Back to resultsEvaluate the Safety and Efficacy of Caspofungin Acetate as Empirical Therapy in Chinese Adults With Persistent Fever and Neutropenia (0991-055)
Primary Purpose
Fungal Infection
Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
MK0991, caspofungin acetate / Duration of Treatment:
Sponsored by
About this trial
This is an interventional treatment trial for Fungal Infection
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
Sites / Locations
Outcomes
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
Full Information
NCT ID
NCT00548080
First Posted
October 19, 2007
Last Updated
December 16, 2015
Sponsor
Merck Sharp & Dohme LLC
1. Study Identification
Unique Protocol Identification Number
NCT00548080
Brief Title
Evaluate the Safety and Efficacy of Caspofungin Acetate as Empirical Therapy in Chinese Adults With Persistent Fever and Neutropenia (0991-055)
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 Type
Interventional
2. Study Status
Record Verification Date
December 2015
Overall Recruitment Status
Completed
Study Start Date
March 2006 (undefined)
Primary Completion Date
November 2006 (Actual)
Study Completion Date
November 2006 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Merck Sharp & Dohme LLC
4. Oversight
5. Study Description
Brief Summary
Registration study
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fungal Infection
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
131 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
MK0991, caspofungin acetate / Duration of Treatment:
Primary Outcome Measure Information:
Title
The proportion of caspofungin-treated patients with SAE
Secondary Outcome Measure Information:
Title
The proportion of caspofungin-treated patients with a favorable efficacy response at the end of caspofungin study therapy
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Monitor
Organizational Affiliation
Merck Sharp & Dohme LLC
Official's Role
Study Director
12. IPD Sharing Statement
Learn more about this trial
Evaluate the Safety and Efficacy of Caspofungin Acetate as Empirical Therapy in Chinese Adults With Persistent Fever and Neutropenia (0991-055)
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