Evaluate the Safety and Efficacy of Caspofungin Acetate as Empirical Therapy in Chinese Adults With Persistent Fever and Neutropenia

This study has been completed.

Sponsored by:	Merck
Information provided by:	Merck
ClinicalTrials.gov Identifier:	NCT00548080

Purpose

Registration study

Condition	Intervention	Phase
Fungal Infection	Drug: MK0991, caspofungin acetate / Duration of Treatment:	Phase III

MedlinePlus related topics: Fever Fungal Infections

Drug Information available for: Caspofungin Caspofungin Acetate

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Official Title:	A Non-Comparative, Multicenter, Open-Label, Study to Evaluate the Safety and Efficacy of Caspofungin Acetate as Empirical Therapy in Chinese Adults With Persistent Fever and Neutropenia

Further study details as provided by Merck:

Primary Outcome Measures:

Secondary Outcome Measures:

The proportion of caspofungin-treated patients with a favorable efficacy response at the end of caspofungin study therapy

Enrollment:	131
Study Start Date:	March 2006
Primary Completion Date:	November 2006 (Final data collection date for primary outcome measure)

Eligibility

Criteria

Inclusion Criteria:

Patient has had an absolute neutrophil count < 500/mm3 for at least 96 hours (the patient must not be expected to recover from neutropenia in the next 48 hours), and has received at least 96 hours of parenteral broad spectrum systemic antibacterial therapy preceding study entry, and patient has fever >38.0 Degrees Centigrade within the last 24 hours prior to study entry
- Appropriate antibiotics are those that provide broad spectrum gram-positive and gram-negative coverage

Exclusion Criteria:

Patient has an inadequately managed bacterial infection at the time of enrollment

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00548080

Sponsors and Collaborators

Merck

Investigators

Study Director:

Medical Monitor

Merck

More Information

(Merck: Patient & Caregiver U.S. Product Web Site) This link exits the ClinicalTrials.gov site

Study ID Numbers:	2007_032
Study First Received:	October 19, 2007
Last Updated:	February 28, 2008
ClinicalTrials.gov Identifier:	NCT00548080
Health Authority:	China: State Food and Drug Administration

Study placed in the following topic categories:

Echinocandins
Hematologic Diseases
Clotrimazole
Miconazole
Caspofungin
Agranulocytosis
Tioconazole

Leukocyte Disorders
Granulocytopenia
Fever
Mycoses
Neutropenia
Leukopenia

Additional relevant MeSH terms:

Anti-Infective Agents
Therapeutic Uses
Antifungal Agents
Infection
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 15, 2009