NCT00721578|CompletedResults
A Study Of Indian Patients Receiving Therapy For Systemic Fungal Infections
An Observational Study Of Patients Receiving Therapy For Systemic Fungal Infections
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An Observational Study Of Patients Receiving Therapy For Systemic Fungal Infections
Sponsor study identifier
observational
23
1 country
3
Study Start
April 2009
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
December 2009
Actual (reported)Study Completion
December 2009
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 2009
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
July 22, 2008
Actual (reported)July 24, 2008
Actual (reported)April 2009
Date type not reportedThis date has not been verified as actual or estimated.
December 2009
Actual (reported)December 2009
Actual (reported)August 26, 2010
Actual (reported)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.
Concomitant Medications
Up to 9 months
Median Duration of Antifungal Therapy
Up to 9 months
Medication Administration
Up to 9 months
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.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
A database of outcomes in patients with proven or probable Systemic Fungal Infections (SFI) treated with antifungals in 5 centers across India.
Pfizer Investigational Site
Pune, Maharashtra, 411 001, India
Pfizer Investigational Site
Pune, Maharashtra, 411004, India
Pfizer Investigational Site
New Delhi, New Delhi, 110 076, India
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.
Pfizer CT.gov Call Center
Pfizer
23 participants (actual enrollment reported by the registry).
First Submitted
July 22, 2008
First Posted
July 24, 2008
Study Start
April 2009
Date type not reportedThis date has not been verified as actual or estimated.
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.
Up to 9 months
Contact the study team to confirm eligibility.
Primary Completion
December 2009
Actual (reported)Study Completion
December 2009
Actual (reported)Last Updated
January 10, 2011
Results First Posted
August 26, 2010
Record last verified: 2011-01
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
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