An Observational Study Of Patients Receiving Therapy For Systemic Fungal Infections - Full Text View

Sponsor:	Pfizer
Information provided by:	Pfizer
ClinicalTrials.gov Identifier:	NCT00721578

Purpose

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 SFI in India.

Condition	Intervention	Phase
Systemic Fungal Infections	Drug: voriconazole	Phase IV

Study Type:	Observational
Study Design:	Prospective
Official Title:	A Study Of Indian Patients Receiving Therapy For Systemic Fungal Infections

Resource links provided by NLM:

MedlinePlus related topics: Fungal Infections Molds

Drug Information available for: Voriconazole

U.S. FDA Resources

Further study details as provided by Pfizer:

Primary Outcome Measures:

Clinical and mycological outcomes [ Time Frame: 1 year ] [ Designated as safety issue: No ]
Management: Choice of treatment, dose and reason for selection of antifungal [ Time Frame: 1 year ] [ Designated as safety issue: No ]
Diagnosis: Evidence of SFI (clinical features, radiological evidence, microbiological evidence), end organ dysfunction (if any) [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

demography data [ Time Frame: 6 months ] [ Designated as safety issue: No ]
safety data (adverse events, concomitant medication, treatment administration details) [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]

Biospecimen Retention: None Retained

Biospecimen Description:

Enrollment:	23
Study Start Date:	April 2009
Study Completion Date:	December 2009
Primary Completion Date:	December 2009 (Final data collection date for primary outcome measure)

Groups/Cohorts	Assigned Interventions
1	Drug: voriconazole Patients must have received (in the 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.

Eligibility

Ages Eligible for Study:	18 Years to 75 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No
Sampling Method:	Probability Sample

Study Population

A database of outcomes in patients with proven or probable SFI treated with antifungals in 5 centers across India.

Criteria

Inclusion Criteria:

To be eligible for enrollment in the study database, patients must have received (in the ICU at study entry) at least 1 day therapy with systemic antifungal agent for treatment of a proven or suspected fungal infection.

Exclusion Criteria:

None

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00721578

Locations

India
Pfizer Investigational Site
New Delhi, India, 110 076
India, Maharashtra
Pfizer Investigational Site
Pune, Maharashtra, India, 411004
Pfizer Investigational Site
Pune, Maharashtra, India, 411 001

Sponsors and Collaborators

Pfizer

Investigators

Study Director:

Pfizer CT.gov Call Center

Pfizer

More Information

Additional Information:

To obtain contact information for a study center near you, click here. This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Pfizer, Inc. ( Director, Clinical Trial Disclosure Group )
Study ID Numbers:	A1501089
Study First Received:	July 22, 2008
Last Updated:	January 28, 2010
ClinicalTrials.gov Identifier:	NCT00721578 History of Changes
Health Authority:	India: Institutional Review Board

Keywords provided by Pfizer:

Observational study
Effectiveness
Safety
Tolerability
Systemic Fungal Infection

Additional relevant MeSH terms:

Anti-Infective Agents
Mycoses
Communicable Diseases
Therapeutic Uses

Antifungal Agents
Voriconazole
Infection
Pharmacologic Actions

ClinicalTrials.gov processed this record on February 08, 2010