Expand Access/Assess Safety and Efficacy of Paromomycin IM Injection for the Treatment of Visceral Leishmaniasis
NCT ID: NCT00604955
Last Updated: 2014-10-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
2000 participants
INTERVENTIONAL
2007-10-31
2010-01-31
Brief Summary
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Detailed Description
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The study is designed to establish a Phase 4 Access Program in a modular, stepwise fashion (Modules 1 to 3). The study will first confirm the safety and efficacy of Paromomycin IM Injection in an expanded VL population treated as an outpatient in experienced centers (Module 1); and then progressively extend the network of treatment facilities, the number and reach of the trained staff, and the implementation of the requisite logistics systems to rural Bihar (Modules 2 and 3). An expanded network of healthcare workers will be trained and supervised to make a preliminary diagnosis of VL; to make appropriate referrals to confirm the diagnosis of VL; to treat with Paromomycin IM Injection; and to assess patient safety and clinical response on an outpatient basis.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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A
Paromomycin IM Injection (approved product in India)
Paromomycin sulfate
Paromomycin will be administered intramuscularly at 11 mg/kg, once a day, for 21 consecutive days
Interventions
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Paromomycin sulfate
Paromomycin will be administered intramuscularly at 11 mg/kg, once a day, for 21 consecutive days
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Significant hematologic, renal or liver dysfunction
* Malaria
* Those unable to be treated as an outpatient.
2 Years
55 Years
ALL
No
Sponsors
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PATH
OTHER
Responsible Party
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Principal Investigators
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P K Sinha, MD
Role: PRINCIPAL_INVESTIGATOR
Rajendra Memorial Research Institute of Medical Sciences
T K Jha, MD
Role: PRINCIPAL_INVESTIGATOR
Kalazar Research Centre
C P Thakur, MD
Role: PRINCIPAL_INVESTIGATOR
Kala-azar Research Centre
Shyam Sundar, MD
Role: PRINCIPAL_INVESTIGATOR
Kala-azar Medical Research Centre
Devendra Nath, MD
Role: PRINCIPAL_INVESTIGATOR
Shrimati Hazari Maternity and Medical Care
Supriyo Mukherjee, MD
Role: PRINCIPAL_INVESTIGATOR
Research Centre for Diabetes, Hypertension and Obesity
Amrendra K Aditya, MD
Role: PRINCIPAL_INVESTIGATOR
Dr. A.K. Aditya Clinic
Locations
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Rajendra Memorial Research Institute of Medical Sciences
Agam Kuan, Patna, Bihar, India
Shrimati Hazari Maternity and Medical Care
Azad Nagar, Balua Tal, Motihari, Bihar, India
Research Centre for Diabetes, Hypertension and Obesity
Bengali Tola, Samastipur, Bihar, India
Dr. A.K. Aditya Clinic
East of Bhola Talkies, Samastipur, Bihar, India
Kala-zar Research Centre
Patna, Bihar, India
Kala-azar Medical Research Centre
Rambagh Road, Muzaffarpur, Bihar, India
Kalazar Research Centre
Brahmpura, Muzaffarpur, Bihar, India
Countries
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References
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Sundar S, Jha TK, Thakur CP, Sinha PK, Bhattacharya SK. Injectable paromomycin for Visceral leishmaniasis in India. N Engl J Med. 2007 Jun 21;356(25):2571-81. doi: 10.1056/NEJMoa066536.
Other Identifiers
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VLPM03
Identifier Type: -
Identifier Source: org_study_id
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