MK0991 in Combination With Standard Antifungal Agent(s) for the Treatment of Salvage Invasive Aspergillosis (0991-037)

Phase 2

Completed

• Conditions: Aspergillosis

• Registration Number: NCT00076869
• Lead Sponsor: Merck Sharp & Dohme LLC

Brief Summary

Invasive aspergillosis is a type of fungal infection typically identified in very sick patients (for example, patients with cancer or who have had a bone marrow or organ transplant). This study will seek to enroll patients (16 years of age or older) with invasive aspergillosis infections (involving organs or deep tissues) who are failing or could not tolerate standard antifungal therapy. Your doctor will make this determination based upon specific study criteria. Patients that fulfill all study criteria will be treated daily with both the investigational drug and another antifungal agent. The choice of the other agent is up to your doctor. This investigational drug is approved for the treatment of invasive aspergillosis by itself. The safety and efficacy of this investigational drug, in combination with other agents is not known.

Detailed Description

The duration of treatment is 12 months.

Study Timeline

• Study Start: 2003-01
• Study First Submitted: 2004-02-05
• Study First Submitted QC: 2004-02-05
• Study First Posted: 2004-02-06
• Primary Completion: 2004-09
• Study Completion: 2005-08
• Status Verified: 2015-01
• Last Update Submitted: 2015-01-12
• Last Update Posted: 2015-01-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 55

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Tolerability.

Secondary Outcome Measures

Name	Time	Method
Clinical response