- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00216346
Safety and Efficacy Study of Paromomycin to Treat Visceral Leishmaniasis
October 2, 2014 updated by: PATH
A Phase 3 Multicenter, Randomized, Controlled, Clinical Trial to Assess the Safety and Efficacy of Injectable Paromomycin in Patients With Visceral Leishmaniasis
Symptomatic Visceral Leishmaniasis(VL)is fatal; Due to the increasing resistance to standard therapy with antimonials, there is a need for new safe, efficacious, low-cost therapies for the treatment of VL.
Paromomycin is an off-patent aminoglycoside antibiotic with anti-leishmaniasis activity.
This study will test the safety and efficacy of paromomycin in the treatment of patients with VL in India.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment
667
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Bihar
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Agam Kuan, Patna, Bihar, India, 800 007
- Rajendra Memorial Research Institute of Medical Sciences (ICMR)
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Brahmpura, Muzaffarpur, Bihar, India, 842003
- Kalazar Research Centre
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Patna, Bihar, India, 800001
- Kalazar Research Centre
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Rambagh Road Muzaffarpur, Bihar, India, 842001
- Kala-azar Medical Research Centre
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
3 years to 53 years (Child, Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Age between 5-55 years (inclusive) of either gender.
- Newly diagnosed VL or VL treatment failure confirmed by spleen or bone marrow aspirate.
- Clinical signs and symptoms compatible with VL: fever of over two weeks duration and splenomegaly.
Biochemical and haematological test values as follows:
- Haemoglobin > 5.0g/100mL
- White blood cell count > 1 x109/L
- Platelet count > 50 x 109/L
- AST, ALT and alkaline phosphatase < 3 times upper normal limit
- Prothrombin time < 5 seconds above control
- Serum creatinine levels within normal limits
- Serum potassium levels within normal limits
- HIV negative
Exclusion Criteria:
- A history of intercurrent or concurrent diseases (e.g. chronic alcohol consumption or drug addiction; renal, hepatic, cardiovascular or central nervous system disease; diabetes; tuberculosis or other infectious or major psychiatric diseases) that may introduce variables affecting the outcome of the study.
- Any condition which the investigator thinks may prevent the patient from completing the study therapy and subsequent follow-up.
- An abnormal baseline audiogram (presentation with 75 dB or higher at 8KHz or below) and/or a history of significant vestibular or auditory dysfunction.
- Proteinuria (> 2+).
- A history of allergy or hypersensitivity to aminoglycosides.
- A history of major surgery within the last two weeks.
- Pregnancy or lactation. [Note: women of childbearing age must use an adequate form of contraception (documented) or agree to a period of sexual abstinence during the treatment phase of the study.]
- Previous treatment for VL within two weeks of enrolment into the study.
- Prior treatment failures with paromomycin or amphotericin B.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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(1) To compare the safety of injectable paromomycin to amphotericin B when administered in the proposed dosage regimens.
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(2) To compare the efficacy of injectable paromomycin to amphotericin B with regards to final cure rates.
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Secondary Outcome Measures
Outcome Measure |
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- Characterization of the pharmacokinetics of injectable paromomycin in adults and children with VL
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- Comparison of initial cure rates for the two regimens
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- Comparison of clinical improvement rates for the two regimens
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Prof S. Sundar, Kala-azar Research Centre
- Principal Investigator: Prof T.K. Jha, Kalazar Research Centre
- Principal Investigator: Prof C.P. Thakur, Kalazar Research Centre
- Principal Investigator: Dr. S.K. Bhattacharya, Rajendra Memorial Research Institute of Medical Sciences (ICMR)
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
June 1, 2003
Study Completion
November 1, 2004
Study Registration Dates
First Submitted
September 13, 2005
First Submitted That Met QC Criteria
September 15, 2005
First Posted (Estimate)
September 22, 2005
Study Record Updates
Last Update Posted (Estimate)
October 3, 2014
Last Update Submitted That Met QC Criteria
October 2, 2014
Last Verified
October 1, 2014
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Skin Diseases
- Infections
- Vector Borne Diseases
- Parasitic Diseases
- Protozoan Infections
- Skin Diseases, Parasitic
- Skin Diseases, Infectious
- Euglenozoa Infections
- Leishmaniasis
- Leishmaniasis, Visceral
- Anti-Infective Agents
- Anti-Bacterial Agents
- Antifungal Agents
- Antiprotozoal Agents
- Antiparasitic Agents
- Amebicides
- Paromomycin
- Amphotericin B
- Liposomal amphotericin B
Other Study ID Numbers
- VLPM01
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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