Epidemiology and treatment of soil-transmitted helminthiasis, with particular consideration to strongyloidiasis, in Yunnan province, China
| ISRCTN | ISRCTN01779485 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN01779485 |
| Secondary identifying numbers | N/A |
- Submission date
- 16/08/2008
- Registration date
- 21/08/2008
- Last edited
- 13/11/2008
- 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 Juerg Utzinger
Scientific
Scientific
Department of Public Health and Epidemiology
Swiss Tropical Institute
Socinstrasse 57
PO Box
Basel
4002
Switzerland
| Phone | +41 61 284 8129 |
|---|---|
| juerg.utzinger@unibas.ch |
Study information
| Study design | Open-label, randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Other |
| Study type | Not Specified |
| Scientific title | |
| Study objectives | 1. Single-dose albendazole and single-dose tribendimidine (both drugs will be administered orally at 200 mg for children aged 5-14 years, and 400 mg for individuals aged >=15 years) are safe and efficacious against soil-transmitted helminth infections (Ascaris lumbricoides, hookworm and Trichuris trichuria) 2. Single-dose tribendimidine has an effect on Strongyloides stercoralis and Taenia spp |
| Ethics approval(s) | Ethics Committee of the University and the State of Basel (Ethikkommission beider Basel) (EKBB) Date of approval: 12/06/2007 (ref: 149/07) |
| Health condition(s) or problem(s) studied | Helminth infections |
| Intervention | The participants who were diagnosed with helminthiases at the baseline parasitological survey were randomly allocated to the following arms: Arm 1: Single-dose albendazole (oral), 200 mg for children aged 5-14 years, and 400 mg for individuals aged >=15 years Arm 2: Single-dose tribendimidine (oral), 200 mg for children aged 5-14 years, and 400 mg for individuals aged >=15 years |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Albendazole, tribendimidine |
| Primary outcome measure | 1. Reduction of infection prevalence of intestinal helminths, assessed by examination of stool samples 2-4 weeks after drug administration 2. Frequency and severity of adverse events were recorded within 24 hours after drug administration |
| Secondary outcome measures | Kato-Katz-derived egg count reduction of common soil-transmitted helminths, assessed 2-4 weeks after drug administration. |
| Overall study start date | 01/05/2007 |
| Completion date | 31/07/2007 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Other |
| Sex | Both |
| Target number of participants | Approximately 300 |
| Key inclusion criteria | 1. Both males and females, age >=5 years 2. Submission of >=1 stool sample for the baseline parasitological survey 3. For females, not pregnant, as verbally assessed by medical personnel on the day of treatment 4. Absence of major systemic illnesses, as assessed by medical personnel on the day of treatment 5. Written informed consent by the head of the household on behalf of the whole family |
| Key exclusion criteria | 1. Presence of any abnormal medical condition, as judged by the medical personnel 2. No stool sample submitted for baseline parasitological survey 3. Enrolled in any other clinical investigation during the study 4. For females: pregnancy |
| Date of first enrolment | 01/05/2007 |
| Date of final enrolment | 31/07/2007 |
Locations
Countries of recruitment
- China
- Switzerland
Study participating centre
Department of Public Health and Epidemiology
Basel
4002
Switzerland
4002
Switzerland
Sponsor information
Swiss National Science Foundation (SNSF) (Switzerland)
Government
Government
Wildhainweg 3
PO Box 8232
Bern
3001
Switzerland
| Phone | +41 31 308 22 22 |
|---|---|
| info@snf.ch | |
| Website | http://www.snf.ch |
"ROR" |
https://ror.org/00yjd3n13 |
Funders
Funder type
Research organisation
Main funder:
No information available
Commission for Research Partnership with Developing Countries (KFPE) through the Swiss Agency for Development and Cooperation (SDC) (Switzerland)
No information available
Other funders:
No information available
Voluntary Academic Society (Freiwillige Akademische Gesellschaft) (Switzerland)
No information available
Janggen-Pöhn Foundation (Janggen-Pöhn-Stiftung) (Switzerland)
No information available
Chinese Ministry of Science and Technology, through their support to the Key Laboratory of Parasite and Vector Biology of the Chinese Ministry of Health (China) (grant ref: 2005DKA21104)
No information available
Swiss National Science Foundation (Switzerland) (project numbers PPOOB-102883 and PPOOB-119129)
Private sector organisation / Trusts, charities, foundations (both public and private)
Private sector organisation / Trusts, charities, foundations (both public and private)
- Alternative name(s)
- Schweizerischer Nationalfonds, Swiss National Science Foundation, Fonds National Suisse de la Recherche Scientifique, Fondo Nazionale Svizzero per la Ricerca Scientifica, Fonds National Suisse, Fondo Nazionale Svizzero, Schweizerische Nationalfonds, SNF, SNSF, FNS
- Location
- Switzerland
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 | 01/08/2008 | Yes | No |
