Condition category
Infections and Infestations
Date applied
15/10/2008
Date assigned
17/10/2008
Last edited
16/06/2010
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Prof Jennifer Keiser

ORCID ID

Contact details

Department of Medical Parasitology and Infection Biology
Swiss Tropical Institute
Basel
4002
Switzerland
+41 (0)61 284 8218
jennifer.keiser@unibas.ch

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Mefloquine, artesunate and mefloquine-artesunate in the treatment of Schistosoma mansoni and Schistosoma haematobium infections in Côte d’Ivoire

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

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)

Study design

Open-label randomised trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

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

Phase

Not Specified

Drug names

Mefloquine, artesunate, praziquantel

Primary outcome measures

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 trial start date

30/10/2008

Overall trial end date

20/10/2009

Reason abandoned

Eligibility

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 type

Patient

Age group

Child

Gender

Both

Target number of participants

Total: 120 (study 1: 60; study 2: 60)

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

Cote d'Ivoire

Trial participating centre

Department of Medical Parasitology and Infection Biology
Basel
4002
Switzerland

Sponsor information

Organisation

Swiss Tropical Institute (Switzerland)

Sponsor details

c/o Jennifer Keiser
Department of Medical Parasitology and Infection Biology
Basel
4002
Switzerland
+41 (0)61 284 8218
jennifer.keiser@unibas.ch

Sponsor type

Research organisation

Website

http://sti.ch

Funders

Funder type

Industry

Funder name

Mepha Pharma AG (Switzerland)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2010 results in http://www.ncbi.nlm.nih.gov/pubmed/20350194

Publication citations

  1. Results

    Keiser J, N'Guessan NA, Adoubryn KD, Silué KD, Vounatsou P, Hatz C, Utzinger J, N'Goran EK, Efficacy and safety of mefloquine, artesunate, mefloquine-artesunate, and praziquantel against Schistosoma haematobium: randomized, exploratory open-label trial., Clin. Infect. Dis., 2010, 50, 9, 1205-1213, doi: 10.1086/651682.

Additional files

Editorial Notes