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)

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-06-30

Study Completion Date

2006-05-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Fungal Infection

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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caspofungin acetate

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.

Intervention Type DRUG

Other Intervention Names

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MK0991 Cancidas

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No