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
Secondary identifying numbers N/A
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

Not provided at time of registration

Contact information

Dr Peter Steinmann
Scientific

Swiss Tropical Institute
Socinstrasse 57
Basel
CH-4051
Switzerland

Phone +41 (0)61 284 8129
Email peter.steinmann@unibas.ch

Study information

Study designCommunity-based, phase IV, open-label/single-blind, randomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeTreatment
Participant information sheet Not available in web format, please use the contact details below to request a patient information sheet
Scientific titleSafety 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 hypothesis1. 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)
ConditionSoil-transmitted helminth infections (Ascaris lumbricoides, Trichuris trichiura, hookworms)
InterventionStool 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 typeOther
Primary outcome measureCure 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 outcome measures1. 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.
Overall study start date01/11/2008
Overall study end date31/01/2009

Eligibility

Participant type(s)Patient
Age groupOther
SexBoth
Target number of participants370 (max. 400)
Participant inclusion criteria1. 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)
Participant exclusion criteria1. 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
Recruitment start date01/11/2008
Recruitment end date31/01/2009

Locations

Countries of recruitment

  • China
  • Switzerland

Study participating centre

Swiss Tropical Institute
Basel
CH-4051
Switzerland

Sponsor information

Swiss Tropical Institute (STI) (Switzerland)
Research organisation

Socinstrasse 57
Basel
CH-4051
Switzerland

Phone +41 (0)61 284 8111
Email peter.steinmann@unibas.ch
Website http://www.sti.ch
ROR logo "ROR" https://ror.org/03adhka07

Funders

Funder type

Government

Stanley Thomas Johnson Foundation (Switzerland)

No information available

Swiss National Science Foundation (SNSF) (Switzerland) (ref: PBBSP3-123193)
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 shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
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