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)
Phase 3
Completed
- Conditions
- Fungal Infection
- Registration Number
- NCT00379964
- Lead Sponsor
- Merck Sharp & Dohme LLC
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 50
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
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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
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Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method Any clinical or laboratory serious drug-related adverse experience during the study drug therapy period plus 14 days posttherapy. during the study drug therapy period plus 14 days posttherapy
- Secondary Outcome Measures
Name Time Method Survival for at least 7 days following study therapy reduce fever during period of low white blood cell counts fungal infection no longer present following study therapy 7 days following study therapy