A Study Of Indian Patients Receiving Therapy For Systemic Fungal Infections

NCT00721578 | Completed Results

• 1 other identifier: A1501089
• Study Type: observational
• Target: 23
• Locations: 1 country
• Sites: 3

Brief 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.

Conditions

Systemic Fungal Infections

Keywords

Observational study; Effectiveness; Safety; Tolerability; Systemic Fungal Infection

Outcome Measures

Primary Outcomes (6)

• 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.

  Up to 9 months

Secondary Outcomes (3)

• Concomitant Medications

  Up to 9 months

• Median Duration of Antifungal Therapy

  Up to 9 months

• Medication Administration

  Up to 9 months

Study Arms (1)

1

Drug: voriconazole

Interventions

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.

Also known as: Vfend

1

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

A database of outcomes in patients with proven or probable Systemic Fungal Infections (SFI) treated with antifungals in 5 centers across India.

You may qualify if:

• 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.

You may not qualify if:

• None.

Sponsors & Collaborators

• Pfizer: lead

Study Sites (3)

Pfizer Investigational Site

Pune, Maharashtra, 411 001, India

Location

Pfizer Investigational Site

Pune, Maharashtra, 411004, India

Location

Pfizer Investigational Site

New Delhi, New Delhi, 110 076, India

Location

Related Links

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

MeSH Terms

Interventions

Voriconazole

Intervention Hierarchy (Ancestors)

Triazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Limitations and Caveats

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.

Results Point of Contact

• Title: Pfizer ClinicalTrials.gov Call Center
• Organization: Pfizer, Inc.

ClinicalTrials.gov_Inquiries@pfizer.com

1-800-718-1021

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: July 22, 2008
• First Posted: July 24, 2008
• Study Start: April 1, 2009
• Primary Completion: December 1, 2009
• Study Completion: December 1, 2009
• Last Updated: January 10, 2011
• Results First Posted: August 26, 2010

Record last verified: 2011-01

Locations

IN (3)