Clinical trial NCT01087099: A Multinational Trial of the Efficacy of Albendazole Against Soil-transmitted Nematode Infections in Children
Official title: A Multinational Trial of the Efficacy of Albendazole Against Soil-transmitted Nematode Infections in Children
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Infections With Soil-Transmitted Helminths (STH)
Lead sponsor: University Ghent
Sponsor class: OTHER
Collaborators: name: World Health Organization
name: George Washington University
name: Commonwealth Scientific and Industrial Research Organisation, Division of Livestock Industries, Brisbane, Australia
name: University of Nottingham
name: Queensland Institute of Medical Research
First posted: 2010-03-15
Enrollment: 1750
Sex: ALL
Minimum age (years): 6
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The three major Soil-Transmitted Helminths (STH), Ascaris lumbricoides, Necator americanus/Ancylostoma duodenal and Trichuris trichiura are among the most prevalent parasites worldwide. The objective of this multicentre international study is to define the efficacy of a single 400 milligram dose of albendazole (ALB) against these three STHs using a standardised protocol. The trial will be undertaken among school age children in seven countries - Brazil, Cameroon, Cambodia, Ethiopia, India, Tanzania (Zanzibar) and Vietnam - each with a different epidemiologic pattern of infection. A trial of this nature is urgently required because in spite of the wide usage of albendazole over the last 3 decades, there is still no key publication reporting the efficacy of the anthelmintic accurately, and to modern conventional standards, that can act as a central reference for the baseline efficacy. The latter is critically important because albendazole is now being used even more widely, as large scale mass treatment campaigns are being implemented in Africa and elsewhere, with the intention of reducing morbidity in children. Such large scale usage of a drug risks resistance developing, but resistance cannot be detected unless benchmark values for baseline efficacy are widely known.


Eligibility criteria: Inclusion Criteria:

* Children should be infected with a minimum of 150 eggs/gram of any of the three species of STH (i.e. Ascaris or hookworms or Trichuris).

Exclusion Criteria:

* Not willing to participate
* Unable to give samples for follow up
* Severe intercurrent medical condition
* Diarrhoea at first sampling

Primary outcomes:
measure: Efficacy of albendazole
timeFrame: 14 to 30 days after treatment
Secondary outcomes:
Other outcomes:
Locations:
city: Minas Gerais
country: Brazil
facility: Instituto René Rachou, Fundação Oswaldo Cruz
city: Phnom Penh
country: Cambodia
facility: Institut Pasteur in Cambodia, Clinical Pathology Unit
city: Yaounde
country: Cameroon
facility: Centre for Schistosomiasis and Parasitology, Faculty of Sciences, University of Yaoundé I
city: Jimma,
country: Ethiopia
facility: Department of Medical Laboratory Sciences and Pathology , College of Public Health and Medical Sciences, Jimma University
city: Vellore
country: India
facility: Department of Gastrointestinal Sciences, Christian Medical College
city: Zanzibar
country: Tanzania
facility: Public Health Laboratory
city: Hanoi
country: Vietnam
facility: National Institute for Malariology, Parasitology and Entomology
Study officials:
affiliation: University Ghent
name: Jozef Vercruysse
role: PRINCIPAL_INVESTIGATOR
References:
citation: Levecke B, Montresor A, Albonico M, Ame SM, Behnke JM, Bethony JM, Noumedem CD, Engels D, Guillard B, Kotze AC, Krolewiecki AJ, McCarthy JS, Mekonnen Z, Periago MV, Sopheak H, Tchuem-Tchuente LA, Duong TT, Huong NT, Zeynudin A, Vercruysse J. Assessment of anthelmintic efficacy of mebendazole in school children in six countries where soil-transmitted helminths are endemic. PLoS Negl Trop Dis. 2014 Oct 9;8(10):e3204. doi: 10.1371/journal.pntd.0003204. eCollection 2014 Oct.
citation: Levecke B, Mekonnen Z, Albonico M, Vercruysse J. The impact of baseline faecal egg counts on the efficacy of single-dose albendazole against Trichuris trichiura. Trans R Soc Trop Med Hyg. 2012 Feb;106(2):128-30. doi: 10.1016/j.trstmh.2011.09.007. Epub 2011 Dec 19.
citation: Vercruysse J, Behnke JM, Albonico M, Ame SM, Angebault C, Bethony JM, Engels D, Guillard B, Nguyen TV, Kang G, Kattula D, Kotze AC, McCarthy JS, Mekonnen Z, Montresor A, Periago MV, Sumo L, Tchuente LA, Dang TC, Zeynudin A, Levecke B. Assessment of the anthelmintic efficacy of albendazole in school children in seven countries where soil-transmitted helminths are endemic. PLoS Negl Trop Dis. 2011 Mar 29;5(3):e948. doi: 10.1371/journal.pntd.0000948.