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 LLC50 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Fungal Infection

Interventions

caspofungin acetateDRUG

Cancidas 50 mg dose followed by 70 mg load on day 1 was administered in Indian adults with persistent fever and neutropenia for a maximum duration of empirical treatment from 28 days ((for patients without documented infection) to 90 days (for patients with documented baseline or emergent fungal infection). Patients were treated until the resolution of neutropenia (ANC\>500/mm3), and for up to 72 hours later.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Any clinical or laboratory serious drug-related adverse experience during the study drug therapy period plus 14 days posttherapy.

Time frame: during the study drug therapy period plus 14 days posttherapy

Secondary Outcomes

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

Time frame: 7 days following study therapy

Data from ClinicalTrials.gov

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