CompletedNot Applicable

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

330 participantsStarted 1997-03

Plain-language 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.

Who can participate

Age range13 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Trial details

NCT IDNCT00230243

SponsorMerck Sharp & Dohme LLC

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2002-09

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