Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Prof Maria Yazdanbakhsh

ORCID ID

Contact details

Department of Parasitology
Leiden University Medical Centre
Albinusdreef 2
Leiden
2333 ZA
Netherlands
M.Yazdanbakhsh@lumc.nl

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

05-PP-35

Study information

Scientific title

Parasitic infections and Inflammatory Diseases: The web of immune responses, host genetics and environmental exposure

Acronym

Study hypothesis

Intestinal helminth infections suppress atopy and incidence of malaria and this suppression is reversible by antihelminthic treatment

Ethics approval

University of Indonesia, approved on 11/09/2006 (ref: 194/ PT02.FK/Etik/2006)

Study design

Randomised double-blind placebo-controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Other

Trial type

Prevention

Patient information sheet

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

Condition

Helminth and malaria parasitic diseases

Intervention

400 mg albendazole (oral) or matching placebo every three months for 2 years.

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

1. Prevalence of malaria parasite, assessed throughout the study for 3 years
2. Infection with intestinal helminth before treatment and within 1, 2 and 3 years after start of treatment
3. Skin reactivity to allergens assessed before treatment and within 1, 2 and 3 years after start of treatment

Secondary outcome measures

Immune response to malaria and helminth antigens, assessed before albendazole treatment and within 1, 2 and 3 years after the start of treatment (with the last treatment given at least 2 months before immunological determination).

Overall trial start date

01/11/2008

Overall trial end date

01/11/2011

Reason abandoned

Eligibility

Participant inclusion criteria

1. Both males and females
2. Age >=2 years. No upper age limit.
3. Those who have given informed consent

Participant type

Patient

Age group

Other

Gender

Both

Target number of participants

4,000

Participant exclusion criteria

1. History of chronic liver, heart or central nervous system (CNS) disease
2. Allergy to albendazole

Recruitment start date

01/11/2008

Recruitment end date

01/11/2011

Locations

Countries of recruitment

Indonesia

Trial participating centre

Department of Parasitology
Leiden
2333 ZA
Netherlands

Sponsor information

Organisation

Royal Netherlands Academy of Arts and Sciences (Netherlands)

Sponsor details

Kloveniersburgwal 29
Amsterdam
1011 JV
Netherlands
knaw@bureau.knaw.nl

Sponsor type

University/education

Website

http://www.knaw.nl

Funders

Funder type

University/education

Funder name

Royal Netherlands Academy of Arts and Sciences (Netherlands) (ref: 05-PP-35)

Alternative name(s)

De Koninklijke Nederlandse Akademie van Wetenschappen, KNAW

Funding Body Type

private sector organisation

Funding Body Subtype

academic

Location

Netherlands

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

2013 results in: http://www.ncbi.nlm.nih.gov/pubmed/23526959

Publication citations

  1. Results

    Wiria AE, Hamid F, Wammes LJ, Kaisar MM, May L, Prasetyani MA, Wahyuni S, Djuardi Y, Ariawan I, Wibowo H, Lell B, Sauerwein R, Brice GT, Sutanto I, van Lieshout L, de Craen AJ, van Ree R, Verweij JJ, Tsonaka R, Houwing-Duistermaat JJ, Luty AJ, Sartono E, Supali T, Yazdanbakhsh M, The effect of three-monthly albendazole treatment on malarial parasitemia and allergy: a household-based cluster-randomized, double-blind, placebo-controlled trial., PLoS ONE, 2013, 8, 3, e57899, doi: 10.1371/journal.pone.0057899.

Editorial Notes