First line therapy for uncomplicated falciparum malaria with Coartem® and Coarsucam® in Burkina Faso

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

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN71912942

Enrollment

197

Registered

2010-06-28

Start date

2009-10-12

Completion date

Unknown

Last updated

2015-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Malaria Infections and Infestations Malaria

Interventions

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.

Eligibility

Sex/Gender

All

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
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	—

Measure

Time frame

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

—

Countries

Burkina Faso

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026