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 measure
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 (if study stopped)
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, 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)
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, 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
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
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, SNSF, FNS
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
Basic results (scientific)
Publication list
1.2011 results in http://www.ncbi.nlm.nih.gov/pubmed/21980373
Publication citations
-
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.