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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)

Information source: Merck Sharp & Dohme Corp.
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Fungal Infection

Intervention: caspofungin acetate (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.

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.

Clinical Details

Official title: A Noncomparative, Multicenter, Open-Label, Study to Evaluate the Safety, Tolerability and Efficacy of MK0991 as Empirical Therapy in Indian 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: Any clinical or laboratory serious drug-related adverse experience during the study drug therapy period plus 14 days posttherapy.

Secondary outcome: 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

Eligibility

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

Criteria:

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

Locations and Contacts

Additional Information

Starting date: June 2005
Last updated: February 23, 2015

Page last updated: August 23, 2015

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