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

Merck Sharp & Dohme (MSD)

Status and phase: Completed; Phase 3

Conditions: Fungal Infection

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

Study type: Interventional

Funder types: Industry

Identifiers

NCT00548080

0991-055

2007_032

Details and patient eligibility

About

Registration study

Enrollment: 131 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)