ehealth digital library

Digital library of
the Tanzania
health
community

Adding a Single Low-dose of Primaquine (0.25 mg/kg) to Artemether-lumefantrine Did not Compromise Treatment Outcome of Uncomplicated Plasmodium Falciparum Malaria in Tanzania: A Randomized, Single-blinded Clinical Trial.

Mwaiswelo, R., Ngasala, B., Jovel, I., Aydin-Schmidt, B., Gosling, R., Premji, Z., Mmbando, B., Björkman, A. and Mårtensson, A. (2016) Adding a Single Low-dose of Primaquine (0.25 mg/kg) to Artemether-lumefantrine Did not Compromise Treatment Outcome of Uncomplicated Plasmodium Falciparum Malaria in Tanzania: A Randomized, Single-blinded Clinical Trial. Malaria journal, 15 (1). p. 435. ISSN 1475-2875

[img]
Preview
PDF
Richard Mwaiswelo.pdf - Updated Version
Available under License Creative Commons Attribution Non-commercial.

Download (1MB) | Preview

Abstract

The World Health Organization (WHO) recently recommended the addition of a single low-dose of the gametocytocidal drug primaquine (PQ) to artemisinin-based combination therapy (ACT) in low transmission settings as a component of pre-elimination or elimination programmes. However, it is unclear whether that influences the ACT cure rate. The study assessed treatment outcome of artemether-lumefantrine (AL) plus a single PQ dose (0.25 mg/kg) versus standard AL regimen for treatment of acute uncomplicated Plasmodium falciparum malaria in Tanzania. A randomized, single-blinded, clinical trial was conducted in Yombo, Bagamoyo district, Tanzania. Acute uncomplicated P. falciparum malaria patients aged ≥1 year, with the exception of pregnant and lactating women, were enrolled and treated with AL plus a single PQ dose (0.25 mg/kg) or AL alone under supervision. PQ was administered together with the first AL dose. Clinical and laboratory assessments were performed at 0, 8, 24, 36, 48, 60, and 72 h and on days 7, 14, 21, and 28. The primary end-point was a polymerase chain reaction (PCR)-adjusted adequate clinical and parasitological response (ACPR) on day 28. Secondary outcomes included: fever and asexual parasitaemia clearance, proportion of patients with PCR-determined parasitaemia on day 3, and proportion of patients with Pfmdr1 N86Y and Pfcrt K76T on days 0, 3 and day of recurrent infection. Overall 220 patients were enrolled, 110 were allocated AL + PQ and AL, respectively. Parasite clearance by microscopy was fast, but PCR detectable parasitaemia on day 3 was 31/109 (28.4 %) and 29/108 (26.9 %) in patients treated with AL + PQ and AL, respectively (p = 0.79). Day 28 PCR-adjusted ACPR and re-infection rate was 105/105 (100 %) and 101/102 (99 %) (p = 0.31), and 5/107 (4.7 %) and 5/8 (4.8 %) (p = 0.95), in AL + PQ and AL arm, respectively. There was neither any statistically significant difference in the proportion of Pfmdr1 N86Y or Pfcrt K76T between treatment arms on days 0, 3 and day of recurrent infection, nor within treatment arms between days 0 and 3 or day 0 and day of recurrent infection. The new WHO recommendation of adding a single low-dose of PQ to AL did not compromise treatment outcome of uncomplicated P. falciparum malaria in Tanzania. Trial registration number NCT02090036.

Item Type: Article
Keywords: Plasmodium falciparum malaria, Artemether-lumefantrine, Primaquine, Cure rate
Subjects: Malaria > Diagnosis & treatment
Divisions: Muhimbili University of Health and Allied Sciences (MUHAS)
Depositing User: Mr Joseph Madata
Date Deposited: 03 Feb 2017 13:41
Last Modified: 03 Feb 2017 13:41
URI: http://ihi.eprints.org/id/eprint/4017

Actions (login required)

Edit Item Edit Item

Downloads

Downloads per month over past year

View more statistics