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

Uncomplicated P. Falciparum Malaria in Children Clinical Trial

— ACTE  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01017770
• Other study ID #: ACTEffectiveness
• Status: Completed
• Phase: Phase 4
• First received: November 20, 2009
• Last updated: July 29, 2015
• Start date: September 2008
• Est. completion date: August 2010

Study information

• Verified date: July 2015
• Source: Centre Muraz
• Contact: n/a
• Is FDA regulated: No
• Health authority: Burkina Faso: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 340
• Est. completion date: August 2010
• Est. primary completion date: January 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 6 Months to 59 Months

Eligibility

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;

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Malaria
• Malaria, Falciparum
• Uncomplicated P. Falciparum Malaria in Children

Intervention

Drug:
• Artesunate-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)
• Artemether-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.

Locations

Country	Name	City	State
Burkina Faso	IRSS-DRO/Centre Muraz	Bobo-Dioulasso	Bp 545
Burkina Faso	Tinto Halidou	Bobo-Dioulasso	Houet
Burkina Faso	Nanoro	Nanoro	Boulkiemdé
Burkina Faso	Nanoro	Nanoro	Boulkiemdé

Sponsors (2)

Lead Sponsor	Collaborator
Centre Muraz	Institute of Tropical Medicine, Belgium

Country where clinical trial is conducted

Burkina Faso, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Polymerase chain reaction (PCR) adjusted treatment failure		Day 28	No
Secondary	Treatment failure up to day 42 (PCR adjusted and unadjusted)		Day 42	Yes
Secondary	Gametocytes (prevalence and density)		At day 7, 14, 21, 28, 35 and 42 days after treatment	Yes
Secondary	Hb changes		Day 35	Yes