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Clinical Trials/NCT00379964
NCT00379964CompletedPhase 3

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

Merck Sharp & Dohme LLC0 sites50 target enrollmentStarted: June 2005Last updated:
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Conditions
Drugs

Trial Snapshot

Phase
Phase 3
Status
Completed
Enrollment
50
Primary Endpoint
Any clinical or laboratory serious drug-related adverse experience during the study drug therapy period plus 14 days posttherapy.
Study OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsRecords & IdentifiersSimilar Trials

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Non Randomized
Intervention Model
Single Group
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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(7 days following study therapy)

Investigators

Sponsor Class
Industry
Responsible Party
Sponsor

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