Plain English Summary
Background and study aims
Between 600 and 800 million people are infected with one or several of the common soil-transmitted helminths, which are Ascaris lumbricoides, Trichuris trichiura, and hookworms. The current strategy to control soil-transmitted helminths is to administer either albendazole or mebendazole to people at risk. However, these drugs are not effective or only partially effective against T. trichiura and hookworm. Therefore new safe drugs are needed. The aim of this study is to compare the effectiveness and safety of albendazole, mebendazole, oxantel pamoate and an albendazole-oxantel pamoate combination against infections with T. trichiura and hookworm.
Who can participate?
Children aged 6-14 infected with T. trichiura or hookworm, or both.
What does the study involve?
Two stool samples will be collected from school-aged children until 380 cases of T. trichiura and/or hookworm infections have been identified. Positive tested children will be randomly assigned to one of the following four treatment groups: group 1 will receive oxantel pamoate on the first day and albendazole and a placebo (dummy) tablet on the next day. Group 2 will receive oxantel pamoate on day 1 and two placebo tablets on day 2. Group 3 will receive a placebo tablet on day 1 and one tablet of albendazole plus a placebo tablet on the next day. Group 4 will be administered a placebo tablet on day 1 and one mebendazole tablet plus one placebo tablet on day 2. Adverse effects will be assessed at 3 and 24 hours after each treatment.
What are the possible benefits and risks of participating?
The three drugs which are being compared are well known and have few adverse effects. All enrolled children will benefit from a free treatment against soil-transmitted helminths.
Where is the study run from?
The study will be carried out in three schools on Pemba, Tanzania and will be conducted by the Public Health Laboratory Ivo de Carneri (Tanzania).
When is the study starting and how long is it expected to run for?
The study will take place from September to November 2012.
Who is funding the study?
The study will be funded by the Medicor Foundation (Liechtenstein).
Who is the main contact?
Jennifer Keiser, Swiss Tropical and Public Health Institute, Basel, Switzerland.
Trial website
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Efficacy and safety of albendazole-oxantel combined and single oxantel albendazole, and mebendazole, in the treatment of Trichuris trichiura and hookworm infections in Pemba: a randomized, double blind trial
Acronym
OXAALB-STH
Study hypothesis
Oxantel-albendazole reaches higher cure rates against T. trichiura and hookworm infections than the standard treatments (mebendazole).
Ethics approval
1. Ethics Committee of Basel [Ethikkomission beider Basel (EKBB)], 20/01/2012, ref: 390/11
2. Ministry of Health and Social Welfare, 27/07/2012, ref: ZAMREC/0001/JAN/011
Study design
Double-blind randomized controlled trial with four treatment arms
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
T. trichiura or/and hookworm infections
Intervention
Group 1:
Day 1: 20 mg/kg oxantel pamoate; Day 2: 1 albendazole tablet plus 1 mebendazole matching placebo
Group 2:
Day 1: 20 mg/kg oxantel pamoate; Day 2: 1 albendazole matching placebo plus 1 mebendazole matching placebo
Group 3:
Day 1: 20 mg/kg oxantel pamoate placebo; Day 2: 1 albendazole tablet plus 1 mebendazole matching placebo
Group 4:
Day 1: 20 mg/kg oxantel pamoate placebo; Day 2: 1 mebendazole tablet plus 1 albendazole matching placebo
Intervention type
Drug
Phase
Not Applicable
Drug names
Oxantel, oxantel-albendazole
Primary outcome measures
Cure rates and egg reduction rates 3 weeks after treatment. For diagnosis two stool samples will be collected before and after treatment. From each stool sample duplicate Kato-Katz thick smears will be examined.
Secondary outcome measures
Adverse events will be assessed 3 and 24 hours after each day of treatment.
Overall trial start date
10/09/2012
Overall trial end date
26/10/2012
Reason abandoned
Eligibility
Participant inclusion criteria
1. Written informed consent signed by parents and/or legal guardian; and oral assent by children
2. Able and willing to be examined by a study physician at the beginning and at the end of the study (3 weeks post-treatment)
3. Able and willing to provide two stool samples at the beginning and at the end of the study
4. Positive for T. trichiura or hookworm, or both STH concurrently (presence of helminth eggs in stool)
5. Absence of major systemic illnesses (e.g. cancer, diabetes, clinical malaria or hepato-splenic schistosomiasis) as assessed by a medical doctor, upon initial clinical assessment
6. No known or reported history of chronic illness such as cancer, diabetes, chronic heart, liver or renal disease
7. No recent anthelminthic treatment (within past 4 weeks)
8. No known allergy to study medications
Participant type
Patient
Age group
Child
Gender
Both
Target number of participants
650
Participant exclusion criteria
1. No written informed consent by parents and/or legal guardian
2. Presence of any abnormal medical condition, judged by the study physician
3. History of acute or severe chronic disease such as cancer, diabetes, chronic heart, liver or renal disease
4. Recent use of anthelminthic drug (within past 4 weeks)
5. Attending other clinical trials during the study
6. Negative diagnostic result for T. trichiura and/or hookworm (absence of helminth eggs in stool)
Recruitment start date
10/09/2012
Recruitment end date
26/10/2012
Locations
Countries of recruitment
Tanzania
Trial participating centre
University of Basel
Basel
4051
Switzerland
Sponsor information
Organisation
Medicor Foundation (Liechtenstein)
Sponsor details
Landstrasse 11
Postfach 141
Triesen
9495
Liechtenstein
Sponsor type
Charity
Website
Funders
Funder type
Charity
Funder name
Medicor Foundation (Liechtenstein)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
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
2014 results in: http://www.ncbi.nlm.nih.gov/pubmed/24521107
Publication citations
-
Results
Speich B, Ame SM, Ali SM, Alles R, Huwyler J, Hattendorf J, Utzinger J, Albonico M, Keiser J, Oxantel pamoate-albendazole for Trichuris trichiura infection., N. Engl. J. Med., 2014, 370, 7, 610-620, doi: 10.1056/NEJMoa1301956.