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A Study Of Indian Patients Receiving Therapy For Systemic Fungal Infections

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00721578
Recruitment Status : Completed
First Posted : July 24, 2008
Results First Posted : August 26, 2010
Last Update Posted : January 10, 2011
Sponsor:
Information provided by:
Pfizer

Study Description
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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.

Condition or disease Intervention/treatment
Systemic Fungal Infections Drug: voriconazole

Study Design
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Study Type : Observational
Actual Enrollment : 23 participants
Time Perspective: Prospective
Official Title: An Observational Study Of Patients Receiving Therapy For Systemic Fungal Infections
Study Start Date : April 2009
Actual Primary Completion Date : December 2009
Actual Study Completion Date : December 2009

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Groups and Cohorts
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Group/Cohort Intervention/treatment
1 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


Outcome Measures
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Primary Outcome Measures :
  1. Diagnosis of Systemic Fungal Infection (SFI) [ Time Frame: Up to 9 months ]
    Evidence of clinical signs and symptoms of systemic fungal infection including: fever, hypotension, or radiological or microbiological evidence, as assessed by the investigator.

  2. Management of SFI: Choice of Treatment [ Time Frame: Up to 9 months ]
    Number of participants treated with each antifungal therapy. Each participant may have recieved 1 or more treatments as deemed clinically necessary by the investigator.

  3. Management of SFI: Reason for Selection of Antifungal Agent [ Time Frame: Up to 9 months ]
    Number of participants with reason for investigator's selection of particular antifungal therapy.

  4. Total Daily Dose for Selected Antifungal Agent [ Time Frame: Up to 9 months ]
  5. Number of Participants With Clinical Outcomes. [ Time Frame: Up to 9 months ]

    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.


  6. Number of Participants With Mycological Outcomes [ Time Frame: Up to 9 months ]

    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.



Secondary Outcome Measures :
  1. Concomitant Medications [ Time Frame: Up to 9 months ]
  2. Median Duration of Antifungal Therapy [ Time Frame: Up to 9 months ]
  3. Medication Administration [ Time Frame: Up to 9 months ]
    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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00721578


Locations
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India
Pfizer Investigational Site
Pune, Maharashtra, India, 411 001
Pfizer Investigational Site
Pune, Maharashtra, India, 411004
Pfizer Investigational Site
New Delhi, India, 110 076
Sponsors and Collaborators
Pfizer
Investigators
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Study Director: Pfizer CT.gov Call Center Pfizer
More Information
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Additional Information:

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Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer, Inc.
ClinicalTrials.gov Identifier: NCT00721578    
Other Study ID Numbers: A1501089
First Posted: July 24, 2008    Key Record Dates
Results First Posted: August 26, 2010
Last Update Posted: January 10, 2011
Last Verified: January 2011
Keywords provided by Pfizer:
Observational study
Effectiveness
Safety
Tolerability
Systemic Fungal Infection
Additional relevant MeSH terms:
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Infections
Communicable Diseases
Mycoses
Disease Attributes
Pathologic Processes
Bacterial Infections and Mycoses
Voriconazole
Antifungal Agents
Anti-Infective Agents
 14-alpha Demethylase Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Steroid Synthesis Inhibitors
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Cytochrome P-450 CYP3A Inhibitors