Artemether-lumefantrine (AL) Versus Artesunate + Amodiaquine (ASAQ) for the Treatment of Uncomplicated Falciparum Malaria in Burkina Faso

Artemether-lumefantrine Vs Co-formulated Amodiaquine + Artesunate for the Treatment of Uncomplicated Falciparum Malaria: a Randomized Open-label Trial to Evaluate the Effectiveness of the Burkina Faso New Drug Policy

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01017770

Acronym

ACTE

Enrollment

340

Registered

2009-11-23

Start date

2008-09-30

Completion date

2010-08-31

Last updated

2015-07-31

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

Conditions

Uncomplicated P. Falciparum Malaria in Children

Keywords

Uncomplicated malaria

Brief summary

Several countries in Africa have changed their first-line treatment for uncomplicated malaria to an ACT. Burkina Faso has changed its policy to Artemether-Lumefantrine (AL) and Artesunate-Amodiaquine (AQ+AS). However, such choice has been done without knowing the local effectiveness of these drugs when they are given to patients in real life conditions, without direct observation of the drug administration. Thus, this study aims at investigating the effectiveness of AQ+AS and AL, when given to children with uncomplicated malaria in Burkina Faso.

Interventions

DRUGArtesunate-amodiaquine

Coformulated AQ+AS by Sanofi-Aventis has been pre-qualified by WHO in 2008. It is administered once daily for three consecutive days, and it is available in three different dosages (25mg/67.5mg; 50mg/135mg; 100mg/270mg)

DRUGArtemether-lumefantrine

Artemether-lumefantrine by Novartis was the first fixed-dose ACT that was prequalified by WHO in April 2004. A 3-day, 6-dose regimen of AL is recommended for infants and children weighing 5-35 kg and adults weighing \> 35 kg.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

6 Months to 59 Months

Healthy volunteers

Inclusion criteria

* Weight \> 5 kg; * Monoinfection with P. falciparum and a parasitaemia of 2,000-200,000 parasites /µl; * Fever (axillary temperature ≥37.5 °C) or history of fever in the preceding 24 hours; * Haemoglobin value above 5.0 g/dl; * Absence of febrile conditions caused by diseases other than malaria.

Exclusion criteria

* Danger signs: not able to drink or breast-feed, vomiting (\> twice in 24hours), recent history of convulsions (\>1 in 24h), unconscious state, unable to sit or stand; * Signs of severe malaria (WHO 2000); * Mixed malaria infection; * Severe malnutrition; * Other underlying diseases (cardiac, renal, hepatic diseases); * History of allergy to study drugs;

Design outcomes

Primary

Measure	Time frame
Polymerase chain reaction (PCR) adjusted treatment failure	Day 28

Secondary

Measure	Time frame
Treatment failure up to day 42 (PCR adjusted and unadjusted)	Day 42
Gametocytes (prevalence and density)	At day 7, 14, 21, 28, 35 and 42 days after treatment
Hb changes	Day 35

Countries

Burkina Faso

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026