Mefloquine and artesunate against schistosomiasis

ISRCTN	ISRCTN06498763
DOI	https://doi.org/10.1186/ISRCTN06498763
Secondary identifying numbers	N/A

Submission date: 15/10/2008
Registration date: 17/10/2008
Last edited: 16/06/2010

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

Department of Medical Parasitology and Infection Biology
Swiss Tropical Institute
Basel
4002
Switzerland

Phone	+41 (0)61 284 8218
Email	jennifer.keiser@unibas.ch

Study information

Study design	Open-label randomised trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Not specified
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	Mefloquine, artesunate and mefloquine-artesunate in the treatment of Schistosoma mansoni and Schistosoma haematobium infections in Côte dIvoire
Study acronym	MQAS-Schisto
Study hypothesis	Mefloquine and artesunate, administered singly or in combination, show efficacy against Schistosoma mansoni and Schistosoma haematobium in school-aged children in Africa.
Ethics approval(s)	1. Ethikkomission beider Basel EKBB (Switzerland) on the 7th April 2008 (ref: 70/08) 2. Ministère de la Santé d'Higiéne et Publique (Cote d'Ivoire) on the 20th June 2008 (ref: 2868/MSHP)
Condition	Schistosomiasis (Schistosoma mansoni; Schistosoma haematobium)
Intervention	1. Mefloquine (1 x 25 mg/kg) 2. Artesunate (10 mg/kg in three divided doses within 1 day) 3. Mefloquine-artesunate combination (300/750 mg in three divided doses within 3 days) 4. Praziquantel (1 x 40 mg/kg) The duration of treatment is, depending on the drug, 1 - 3 days; duration of follow-up is 3 - 5 days.
Intervention type	Drug
Pharmaceutical study type(s)
Phase	Not Specified
Drug / device / biological / vaccine name(s)	Mefloquine, artesunate, praziquantel
Primary outcome measure	Cure rate and egg reduction rate, measured 21 - 28 days post-treatment by multiple stool sampling using the Kato-Katz method (study 1) and multiple urine sampling using standard urine filtration method (study 2).
Secondary outcome measures	Patients will be monitored for three hours post-treatment and once daily for 5 days. Details of adverse events will be recorded by the study physician during the trial including variables describing their incidence, onset, cessation, duration, intensity, frequency, seriousness and causality.
Overall study start date	30/10/2008
Overall study end date	20/10/2009

Eligibility

Participant type(s)	Patient
Age group	Child
Lower age limit	8 Years
Upper age limit	16 Years
Sex	Both
Target number of participants	Total: 120 (study 1: 60; study 2: 60)
Participant inclusion criteria	1. Schoolchild (aged 8 - 16 years, either sex) infected with S. mansoni (study 1) or S. haematobium (study 2), as assessed by the presence of egg(s) in the stool (S. mansoni) or urine (S. haematobium) 2. Weight of schoolchild greater than 25 kg 3. Able and willing to be examined by a physician at the beginning of the study and at the end of study (3 weeks post-treatment) 4. Able and willing to provide multiple stool or 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 disorders and epilepsy 7. No known or reported hypersensitivity to mefloquine 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 by parents/legual guardians and child 10. For females aged 12 years and above, not pregnant in the first trimester, as assessed by a female nurse (interview and pregnancy test if need be), upon initial clinical assessment
Participant exclusion criteria	1. Schoolchild who has clinical malaria (i.e. axillary temperature greater than or equal to 37.5°C and parasitaemia, as assessed by thick and thin blood film examination) 2. Pregnancy first trimester 3. Presence of any abnormal medical condition, judged by the study physician 4. History of acute or severe chronic disease, including hepato-splenic schistosomiasis, macrohaematuria and bloody stools 5. Psychiatric disorders and epilepsy 6. Use of artesunate, artemether, any artemisinin-based combination therapy, mefloquine or praziquantel within the past 7 days 7. Attending other clinical trials during the study
Recruitment start date	30/10/2008
Recruitment end date	20/10/2009

Locations

Countries of recruitment

Côte d'Ivoire
Switzerland

Study participating centre

Department of Medical Parasitology and Infection Biology

Basel
4002
Switzerland

Sponsor information

Swiss Tropical Institute (Switzerland)
Research organisation

c/o Jennifer Keiser
Department of Medical Parasitology and Infection Biology
Basel
4002
Switzerland

Phone	+41 (0)61 284 8218
Email	jennifer.keiser@unibas.ch
Website	http://sti.ch
"ROR"	https://ror.org/03adhka07

Funders

Funder type

Industry

Mepha Pharma AG (Switzerland)

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	01/05/2010		Yes	No