A Randomized Open-Label Evaluation of the Antimalarial Prophylactic Efficacy of Azithromycin-Piperaquine versus Sulfadoxine-Pyrimethamine in Pregnant Papua New Guinean Women
| Autor: | Timothy M. E. Davis, Charles Kong, Bernadine Kasian, Stephen J. Rogerson, John Benjamin, Maria Ome-Kaius, Roselyn Tobe, Gumul Yadi, Brioni R. Moore, Leanne J. Robinson, Moses Laman, Ivo Mueller |
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| Rok vydání: | 2019 |
| Předmět: |
Adult
medicine.medical_specialty Erythrocytes Sulfadoxine medicine.medical_treatment Plasmodium falciparum 030231 tropical medicine Gestational Age Clinical Therapeutics Azithromycin Parasitemia Chemoprevention Severity of Illness Index Antimalarials Papua New Guinea Random Allocation 03 medical and health sciences 0302 clinical medicine Dihydroartemisinin/piperaquine Pregnancy Piperaquine Internal medicine Severity of illness Malaria Vivax medicine Humans Pharmacology (medical) 030212 general & internal medicine Malaria Falciparum Pharmacology business.industry Stillbirth Sulfadoxine/pyrimethamine Drug Combinations Pyrimethamine Infectious Diseases Tolerability Relative risk Asymptomatic Diseases Quinolines Female Plasmodium vivax business Live Birth medicine.drug |
| Zdroj: | Antimicrobial Agents and Chemotherapy. 63 |
| ISSN: | 1098-6596 0066-4804 |
| DOI: | 10.1128/aac.00302-19 |
| Popis: | 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. |
| Databáze: | OpenAIRE |
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