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Safety and efficacy of single-dose and triple-dose albendazole and mebendazole against soil-transmitted helminth infections in humans

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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN47375023
Enrollment
370
Registered
2008-11-28
Start date
2008-11-01
Completion date
Unknown
Last updated
2015-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Soil-transmitted helminth infections (Ascaris lumbricoides, Trichuris trichiura, hookworms) Infections and Infestations Other helminthiases

Interventions

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 m

Sponsors

Swiss Tropical Institute (STI) (Switzerland)
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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, People?s 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)

Exclusion criteria

Exclusion criteria: 1. Age: less than 5 years 2. Residency: not a permanent resident of Nongyang village in Menghai county, Yunnan province, People?s 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

Design outcomes

Primary

MeasureTime frame
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.

Secondary

MeasureTime frame
1. Safety of single-dose and triple-dose oral albendazole and mebendazole against common STH infections 2. Egg-reduction rates of single-dose and triple-dose oral albendazole and mebendazole against common STH infections Assessed at 2 - 3 weeks post-treatment.

Countries

China

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Mar 28, 2026