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

Phase 3

Completed

• Conditions: Fungal Infection

• Registration Number: NCT00548080
• Lead Sponsor: Merck Sharp & Dohme LLC

Brief Summary

Registration study

Detailed Description

Not available

Study Timeline

• Study Start: 2006-03
• Primary Completion: 2006-11
• Study Completion: 2006-11
• Study First Submitted: 2007-10-19
• Study First Submitted QC: 2007-10-22
• Study First Posted: 2007-10-23
• Status Verified: 2015-12
• Last Update Submitted: 2015-12-16
• Last Update Posted: 2015-12-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 131

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

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Exclusion Criteria

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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
The proportion of caspofungin-treated patients with SAE

Secondary Outcome Measures

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