Status:

COMPLETED

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)

Lead Sponsor:

Merck Sharp & Dohme LLC

Conditions:

Fungal Infection

Eligibility:

All Genders

18+ years

Phase:

PHASE3

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 pyelonephriti...

Eligibility Criteria

Inclusion

  • 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

  • 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

Key Trial Info

Start Date :

June 1 2005

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

May 1 2006

Estimated Enrollment :

50 Patients enrolled

Trial Details

Trial ID

NCT00379964

Start Date

June 1 2005

End Date

May 1 2006

Last Update

February 23 2017

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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) | DecenTrialz