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A Study Of Indian Patients Receiving Therapy For Systemic Fungal Infections

Last updated on November 12, 2019

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Study Location
Pfizer Investigational Site
Pune, Maharashtra, 411 001 India
Contact
1-800-718-1021
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.
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- 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.
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NCT00721578
Pfizer
Completed
A Study Of Indian Patients Receiving Therapy For Systemic Fungal Infections

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Descriptive Information
Brief TitleA Study Of Indian Patients Receiving Therapy For Systemic Fungal Infections
Official TitleAn Observational Study Of Patients Receiving Therapy For Systemic Fungal Infections
Brief SummaryTo 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 DescriptionNot Provided
Study TypeObservational
Study DesignTime Perspective: Prospective
Target Follow-Up DurationNot Provided
BiospecimenNot Provided
Sampling MethodProbability Sample
Study PopulationA database of outcomes in patients with proven or probable Systemic Fungal Infections (SFI) treated with antifungals in 5 centers across India.
ConditionSystemic Fungal Infections
InterventionDrug: 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/Cohorts1
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 StatusCompleted
Actual Enrollment
 (submitted: January 28, 2010)
23
Original Estimated Enrollment
 (submitted: July 23, 2008)
200
Actual Study Completion DateDecember 2009
Actual Primary Completion DateDecember 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
Ages18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy VolunteersNo
ContactsContact information is only displayed when the study is recruiting subjects
Listed Location CountriesIndia
Removed Location Countries  
 
Administrative Information
NCT NumberNCT00721578
Other Study ID NumbersA1501089
Has Data Monitoring CommitteeNo
U.S. FDA-regulated ProductNot Provided
IPD Sharing StatementNot Provided
Responsible PartyDirector, Clinical Trial Disclosure Group, Pfizer, Inc.
Study SponsorPfizer
CollaboratorsNot Provided
Investigators
Study Director:Pfizer CT.gov Call CenterPfizer
PRS AccountPfizer
Verification DateJanuary 2011

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Contact a representative by phone, email, or visiting the study website. Please see the references below:

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Pfizer Clinical Trials Contact Center

1-800-718-1021

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Contact

[email protected]

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