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

Condition(s) targeted: Fungal Infection

Intervention: MK0991, caspofungin acetate / Duration of Treatment: (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Merck Sharp & Dohme Corp.

Official(s) and/or principal investigator(s):
Medical Monitor, Study Director, Affiliation: Merck Sharp & Dohme Corp.

Registration study

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

Primary outcome: The proportion of caspofungin-treated patients with SAE

Secondary outcome: The proportion of caspofungin-treated patients with a favorable efficacy response at the end of caspofungin study therapy

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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

(MedWatch - FDA maintained medical product safety Information)

(Merck: Patient & Caregiver U.S. Product Web Site)

Starting date: March 2006
Last updated: November 14, 2014