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)
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
2 other identifiers
interventional
50
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3
Started Jun 2005
Shorter than P25 for phase_3
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2006
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2006
CompletedFirst Submitted
Initial submission to the registry
September 22, 2006
CompletedFirst Posted
Study publicly available on registry
September 25, 2006
CompletedFebruary 23, 2017
February 1, 2017
11 months
September 22, 2006
February 20, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
Any clinical or laboratory serious drug-related adverse experience during the study drug therapy period plus 14 days posttherapy.
during the study drug therapy period plus 14 days posttherapy
Secondary Outcomes (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
7 days following study therapy
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Medical Monitor
Merck Sharp & Dohme LLC
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 22, 2006
First Posted
September 25, 2006
Study Start
June 1, 2005
Primary Completion
May 1, 2006
Study Completion
May 1, 2006
Last Updated
February 23, 2017
Record last verified: 2017-02