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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)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00379964
Recruitment Status : Completed
First Posted : September 25, 2006
Last Update Posted : February 23, 2017
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

Tracking Information
First Submitted Date  ICMJE September 22, 2006
First Posted Date  ICMJE September 25, 2006
Last Update Posted Date February 23, 2017
Study Start Date  ICMJE June 2005
Actual Primary Completion Date May 2006   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 3, 2008)
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 ]
Original Primary Outcome Measures  ICMJE
 (submitted: September 22, 2006)
Any clinical or laboratory serious drug-related adverse experience during the study drug therapy period plus 14 days posttherapy.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 3, 2008)
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 ]
Original Secondary Outcome Measures  ICMJE
 (submitted: September 22, 2006)
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
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE 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)
Official Title  ICMJE 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
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Fungal Infection
Intervention  ICMJE Drug: 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.
Other Names:
  • MK0991
  • Cancidas
Study Arms  ICMJE Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: September 22, 2006)
50
Original Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE May 2006
Actual Primary Completion Date May 2006   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00379964
Other Study ID Numbers  ICMJE 0991-053
2006_037
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Merck Sharp & Dohme Corp.
Study Sponsor  ICMJE Merck Sharp & Dohme Corp.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Medical Monitor Merck Sharp & Dohme Corp.
PRS Account Merck Sharp & Dohme Corp.
Verification Date February 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP