Details:

Alternative Title:
BMC Infect Dis
Publisher's site:
http://dx.doi.org/10.1186/s12879-019-3862-1
Personal Author:
Dysoley, Lek ; Kim, Saorin ; Lopes, Sergio ; Khim, Nimol ; Bjorges, Steven ; ... More +
Dysoley, Lek ; Kim, Saorin ; Lopes, Sergio ; Khim, Nimol ; Bjorges, Steven ; Top, Samphornarann ; Huch, Chea ; Rekol, Huy ; Westercamp, Nelli ; Fukuda, Mark M. ; Hwang, Jimee ; Roca-Feltrer, Arantxa ; Mukaka, Mavuto ; Menard, Didier ; Taylor, Walter R. Less -
Description:
Background

The WHO recommends single low-dose primaquine (SLDPQ, 0.25 mg/kg body weight) in falciparum-infected patients to block malaria transmission and contribute to eliminating multidrug resistant Plasmodium falciparum from the Greater Mekong Sub region (GMS). However, the anxiety regarding PQ-induced acute haemolytic anaemia in glucose-6-phosphate dehydrogenase deficiency (G6PDd) has hindered its use. Therefore, we assessed the tolerability of SLDPQ in Cambodia to inform national policy.

Methods

This open randomised trial of dihydroartemisinin-piperaquine (DHAPP) + SLDPQ vs. DHAPP alone recruited Cambodians aged ≥1 year with acute uncomplicated P. falciparum. Randomisation was 4:1 DHAPP+SLDPQ: DHAPP for G6PDd patients and 1:1 for G6PDn patients, according to the results of the qualitative fluorescent spot test. Definitive G6PD status was determined by genotyping. Day (D) 7 haemoglobin (Hb) concentration was the primary outcome measure.

Results

One hundred nine patients (88 males, 21 females), aged 4–76 years (median 23) were enrolled; 12 were G6PDd Viangchan (9 hemizygous males, 3 heterozygous females). Mean nadir Hb occurred on D7 [11.6 (range 6.4 ─ 15.6) g/dL] and was significantly lower (p = 0.040) in G6PDd (n = 9) vs. G6PDn (n = 46) DHAPP+SLDPQ recipients: 10.9 vs. 12.05 g/dL, Δ = -1.15 (95% CI: -2.24 ─ -0.05) g/dL. Three G6PDn patients had D7 Hb concentrations < 8 g/dL; D7-D0 Hbs were 6.4 ─ 6.9, 7.4 ─ 7.4, and 7.5 ─ 8.2 g/dL.

Conclusions

DHAPP+SLDPQ was associated with modest Hb declines in G6PD Viangchan, a moderately severe variant. Our data augment growing evidence that SLDPQ in SE Asia is well tolerated and appears safe in G6PDd patients. Cambodia is now deploying SLDPQ and this should encourage other GMS countries to follow suit.

Trial registration

The clinicaltrials.gov reference number is NCT02434952.

Electronic supplementary material

The online version of this article (10.1186/s12879-019-3862-1) contains supplementary material, which is available to authorized users.


Subjects:
[+]
Adolescent Adult Aged Antimalarials Artemisinins Child Child, Preschool Female Glucose-6-Phosphate Glucosephosphate Dehydrogenase Deficiency Humans Malaria, Falciparum Male Middle Aged Parasitemia Plasmodium Falciparum Research Article Young Adult
Source:
BMC Infect Dis. 19
Pubmed ID:
30871496
Pubmed Central ID:
PMC6419451
Document Type:
Journal Article
Funding:
001/World Health Organization/International
Place as Subject:
Cambodia
Collection(s):
CDC Public Access
Main Document Checksum:
[+]
urn:sha256:ba3aba2a7548ccbafbe4b8fdc2c22965a9b179481ae7bca8650db8b72baf0d64
Download URL:
https://stacks.cdc.gov/view/cdc/80244/cdc_80244_DS1.pdf
File Type:

Supporting Files

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