Oxantel and oxantel-albendazole in the treatment of whipworm and hookworm infections
| ISRCTN | ISRCTN54577342 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN54577342 |
| Secondary identifying numbers | N/A |
- Submission date
- 15/08/2012
- Registration date
- 22/08/2012
- Last edited
- 12/06/2014
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Infections and Infestations
Plain English summary of protocol
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.
Contact information
Scientific
University of Basel
Socinstr. 57
Basel
4051
Switzerland
Study information
| Study design | Double-blind randomized controlled trial with four treatment arms |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| 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 combined and single oxantel albendazole, and mebendazole, in the treatment of Trichuris trichiura and hookworm infections in Pemba: a randomized, double blind trial |
| Study acronym | OXAALB-STH |
| Study objectives | Oxantel-albendazole reaches higher cure rates against T. trichiura and hookworm infections than the standard treatments (mebendazole). |
| Ethics approval(s) | 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 |
| Health condition(s) or problem(s) studied | 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 |
| Pharmaceutical study type(s) | |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | Oxantel, oxantel-albendazole |
| Primary outcome measure | 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 study start date | 10/09/2012 |
| Completion date | 26/10/2012 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Child |
| Sex | Both |
| Target number of participants | 650 |
| Key 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 |
| Key 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) |
| Date of first enrolment | 10/09/2012 |
| Date of final enrolment | 26/10/2012 |
Locations
Countries of recruitment
- Switzerland
- Tanzania
Study participating centre
4051
Switzerland
Sponsor information
Charity
Landstrasse 11
Postfach 141
Triesen
9495
Liechtenstein
| Website | http://www.medicor.li/ |
|---|---|
"ROR" |
https://ror.org/0469pxf24 |
Funders
Funder type
Charity
No information available
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 | 13/02/2014 | Yes | No |
