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

This study has been completed.
Sponsor:
Information provided by:
Merck
ClinicalTrials.gov Identifier:
NCT00548080
First received: October 19, 2007
Last updated: February 28, 2008
Last verified: February 2008
History of Changes
  Purpose

Registration study


Condition Intervention Phase
Fungal Infection
 Drug: MK0991, caspofungin acetate / Duration of Treatment:
 Phase 3

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 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Merck:

Primary Outcome Measures:
  • The proportion of caspofungin-treated patients with SAE

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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

Additional Information:
(MedWatch - FDA maintained medical product safety Information)  This link exits the ClinicalTrials.gov site
(Merck: Patient & Caregiver U.S. Product Web Site)  This link exits the ClinicalTrials.gov site

No publications provided

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

Additional relevant MeSH terms:
Mycoses
Neutropenia
Agranulocytosis
Leukopenia
Leukocyte Disorders
Hematologic Diseases
 Caspofungin
Echinocandins
Antifungal Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 23, 2013