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

This study has been completed.

First Received on September 28, 2005. Last Updated on May 31, 2006 History of Changes

Sponsor:	Schering-Plough
Information provided by:	Schering-Plough
ClinicalTrials.gov Identifier:	NCT00230243

Purpose

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.

Condition
Infection, Invasive Fungal

Study Type:	Observational
Study Design:	Observational Model: Defined Population Observational Model: Natural History Time Perspective: Cross-Sectional Time Perspective: Retrospective
Official Title:	A Retrospective Study to Establish an Historical Database on the Efficacy of Standard Antifungal Therapy in Patients With Invasive Fungal Infections

Resource links provided by NLM:

MedlinePlus related topics: Fungal Infections Molds

U.S. FDA Resources

Further study details as provided by Schering-Plough:

Estimated Enrollment:	330
Study Start Date:	October 2001

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.

Eligibility

Ages Eligible for Study:	13 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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:

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

Contacts and Locations

No Contacts or Locations Provided

More Information

No publications provided

ClinicalTrials.gov Identifier:	NCT00230243 History of Changes
Other Study ID Numbers:	P02387
Study First Received:	September 28, 2005
Last Updated:	May 31, 2006
Health Authority:	United States: Food and Drug Administration

Keywords provided by Schering-Plough:

Aspergillosis
CandidiasisMucormycosis
FusariosisCryptococcosis
Endemic Fungal infections
Phaeohyphomycosis

Additional relevant MeSH terms:

Mycoses
Antifungal Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 21, 2012