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)

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.

Completed

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Key information

Conditions

Fungal Infection Bacterial Infections and Mycoses Infections Mycoses

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

caspofungin acetate

Drug

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.

Other names: MK0991, Cancidas

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

Sponsors and collaborators

Lead sponsor

Merck Sharp & Dohme LLC

Industry

Registry information

Official study 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

Important dates

Study start: 2005
Primary completion: 2006
Study completion: 2006
First posted: Sep 25, 2006
Registry last updated: Feb 23, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed