Condition category
Infections and Infestations
Date applied
06/05/2010
Date assigned
27/05/2010
Last edited
17/12/2015
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

Socinstr. 57
Basel
4051
Switzerland

Additional identifiers

EudraCT 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

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

Trial setting

Other

Trial 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

Phase

Phase II

Drug names

Praziquantel, mefloquine, mefloquine-artesunate

Primary outcome measures

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 trial start date

01/07/2011

Overall trial end date

30/09/2011

Reason abandoned

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

Patient

Age group

Child

Gender

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

Trial 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

http://www.swisstph.ch/

Funders

Funder type

Research organisation

Funder name

Swiss National Science Foundation (Fonds National Suisse de la Recherche Scientifique [SNSF]) (Switzerland)

Alternative name(s)

Swiss National Science Foundation, Fonds National Suisse de la Recherche Scientifique, Fondo Nazionale Svizzero per la Ricerca Scientifica, Fonds National Suisse, Fondo Nazionale Svizzero, Schweizerischer Nationalfonds, SNF

Funding Body Type

private sector organisation

Funding Body Subtype

foundation

Location

Switzerland

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

2014 results in: http://www.ncbi.nlm.nih.gov/pubmed/25033291

Publication citations

Additional files

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.