Condition category
Infections and Infestations
Date applied
10/11/2008
Date assigned
28/11/2008
Last edited
10/04/2012
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Peter Steinmann

ORCID ID

Contact details

Swiss Tropical Institute
Socinstrasse 57
Basel
CH-4051
Switzerland
+41 (0)61 284 8129
peter.steinmann@unibas.ch

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

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

Acronym

Study hypothesis

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

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)

Study design

Community-based, phase IV, open-label/single-blind, randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

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

Phase

Phase IV

Drug names

Primary outcome measures

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 outcome measures

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.

Overall trial start date

01/11/2008

Overall trial end date

31/01/2009

Reason abandoned

Eligibility

Participant 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)

Participant type

Patient

Age group

Other

Gender

Both

Target number of participants

370 (max. 400)

Participant 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

Recruitment start date

01/11/2008

Recruitment end date

31/01/2009

Locations

Countries of recruitment

China

Trial participating centre

Swiss Tropical Institute
Basel
CH-4051
Switzerland

Sponsor information

Organisation

Swiss Tropical Institute (STI) (Switzerland)

Sponsor details

Socinstrasse 57
Basel
CH-4051
Switzerland
+41 (0)61 284 8111
peter.steinmann@unibas.ch

Sponsor type

Research organisation

Website

http://www.sti.ch

Funders

Funder type

Government

Funder name

Stanley Thomas Johnson Foundation (Switzerland)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Swiss National Science Foundation (SNSF) (Switzerland) (ref: PBBSP3-123193)

Alternative name(s)

Swiss National Science Foundation, Fonds National Suisse de la Recherche Scientifique, Fondo Nazionale Svizzero per la Ricerca Scientifica, Fonds National Suisse, Fondo Nazionale Svizzero, Schweizerischer Nationalfonds, SNF

Funding Body Type

private sector organisation

Funding Body Subtype

foundation

Location

Switzerland

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

1.2011 results in http://www.ncbi.nlm.nih.gov/pubmed/21980373

Publication citations

  1. Steinmann P, Utzinger J, Du ZW, Jiang JY, Chen JX, Hattendorf J, Zhou H, Zhou XN, Efficacy of single-dose and triple-dose albendazole and mebendazole against soil-transmitted helminths and Taenia spp.: a randomized controlled trial., PLoS ONE, 2011, 6, 9, e25003, doi: 10.1371/journal.pone.0025003.

Additional files

Editorial Notes