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Randomised trial of azithromycin to eradicate Ureaplasma in preterm infants
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Randomised trial of azithromycin to eradicate Ureaplasma in preterm infants
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Randomised trial of azithromycin to eradicate Ureaplasma in preterm infants
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Journal Article
Randomised trial of azithromycin to eradicate Ureaplasma in preterm infants
2020
Overview
ObjectiveTo test whether azithromycin eradicates Ureaplasma from the respiratory tract in preterm infants.DesignProspective, phase IIb randomised, double-blind, placebo-controlled trial.SettingSeven level III–IV US, academic, neonatal intensive care units (NICUs).PatientsInfants 240–286 weeks’ gestation (stratified 240–266; 270–286 weeks) randomly assigned within 4 days following birth from July 2013 to August 2016.InterventionsIntravenous azithromycin 20 mg/kg or an equal volume of D5W (placebo) every 24 hours for 3 days.Main outcome measuresThe 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.ResultsOne 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.ConclusionA 3-day azithromycin regimen effectively eradicated respiratory tract Ureaplasma colonisation in this study.Trial registration number NCT01778634.
Publisher
BMJ Publishing Group LTD,BMJ Publishing Group
Subject
Anti-Bacterial Agents - administration & dosage
/ Anti-Bacterial Agents - pharmacokinetics
/ Anti-Bacterial Agents - therapeutic use
/ Azithromycin - administration & dosage
/ Azithromycin - pharmacokinetics
/ Azithromycin - therapeutic use
/ Bronchopulmonary Dysplasia - etiology
/ Drug Administration Schedule
/ Female
/ Humans
/ Infant, Premature, Diseases - drug therapy
/ Infants
/ Intensive Care Units, Neonatal
/ Male
/ Neonates
/ Respiratory Tract Infections - complications
/ Respiratory Tract Infections - drug therapy
/ Ureaplasma Infections - complications
