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OpenTrials
Completed

NCT Number: NCT00076869

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

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.

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Key information

Conditions

Aspergillosis Bacterial Infections and Mycoses Infections Mycoses

Age range

16 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

About this study

The duration of treatment is 12 months.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

  • Patients must meet a specific definition of probable or definite invasive aspergillosis and be considered to have failed or be intolerant of standard antifungal therapy.
  • The patient must be at least 16 years old and if a woman of childbearing potential, must have a negative serum or urine pregnancy test sensitive to 25 IU hCG prior to enrollment.

Treatment and study plan

MK0991, caspofungin acetate

Drug

Comparator: amphotericin B

Drug

Comparator: lipid formulation of amphotericin B and/or azole

Drug

Primary outcomes

  1. Tolerability.

Secondary outcomes

  1. Clinical response

Sponsors and collaborators

Lead sponsor

Merck Sharp & Dohme LLC

Industry

Registry information

Official study title

A Multicenter, Open, Noncomparative Study to Estimate the Safety, Tolerability, and Efficacy of MK0991 in Combination With Amphotericin B, Lipid Formulations of Amphotericin B, or Azoles in the Treatment of Invasive Aspergillus Infection in Adults Who Are Refractory to or Intolerant of Standard Therapy

Important dates

Study start
2003
Primary completion
2004
Study completion
2005
First posted
Feb 6, 2004
Registry last updated
Jan 13, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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