In Vivo and in Vitro Efficacy of Antimalarial Treatments in Children in Burkina Faso
1 other identifier
interventional
440
1 country
1
Brief Summary
Resistance to antimalarial drugs represents a major obstacle for controlling malaria in endemic countries, so that most sub-Saharan countries have changed their antimalarial drug policy to the new Artemisinin Containing Therapies. Burkina Faso has changed its policy for uncomplicated malaria to Artemether-Lumefantrine (AL) and Artesunate-Amodiaquine (AQ+AS), but there are still little available data on safety and efficacy of these treatments in Burkina Faso; both treatments have shown to be efficacious, but AL seems to have higher occurrence of recurrent malaria infections during a 28-day follow up period. Thus, this study aims at comparing the safety and efficacy of AL and AS-AQ (42-day follow-up), AND also at comparing their in vitro sensitivity, in patients with recurrent infection, with the results obtained in vivo.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Dec 2008
Typical duration for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2008
CompletedFirst Submitted
Initial submission to the registry
December 5, 2008
CompletedFirst Posted
Study publicly available on registry
December 16, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2011
CompletedAugust 3, 2015
July 1, 2015
1.8 years
December 5, 2008
July 30, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
PCR unadjusted treatment failure (regardless of genotyping).
42 days
Secondary Outcomes (8)
PCR adjusted treatment failure
42 days
PCR unadjusted treatment failure
28 days
PCR adjusted treatment failure
28 days
Fever clearance time
day 1, 2, 3
Asexual parasite clearance time
day 7, 14, 21, 28, 35, 42
- +3 more secondary outcomes
Study Arms (2)
Artemether -lumefantrine
EXPERIMENTALTreatment of malaria with Artemether-lumefantrine (AL), according to one of the two options given by national protocol in Burkina Faso
Artesunate-amodiaquine
EXPERIMENTALTreatment of malaria with Artesunate-amodiaquine(AS-AQ), according to one of the two options given by national protocol in Burkina Faso
Interventions
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 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.
Eligibility Criteria
You may qualify if:
- Age 6 - 59 months
- Weight \> 5 kg
- Mono-infection with P. falciparum
- Parasitemia of 4,000-200,000 asexual parasites per µl
- Fever: \> 37.5 °C or history of fever in the preceding 24 hours
- Haemoglobin \> 5.0 g/dl
- Signed informed consent by the parents or guardians
- Parents' or guardians' willingness and ability to comply with the study protocol for the duration of the trial.
You may not qualify if:
- Participation in any other clinical trial during the previous 30 days
- Known hypersensitivity to the study drugs
- Severe and/or complicated malaria (cases will be referred to Bobo-Dioulasso University hospital for treatment)
- 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;
- Known intercurrent illness or any condition which would place the subject at undue risk or interfere with the results of the study.
- Severe malnutrition (weight for height \<70% of the median NCHS/WHO reference)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Centre Murazlead
- Institute of Tropical Medicine, Belgiumcollaborator
Study Sites (1)
Tinto Halidou
Bobo-Dioulasso, Houet, 01, Burkina Faso
Related Publications (1)
Lingani M, Bonkian LN, Yerbanga I, Kazienga A, Valea I, Sorgho H, Ouedraogo JB, Mens PF, Schallig HDFH, Ravinetto R, d'Alessandro U, Tinto H. In vivo/ex vivo efficacy of artemether-lumefantrine and artesunate-amodiaquine as first-line treatment for uncomplicated falciparum malaria in children: an open label randomized controlled trial in Burkina Faso. Malar J. 2020 Jan 6;19(1):8. doi: 10.1186/s12936-019-3089-z.
PMID: 31906948DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Halidou Tinto, PhD
Centre Muraz
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- PharmD, PhD
Study Record Dates
First Submitted
December 5, 2008
First Posted
December 16, 2008
Study Start
December 1, 2008
Primary Completion
October 1, 2010
Study Completion
February 1, 2011
Last Updated
August 3, 2015
Record last verified: 2015-07