A Study Of Indian Patients Receiving Therapy For Systemic Fungal Infections

Systemic Fungal Infections Clinical Trial

Official title:

An Observational Study Of Patients Receiving Therapy For Systemic Fungal Infections

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00721578
• Other study ID #: A1501089
• Status: Completed
• Phase: N/A
• First received: July 22, 2008
• Last updated: January 6, 2011
• Start date: April 2009
• Est. completion date: December 2009

Study information

• Verified date: January 2011
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Health authority: India: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 23
• Est. completion date: December 2009
• Est. primary completion date: December 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• To be eligible for enrollment in the study database, 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.

Exclusion Criteria:

Study Design

Time Perspective: Prospective

Related Conditions & MeSH terms

• Communicable Diseases
• Infection
• Mycoses
• Systemic Fungal Infections

Intervention

Drug:
• voriconazole
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.

Locations

Country	Name	City	State
India	Pfizer Investigational Site	New Delhi
India	Pfizer Investigational Site	Pune	Maharashtra
India	Pfizer Investigational Site	Pune	Maharashtra

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
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.	Up to 9 months	No
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.	Up to 9 months	No
Primary	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	No
Primary	Total Daily Dose for Selected Antifungal Agent		Up to 9 months	No
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.	Up to 9 months	No
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.	Up to 9 months	No
Secondary	Concomitant Medications		Up to 9 months	Yes
Secondary	Median Duration of Antifungal Therapy		Up to 9 months	Yes
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.	Up to 9 months	Yes

External Links

•   To obtain contact information for a study center near you, click here.