Assessment of the safety and efficacy of different drugs and drug combinations in children infected with schistosomes
| ISRCTN | ISRCTN63657086 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN63657086 |
| Secondary identifying numbers | 01 |
- Submission date
- 27/04/2015
- Registration date
- 19/07/2015
- Last edited
- 17/08/2023
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Infections and Infestations
Plain English Summary
Background and study aims
Schistosomiasis is an infection caused by parasites that live in fresh water in subtropical and tropical regions of the world. There are six species of schistosomes; S. mansoni, S. japonicum and S. haematobium are the most common. Each year around 230 million people are infected with schistosomes, and around 11,000 people die from the infection. Schistosomiasis can become a persistent chronic disorder in areas with high infection rates, which results in common disabling complications such as anaemia, stunted growth, slow mental development and decreased fitness. The aim of this study is to test how well 4 different drugs work to cure the infection and reduce the number of schistosomes eggs in an infected person’s body. We will be testing how well moxidectin, Synriam® and a Synriam®-praziquantel combination work against schistosome infections compared to taking praziquantel alone. This study will also be testing how safe the drugs are for school children, how effective moxidectin, Synriam® and Synriam®/praziquantel combination are against possible co-infections (Ascaris lumbricoides, Trichuris trichiura, hookworm, Strongyloides stercoralis) and how effective Synriam® is against malaria infection.
Who can participate?
Children infected with schistosomes.
What does the study involve?
Participants are randomly allocated into one of four groups. Those in group 1 (intervention group) are given the drug moxidectin. Those in group 2 (intervention group) are given the drug Synriam®. Those in group 3 (intervention group) are given the drug combination Synriam® and praziquantel. Those in group 4 (intervention group) are given the drug praziquantel. Participants are asked to give urine and stool samples, and a finger prick blood test at the start of the study, then again 3 and 6 weeks after treatment. The medical history of participants is assessed using a questionnaire, and a clinical examination is carried out by the study physician on the day of treatment. There are interviews before treatment, then 2, 24, 48 and 72 hours after treatment.
What are the possible benefits and risks of participating?
All participants have a free diagnosis for intestinal parasitic infection and malaria infection. All are treated and, if not cured by the drug provided, treated with the currently recommended drug (albendazole and praziquantel and malaria treatment according to local guidelines). Risks are represented by side effects linked to the treatment.
Where is the study run from?
1. Centre Suisse de Recherches Scientifiques (CSRS) (Côte d’Ivoire)
2. University Felix Houphouet Boigny (Université Félix Houphouët Boigny (UFHB)) (Côte d’Ivoire)
When is the study starting and how long is it expected to run for?
May 2015 to October 2015
Who is funding the study?
Rudolf Geigy Foundation (Switzerland)
Who is the main contact?
Prof J Keiser
Contact information
Scientific
Socinstrasse 57
Basel
4002
Switzerland
Study information
| Study design | Randomised controlled phase 2 single blind trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | School |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use contact details to request a participant information sheet. |
| Scientific title | Assessment of the safety and efficacy of oral Moxidectin, Synriam®, Synriam®-Praziquantel combination versus Praziquantel in school children infected with Schistosoma haematobium and Schistosoma mansoni |
| Study hypothesis | The aim of this study is to assess the efficacy of Moxidectin and Synriam in treating schistosomes. |
| Ethics approval(s) | 1. Nordwest und Zentralschweiz Ethics Committee (Ethikkommission Nordwest und Zentralschweiz EKNZ) ref: EKNZ UBE-15/01, 12/01/2015 2. National Ethics & Research Committee (Comite National d'Ethique et de la Recherche CNER) 16./06/2015 |
| Condition | Schistosomiasis |
| Intervention | This study has four treatment arms - Two stool samples (study 1), three urine samples (study 2) and one blood finger prick sample will be collected if possible on two consecutive days or otherwise within a maximum of 5 days): 1. Moxidectin 8 mg single dose 2. Synriam® 150 mg (arterolane + 750 piperaquine) for three consecutive days 3. Synriam® 150 mg (arterolane + 750 piperaquine) for three consecutive days + praziquantel 40 mg/kg single dose 4. Praziquantel 40 mg/kg single dose |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Phase II |
| Drug / device / biological / vaccine name(s) | Moxidectin, Synriam (arterolane + piperaquine), Praziquantel |
| Primary outcome measure | Efficacy: cure and egg reduction rate of S. mansoni and S. haematobium |
| Secondary outcome measures | 1. Drug safety 2. Cure and egg reduction rate against possible co-infections (Ascaris lumbricoides, Trichuris trichiura, hookworm Strongyloides stercoralis) 3. To determine the efficacy of Synriam® against malaria infection |
| Overall study start date | 04/05/2015 |
| Overall study end date | 01/10/2015 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Child |
| Sex | Both |
| Target number of participants | 240 |
| 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 of the study 3. Able and willing to provide two stool samples, three urine samples and one finger prick test at baselin and approximately three weeks after treatment (follow-up) 4. Positive for S. mansoni or S. haematobium eggs in the stool and/or in urine 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, e.g. cancer, diabetes, chronic heart, liver or renal disease 7. No anthelminthic or antimalarial treatments within past 4 weeks 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 or antimalarial drugs (within past 4 weeks) 5. Attending other clinical trials during the study 6. Negative diagnostic result for S. mansoni or S. haematobium (absence of helminth eggs in stool/urine) |
| Recruitment start date | 04/05/2015 |
| Recruitment end date | 15/05/2015 |
Locations
Countries of recruitment
- Côte d'Ivoire
Study participating centres
-
Côte d'Ivoire
-
Côte d'Ivoire
Sponsor information
Research organisation
Socinstrasse 59
Basel
4002
Switzerland
Research council
Covent Garden
Place Charles Rogier 16
1210 Saint-Josse-ten-Noode
Brussels
1210
Belgium
Funders
Funder type
Research organisation
No information available
Results and Publications
| Intention to publish date | 31/12/2015 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not expected to be made available |
| Publication and dissemination plan | One manuscript will be submitted to a scientific journal by the end of 2015. |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 16/09/2016 | Yes | No | |
| Protocol (other) | 16/09/2016 | 17/08/2023 | No | No |
Editorial Notes
17/08/2023: Protocol added.
07/10/2016: Publication reference added.
