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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. Identifier: NCT00379964
Recruitment Status : Completed
First Posted : September 25, 2006
Last Update Posted : February 23, 2017
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

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.

Condition or disease Intervention/treatment Phase
Fungal Infection Drug: caspofungin acetate Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 50 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official 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
Study Start Date : June 2005
Actual Primary Completion Date : May 2006
Actual Study Completion Date : May 2006

Intervention Details:
  • 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

Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. 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 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00379964

Sponsors and Collaborators
Merck Sharp & Dohme Corp.
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Study Director: Medical Monitor Merck Sharp & Dohme Corp.
Study Data/Documents: CSR Synopsis  This link exits the site

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Responsible Party: Merck Sharp & Dohme Corp. Identifier: NCT00379964    
Other Study ID Numbers: 0991-053
First Posted: September 25, 2006    Key Record Dates
Last Update Posted: February 23, 2017
Last Verified: February 2017
Additional relevant MeSH terms:
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Leukocyte Disorders
Hematologic Diseases
Antifungal Agents
Anti-Infective Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action