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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00230243
First received: September 28, 2005
Last updated: September 9, 2015
Last verified: September 2015
  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: 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:


Further study details as provided by Merck Sharp & Dohme Corp.:

Estimated Enrollment: 330
Study Start Date: March 1997
Study Completion Date: September 2002
Primary Completion Date: September 2002 (Final data collection date for primary outcome measure)
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   (Child, Adult, Senior)
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:

  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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

No Contacts or Locations Provided
  More Information

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00230243     History of Changes
Other Study ID Numbers: P02387 
Study First Received: September 28, 2005
Last Updated: September 9, 2015
Health Authority: United States: Food and Drug Administration

Keywords provided by Merck Sharp & Dohme Corp.:
Aspergillosis
CandidiasisMucormycosis
FusariosisCryptococcosis
Endemic Fungal infections
Phaeohyphomycosis

Additional relevant MeSH terms:
Infection
Communicable Diseases
Mycoses
Antifungal Agents
Miconazole
Anti-Infective Agents
14-alpha Demethylase Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Steroid Synthesis Inhibitors
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Cytochrome P-450 CYP2C9 Inhibitors
Cytochrome P-450 CYP3A Inhibitors

ClinicalTrials.gov processed this record on July 21, 2016