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

Fungal Infection Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00548080
• Other study ID #: 0991-055
• Secondary ID: 2007_032
• Status: Completed
• Phase: Phase 3
• First received: October 19, 2007
• Last updated: December 16, 2015
• Start date: March 2006
• Est. completion date: November 2006

Study information

• Verified date: December 2015
• Source: Merck Sharp & Dohme Corp.
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

Registration study

Recruitment information / eligibility

• Status: Completed
• Enrollment: 131
• Est. completion date: November 2006
• Est. primary completion date: November 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Fungal Infection
• Mycoses
• Neutropenia

Intervention

Drug:
• MK0991, caspofungin acetate / Duration of Treatment:

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Merck Sharp & Dohme Corp.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The proportion of caspofungin-treated patients with SAE
Secondary	The proportion of caspofungin-treated patients with a favorable efficacy response at the end of caspofungin study therapy

External Links

•   (MedWatch - FDA maintained medical product safety Information)
•   (Merck: Patient & Caregiver U.S. Product Web Site)