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 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN68386084 |
| ClinicalTrials.gov number | NCT00216346 |
| Secondary identifying numbers | A20643, A20485, A20648, A20599 |
- Submission date
- 05/04/2005
- Registration date
- 07/06/2005
- Last edited
- 15/01/2008
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Infections and Infestations
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Juntra Karbwang
Scientific
Scientific
20, Avenue Appia
Geneva -27
CH 1211
Switzerland
| karbwangj@who.int |
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Treatment |
| Scientific title | |
| Study objectives | The aim of this trial is to assess the safety and efficacy of injectable paromomycin in patients with Visceral Leishmaniasis (VL). |
| Ethics approval(s) | 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. |
| Health condition(s) or problem(s) studied | Visceral leishmaniasis (VL) |
| Intervention | 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. |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Phase III |
| Drug / device / biological / vaccine name(s) | Paromomycin, amphotericin B |
| Primary outcome measure | Safety: 1. Reported adverse events 2. Protocol-defined nephrotoxicity and ototoxicity 3. Laboratory evaluations 4. Vital signs |
| Secondary outcome measures | Efficacy: 1. Parasite density 2. Final cure 3. Relapse 4. Treatment failure |
| Overall study start date | 23/05/2003 |
| Completion date | 30/06/2003 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 667 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 23/05/2003 |
| Date of final enrolment | 30/06/2003 |
Locations
Countries of recruitment
- India
- Switzerland
Study participating centre
20, Avenue Appia
Geneva -27
CH 1211
Switzerland
CH 1211
Switzerland
Sponsor information
UNICEF/UNDP/World Bank/WHO Special Programme for Research and Training in Tropical Diseases (TDR)
Research organisation
Research organisation
20, Avenue Appia
Geneva -27
CH 1211
Switzerland
| Website | http://www.who.int |
|---|---|
"ROR" |
https://ror.org/01f80g185 |
Funders
Funder type
Research organisation
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)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | Results | 21/06/2007 | Yes | No |
