Historical Control Study of Refractory IFI or Patients Intolerant to Standard Antifungal Therapy in Patients With Invasive Fungal Infections (Study P02387)

NCT ID: NCT00230243

Last Updated: 2017-03-10

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 330 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 1997-03-31
• Study Completion Date: 2002-09-30

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 therapies used as salvage treatments for patients with refractory IFI or for patients with refractory IFI or for patients with IFI who are intolerant to standard antifungal therapies.

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 to standard antifungal therapies or b) patients who have developed intolerance to standard antifungal therapy. This clinical trial also serves to allow collection of historical data regarding the efficacy of available antifungal therapies against a variety of invasive fungal infections which although serious and life-threatening are sufficiently rare so that they cannot be studied in a controlled, randomized clinical trial.

This trial will be conducted primarily at the investigative sites that enrolled subjects into P00041 and/or investigators who are members of the Mycosis Study Group.

Conditions

Infection, Invasive Fungal

Study Design

• Study Time Perspective: RETROSPECTIVE

Eligibility Criteria

Inclusion Criteria

• 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 Criteria

1. Female subject who was pregnant or nursing at the time IFI was diagnosed

2. Hepatic function tests: ALT or AST greater than 10 times the upper limit of normal at the time IFI was diagnosed

3. Enrollment in P00041 for treatment of the IFI

4. Patient with sarcoidosis, aspergilloma, or allergic bronchopulmonary aspergillosis

5. Patients with chronic invasive aspergillosis (chronic necrotizing pulmonary aspergillosis)

6. Patients with diagnosis of CMV pneumonia

7. Patients with a diagnosis of pulmonary tuberculosis

8. Death within 72 hours of the start of antifungal therapy

9. Patients on artificial ventilation, who were not extubated within 24 hours of commencing standard antifungal therapy

• Minimum Eligible Age: 13 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Study Documents

Document Type: CSR Synopsis

View Document

Other Identifiers

P02387

Identifier Type: -

Identifier Source: org_study_id