Albendazole-oxantel, albendazole-ivermectin, albendazole-mebendazole, and mebendazole in the treatment of whipworm infections
| ISRCTN | ISRCTN80245406 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN80245406 |
| Secondary identifying numbers | N/A |
- Submission date
- 16/07/2013
- Registration date
- 01/08/2013
- Last edited
- 08/11/2016
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Infections and Infestations
Plain English Summary
Background and study aims
Parasitic worm infections are widespread and they affect the health and wellbeing of mainly rural communities in the developing world. More than one billion people are infected with one or several of the common soil-transmitted helminths (STH). Treatment of STH infection with a single oral dose of current drugs is unsatisfactory. Several drug combinations have shown to be more effective than the currently recommended standard drug mebendazole. In this study we would like to assess various drug combinations and find out which combination should be recommended for the treatment of STH infection. In addition, we would like to monitor the effect of the three drug combinations on other parasitic infections and to find out the clinical benefit of the tested drug combinations based on history of self-reported signs and symptoms, physical examination and blood tests.
Who can participate?
Children aged 6 to 14 years can participate in this study.
What does the study involve?
Children will be given a written consent form and two containers. If willing to participate they shall return the consent form signed by their parents and the two containers filled with a fresh morning stool sample each. Stool samples will be tested for STH eggs. Children diagnosed positive for infection will be randomly allocated to one of the four treatment groups. Before receiving treatment, children will be checked by a physician. A finger prick blood sample will be taken from children before treatment. Children will be interviewed 2 hours and 24 hours after treatment about the occurrence of side effects. The effectiveness of the treatment will be determined 19-25 days after treatment, testing stool samples for STH eggs. About three months after treatment, when the clinical benefits are more likely to be measurable, children will again undergo a rigorous clinical examination. A finger prick blood sample will again be tested for hemoglobin levels and a questionnaire focusing on signs and symptoms will be given. To check if children were re-infected they will be asked to provide more stool samples which will be examined for STH eggs.
What are the possible benefits and risks of participating?
All children participating will benefit from a free treatment of a potentially active drug against STH. At the end of the study, all children diagnosed as infected with a parasite will be treated according to national guidelines. If the prevalence of any parasite is over 50%, all children in the school will be treated according to national guidelines. In general, few and mild side effects are expected, the most common being stomach pain, diarrhea (watery stool), nausea, headache and dizziness.
Where is the study run from?
The study will be carried out at two schools on Pemba Island (Public Health Laboratory-Ivo de Carneri), United Republic of Tanzania.
When is the study starting and how long is it expected to run for?
August 2013 to December 2013
Who is funding the study?
Swiss National Science Foundation (Switzerland)
Who is the main contact?
Prof Jennifer Keiser
jennifer.keiser@unibas.ch
Contact information
Scientific
Swiss Tropical and Public Health Institute
Socinstr. 57
Basel
4057
Switzerland
| jennifer.keiser@unibas.ch |
Study information
| Study design | Randomized controlled trial with four treatment arms |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Other |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | Efficacy and safety of albendazole-OXantel pamoate, albendazole-mebendazole, albendazole-IVermectin and single MEBendazole in the treatment of Trichuris trichiura and concomitant Soil-Transmitted Helminth infections in Pemba: a randomized controlled trial |
| Study acronym | OXIVMEB-STH |
| Study hypothesis | The three drug combinations (i.e. albendazole-oxantel pamoate, albendazole-mebendazole, and albendazole-ivermectin) achieve higher cure and egg reduction rates against T. trichiura infections compared to single-dose mebendazole (500 mg). |
| Ethics approval(s) | 1. Ethics Committee of Basel (Ethikkomission beider Basel [EKBB]), 02/07/2013, ref: 123/13 2. Ministry of Health and Social Welfare, 01/07/2013, ref: ZAMREC/0001/JUNE/013 |
| Condition | Trichuriasis |
| Intervention | Group 1: Albendazole (400 mg) + ivermectin (200 µg/kg) Group 2: Albendazole (400 mg) + mebendazole (500 mg) Group 3: Albendazole (400 mg) + oxantel pamoate (20 mg/kg) Group 4: Mebendazole (500 mg) All interventions will be done on one day (single dose). This means that children from treatment group 1-3 receive albendazole together with either ivermectin, mebendazole, or oxantel pamoate, while treatment group 4 receives mebendazole. Baseline and follow-up will last a maximum of 5 days (two stool samples collected over maximum 5 days). |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | Albendazole-oxantel, albendazole-ivermectin, albendazole-mebendazole, mebendazole |
| Primary outcome measure | Efficacy (cure rate and egg reduction rate) against T. trichiura |
| Secondary outcome measures | 1. Adverse events observed with study drugs (before treatment, 2 and 24 hours after treatment). 2. The effect of the three drug combinations on infections with S. stercoralis, A. lumbricoides, A. duodenale, N. americanus. (Effect will be measured as reduction of eggs per gram of faeces [A. lumbricoides, A. duodenale, N. americanus] or if living larvae disappear after treatment from stool sample [S. stercoralis]. Measured at baseline and 3 weeks after treatment). 3. The clinical benefit of the tested drug combinations based on history of self-reported signs and symptoms, physical examination, and hemoglobin levels. (Measured at baseline [physical examination, questionnaire about general health using the visual analogue scale, and finger prick blood samples], 3 weeks after treatment [questionnaire about general health using the visual analogue scale], 3 months after treatment [physical examination, questionnaire about general health using the visual analogue scale, and finger prick blood samples]. |
| Overall study start date | 15/08/2013 |
| Overall study end date | 15/12/2013 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Child |
| Lower age limit | 6 Years |
| Upper age limit | 14 Years |
| Sex | Both |
| Target number of participants | 440 |
| Participant inclusion criteria | 1. Written informed consent signed by parents and/or legal guardian; and oral assent by children (aged 6-14 years) 2. Able and willing to be examined by a study physician and answer a questionnaire about signs and symptoms at the beginning of the study, 3 weeks and 3 months after treatment 3. Able and willing to provide two stool samples at the beginning of the study, 3 weeks and 3 months after treatment 4. Able and willing to provide a urine sample and a finger prick blood sample before treatment and 3 months after treatment 5. Positive for T. trichiura (presence of eggs in stool) at the baseline parasitology survey 6. Absence of major systemic illnesses (e.g. clinical malaria or hepato-splenic schistosomiasis) as assessed by a medical doctor, upon initial clinical assessment 7. No known or reported history of chronic illness such as cancer, diabetes, heart, liver or renal disease 8. No known allergy to study medications |
| 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 drugs (within the past 4 weeks) 5. Attending other clinical trials during the study 6. Negative diagnostic result for T. trichiura (absence of eggs in stool) at baseline parasitological survey |
| Recruitment start date | 15/08/2013 |
| Recruitment end date | 15/12/2013 |
Locations
Countries of recruitment
- Switzerland
- Tanzania
Study participating centre
4057
Switzerland
Sponsor information
Research organisation
c/o Prof Jennifer Keiser
Socinstr. 57
Basel
4057
Switzerland
| jennifer.keiser@unibas.ch | |
| Website | http://www.swisstph.ch/ |
"ROR" |
https://ror.org/03adhka07 |
Funders
Funder type
Research organisation
Private sector organisation / Trusts, charities, foundations (both public and private)
- Alternative name(s)
- Schweizerischer Nationalfonds, Swiss National Science Foundation, Fonds National Suisse de la Recherche Scientifique, Fondo Nazionale Svizzero per la Ricerca Scientifica, Fonds National Suisse, Fondo Nazionale Svizzero, Schweizerische Nationalfonds, SNF, SNSF, FNS
- Location
- Switzerland
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/03/2015 | Yes | No | |
| Results article | results | 02/03/2016 | Yes | No |
Editorial Notes
03/03/2016: Publication reference added.
