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Evaluate the Safety and Efficacy of Caspofungin Acetate as Empirical Therapy in Chinese Adults With Persistent Fever and Neutropenia (0991-055)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00548080
Recruitment Status : Completed
First Posted : October 23, 2007
Last Update Posted : December 17, 2015
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
Registration study

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

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 131 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : March 2006
Primary Completion Date : November 2006
Study Completion Date : November 2006

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fever
U.S. FDA Resources

Arms and Interventions


Outcome Measures

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

Secondary Outcome Measures :
  1. The proportion of caspofungin-treated patients with a favorable efficacy response at the end of caspofungin study therapy

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00548080


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

Additional Information:
Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00548080     History of Changes
Other Study ID Numbers: 0991-055
2007_032
First Posted: October 23, 2007    Key Record Dates
Last Update Posted: December 17, 2015
Last Verified: December 2015

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