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22 May 2012
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| [ Print-friendly version ] |
| A phase III multicentre, randomised, controlled, clinical trial to assess the safety and efficacy of injectable paromomycin in patients with visceral leishmaniasis (India) |
| ISRCTN | ISRCTN68386084 |
| ClinicalTrials.gov identifier | NCT00216346 |
| Public title | A phase III multicentre, randomised, controlled, clinical trial to assess the safety and efficacy of injectable paromomycin in patients with visceral leishmaniasis (India) |
| Scientific title | |
| Acronym | N/A |
| Serial number at source | A20643, A20485, A20648, A20599 |
| Study hypothesis | The aim of this trial is to assess the safety and efficacy of injectable paromomycin in patients with Visceral Leishmaniasis (VL). |
| Lay summary | |
| Ethics approval | The protocol was approved by the independent ethics committee at each of the four participating centers, the Drug Controller General of India, and the Steering Committee on Research Involving Human Subjects of the World Health Organization. |
| Study design | Randomised controlled trial |
| Countries of recruitment | India |
| Disease/condition/study domain | Visceral leishmaniasis (VL) |
| Participants - inclusion criteria |
1. Aged 5 to 55 years (inclusive) of either gender
2. Confirmed diagnosis by spleen or bone marrow aspirate 3. Clinical signs and symptoms compatible with VL 4. Lab tests: 4.1. Haemoglobin more than 5.0/100 ml 4.2. White Blood Cell (WBC) count more than 1 x 10^9 l 4.3. Platelet count more than 50 x 10^9 l 4.4. Aspartate transaminase (AST), alanine transaminase (ALT) and Alkaline Phosphatase less than three times upper normal limit 4.5. Prothrombin time less than five seconds above control 4.6. Serum creatinine within normal limits 4.7. Serum potassium within normal limits 5. Human Immunodeficiency Virus (HIV) negative |
| Participants - exclusion criteria |
1. History of intercurrent or concurrent diseases that may introduce variable that affect the outcome of the study
2. Any condition which the investigator thinks may prevent the patient from completing the study therapy 3. An abnormal baseline audiogram and/or a history of vestibular or auditory dysfunction 4. Proteinuria (more than 2 g/day) 5. A history of hypersensitivity or allergy to aminoglycosides 6. History of major surgery within last two weeks 7. Pregnancy or lactation 8. Previous treatment for VL within two weeks of enrolment into the study 9. Prior treatment failures with paromomycin or amphotericin B |
| Anticipated start date | 23/05/2003 |
| Anticipated end date | 30/06/2003 |
| Status of trial | Completed |
| Patient information material | |
| Target number of participants | 667 |
| Interventions |
Intervention group (500 patients):
Injectable paromomycin sulphate 15 mg/kg intramuscular per day x 30 days. Control group (167 patients): Injectable amphotericin B 1 mg/kg continuous intravenous infusion every other day, total 15 doses. |
| Primary outcome measure(s) |
Safety:
1. Reported adverse events 2. Protocol-defined nephrotoxicity and ototoxicity 3. Laboratory evaluations 4. Vital signs |
| Secondary outcome measure(s) |
Efficacy:
1. Parasite density 2. Final cure 3. Relapse 4. Treatment failure |
| Sources of funding | United Nations Children's Fund (UNICEF)/United Nations Development Programme (UNDP)/World Bank/World Health Organization (WHO) - Special Programme for Research and Training in Tropical Diseases (TDR) |
| Trial website | |
| Publications | Results in http://www.ncbi.nlm.nih.gov/pubmed/17582067 |
| Contact name | Dr Juntra Karbwang |
| Address | 20, Avenue Appia |
| City/town | Geneva -27 |
| Zip/Postcode | CH 1211 |
| Country | Switzerland |
| karbwangj@who.int | |
| Sponsor | UNICEF/UNDP/World Bank/WHO Special Programme for Research and Training in Tropical Diseases (TDR) |
| Address | 20, Avenue Appia |
| City/town | Geneva -27 |
| Zip/Postcode | CH 1211 |
| Country | Switzerland |
| Sponsor website: | http://www.who.int |
| Date applied | 05/04/2005 |
| Last edited | 15/01/2008 |
| Date ISRCTN assigned | 07/06/2005 |
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| © 2012 ISRCTN unless otherwise stated. | |
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