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: Md Mushfiqur Rahman, Arjen M Dondorp, Nicholas P J Day, Niklas Lindegardh, Mallika Imwong, M A Faiz, A Mannan Bangali, A T M Mustafa Kamal, Jahirul Karim, Jaranit Kaewkungwal, Pratap Singhasivanon
• Journal: Transactions of the Royal Society of Tropical Medicine and Hygiene (Trans R Soc Trop Med Hyg) Vol. 102 Issue 9 Pg. 861-7 (Sep 2008) ISSN: 0035-9203 [Print] England
• PMID: 18606428 (Publication Type: Journal Article, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)

Chemical References

• Antimalarials
• Artemisinins
• Drug Combinations
• Ethanolamines
• Fluorenes
• Artemether
• Lumefantrine

Topics

• Adolescent
• Adult
• Animals
• Antimalarials (blood, therapeutic use)
• Artemether
• Artemisinins (blood, therapeutic use)
• Child
• Child, Preschool
• Directly Observed Therapy
• Drug Combinations
• Ethanolamines (blood, therapeutic use)
• Female
• Fluorenes (blood, therapeutic use)
• Humans
• Lumefantrine
• Malaria, Falciparum (drug therapy)
• Male
• Medication Adherence
• Middle Aged
• Plasmodium falciparum (isolation & purification)
• Polymerase Chain Reaction
• Treatment Outcome