Claire Oluwalana1, Bully Camara1, Christian Bottomley2, Sean Goodier3, Abdoulie Bojang1, Beate Kampmann1,4, Samba Ceesay5, Umberto D'Alessandro1,2,6, Anna Roca7,2. 1. Medical Research Council Unit, Banjul, The Gambia. 2. London School of Hygiene and Tropical Medicine, London, United Kingdom. 3. London School of Economics, London, United Kingdom. 4. Imperial College, London, United Kingdom. 5. Ministry of Health and Social Welfare, Banjul, The Gambia; and. 6. Institute of Tropical Medicine, Antwerp, Belgium. 7. Medical Research Council Unit, Banjul, The Gambia; aroca@mrc.gm.
Abstract
BACKGROUND AND OBJECTIVES: We have recently completed a proof-of-concept trial showing that bacterial colonization decreased in women and newborns after the administration of azithromycin during labor. Here, we aim to assess the effect of the intervention on maternal and neonatal clinical infections. METHODS: This was a double-blind, placebo-controlled randomized trial. Gambian women in labor were given either an oral dose of azithromycin (2 g) or placebo. Follow-up was conducted for 8 weeks after delivery. RESULTS: From April 2013 to April 2014, we recruited 829 mothers and their 830 newborns. Sixteen infants died during the follow-up period (8 per arm). No maternal deaths or serious adverse events related to the intervention were reported. Maternal infections were lower in the azithromycin group (3.6% vs 9.2%; relative risk [RR], 0.40; 95% confidence interval [CI], 0.22-0.71; P = .002), as was the prevalence of mastitis (1.4% vs 5.1%; RR, 0.29; 95% CI, 0.12-0.70; P = .005) and fever (1.9% vs 5.8%; RR, 0.33; 95% CI, 0.15-0.74; P = .006). Among newborns, the overall prevalence of infections was also lower in the azithromycin group (18.1% vs 23.8%; RR, 0.76; 95% CI, 0.58-0.99; P = .052) and there was a marked difference in prevalence of skin infections (3.1% vs 6.4%; RR, 0.49; 95% CI, 0.25-0.93; P = .034). CONCLUSIONS: Azithromycin given to women in labor decreases infections in both women and newborns during the puerperal period. Larger studies designed to evaluate the effect of the intervention on severe morbidity and mortality are warranted.
BACKGROUND AND OBJECTIVES: We have recently completed a proof-of-concept trial showing that bacterial colonization decreased in women and newborns after the administration of azithromycin during labor. Here, we aim to assess the effect of the intervention on maternal and neonatal clinical infections. METHODS: This was a double-blind, placebo-controlled randomized trial. Gambian women in labor were given either an oral dose of azithromycin (2 g) or placebo. Follow-up was conducted for 8 weeks after delivery. RESULTS: From April 2013 to April 2014, we recruited 829 mothers and their 830 newborns. Sixteen infants died during the follow-up period (8 per arm). No maternal deaths or serious adverse events related to the intervention were reported. Maternal infections were lower in the azithromycin group (3.6% vs 9.2%; relative risk [RR], 0.40; 95% confidence interval [CI], 0.22-0.71; P = .002), as was the prevalence of mastitis (1.4% vs 5.1%; RR, 0.29; 95% CI, 0.12-0.70; P = .005) and fever (1.9% vs 5.8%; RR, 0.33; 95% CI, 0.15-0.74; P = .006). Among newborns, the overall prevalence of infections was also lower in the azithromycin group (18.1% vs 23.8%; RR, 0.76; 95% CI, 0.58-0.99; P = .052) and there was a marked difference in prevalence of skin infections (3.1% vs 6.4%; RR, 0.49; 95% CI, 0.25-0.93; P = .034). CONCLUSIONS: Azithromycin given to women in labor decreases infections in both women and newborns during the puerperal period. Larger studies designed to evaluate the effect of the intervention on severe morbidity and mortality are warranted.
Authors: Malene Plejdrup Hansen; Anna M Scott; Amanda McCullough; Sarah Thorning; Jeffrey K Aronson; Elaine M Beller; Paul P Glasziou; Tammy C Hoffmann; Justin Clark; Chris B Del Mar Journal: Cochrane Database Syst Rev Date: 2019-01-18
Authors: A Roca; A Bojang; B Camara; C Oluwalana; K Lette; P West; U D'Alessandro; C Bottomley Journal: Clin Microbiol Infect Date: 2017-05-03 Impact factor: 8.067
Authors: Sarah E Burr; Bully Camara; Claire Oluwalana; Ebrima Bojang; Christian Bottomley; Abdoulie Bojang; Robin L Bailey; Umberto D'Alessandro; Anna Roca Journal: BMC Infect Dis Date: 2017-12-28 Impact factor: 3.090
Authors: Catherine E Oldenburg; Ahmed M Arzika; Ramatou Maliki; Mohamed Salissou Kane; Elodie Lebas; Kathryn J Ray; Catherine Cook; Sun Y Cotter; Zhaoxia Zhou; Sheila K West; Robin Bailey; Travis C Porco; Jeremy D Keenan; Thomas M Lietman Journal: PLoS Negl Trop Dis Date: 2018-11-12