A 28 - 90 Days Study to Evaluate the Safety, Tolerability, and Efficacy of Caspofungin Injection as Empirical Therapy in Indian Adults With Persistent Fever and Neutropenia (0991-053)(COMPLETED)

Merck Sharp & Dohme (MSD)

Status and phase: Completed; Phase 3

Conditions: Fungal Infection

Treatments: Drug: caspofungin acetate

Study type: Interventional

Funder types: Industry

Identifiers

NCT00379964

2006_037

0991-053

Details and patient eligibility

About

The purpose of this study is to evaluate the safety, tolerability and efficacy of ertapenem sodium as initial therapy for the treatment of complicated urinary tract infections, including pyelonephritis in indian adults.

Enrollment: 50 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patient has a low white cell count (less than 500/mm3) for at least 96 hours
• Patient is indian and is greater than 18 years of age
• Patient received chemotherapy for blood disorders and blood cancers

Exclusion criteria

• Patient has an invasive fungal infection
• Patient has a bacterial infection that is not controlled
• Patient has allergy to the class of antifungals of study drug
• Patient is not expected to survive at least 5 days
• Patient is pregnant or breast-feeding

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)