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 Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00548080
First received: October 19, 2007
Last updated: February 28, 2008
Last verified: February 2008
  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:


Further study details as provided by Merck Sharp & Dohme Corp.:

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Sponsors and Collaborators
Merck Sharp & Dohme Corp.
Investigators
Study Director: Medical Monitor Merck Sharp & Dohme Corp.
  More Information

Additional Information:
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
Hematologic Diseases
Leukocyte Disorders
Leukopenia
Caspofungin
Echinocandins
Anti-Infective Agents
Antifungal Agents
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on October 23, 2014