Efficacy and safety of anti-worm drugs in schoolchildren in Zanzibar, Tanzania
| ISRCTN | ISRCTN08336605 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN08336605 |
| Secondary identifying numbers | N/A |
- Submission date
- 18/02/2009
- Registration date
- 24/02/2009
- Last edited
- 24/09/2012
- 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
Prof Juerg Utzinger
Scientific
Scientific
Department of Public Health and Epidemiology
Swiss Tropical Institute
P.O. Box
Basel
4002
Switzerland
| Phone | +41 (0)61 284 8129 |
|---|---|
| juerg.utzinger@unibas.ch |
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Other |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | Efficacy and safety of albendazole and mebendazole as single-dose or in combination with ivermectin against soil-transmitted helminth infections, particularly Trichuris trichiura, in schoolchildren in Zanzibar, Tanzania: a randomised controlled trial |
| Study acronym | Alben-Meben-Ivermect-Zanzibar |
| Study objectives | 1. Combination therapy with either albendazole or mebendazole plus ivermectin is more efficacious against Trichuris trichiura that single therapy with either albendazole or mebendazole 2. Current efficacy of either albendazole or mebendazole (single dose) is low due the long-term administration of these drugs in the national helminth control programme in Zanzibar 3. The FLOTAC® technique is more sensitive than the Kato-Katz technique for helminth egg detection |
| Ethics approval(s) | Ethikkommission beider Basel EKBB gave approval on the 15th January 2009 (ref: 13/09) |
| Health condition(s) or problem(s) studied | Soil-transmitted helminthiasis |
| Intervention | Four treatment groups as follows: 1. Single-dose albendazole; children will receive one tablet of albendazole (400 mg) and a placebo resembling ivermectin (number of tablets according to weight) 2. Mebendazole; children will receive a single dose of mebendazole (500 mg) and a placebo resembling ivermectin (number of tablets according to weight) 3. Albendazole plus ivermectin; children will receive one tablet of albendazole (400 mg) plus ivermectin tablets according to their weight (200 µg/kg) 4. Mebendazole plus ivermectin; children will receive one tablet of mebendazole (500 mg) plus ivermectin tablets according to their weight (200 µg/kg) The treatment for the four arms will be administered on a single day; follow-up is 3 - 4 weeks post-treatment. |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | Albendazole, mebendazole, ivermectin |
| Primary outcome measure | 1. Cure rate of Trichuris trichiura infection (percentage of children with egg counts greater than 0 before treatment who become negative after treatment) 2. Egg reduction rate of Trichuris trichiura infection (reduction in egg count in a measured quantity of faeces following treatment in those not cured) |
| Secondary outcome measures | Cure rate and egg reduction rate of Ascaris lumbricoides and hookworm |
| Overall study start date | 01/03/2009 |
| Completion date | 31/05/2009 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Child |
| Lower age limit | 5 Years |
| Sex | Both |
| Target number of participants | 2000 children screened for helminth infections; ~600 children treated with anthelminthic drugs |
| Key inclusion criteria | 1. Aged greater than or equal to 5 years, both sexes 2. Submission of one stool sample of sufficient size to perform a total of two thick Kato-Katz smears at the baseline parasitological survey 3. Submission of one stool sample of sufficient size to perform a total of two thick Kato-Katz smears at the day of treatment 4. Infection with Trichuris trichiura as determined with the Kato-Katz method at the baseline survey. Additionally, also children with A. lumbricoides and/or hookworm infections will be included in one of the four treatment arms. 5. For females, not pregnant, as verbally assessed by medical personnel on the day of treatment 6. Absence of major systemic illnesses, as assessed by female medical personnel on the day of treatment 7. No anthelminthic treatment in the past 4 weeks, as verbally confirmed by the participant at the baseline survey 8. Written informed consent by the parent/legal guardian |
| Key exclusion criteria | 1. No stool sample given at baseline survey or day of treatment 2. No infection with T. trichiura, A. lumbricoides and/or hookworm at baseline 3. Subjects with fever or other signs of acute illness 4. Subjects with severe neurological disorder 5. Subjects with severe liver disorder 6. Pregnant schoolgirls 7. Recent history of anthelminthic treatment 8. Consent not given |
| Date of first enrolment | 01/03/2009 |
| Date of final enrolment | 31/05/2009 |
Locations
Countries of recruitment
- Switzerland
- Tanzania
Study participating centre
Department of Public Health and Epidemiology
Basel
4002
Switzerland
4002
Switzerland
Sponsor information
Swiss Tropical Institute (STI) (Switzerland)
Research organisation
Research organisation
c/o Juerg Utzinger
Department of Public Health and Epidemiology
P.O. Box
Basel
4002
Switzerland
| Phone | +41 (0)61 284 8129 |
|---|---|
| juerg.utzinger@unibas.ch | |
| Website | http://www.sti.ch |
"ROR" |
https://ror.org/03adhka07 |
Funders
Funder type
Research organisation
Commission for Research Partnerships with Developing Countries (KFPE) (Switzerland)
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 | 15/12/2010 | Yes | No | |
| Results article | results | 12/04/2011 | Yes | No | |
| Results article | results | 01/04/2012 | Yes | No |
