A Study Of Indian Patients Receiving Therapy For Systemic Fungal Infections

NCT00721578

Last updated date
Study Location
Pfizer Investigational Site
Pune, Maharashtra, 411 001, India
Contact
1-800-718-1021

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Systemic Fungal Infections
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18-75 years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- None.

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Systemic Fungal InfectionsA Study Of Indian Patients Receiving Therapy For Systemic Fungal Infections
NCT00721578
  1. Pune, Maharashtra
  2. Pune, Maharashtra
  3. New Delhi,
ALL GENDERS
18 Years+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
Brief Title A Study Of Indian Patients Receiving Therapy For Systemic Fungal Infections
Official Title An Observational Study Of Patients Receiving Therapy For Systemic Fungal Infections
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.
Detailed Description Not Provided
Study Type Observational
Study Design Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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.
Condition 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.
Other Name: Vfend
Study Groups/Cohorts 1
Intervention: Drug: voriconazole
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: January 28, 2010)
23
Original Estimated Enrollment
 (submitted: July 23, 2008)
200
Actual Study Completion Date December 2009
Actual Primary Completion Date December 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria

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:

  • None.
Sex/Gender
Sexes Eligible for Study:All
Ages 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries India
Removed Location Countries  
 
Administrative Information
NCT Number NCT00721578
Other Study ID Numbers A1501089
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Director, Clinical Trial Disclosure Group, Pfizer, Inc.
Study Sponsor Pfizer
Collaborators Not Provided
Investigators
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account Pfizer
Verification Date January 2011