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Sponsored by: |
Drugs for Neglected Diseases |
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Information provided by: | Drugs for Neglected Diseases |
ClinicalTrials.gov Identifier: | NCT00255567 |
The purpose of this study is to assess the efficacy and safety of SSG 30 days alone, PM 21 days alone and SSG and PM as a combination course of 17 days in the treatment of patients with VL.
Condition | Intervention | Phase |
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Visceral Leishmaniasis |
Drug: Sodium Stibogluconate Drug: Paromomycin sulphate Drug: SSG and Paromomycin sulphate |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Multicentre Comparative Trial of Efficacy and Safety of Sodium Stibogluconate (SSG) Versus Paromomycin (PM) Versus Combination of SSG and PM as the First Line Treatment for Visceral Leishmaniasis in Ethiopia, Kenya and Sudan |
Estimated Enrollment: | 1100 |
Study Start Date: | November 2004 |
Estimated Study Completion Date: | November 2009 |
Estimated Primary Completion Date: | August 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Active Comparator
Sodium Stibogluconate (30 days)
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Drug: Sodium Stibogluconate
Sodium Stibogluconate 20mg/kg/day for 30 days
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2: Experimental
Paromomycin Sulphate (21 days)
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Drug: Paromomycin sulphate
Paromomycin sulphate
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3: Experimental
Sodium Stibogluconate + Paromomycin Sulphate (17 days)
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Drug: SSG and Paromomycin sulphate
SSG and Paromomycin Sulphate 17 days
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Currently in the three countries, Sudan, Kenya and Ethiopia many of the patients present themselves in remote areas and need to be treated in relative resource poor settings. It is for this reason that standardised treatment with proven efficacy is much needed. A shorter course of treatment is not only advantageous for the patient but also reduces the overall case load in the clinics thus reducing the risk of disease outbreaks in already immuno-compromised kala-azar patients. Paromomycin, either alone or in combination with SSG would decrease the treatment duration substantially. An additional added value of combination therapy is that it is likely to reduce the chances of development of parasite resistance against the individual drugs.
Leishmaniasis experts in the three countries are in agreement that there are potential benefits of the combination treatment of SSG and PM and that its efficacy should be evaluated with the view to introduce this protocol if proven efficacious and safe. There is ample circumstantial evidence of the use of this combination therapy and its efficacy and tolerability as a standardized protocol. This can only be confirmed through a randomised controlled study with 6 months follow up.
Ages Eligible for Study: | 4 Years to 60 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Sally Ellis | sellis@dndi.org |
Ethiopia | |
Arba Minch Hospital | Recruiting |
Arba Minch, Ethiopia | |
Contact: Asrat Hailu hailu_a2004@yahoo.com | |
Gondar hospital | Recruiting |
Gondar, Ethiopia | |
Contact: Asrat Hailu hailu_a2004@yahoo.com | |
Kenya | |
KEMRI | Recruiting |
Nairobi, Kenya | |
Contact: Monique Wasunna AfricaDNDi@NAIROBI.MIMCOM.NET | |
Sudan | |
Kassab Hospital | Recruiting |
Kassab, Sudan | |
Contact: Musa Amudawi amudawi@hotmail.com | |
Uganda, Nakipiripirit district | |
Amudat Hospital | Not yet recruiting |
Amudat, Nakipiripirit district, Uganda | |
Contact: Elizabeth Sentongo, MD sentongom@yahoo.com | |
Principal Investigator: Elizabeth Sentongo, MD |
Study Director: | Manica Balasegaram | DNDi |
Responsible Party: | DNDi ( Sally Ellis, Clinical Project Coordinator ) |
Study ID Numbers: | DNDi-LEAP0104 |
Study First Received: | November 16, 2005 |
Last Updated: | June 11, 2008 |
ClinicalTrials.gov Identifier: | NCT00255567 |
Health Authority: | Kenya: KEMRI/National Ethical Committee; Ethiopia: Natioanl Ethics committee and Addis Ababa Science and Technology committee; Sudan: Institute of endemic diseases ethics committee; Uganda: Makarere University Ethics committee |
Visceral Leishmaniasis Combination |
Leishmaniasis Protozoan Infections Skin Diseases, Infectious Antimony Sodium Gluconate |
Skin Diseases Parasitic Diseases Leishmaniasis, Visceral Paromomycin |
Anti-Infective Agents Antiprotozoal Agents Skin Diseases, Parasitic Antiplatyhelmintic Agents Mastigophora Infections Anthelmintics Schistosomicides |
Pharmacologic Actions Anti-Bacterial Agents Antiparasitic Agents Therapeutic Uses Sarcomastigophora Infections Amebicides |