MK0991 in Combination With Standard Antifungal Agent(s) for the Treatment of Salvage Invasive Aspergillosis - Full Text View

Sponsored by:	Merck
Information provided by:	Merck
ClinicalTrials.gov Identifier:	NCT00076869

Purpose

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.

Condition	Intervention	Phase
Aspergillosis	Drug: MK0991, caspofungin acetate Drug: Comparator: amphotericin B Drug: Comparator: lipid formulation of amphotericin B and/or azole	Phase II

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Official 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

Resource links provided by NLM:

Drug Information available for: Lipids Caspofungin Caspofungin Acetate Amphotericin B

U.S. FDA Resources

Further study details as provided by Merck:

Primary Outcome Measures:

Tolerability.

Secondary Outcome Measures:

Clinical response

Estimated Enrollment:	50
Study Start Date:	January 2003

Detailed Description:

The duration of treatment is 12 months.

Eligibility

Ages Eligible for Study:	16 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00076869

Sponsors and Collaborators

Merck

Investigators

Study Director:

Medical Monitor

Merck

More Information

Publications:

Maertens J, Glasmacher A, Herbrecht R, Thiebaut A, Cordonnier C, Segal BH, Killar J, Taylor A, Kartsonis N, Patterson TF, Aoun M, Caillot D, Sable C; Caspofungin Combination Therapy Study Group. Multicenter, noncomparative study of caspofungin in combination with other antifungals as salvage therapy in adults with invasive aspergillosis. Cancer. 2006 Dec 15;107(12):2888-97.

Study ID Numbers:	2006_400, Formally-0121FI
Study First Received:	February 5, 2004
Last Updated:	May 17, 2007
ClinicalTrials.gov Identifier:	NCT00076869 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Merck:

Definite or probable Invasive Aspergillosis either refractory or intolerant to prior antifungal treatment.

Study placed in the following topic categories:

Abelcet
Anti-Bacterial Agents
Anti-Infective Agents
Amphotericin B
Mycoses

Antifungal Agents
Caspofungin
Aspergillosis
Liposomal amphotericin B

Additional relevant MeSH terms:

Abelcet
Amphotericin B
Anti-Infective Agents
Antiprotozoal Agents
Caspofungin
Aspergillosis
Liposomal amphotericin B
Pharmacologic Actions

Anti-Bacterial Agents
Mycoses
Antiparasitic Agents
Therapeutic Uses
Antifungal Agents
Antibiotics, Antifungal
Amebicides

ClinicalTrials.gov processed this record on August 30, 2009