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Completed

NCT Number: NCT01017770

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

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.

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Key information

Conditions

Uncomplicated P. Falciparum Malaria in Children

Age range

6 month–59 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Nanoro, Boulkiemdé, Burkina Faso

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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;

Treatment and study plan

artesunate-amodiaquine

Drug

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)

Other names: ASAQ, Coarsucam

Artemether-lumefantrine

Drug

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.

Other names: AL, Coartem(R), Riamet(R)

Primary outcomes

  1. Polymerase chain reaction (PCR) adjusted treatment failure

    Time frame: Day 28

Secondary outcomes

  1. Treatment failure up to day 42 (PCR adjusted and unadjusted)

    Time frame: Day 42

  2. Gametocytes (prevalence and density)

    Time frame: At day 7, 14, 21, 28, 35 and 42 days after treatment

  3. Hb changes

    Time frame: Day 35

Sponsors and collaborators

Lead sponsor

Centre Muraz

Other

Collaborators

  • Institute of Tropical Medicine, Belgium

Registry information

Official study 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

Acronym: ACTE

Important dates

Study start
2008
Primary completion
2010
Study completion
2010
First posted
Nov 23, 2009
Registry last updated
Jul 31, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.