title: Adherence and efficacy of supervised versus non-supervised treatment with artemether/lumefantrine for the treatment of uncomplicated Plasmodium falciparum malaria in Bangladesh: a randomised controlled trial.
abstract: As artemether/lumefantrine is now deployed as the first-line treatment for uncomplicated falciparum malaria in Bangladesh, information on its efficacy and adherence to its use is important. A randomised controlled non-inferiority trial comparing directly observed treatment (DOT) and non-directly observed treatment (NDOT) was conducted in 320 patients with uncomplicated falciparum malaria in Bandarban Hill Tract District, Bangladesh. Both regimens showed similar high levels of PCR-corrected 42-day parasitological and clinical cure rates (99.3% in the NDOT group and 100% in the DOT group; P=0.49). Survival analysis for the time to recurrence of infection showed no difference between treatment groups (log rank, P=0.98). Adherence, as assessed by counting remaining tablets and oral interviews, was 93% in the NDOT group and was confirmed by Day 7 lumefantrine concentrations. Adherence was independent of educational level. Patients with plasma lumefantrine concentrations < 280 ng/ml at Day 7 were at greater risk for re-infection (relative risk 5.62; P=0.027). The efficacy of artemether/lumefantrine for the treatment of uncomplicated falciparum malaria in Bangladesh is high and is similar for DOT and NDOT. Adherence to therapy is high.
authors.affiliation: Faculty of Tropical Medicine, Mahidol University, Bangkok 10400, Thailand. musfiqr2003@yahoo.com
authors.forename: Md Mushfiqur
authors.initials: MM
authors.lastname: Rahman
authors.forename: Arjen M
authors.initials: AM
authors.lastname: Dondorp
authors.forename: Nicholas P J
authors.initials: NP
authors.lastname: Day
authors.forename: Niklas
authors.initials: N
authors.lastname: Lindegardh
authors.forename: Mallika
authors.initials: M
authors.lastname: Imwong
authors.forename: M A
authors.initials: MA
authors.lastname: Faiz
authors.forename: A Mannan
authors.initials: AM
authors.lastname: Bangali
authors.forename: A T M Mustafa
authors.initials: AT
authors.lastname: Kamal
authors.forename: Jahirul
authors.initials: J
authors.lastname: Karim
authors.forename: Jaranit
authors.initials: J
authors.lastname: Kaewkungwal
authors.forename: Pratap
authors.initials: P
authors.lastname: Singhasivanon
mesh_terms: D000293:Adolescent; D000328:Adult; D000818:Animals; D000962:Antimalarials / Q000097:blood / Q000627:therapeutic use*; D000077549:Artemether; D037621:Artemisinins / Q000097:blood / Q000627:therapeutic use*; D002648:Child; D002675:Child, Preschool; D023801:Directly Observed Therapy; D004338:Drug Combinations; D004983:Ethanolamines / Q000097:blood / Q000627:therapeutic use*; D005260:Female; D005449:Fluorenes / Q000097:blood / Q000627:therapeutic use*; D006801:Humans; D000078102:Lumefantrine; D016778:Malaria, Falciparum / Q000188:drug therapy*; D008297:Male; D055118:Medication Adherence; D008875:Middle Aged; D010963:Plasmodium falciparum / Q000302:isolation & purification; D016133:Polymerase Chain Reaction; D016896:Treatment Outcome
chemical_list: D000962:Antimalarials; D037621:Artemisinins; D004338:Drug Combinations; D004983:Ethanolamines; D005449:Fluorenes; D000077549:Artemether; D000078102:Lumefantrine