Randomized Noninferiority Trial of Dihydroartemisinin-Piperaquine Compared with Sulfadoxine-Pyrimethamine plus Amodiaquine for Seasonal Malaria Chemoprevention in Burkina Faso

Autor: A. Fabrice Some, Paul Milligan, François Nosten, Issaka Zongo, Philip J. Rosenthal, Colin J. Sutherland, Jean-Bosco Ouédraogo, Brian Greenwood, Yves Daniel Compaoré, Joel Tarning
Rok vydání: 2015
Předmět:
Male
medicine.medical_treatment
Drug Resistance
Drug resistance
Pharmacology
law.invention
0302 clinical medicine
Dihydroartemisinin/piperaquine
Randomized controlled trial
law
Pharmacology (medical)
Child
Pediatric
0303 health sciences
Pharmacology and Pharmaceutical Sciences
Artemisinins
3. Good health
Drug Combinations
Pyrimethamine
Infectious Diseases
Medical Microbiology
Child
Preschool
6.1 Pharmaceuticals
Combination
Quinolines
Drug Therapy
Combination
Female
Seasons
Infection
medicine.drug
medicine.medical_specialty
Sulfadoxine
Clinical Trials and Supportive Activities
030231 tropical medicine
Amodiaquine
Chemoprevention
Microbiology
Epidemiology and Surveillance
Antimalarials
03 medical and health sciences
Rare Diseases
Drug Therapy
Clinical Research
Internal medicine
Burkina Faso
parasitic diseases
medicine
Humans
Preschool
030306 microbiology
business.industry
Prevention
Infant
Evaluation of treatments and therapeutic interventions
medicine.disease
Sulfadoxine/pyrimethamine
Malaria
Vector-Borne Diseases
Orphan Drug
Good Health and Well Being
Case-Control Studies
business
Zdroj: Antimicrobial agents and chemotherapy, vol 59, iss 8
ISSN: 1098-6596
0066-4804
DOI: 10.1128/aac.04923-14
Popis: The WHO recommends that children living in areas of highly seasonal malaria transmission in the Sahel subregion should receive seasonal malaria chemoprevention (SMC) with sulfadoxine-pyrimethamine plus amodiaquine (SPAQ). We evaluated the use of dihydroartemisinin-piperaquine (DHAPQ) as an alternative drug that could be used if SPAQ starts to lose efficacy. A total of 1,499 children 3 to 59 months old were randomized to receive SMC with SPAQ or DHAPQ over 3 months. The primary outcome measure was the risk of clinical malaria (fever or a history of fever with a parasite density of at least 3,000/μl). A cohort of 250 children outside the trial was followed up as a control group. Molecular markers of drug resistance were assessed. The risk of a malaria attack was 0.19 in the DHAPQ group and 0.15 in the SPAQ group, an odds ratio of 1.33 (95% confidence interval [CI], 1.02 to 1.72). Efficacy of SMC compared to the control group was 77% (67% to 84%) for DHAPQ and 83% (74% to 89%) for SPAQ. pfdhfr and pfdhps mutations associated with antifolate resistance were more prevalent in parasites from children who received SPAQ than in children who received DHAPQ. Both regimens were highly efficacious and well tolerated. DHAPQ is a potential alternative drug for SMC. (This trial is registered at ClinicalTrials.gov under registration no. NCT00941785.)
Databáze: OpenAIRE
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