A randomized open-label evaluation of the antimalarial prophylactic efficacy of azithromycin-piperaquine versus sulfadoxine-pyrimethamine in pregnant Papua New Guinean women
- Author(s)
- Moore, BR; Benjamin, JM; Tobe, R; Ome-Kaius, M; Yadi, G; Kasian, B; Kong, C; Robinson, LJ; Laman, M; Mueller, I; Rogerson, S; Davis, TME;
- Details
- Publication Year 2019-09-23,Volume 63,Issue #10,Page e00302-19
- Journal Title
- Antimicrobial Agents and Chemotherapy
- Publication Type
- Journal Article
- Abstract
- Background: Emerging sulfadoxine-pyrimethamine (SP) malaria parasite resistance has prompted assessment of alternatives for intermittent preventive treatment in pregnancy (IPTp).Objective: To evaluate the tolerability and prophylactic efficacy of azithromycin (AZ) plus piperaquine (PQ) in pregnant Papua New Guinean women.Study design: Open-label, randomized, parallel-group trial.Methods: 122 women (median gestation 26 [range 14-32] weeks) were randomized 1:1 to three daily doses of 1g AZ plus 960 mg PQ tetraphosphate or single-dose SP (4,500 mg sulfadoxine, 225 mg pyrimethamine) based on computer-generated block randomization. Tolerability was assessed to Day 7, and efficacy to Day 42 (when participants were returned to usual care) and at delivery.Results: Data from 119 participants (AZ-PQ n=61, SP n=58) were analyzed. Both regimens were well tolerated, but AZ-PQ was associated with more gastrointestinal side-effects (31%) and dizziness (21%). Eight women (6.7%) were parasitemic at recruitment but all were aparasitemic by 72 hours. There was no difference in blood smear positivity between AZ-PQ and SP up to Day 42 (0% versus 5.2%; relative risk (RR) (95% CI) 0.14 (0.01,2.58), P=0.18; absolute risk reduction (ARR) (95% CI) 5.2 (-1.3,11.6)%) and by the time of delivery (0% versus 8.7%; RR 0.11 (0.01,2.01), P=0.14; ARR 8.7 (-0.2,17.6)%). Of 92 women followed to parturition, 89 (97%) delivered healthy babies and there were three stillbirths (SP n=1, AZ-PQ n=2 (twins)). There was a higher mean+/-SD live birthweight in the AZ-PQ group (3.13+/-0.42 versus 2.88+/-0.55 kg; P=0.016 (mean difference (95% CI) 0.25 (0.02,0.48) kg).Conclusion: AZ-PQ is a promising candidate for IPTp.
- Publisher
- ASM
- Research Division(s)
- Population Health And Immunity
- PubMed ID
- 31405866
- Link To PubMed Central Version
- https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6761509/
- Publisher's Version
- https://doi.org/10.1128/AAC.00302-19
- NHMRC Grants
- NHMRC/1043345,
- Terms of Use/Rights Notice
- Refer to copyright notice on published article.
Creation Date: 2019-08-21 11:19:30
Last Modified: 2021-06-21 11:50:03