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

March 7, 2017 updated by: Merck Sharp & Dohme LLC

A Retrospective Study to Establish an Historical Database on the Efficacy of Standard Antifungal Therapy in Patients With Invasive Fungal Infections

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.

Study Overview

Status

Completed

Conditions

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.

Study Type

Observational

Enrollment

330

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

13 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Merck Sharp & Dohme LLC

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 1997

Primary Completion (Actual)

September 1, 2002

Study Completion (Actual)

September 1, 2002

Study Registration Dates

First Submitted

September 28, 2005

First Submitted That Met QC Criteria

September 28, 2005

First Posted (Estimate)

September 30, 2005

Study Record Updates

Last Update Posted (Actual)

March 10, 2017

Last Update Submitted That Met QC Criteria

March 7, 2017

Last Verified

March 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • P02387

Plan for Individual participant data (IPD)

Study Data/Documents

  1. CSR Synopsis

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Infection, Invasive Fungal

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Finland

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe