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Trial record 20 of 799 for:    Clotrimazole AND Fungal Infections

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

Tracking Information
First Submitted Date July 22, 2008
First Posted Date July 24, 2008
Results First Submitted Date July 28, 2010
Results First Posted Date August 26, 2010
Last Update Posted Date January 10, 2011
Study Start Date April 2009
Actual Primary Completion Date December 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: January 6, 2011)
  • 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.
  • 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.
  • 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.
  • Total Daily Dose for Selected Antifungal Agent [ Time Frame: Up to 9 months ]
  • 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.
  • 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.
Original Primary Outcome Measures
 (submitted: July 23, 2008)
  • Diagnosis: Evidence of SFI (clinical features, radiological evidence, microbiological evidence), end organ dysfunction (if any) [ Time Frame: 01 year ]
  • Management: Choice of treatment, dose and reason for selection of antifungal [ Time Frame: 01 year ]
  • Clinical and mycological outcomes [ Time Frame: 01 year ]
Change History
Current Secondary Outcome Measures
 (submitted: July 29, 2010)
  • Concomitant Medications [ Time Frame: Up to 9 months ]
  • Median Duration of Antifungal Therapy [ Time Frame: Up to 9 months ]
  • 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.
Original Secondary Outcome Measures
 (submitted: July 23, 2008)
  • demography data [ Time Frame: 06 months ]
  • safety data (adverse events, concomitant medication, treatment administration details) [ Time Frame: 01 year ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
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 Center Pfizer
PRS Account Pfizer
Verification Date January 2011