Does azithromycin given to women in labour decrease ocular bacterial infection in neonates? A double-blind, randomized trial

Sarah E Burr, Bully Camara, Claire Oluwalana, Ebrima Bojang, Christian Bottomley, Abdoulie Bojang, Robin L Bailey, Umberto D'Alessandro, Anna Roca, Sarah E Burr, Bully Camara, Claire Oluwalana, Ebrima Bojang, Christian Bottomley, Abdoulie Bojang, Robin L Bailey, Umberto D'Alessandro, Anna Roca

Abstract

Background: Vertical transmission can result in neonatal infection and disease. Reducing the transmission of bacterial pathogens from mother to infant may be an effective means of preventing neonatal infection, including bacterial conjunctivitis.

Methods: In a double-blind, randomized trial, we assessed the effect of administering a single dose of oral azithromycin to women in labour on bacterial colonization of the neonate. A reduction in purulent neonatal conjunctivitis was a secondary objective of the trial. Ocular samples were collected from the lower fornix of infants presenting with clinical signs of purulent conjunctivitis during the first eight weeks of life. Incidence of purulent conjunctivitis was compared between trial arms. Bacterial infection was assessed using PCR and incidence of purulent conjunctivitis due to bacteria was also compared between arms.

Results: Forty of 843 infants (4.7%) presented clinical signs of purulent conjunctivitis. No significant difference in incidence of purulent conjunctivitis was seen between azithromycin and placebo arms [4.3% (18/419) versus 5.2% (22/424), OR = 0.82, 95% CI (0.44,1.54), p = 0.628]. S. aureus was the most commonly identified pathogen, detected in 38% of cases. Incidence of purulent-conjunctivitis due to bacterial infection was lower in the azithromycin arm [1.2% (5/419) versus 3.8% (16/424), OR = 0.31, 95% CI (0.12-0.82), p = 0.025)]. The incidence of gram-positive bacteria was also lower in the azithromycin arm [1.0% (4/419) versus 3.3% (14/424), OR = 0.28, 95%CI (0.10-0.82), p = 0.029].

Conclusions: Oral azithromycin given to women during labour may have the potential to reduce the incidence of bacterial neonatal conjunctivitis.

Trial registration: ClinicalTrials.gov, identifier NCT01800942 , registration date 26 Feb 2013.

Keywords: Azithromycin; Conjunctivitis; Labour; Neonate; Randomized trial.

Conflict of interest statement

Ethics approval and consent to participate

The trial was approved by the Joint Gambian Government/ Medical Research Council Ethics Committee. Written, informed consent was obtained from all participants.

Consent for publication

Not applicable.

Competing interests

The authors declare that they have no competing interests.

Publisher’s Note

Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.

References

    1. Adachi K, Nielsen-Saines K, Klausner JD. Chlamydia trachomatis infection in pregnancy: the global challenge of preventing adverse pregnancy and infant outcomes in sub-Saharan Africa and Asia. Biomed Res Int. 2016;2016:9315757.
    1. Moore DL, MacDonald NE, Canadian Paediatric Society Preventing ophthalmia neonatorum. Can J Infect Dis Med Microbiol. 2015;26:122–125.
    1. Mallika P, Asok T, Faisal H, Aziz S, Tan A, Intan G. Neonatal conjunctivitis - a review. Malays Fam Physician. 2008;3:77–81.
    1. Liu L, Oza S, Hogan D, Perin J, Rudan I, Lawn JE, Cousens S, Mathers C, Black RE. Global, regional, and national causes of child mortality in 2000-13, with projections to inform post-2015 priorities: an updated systematic analysis. Lancet. 2008;385:430–440. doi: 10.1016/S0140-6736(14)61698-6.
    1. Waters D, Jawad I, Ahmad A, Lukšić I, Nair H, Zgaga L, Theodoratou E, Rudan I, Zaidi AK, Campbell H. Aetiology of community-acquired neonatal sepsis in low and middle income countries. J Glob Health. 2011;1:154–170.
    1. Verani JR, McGee L, Schrag SJ. Prevention of perinatal group B streptococcal disease: revised guidelines from CDC, 2010. MMWR. 2010;59:1–36.
    1. Di Renzo GC, Melin P, Berardi A, Blennow M, Carbonell-Estraany X, Donzelli GP, Hakansson S, Hod M, Hughes R, Kurtzer M, Poyart C, Shinwell E, Stray-Pedersend B, Wielgos M, El Helali N. Intrapartum GBS screening and antibiotic prophylaxis: a European consensus conference. J Matern Fetal Neonatal Med. 2015;28:766–782. doi: 10.3109/14767058.2014.934804.
    1. Roca A, Oluwalana C, Camara B, Bojang A, Burr S, Davis TM, Bailey R, Kampmann B, Mueller J, Bottomley C, D'Alessandro U. Prevention of bacterial infections in the newborn by pre-delivery administration of azithromycin: study protocol of a randomized efficacy trial. BMC Pregnancy Childbirth. 2015;15:302. doi: 10.1186/s12884-015-0737-3.
    1. Roca A, Oluwalana C, Bojang A, Camara B, Kampmann B, Bailey R, Demba A, Bottomley C, D'Alessandro U. Oral azithromycin given during labour decreases bacterial carriage in the mothers and their offspring: a double-blind randomized trial. Clin Microbiol Infect. 2016;22:565. doi: 10.1016/j.cmi.2016.03.005.
    1. Oluwalana C, Camara B, Bottomley C, Goodier S, Bojang A, Kampmann B, Ceesay S, D'Alessandro U, Roca A. Azithromycin in labor lowers clinical infections in mothers and newborns: a double-blind trial. Pediatrics. 2017;139:e20162281. doi: 10.1542/peds.2016-2281.
    1. Roberts CH, Last A, Molina-Gonzalez S, Cassama E, Butcher R, Nabicassa M, McCarthy E, Burr SE, Mabey DC, Bailey RL, Holland MJ. Development and evaluation of a next-generation digital PCR diagnostic assay for ocular Chlamydia trachomatis infections. J Clin Microbiol. 2013;51:2195–2203. doi: 10.1128/JCM.00622-13.
    1. Ayena KD, Amedome KM, Diallo JW, Dzidzinyo KB, Azoumah KD, Aboubakari AS, Salou M, Koffi SK, Tchassi N, Balo KP. [what remains today of neonatal conjunctivitis in prefecture of Kozah in Togo?] French. J Fr Ophtalmol. 2012;35:432–436. doi: 10.1016/j.jfo.2011.10.006.
    1. Olatunji FO, Fadeyi A, Ayanniyi AA, Akanbi AA., 2nd Non-gonococcal bacterial agents of conjunctivitis and their antibiotic susceptibility patterns in Llorin, Nigeria. Afr J Med Med Sci. 2007;36:243–247.
    1. Mabey DCW, Whittle HC. Genital and neonatal chlamydial infection in a trachoma endemic area. Lancet. 1982;320:300–301. doi: 10.1016/S0140-6736(82)90273-2.
    1. Walraven G, Scherf C, West B, Ekpo G, Paine K, Coleman R, Bailey R, Morison L. The burden of reproductive-organ disease in rural women in the Gambia, West Africa. Lancet. 2001;357:1161–1167. doi: 10.1016/S0140-6736(00)04333-6.
    1. Matejcek A, Goldman RD. Treatment and prevention of opthalmia neonatorum. Can Fam Physician. 2013;59:1187–1190.
    1. Zuppa AA, D'Andrea V, Catenazzi P, Scorrano A, Romagnoli C. Opthalmia neonatorum: what kind of prophylaxis? J Matern Fetal Neonatal Med. 2011;24:769–773. doi: 10.3109/14767058.2010.531326.
    1. Msukwa G, Batumba N, Drucker M, Menezes L, Ranjit R. Maternal and neonatal risk factors associated with vertical transmission of ophthalmia neonatorum in neonates receiving health care in Blantyre, Malawi. Middle East Afr J Ophthalmol. 2014;21:240–243. doi: 10.4103/0974-9233.134684.

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