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    Randomised trial of azithromycin to eradicate Ureaplasma in preterm infants

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    Author
    Viscardi, R.M.
    Terrin, M.L.
    Magder, L.S.
    Davis, N.L.
    Dulkerian, S.J.
    Hassan, H.E.
    Eddington, N.D.
    Date
    2020
    Journal
    Archives of Disease in Childhood: Fetal and Neonatal Edition
    Publisher
    BMJ Publishing Group
    Type
    Article
    
    Metadata
    Show full item record
    See at
    https://doi.org/10.1136/archdischild-2019-318122
    Abstract
    Objective: To test whether azithromycin eradicates Ureaplasma from the respiratory tract in preterm infants. Design: Prospective, phase IIb randomised, double-blind, placebo-controlled trial. Setting: Seven level III-IV US, academic, neonatal intensive care units (NICUs). Patients: Infants 240-286 weeks' gestation (stratified 240-266; 270-286 weeks) randomly assigned within 4 days following birth from July 2013 to August 2016. Interventions: Intravenous azithromycin 20 mg/kg or an equal volume of D5W (placebo) every 24 hours for 3 days. Main outcome measures: The primary efficacy outcome was Ureaplasma-free survival. Secondary outcomes were all-cause mortality, Ureaplasma clearance, physiological bronchopulmonary dysplasia (BPD) at 36 weeks' postmenstrual age, comorbidities of prematurity and duration of respiratory support. Results: One hundred and twenty-one randomised participants (azithromycin: n=60; placebo: n=61) were included in the intent-to-treat analysis (mean gestational age 26.2±1.4 weeks). Forty-four of 121 participants (36%) were Ureaplasma positive (azithromycin: n=19; placebo: n=25). Ureaplasma-free survival was 55/60 (92% (95% CI 82% to 97%)) for azithromycin compared with 37/61 (61% (95% CI 48% to 73%)) for placebo. Mortality was similar comparing the two treatment groups (5/60 (8%) vs 6/61 (10%)). Azithromycin effectively eradicated Ureaplasma in all azithromycin-assigned colonised infants, but 21/25 (84%) Ureaplasma-colonised participants receiving placebo were culture positive at one or more follow-up timepoints. Most of the neonatal mortality and morbidity was concentrated in 21 infants with lower respiratory tract Ureaplasma colonisation. In a subgroup analysis, physiological BPD-free survival was 5/10 (50%) (95% CI 19% to 81%) among azithromycin-assigned infants with lower respiratory tract Ureaplasma colonisation versus 2/11 (18%) (95% CI 2% to 52%) in placebo-treated infants. Conclusion: A 3-day azithromycin regimen effectively eradicated respiratory tract Ureaplasma colonisation in this study. Copyright Author(s) 2020.
    Keyword
    bronchopulmonary dysplasia
    neonatology
    prematurity
    ureaplasma parvum
    ureaplasma urealyticum
    Identifier to cite or link to this item
    https://www.scopus.com/inward/record.uri?eid=2-s2.0-85082194897&doi=10.1136%2farchdischild-2019-318122&partnerID=40&md5=ff4425b89d1d1e1667bf6a6ef8cfd621; http://hdl.handle.net/10713/12485
    ae974a485f413a2113503eed53cd6c53
    10.1136/archdischild-2019-318122
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