Safety and efficacy of single-dose and triple-dose albendazole and mebendazole against soil-transmitted helminth infections in humans
| ISRCTN | ISRCTN47375023 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN47375023 |
| Protocol serial number | N/A |
| Sponsor | Swiss Tropical Institute (STI) (Switzerland) |
| Funders | Stanley Thomas Johnson Foundation (Switzerland), Swiss National Science Foundation (SNSF) (Switzerland) (ref: PBBSP3-123193) |
- Submission date
- 10/11/2008
- Registration date
- 28/11/2008
- Last edited
- 10/04/2012
- 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
Dr Peter Steinmann
Scientific
Scientific
Swiss Tropical Institute
Socinstrasse 57
Basel
CH-4051
Switzerland
| Phone | +41 (0)61 284 8129 |
|---|---|
| peter.steinmann@unibas.ch |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Community-based, phase IV, open-label/single-blind, randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Study type | Participant information sheet |
| Scientific title | Safety and efficacy of single-dose and triple-dose albendazole and mebendazole against soil-transmitted helminth infections in humans: open-label randomised-controlled trial in China |
| Study objectives | 1. Both albendazole and mebendazole are safe for treating common soil-transmitted helminth infections in humans 2. Single-dose oral albendazole and single-dose oral mebendazole are both highly active against Ascaris lumbricoides, and result in high faecal egg count reduction rates for hookworm and Trichuris trichiura 3. Single-dose oral albendazole is more efficacious than single-dose oral mebendazole against hookworm infections 4. Triple-dose oral albendazole and triple-dose oral mebendazole are significantly more efficacious against T. trichiura than single-dose oral regimens |
| Ethics approval(s) | 1. Ethics Committee of Basel (Ethikkommission beider Basel [EKBB]), approved on the 23rd September 2008 (ref: 294/08) 2. Academic Board of the National Institute of Parasitic Diseases (IPD), Chinese Centre for Disease Control and Prevention (China CDC), approved on the 17th September 2008 (ref: 2008091701) |
| Health condition(s) or problem(s) studied | Soil-transmitted helminth infections (Ascaris lumbricoides, Trichuris trichiura, hookworms) |
| Intervention | Stool collection will be carried out for baseline parasitological assessment (two stools/participant, each stool tested for the presence of helminth eggs by the Kato-Katz [2 slides/stool] and FLOTAC method). The participants will be randomly allocated to the following four trial arms: 1. Albendazole (oral) single dose: 400 mg 2. Mebendazole (oral) single dose: 500 mg 3. Triple-dose albendazole (oral): 400 mg daily for 3 days 4. Triple-dose mebendazole (oral): 500 mg daily for 3 days The participants are blinded regarding which drug they receive but not regarding which treatment schedule they belong to (1 or 3 day treatment) since no placebos are used. The investigators are aware of drug type and schedule at each stage of the trial. Adverse drug-related events will be monitored for 24 hours post-application. Stool collection will be repeated for parasitological treatment efficacy assessment (two stools/participant, each stool tested for the presence of helminth eggs by the Kato-Katz [2 slides/stool] and FLOTAC method). Details of Joint Sponsor: National Institute of Parasitic Diseases Chinese Centre for Disease Control and Prevention 207 Rui Jin Er Road Shanghai 200025 China Tel: +86 (0)136 7161 6056 |
| Intervention type | Other |
| Primary outcome measure(s) |
Cure rates of single-dose and triple-dose oral albendazole and mebendazole for treating common soil-transmitted helminth (STH) infections, especially hookworms, assessed at 2 - 3 weeks post-treatment. |
| Key secondary outcome measure(s) |
1. Safety of single-dose and triple-dose oral albendazole and mebendazole against common STH infections |
| Completion date | 31/01/2009 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Other |
| Sex | All |
| Target sample size at registration | 370 |
| Key inclusion criteria | 1. Age: greater than or equal to 5 years old 2. Sex: males and females 3. Residency: resident of Nongyang village in Menghai county, Yunnan province, Peoples Republic of China 4. Registration, participation: signing of written informed consent sheet (5 - 17 year olds: additional written approval by parents or legal guardians), willingness to comply with study procedures (stool submission, drug treatment, alcohol abstinence at day of treatment) 5. Absence of systemic or chronic diagnosed or perceivable illness as assessed by medical personnel upon enrolment and again at each day of treatment 6. Females: not pregnant (as verbally assessed by female medical personnel upon enrolment and again at each day of treatment) |
| Key exclusion criteria | 1. Age: less than 5 years 2. Residency: not a permanent resident of Nongyang village in Menghai county, Yunnan province, Peoples Republic of China 3. Registration, participation: no written informed consent sheet signed or parental approval not obtained, unwillingness to comply with all study procedures 4. Presence or suspicion of any abnormal medical condition which is known or suspected to interfere with anthelminthic treatment 5. Known hypersensitivity to any anthelminthic drugs 6. Recent history of anthelminthic treatment 7. Current or past (within 1 month) participation in any other medical trial 8. For females: suspected or verified pregnancy |
| Date of first enrolment | 01/11/2008 |
| Date of final enrolment | 31/01/2009 |
Locations
Countries of recruitment
- China
- Switzerland
Study participating centre
Swiss Tropical Institute
Basel
CH-4051
Switzerland
CH-4051
Switzerland
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | 1. results | 01/06/2011 | Yes | No | |
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
