Assessment |
|
| Sepsis | Infections and infestations | MedDRA v12.1 | Systematic Assessment |
|
| Septic shock | Infections and infestations | MedDRA v12.1 | Systematic Assessment |
|
| Coma | Nervous system disorders | MedDRA v12.1 | Systematic Assessment |
|
| Somnolence | Nervous system disorders | MedDRA v12.1 | Systematic Assessment |
|
| Azotaemia | Renal and urinary disorders | MedDRA v12.1 | Systematic Assessment |
|
| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | MedDRA v12.1 | Systematic Assessment |
|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA v12.1 | Systematic Assessment |
|
| Urinary incontinence | Renal and urinary disorders | MedDRA v12.1 | Systematic Assessment |
|
| Decubitus ulcer | Skin and subcutaneous tissue disorders | MedDRA v12.1 | Systematic Assessment |
|
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 | Measurements |
|---|---|
|
| Amphotericine B, liposome |
|
| Amphotericin B |
|
| Caspofungin |
|
| Title | Measurements |
|---|
|
| Deteriorated |
|
| Title | Measurements |
|---|---|
|
| Not Recorded |
|
| Acetylsalicylic acid/clopidogrel |
|
| Aciclovir |
|
| Allopurinol |
|
| Ambroxol |
|
| Ambroxol Hydrochloride |
|
| Amikacin |
|
| Amiodarone Hydrochloride |
|
| Amlodipine |
|
| Atorvastatin |
|
| Atracurium |
|
| B-Komplex "Leciva" |
|
| Breva |
|
| Budesonide |
|
| Carvedilol |
|
| Cefazolin |
|
| Cefepime |
|
| Cefotaxime |
|
| Cefotaxime/sulbactam |
|
| Ciprofloxacin |
|
| Clindamycin |
|
| Clopidogrel |
|
| Colistin mesilate sodium |
|
| Cordalin/old form/ |
|
| Deflazacort |
|
| Diltiazem hydrochloride |
|
| Doripenem |
|
| Doxofylline |
|
| Enalapril maleate |
|
| Enoxaparin |
|
| Epoetin alfa |
|
| Escitalopram |
|
| Esomeprazole |
|
| Esomeprazole magnesium |
|
| Ethambutol |
|
| Fludrocortisone |
|
| Fluoxetine hydrochloride |
|
| Folic acid |
|
| Folinic acid |
|
| Furosemide |
|
| Granulocyte colony stimulating factor |
|
| Haloperidol |
|
| Heparin-fraction, sodium salt |
|
| Hydrocortisone |
|
| Hydrocortisone hydrogen succinate |
|
| Imipenem |
|
| Immunoglobulins |
|
| Insulin glargine |
|
| Isoniazid |
|
| Lactulose |
|
| Lekovit ca |
|
| Levetiracetam |
|
| Levocetirizine |
|
| Levofloxacin |
|
| Linezolid |
|
| Meropenem |
|
| Methylprednisolone |
|
| Metoclopramide hydrochloride |
|
| Metronidazole |
|
| Moxifloxacin |
|
| Mycophenolate mofetil |
|
| Ofloxacin |
|
| Ondansetron |
|
| Pantoprazole |
|
| Pantoprazole sodium |
|
| Paracetamol |
|
| Pazufloxacin |
|
| Pheniramine maleate |
|
| Phenobarbital |
|
| Phenytoin sodium |
|
| Pip/tazo |
|
| Piperacillin |
|
| Piperacillin/tazobactam |
|
| Polybion |
|
| Polymyxin B |
|
| Polymyxin B sulfate |
|
| Potassium |
|
| Prednisolone |
|
| Primaxin |
|
| Propylthiouracil |
|
| Prulifloxacin |
|
| Pyridoxine |
|
| Ramipril |
|
| Ranolazine |
|
| Ribolac |
|
| Sertraline |
|
| Simvastatin |
|
| Solifenacin |
|
| Sulperazon |
|
| Teicoplanin |
|
| Tienam |
|
| Tramadol |
|
| Valproic acid |
|
| Vancomycin |
|
| Vancomycin hydrochloride |
|
| Vitamin B-complex |
|
| Vitamin B12 (cyanocobalamin and derivatives) |
|
| Title | Measurements |
|---|---|
|
| Voriconazole Oral |
|