A Randomized Open-Label Evaluation of the Antimalarial Prophylactic Efficacy of Azithromycin-Piperaquine versus Sulfadoxine-Pyrimethamine in Pregnant Papua New Guinean Women.
Brioni R MooreJohn M BenjaminRoselyn TobeMaria Ome-KaiusGumul YadiBernadine KasianCharles KongLeanne J RobinsonMoses LamanIvo MuellerStephen RogersonTimothy M E DavisPublished in: Antimicrobial agents and chemotherapy (2019)
Emerging malaria parasite sulfadoxine-pyrimethamine (SP) resistance has prompted assessment of alternatives for intermittent preventive treatment in pregnancy (IPTp). The objective was to evaluate the tolerability and prophylactic efficacy of azithromycin (AZ) plus piperaquine (PQ) in pregnant women in Papua New Guinea. The study was an open-label, randomized, parallel-group trial. A total of 122 women (median gestation, 26 weeks [range, 14 to 32 weeks]) were randomized 1:1 to three daily doses of 1 g AZ plus 960 mg PQ tetraphosphate or single-dose SP (4,500 mg sulfadoxine plus 225 mg pyrimethamine), based on computer-generated block randomization. Tolerability was assessed to day 7, and efficacy was assessed to day 42 (when participants were returned to usual care) and at delivery. Data for 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 h. There were no differences in blood smear positivity rates between AZ-PQ and SP up to day 42 (0% versus 5.2%; relative risk [RR], 0.14 [95% confidence interval [CI], 0.01 to 2.58] [P = 0.18]; absolute risk reduction [ARR], 5.2% [95% CI, -1.3 to 11.6%]) and at the time of delivery (0% versus 8.7%; RR, 0.11 [95% CI, 0.01 to 2.01] [P = 0.14]; ARR, 8.7% [95% CI, -0.2 to 17.6%]). Of 92 women who were monitored to parturition, 89 (97%) delivered healthy babies; there were 3 stillbirths (SP, n = 1; AZ-PQ, n = 2 [twins]). There was a higher live birth weight (mean ± standard deviation) in the AZ-PQ group (3.13 ± 0.42 versus 2.88 ± 0.55 kg [P = 0.016]; mean difference, 0.25 kg [95% CI, 0.02 to 0.48 kg]). AZ-PQ is a promising candidate for IPTp.
Keyphrases
- open label
- plasmodium falciparum
- gestational age
- pregnancy outcomes
- phase iii
- pregnant women
- polycystic ovary syndrome
- phase ii
- birth weight
- double blind
- clinical trial
- placebo controlled
- breast cancer risk
- preterm birth
- study protocol
- healthcare
- cervical cancer screening
- phase ii study
- big data
- insulin resistance
- randomized controlled trial
- squamous cell carcinoma
- pain management
- mycobacterium tuberculosis
- machine learning
- artificial intelligence
- type diabetes
- toxoplasma gondii
- high intensity
- radiation therapy
- metabolic syndrome
- electronic health record
- deep learning
- drug administration