Condition category
Infections and Infestations
Date applied
09/10/2009
Date assigned
28/06/2010
Last edited
28/06/2010
Prospective/Retrospective
Retrospectively 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 Jean Bosco

ORCID ID

Contact details

Institut de Recherche en Sciences de la Santé - Direction Régionale de l'Ouest (IRSS-DRO)
399 Avenue de la Liberte
BP: 545
Bobo-Dioulasso
01
Burkina Faso

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Assessment of first line therapy for uncomplicated falciparum malaria with artemether/lumefantrine (Coartem®) and artesunate/amodiaquine (Coarsucam®) in Bobo-Dioulasso, Burkina Faso: a randomised controlled trial

Acronym

Study hypothesis

Artemether/lumefantrine (Coartem®) and artesunate/amodiaquine (Coarsucam®) remain effective and well tolerated for the treatment of uncomplicated falciparum malaria in Burkina Faso.

Ethics approval

Ethics Committee of the Muraz Centre (Comite d'Ethique Institutionnelle du Centre Muraz), approval pending as of 09/10/2009

Study design

Randomised controlled 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

Malaria

Intervention

Artemether/lumefantrine (Coartem®) versus artesunate/amodiaquine (Coarsucam®). The drugs will be administrated over three days orally. The dose will be calculated based on the child's weight.

Intervention type

Drug

Phase

Not Applicable

Drug names

Artemether/lumefantrine (Coartem®), artesunate/amodiaquine (Coarsucam®)

Primary outcome measures

The following will be assessed at 28 days:
1. Risk of recurrent malaria
2. Risk of recurrent parasitaemia
3. Risk of clinical treatment failure
4. Risk of parasitological treatment failure

Secondary outcome measures

1. Prevalence of fever (defined as both subjective fever in the previous 24 hours and measured axillary temperature greater than 37.5°C) on follow-up days 1, 2, and 3
2. Prevalence of parasitaemia on follow-up days 2 and 3
3. Change in mean haemoglobin from day 0 to 28 (or day of rescue therapy for patients classified as late clinical failure [LCF] or late parasitological failure [LPF])
4. Prevalence of gametocytaemia and gametocyte density on follow-up days 2, 3, 7, 14, 21, 28
5. Risk of serious adverse events: proportion of patients experiencing any serious adverse event in each treatment group during the 28-day follow-up period (both including and excluding patients classified as early treatment failure [ETF] or LCF, as recurrent malaria can be confounding)
6. Risk of adverse events of moderate or greater severity, at least possibly related to the study medications (both including and excluding patients classified as ETF or LCF)
7. Change in the prevalence of molecular markers associated with drug resistance from day 0 to the day of recurrent parasitaemia

Overall trial start date

12/10/2009

Overall trial end date

31/01/2010

Reason abandoned

Eligibility

Participant inclusion criteria

1. Not previously enrolled in this study
2. Both males and females, aged greater than 6 months
3. Weight greater than 5 kg
4. Fever (greater than 37.5ºC axillary) or history of fever in the previous 24 hours
5. Absence of any history of serious side effects to study medications
6. No evidence of a concomitant febrile illness in addition to malaria
7. Provision of informed consent and ability to participate in 28-day follow-up (patient has easy access to health unit)
8. No danger signs or evidence of severe malaria defined as:
8.1. Unarousable coma (if after convulsion, greater than 30 minutes)
8.2. Repeated convulsions (greater than two within 24 hours)
8.3. Recent convulsions (one to two within 24 hours)
8.4. Altered consciousness (confusion, delirium, psychosis, coma)
8.5. Lethargy
8.6. Unable to drink or breast feed
8.7. Vomiting everything
8.8. Unable to stand/sit due to weakness
8.9. Severe anaemia (Hb less than 5.0 g/dL)
8.10. Respiratory distress (laboured breathing at rest)
8.11. Jaundice
9. Plasmodium falciparum mono-infection
10. Parasite density greater than 2,000/ul and less than 200,000/ul

Participant type

Patient

Age group

Other

Gender

Both

Target number of participants

197

Participant exclusion criteria

1. Severe malaria
2. Unable to comply with planned follow up
3. Pregnancy

Recruitment start date

12/10/2009

Recruitment end date

31/01/2010

Locations

Countries of recruitment

Burkina Faso

Trial participating centre

Institut de Recherche en Sciences de la Santé - Direction Régionale de l'Ouest (IRSS-DRO)
Bobo-Dioulasso
01
Burkina Faso

Sponsor information

Organisation

Institute of Research in Health Sciences (Institut de Recherche en Sciences de la Santé [IRSS]) (Burkina Faso)

Sponsor details

Direction Régionale de l'Ouest (DRO)
399 Avenue de la Liberte
BP: 545
Bobo-Dioulasso
01
Burkina Faso

Sponsor type

Government

Website

Funders

Funder type

Government

Funder name

National Malaria Control Programme (Burkina Faso)

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

Publication citations

Additional files

Editorial Notes