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

This study has been completed.
Sponsor:
Collaborator:
Institute of Tropical Medicine, Belgium
Information provided by:
Centre Muraz
ClinicalTrials.gov Identifier:
NCT01017770
First received: November 20, 2009
Last updated: November 1, 2010
Last verified: November 2010
  Purpose

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.


Condition Intervention Phase
Uncomplicated P. Falciparum Malaria in Children
Drug: Artesunate-amodiaquine
Drug: Artemether-lumefantrine
Phase 4

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

Resource links provided by NLM:


Further study details as provided by Centre Muraz:

Primary Outcome Measures:
  • Polymerase chain reaction (PCR) adjusted treatment failure [ Time Frame: Day 28 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Treatment failure up to day 42 (PCR adjusted and unadjusted) [ Time Frame: Day 42 ] [ Designated as safety issue: Yes ]
  • Gametocytes (prevalence and density) [ Time Frame: At day 7, 14, 21, 28, 35 and 42 days after treatment ] [ Designated as safety issue: Yes ]
  • Hb changes [ Time Frame: Day 35 ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 340
Study Start Date: September 2008
Study Completion Date: August 2010
Primary Completion Date: January 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Artemether -lumefantrine
Experimental Treatment of malaria with Artemether-lumefantrine (AL), according to one of the two options given by national protocol in Burkina Faso
Drug: 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.
Other Name: AL, Coartem(R), Riamet(R)
Experimental: Artesunate-amodiaquine
Treatment of malaria with Artesunate-amodiaquine(AS-AQ), according to one of the two options given by national protocol in Burkina Faso
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)
Other Name: ASAQ, Coarsucam

  Eligibility

Ages Eligible for Study:   6 Months to 59 Months
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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;
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01017770

Locations
Burkina Faso
Nanoro
Nanoro, Boulkiemdé, Burkina Faso, 115
Nanoro
Nanoro, Boulkiemdé, Burkina Faso
IRSS-DRO/Centre Muraz
Bobo-Dioulasso, Bp 545, Burkina Faso, 01
Tinto Halidou
Bobo-Dioulasso, Houet, Burkina Faso, 01
Sponsors and Collaborators
Centre Muraz
Institute of Tropical Medicine, Belgium
  More Information

No publications provided

Responsible Party: Dr Tinto Halidou, IRSS-DRO/Centre Muraz
ClinicalTrials.gov Identifier: NCT01017770     History of Changes
Other Study ID Numbers: ACTEffectiveness
Study First Received: November 20, 2009
Last Updated: November 1, 2010
Health Authority: Burkina Faso: Ministry of Health

Keywords provided by Centre Muraz:
Uncomplicated malaria

Additional relevant MeSH terms:
Malaria
Malaria, Falciparum
Parasitic Diseases
Protozoan Infections
Amodiaquine
Artemether
Artemether-lumefantrine combination
Artemisinins
Artesunate
Lumefantrine
Amebicides
Anthelmintics
Anti-Infective Agents
Antifungal Agents
Antimalarials
Antiparasitic Agents
Antiplatyhelmintic Agents
Antiprotozoal Agents
Coccidiostats
Pharmacologic Actions
Schistosomicides
Therapeutic Uses

ClinicalTrials.gov processed this record on October 23, 2014