Condition category
Infections and Infestations
Date applied
29/09/2011
Date assigned
30/01/2012
Last edited
23/10/2012
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Lay summary under review 4

Trial website

Contact information

Type

Scientific

Primary contact

Prof Jean Bosco Ouedraogo

ORCID ID

Contact details

BP 545
Bobo Dioulasso
150000
Burkina Faso

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Efficacy and tolerability of artemether lumefantrine and amodiaquine artesunate for the treatment of uncomplicated falciparum malaria in Burkina Faso

Acronym

Study hypothesis

Artemether-lumefantrine (AL) and artesunate-amodiaquine are equally effective in the treatment of malaria in Burkina Faso.

Ethics approval

Centre Muraz Ethics Committee

Study design

Randomized controlled open trial

Primary study design

Interventional

Secondary study design

Randomised controlled 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

Malaria

Intervention

Subjects will be randomized to receive either artemether-lumefantrine (AL) or artesunate-amodiaquine (ASAQ). Subjects who fail initial therapy will receive quinine which is the standard treatment for recurrent malaria in Burkina Faso.

Subjects will be followed for 42 days and will be asked to return for follow-up

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

Risk of treatment failure unadjusted and adjusted by genotyping at day 28 and tolerability

Secondary outcome measures

1. Prevalence of fever on days 1-3
2. Prevalence of parasitemia on days 2 and 3
3. Change in mean hemoglobin level between days 0 and 28 (or day of treatment failure)
4. Prevalence of gametocytes during follow-up
5. Risk of serious adverse events during follow-up
6. Risk of adverse events of moderate or greater severity, at least possibly related to the study medications, excluding patients requiring quinine therapy
7. Selection of molecular markers associated with drug resistance

Overall trial start date

29/09/2011

Overall trial end date

31/12/2012

Reason abandoned

Eligibility

Participant inclusion criteria

1. Age > 6 months
2. Weight > 5 kg
3. Fever (> 37.5ºC axillary) or history of fever in the previous 24 hours
4. Absence of any history of serious side effects to study medications
5. No evidence of a concomitant febrile illness
6. Provision of informed consent and agreement to follow-up for 28 days
7. No evidence of severe malaria or danger signs
8. Absence of repeated vomiting of study medications on day 0
9. P. falciparum mono-infection
10. Parasite density > 2000/ul and < 200,000/ul

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

780 patients

Participant exclusion criteria

1. Severe malaria
2. Unable to respect the follow up schedule
3. Known allergy to the study medication
4. Other chronic disease requiring care

Recruitment start date

29/09/2011

Recruitment end date

31/12/2012

Locations

Countries of recruitment

Burkina Faso

Trial participating centre

BP 545
Bobo Dioulasso
150000
Burkina Faso

Sponsor information

Organisation

National Malaria Control Program (Burkina Faso)

Sponsor details

BP 7009
Ouagadougou
01
Burkina Faso

Sponsor type

Government

Website

Funders

Funder type

Government

Funder name

Ministry of Health (Burkina Faso)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

National Malaria Control Program (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