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

Sponsor:	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:	Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
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:

MedlinePlus related topics: Aspergillosis

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.

ClinicalTrials.gov Identifier:	NCT00076869 History of Changes
Other Study ID Numbers:	2006_400, Formally-0121FI, MK0991-037
Study First Received:	February 5, 2004
Last Updated:	January 14, 2010
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.

Additional relevant MeSH terms:

Aspergillosis
Mycoses
Amphotericin B
Liposomal amphotericin B
Antifungal Agents
Caspofungin
Echinocandins

Amebicides
Antiprotozoal Agents
Antiparasitic Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Anti-Bacterial Agents

ClinicalTrials.gov processed this record on February 09, 2012