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Tytuł pozycji:

Randomised trial of azithromycin to eradicate Ureaplasma in preterm infants.

Tytuł:
Randomised trial of azithromycin to eradicate Ureaplasma in preterm infants.
Autorzy:
Viscardi RM; Department of Pediatrics, University of Maryland School of Medicine, Baltimore, Maryland, USA .
Terrin ML; Department of Epidemiology and Preventive Medicine, University of Maryland School of Medicine, Baltimore, Maryland, USA.
Magder LS; Department of Epidemiology and Preventive Medicine, University of Maryland School of Medicine, Baltimore, Maryland, USA.
Davis NL; Department of Pediatrics, University of Maryland Baltimore, Baltimore, Maryland, USA.
Dulkerian SJ; Department of Pediatrics, University of Maryland School of Medicine, Baltimore, Maryland, USA.
Waites KB; Department of Pathology, University of Alabama at Birmingham, Birmingham, Alabama, USA.
Ambalavanan N; Department of Pediatrics, University of Alabama at Birmingham, Birmingham, Alabama, USA.
Kaufman DA; Department of Pediatrics, University of Virginia School of Medicine, Charlottesville, Virginia, USA.
Donohue P; Department of Pediatrics, Johns Hopkins Medicine, Baltimore, Maryland, USA.
Tuttle DJ; Department of Pediatrics, Christiana Care Health System, Newark, Delaware, USA.
Weitkamp JH; Department of Pediatrics, Vanderbilt University Medical Center, Nashville, Tennessee, USA.
Hassan HE; University of Maryland School of Pharmacy, Baltimore, Maryland, USA.
Eddington ND; University of Maryland School of Pharmacy, Baltimore, Maryland, USA.
Źródło:
Archives of disease in childhood. Fetal and neonatal edition [Arch Dis Child Fetal Neonatal Ed] 2020 Nov; Vol. 105 (6), pp. 615-622. Date of Electronic Publication: 2020 Mar 13.
Typ publikacji:
Clinical Trial, Phase II; Journal Article; Randomized Controlled Trial
Język:
English
Imprint Name(s):
Original Publication: London : British Medical Association,
MeSH Terms:
Anti-Bacterial Agents/*therapeutic use
Azithromycin/*therapeutic use
Infant, Premature, Diseases/*drug therapy
Respiratory Tract Infections/*drug therapy
Ureaplasma Infections/*drug therapy
Anti-Bacterial Agents/administration & dosage ; Anti-Bacterial Agents/pharmacokinetics ; Azithromycin/administration & dosage ; Azithromycin/pharmacokinetics ; Bronchopulmonary Dysplasia/etiology ; Double-Blind Method ; Drug Administration Schedule ; Female ; Gestational Age ; Humans ; Infant, Extremely Premature ; Infant, Newborn ; Intensive Care Units, Neonatal ; Intention to Treat Analysis ; Male ; Prospective Studies ; Respiratory Tract Infections/complications ; Risk Factors ; Ureaplasma Infections/complications
References:
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Grant Information:
R01 HD067126 United States HD NICHD NIH HHS
Contributed Indexing:
Keywords: bronchopulmonary dysplasia; neonatology; prematurity; ureaplasma parvum; ureaplasma urealyticum
Molecular Sequence:
ClinicalTrials.gov NCT01778634
Substance Nomenclature:
0 (Anti-Bacterial Agents)
83905-01-5 (Azithromycin)
Entry Date(s):
Date Created: 20200315 Date Completed: 20201103 Latest Revision: 20220304
Update Code:
20240105
PubMed Central ID:
PMC7592356
DOI:
10.1136/archdischild-2019-318122
PMID:
32170033
Czasopismo naukowe
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 24 0 -28 6 weeks' gestation (stratified 24 0 -26 6 ; 27 0 -28 6 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.
Trial Registration Number: NCT01778634.
Competing Interests: Competing interests: None declared.
(© Author(s) (or their employer(s)) 2020. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)
Comment in: Acta Paediatr. 2022 Mar;111(3):696-697. (PMID: 34762753)

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