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)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00379964
First received: September 22, 2006
Last updated: March 11, 2014
Last verified: March 2014
  Purpose

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 Intervention Phase
Fungal Infection
Drug: caspofungin acetate
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Merck Sharp & Dohme Corp.:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Enrollment: 50
Study Start Date: June 2005
Study Completion Date: May 2006
Primary Completion Date: May 2006 (Final data collection date for primary outcome measure)
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
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00379964

Sponsors and Collaborators
Merck Sharp & Dohme Corp.
Investigators
Study Director: Medical Monitor Merck Sharp & Dohme Corp.
  More Information

No publications provided

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00379964     History of Changes
Other Study ID Numbers: 0991-053, 2006_037
Study First Received: September 22, 2006
Last Updated: March 11, 2014
Health Authority: India: Indian Council of Medical Research

Additional relevant MeSH terms:
Mycoses
Neutropenia
Agranulocytosis
Leukopenia
Leukocyte Disorders
Hematologic Diseases
Caspofungin
Echinocandins
Antifungal Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 31, 2014