Additional identifiers
EudraCT/CTIS number
IRAS number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Praziquantel, praziquantel plus mefloquine and praziquantel plus mefloquine-artesunate in the treatment of infections with Schistosoma spp. in Cote d'Ivoire
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
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
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
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
Reason abandoned (if study stopped)
Eligibility
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 type(s)
Patient
Age group
Child
Lower age limit
8 Years
Sex
Both
Target number of participants
150 (60 at time of registration)
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
Cote d'Ivoire, Switzerland
Study participating centre
Socinstr. 57
Basel
4051
Switzerland
Sponsor information
Organisation
Swiss Tropical and Public Health Institute (Switzerland)
Sponsor details
Socinstr. 57
Basel
4051
Switzerland
Sponsor type
Research organisation
Website
ROR
Funders
Funder type
Research organisation
Funder name
Swiss National Science Foundation (Fonds National Suisse de la Recherche Scientifique [SNSF]) (Switzerland)
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
Funding Body Type
private sector organisation
Funding Body Subtype
Trusts, charities, foundations (both public and private)
Location
Switzerland
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Individual participant data (IPD) sharing plan
IPD sharing plan summary
Not provided at time of registration
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 17/07/2014 | Yes | No |