A randomized clinical trial comparing safety, clinical and parasitological response to artemether-lumefantrine and chlorproguanil-dapsone in treatment of uncomplicated malaria in pregnancy in Mulago hospital, Uganda.
BACKGROUND
Malaria infection during pregnancy is a major public health problem. Due to increasing resistance to Chloroquine and Sulphadoxine/Pyrimethamine, the Ugandan national policy on malaria treatment was changed in 2005 to Artemisinin-based combination therapy (ACT) as the first-line treatment for uncomplicated malaria. The policy recommends assessment of safety and efficacy of alternative drugs for treatment of uncomplicated malaria. We compared the efficacy and safety of Artemether-Lumefantrine (Coartem) and Chlorproguanil-Dapsone (Lapdap) in the management of uncomplicated malaria in pregnancy.


METHODS
We enrolled 110 pregnant women in the second and third trimester of pregnancy who presented to Mulago hospital, Uganda, with uncomplicated malaria. The study design was an open-label randomized clinical trial. Participants were randomized to receive either Artemether-Lumefantrine (Coartem 20 mg/120 mg) orally or Chlorproguanil-Dapsone (Lapdap) orally for 3 consecutive days. Primary endpoints were clinical and parasitological response assessed on days 0, 1, 2, 4, 7, 14 and 28. Adverse effects, clinical response (treatment failure) and parasitological response were compared. Analysis was by intention to treat.


RESULTS
Of the 100 women who completed the study, there was no statistically significant difference in clinical and parasitological response by Day 4. The mean fever clearance time 3.0 days with Lapdap versus 2.5 days with Coartem was comparable. Likewise, mean parasite clearance time of 2.4 and 2.2 days for Lapdap and Coartem respectively was comparable. The adverse effects were comparable between the two groups.


CONCLUSIONS
Artemether-Lumefantrine and Chlorproguanil-Dapsone have high and comparable cure rates and similar safety profiles when used for treatment of uncomplicated malaria in pregnancy.
Kaye
Daniel Kabonge
DK
Department of Obstetrics and Gynecology, Makerere University Medical School, PO Box 7072, Kampala, Uganda. dankkaye@yahoo.com
Nshemerirwe
Ruth
R
Mutyaba
Twaha Serunjogi
TS
Ndeezi
Grace
G
D000293:Adolescent; D000328:Adult; D000962:Antimalarials / Q000627:therapeutic use*; D000077611:Artemether, Lumefantrine Drug Combination; D037621:Artemisinins / Q000627:therapeutic use*; D003622:Dapsone / Q000627:therapeutic use*; D004338:Drug Combinations; D004983:Ethanolamines / Q000627:therapeutic use*; D005260:Female; D005449:Fluorenes / Q000627:therapeutic use*; D006801:Humans; D016778:Malaria, Falciparum / Q000188:drug therapy*; D011247:Pregnancy; D015597:Pregnancy Complications, Parasitic / Q000188:drug therapy*; D002727:Proguanil / Q000031:analogs & derivatives* / Q000627:therapeutic use; D014454:Uganda; D055815:Young Adult
D000962:Antimalarials; D000077611:Artemether, Lumefantrine Drug Combination; D037621:Artemisinins; D004338:Drug Combinations; D004983:Ethanolamines; D005449:Fluorenes; C519882:chloroguanil, dapsone drug combination; D003622:Dapsone; D002727:Proguanil