Status:
COMPLETED
Historical Control Study of Refractory IFI or Patients Intolerant to Standard Antifungal Therapy in Patients With Invasive Fungal Infections (Study P02387)
Lead Sponsor:
Merck Sharp & Dohme LLC
Conditions:
Infection, Invasive Fungal
Eligibility:
All Genders
13+ years
Brief Summary
This retrospective study is designed to provide a consistent method of screening and collecting data on patients who will serve as controls for a comparison of the efficacy of the available antifungal...
Detailed Description
The current clinical trial is designed to provide historicals controls comparable to the P00041 study population, that is, a) patients with invasive fungal infections which are refractory or resistant...
Eligibility Criteria
Inclusion
- Males and females of any race greater than or equal to 13 years of age
- Treatment for an IFI between April 30, 1996 and April 30, 2001 at one of the centers participating in P00041 or at other non-P00041 centers
- A diagnosis of proven or probable IFI based on MSG/EORTC criteria
- Refractory IFI or intolerence to standard therapy
- The date of diagnosis of an IFI will be the earliest date on which one or more of the following diagnostic procedures used to establish the diagnosis was performed:
- Fungal culture, histopathology, bronchoscopy, and autopsy report
- X-Rays, CT scan, MRI, ultrasound, and bone scan
- Serology
Exclusion
- Female subject who was pregnant or nursing at the time IFI was diagnosed
- Hepatic function tests: ALT or AST greater than 10 times the upper limit of normal at the time IFI was diagnosed
- Enrollment in P00041 for treatment of the IFI
- Patient with sarcoidosis, aspergilloma, or allergic bronchopulmonary aspergillosis
- Patients with chronic invasive aspergillosis (chronic necrotizing pulmonary aspergillosis)
- Patients with diagnosis of CMV pneumonia
- Patients with a diagnosis of pulmonary tuberculosis
- Death within 72 hours of the start of antifungal therapy
- Patients on artificial ventilation, who were not extubated within 24 hours of commencing standard antifungal therapy
Key Trial Info
Start Date :
March 1 1997
Trial Type :
OBSERVATIONAL
End Date :
September 1 2002
Estimated Enrollment :
330 Patients enrolled
Trial Details
Trial ID
NCT00230243
Start Date
March 1 1997
End Date
September 1 2002
Last Update
March 10 2017
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