Praziquantel, praziquantel plus mefloquine and praziquantel plus mefloquine-artesunate in the treatment of schistosomiasis
| ISRCTN | ISRCTN00393859 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN00393859 |
| Secondary identifying numbers | N/A |
- Submission date
- 06/05/2010
- Registration date
- 27/05/2010
- Last edited
- 17/12/2015
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Infections and Infestations
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English Summary
Not provided at time of registration
Contact information
Prof Jennifer Keiser
Scientific
Scientific
Socinstr. 57
Basel
4051
Switzerland
Study information
| Study design | Randomised exploratory open-label active-controlled parallel-group phase II trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised parallel 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 | Praziquantel, praziquantel plus mefloquine and praziquantel plus mefloquine-artesunate in the treatment of infections with Schistosoma spp. in Cote d'Ivoire |
| Study acronym | PZQMQ-Schisto |
| Study hypothesis | Combinations of mefloquine and mefloquine-artesunate plus praziquantel show a better efficacy against Schistosoma spp. infections in school-aged children in Africa. |
| Ethics approval(s) | 1. Ethikkomission beider Basel EKBB, Switzerland, 21/08/2009, ref: 70/08 2. Ministry of Health Cote d'Ivoire, 03/04/2010 |
| Condition | Infection with Schistosoma spp. |
| Intervention | Drug administration, namely: 1. Praziquantel (1 x 40 mg/kg) 2. Mefloquine (1 x 25 mg/kg) plus praziquantel (1 x 40 mg/kg) on the next day 3. Mefloquine-artesunate combination (300/750 mg in three divided doses within 3 days) plus praziquantel (1 x 40 mg/kg) on day 4 The duration of treatment is dependant on the drug regimen (i.e., 1 - 4 days). The total duration of follow-up is 3 - 5 days. |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Phase II |
| Drug / device / biological / vaccine name(s) | Praziquantel, mefloquine, mefloquine-artesunate |
| Primary outcome measure | Cure rate and egg reduction rate, measured at 21 - 28 days and 2 - 3 months post-treatment by multiple stool and urine sampling (Kato Katz method, urine filtration and ether concentration technique) |
| Secondary outcome measures | Adverse events. Patients will be monitored for 3 hours post-treatment and once daily during treatment and for 3 days after the last dose. Details of adverse events will recorded by the study physician during the trial, including variables describing their incidence, onset, cessaton, duration, intensity, frequency, seriousnes and causality. |
| Overall study start date | 01/07/2011 |
| Overall study end date | 30/09/2011 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Child |
| Lower age limit | 8 Years |
| Sex | Both |
| Target number of participants | 150 (60 at time of registration) |
| Participant inclusion criteria | 1. Patients (male and female school children older than 8 years) infected with Schistosoma mansoni and S. haematobium, as assessed by the presence of eggs in the urine or stool 2. Weight of patient greater than 25 kg 3. Able and willing to be examined by a study physician at the beginning of the study and at the end of study (3 weeks post-treatment and 2 - 3 months post-treatment) 4. Able and willing to provide multiple stool and urine samples at the beginning and end of study 5. Absence of major systemic illnesses, as assessed by the medical doctor, upon initial clinical assessment 6. Absence of psychiatric and neurological disorders 7. No known or reported hypersensitivity to mefloquine, praziquantel and/or artesunate 8. No known or reported history of chronical illness as cancer, diabetes, chronic heart, liver or renal disease 9. Signed written informed consent sheet 10. For females aged 12 years and above, not pregnant in the first trimester, as assessed by a pregnancy test, upon initial clinical assessment |
| Participant exclusion criteria | 1. Pregnancy first trimester 2. Presence of any abnormal medical condition, judged by the study physician 3. History of acute or severe chronic disease 4. Known or reported psychiatric or neurological disorders 5. Use of antimalarial or anthelminthic drug within the past month 6. Attending other clinical trials during the study |
| Recruitment start date | 01/07/2011 |
| Recruitment end date | 30/09/2011 |
Locations
Countries of recruitment
- Côte d'Ivoire
- Switzerland
Study participating centre
Socinstr. 57
Basel
4051
Switzerland
4051
Switzerland
Sponsor information
Swiss Tropical and Public Health Institute (Switzerland)
Research organisation
Research organisation
Socinstr. 57
Basel
4051
Switzerland
| Website | http://www.swisstph.ch/ |
|---|---|
"ROR" |
https://ror.org/03adhka07 |
Funders
Funder type
Research organisation
Swiss National Science Foundation (Fonds National Suisse de la Recherche Scientifique [SNSF]) (Switzerland)
Private sector organisation / Trusts, charities, foundations (both public and private)
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 | 17/07/2014 | Yes | No |
Editorial Notes
Please note, as of 24/05/2011 updates have been made to this record. The overall trial start date has been changed from 24/05/2010 to 01/07/2011, the overall trial end date has been changed from 31/01/2011 to 30/09/2011 and the target number of participants has been increased from 60 to 150.
