Evidence map›Paper›PMID 21098694›Full record

ArticleJournal of clinical pharmacology2011

Pharmacokinetics, safety, and biologic effects of azithromycin in extremely preterm infants at risk for ureaplasma colonization and bronchopulmonary dysplasia.

Hazem E Hassan, Ahmed A Othman, Natalie D Eddington, Lynn Duffy, Li Xiao, Ken B Waites, David A Kaufman, Karen D Fairchild, Michael L Terrin, Rose M Viscardi

Registry-linked trialOpen access · greenAbstract readComparative Study
In one paragraph

Article in Journal of clinical pharmacology, 2011. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01778634 (A Phase IIb Randomized, Placebo-controlled, Double-blind Trial of Azithromycin to Eradicate Ureaplasma Respiratory Tract Infection in Preterm Infants), which is not on this map. Cited by 29 papers, 5 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
29citing papers in PubMed, 5 pooled it
1.9field-weighted citation impact, top 14% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT01778634 phase2completednot on this mapstarted 2013, after this paper: background citation

A Phase IIb Randomized, Placebo-controlled, Double-blind Trial of Azithromycin to Eradicate Ureaplasma Respiratory Tract Infection in Preterm Infants

TypeinterventionalSponsorUniversity of Maryland, BaltimoreRan2013 to 2020Enrolled121ConditionsUreaplasma InfectionsArmsAzithromycin, Placebo
3 · Its place in the literature

Who cites it

29 citing papers in PubMed, 5 syntheses or guidelines pooled it, 52 citations in OpenAlex.

  1. Azithromycin for eradication ofArchives of disease in childhood. Fetal and neonatal edition · 2026
    Pooled it
  2. Pooled it
  3. Pooled it
  4. Pooled it
  5. A systematic review of randomized controlled trials for the prevention of bronchopulmonary dysplasia in infants.Journal of perinatology : official journal of the California Perinatal Association · 2014
    Pooled it
  6. Trial
  7. Randomised trial of azithromycin to eradicateArchives of disease in childhood. Fetal and neonatal edition · 2020
    Trial
  8. Trial
  9. Perinatal pharmacokinetics of azithromycin for cesarean prophylaxis.American journal of obstetrics and gynecology · 2015
    Trial
  10. Trial
  11. Trial
  12. Article
  13. Article
  14. Predicting the likelihood of lower respiratory tractArchives of disease in childhood. Fetal and neonatal edition · 2023
    Article
  15. Review
  16. PlacingChildren (Basel, Switzerland) · 2023
    Article
  17. Azithromycin for Eradication ofThe journal of pediatric pharmacology and therapeutics : JPPT : the official journal of PPAG · 2023
    Article
  18. Review
  19. Article
  20. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

10 authors at 4 institutions in 2 countries.

Hazem E HassanPharmacokinetics and Biopharmaceutics Laboratory, Department of Pharmaceutical Sciences, School of Pharmacy, University of Maryland, Baltimore, Maryland, USA.
Ahmed A Othman
Natalie D Eddington
Lynn Duffy
Li Xiao
Ken B Waites
David A Kaufman
Karen D Fairchild
Michael L Terrin
Rose M Viscardi
University of Maryland, Baltimore · USUniversity of Alabama at Birmingham · USUniversity of Virginia · USCairo University · EG

Funding

Azithromycin to prevent BPD in Ureaplasma-infected Preterms: Single Dose PK studyR21HD056424 · NICHD · UNIVERSITY OF MARYLAND BALTIMORE · PI VISCARDI, ROSE MARIE · 2007 to 2009
$508k
Role of Intrauterine Ureaplasma-Infection in BPD PathogenesisR21HD054876 · NICHD · UNIVERSITY OF MARYLAND BALTIMORE · PI VISCARDI, ROSE MARIE · 2009 to 2010
$411k
NICHD NIH HHS HD054876NICHD NIH HHS R21 HD054876NICHD NIH HHS R21 HD056424PHS HHS R01A1072577
6 · The paper itself

Abstract

Ureaplasma spp. respiratory tract colonization is a significant risk factor for bronchopulmonary dysplasia (BPD), a chronic lung disorder in preterm infants. As an initial step preparatory to future clinical trials to evaluate the clinical efficacy of azithromycin to prevent BPD, the authors characterized the pharmacokinetics, safety, and biological effects of a single intravenous dose of azithromycin (10 mg/kg) in preterm neonates (n = 12) 24 to 28 weeks gestation at risk for Ureaplasma infection and BPD. A 2-compartment structural model with the clearance and volume of peripheral compartment (V2) allometrically scaled on body weight (WT) best described the pharmacokinetics of azithromycin in preterm neonates. The estimated parameters were clearance [0.18 L/h × WT(kg)(0.75)], intercompartmental clearance [1.0 L/h], volume of distribution of central compartment [0.93 L], and V2 [14.2 L × WT(kg)]. There were no serious adverse events attributed to azithromycin. A single dose of azithromycin did not suppress inflammatory cytokines or myeloperoxidase activity in tracheal aspirates. These results demonstrated the safety of azithromycin and developed a pharmacokinetic model that is useful for future simulation-based clinical trials for eradicating Ureaplasma and preventing BPD in preterm neonates.

Indexed as

AzithromycinBronchopulmonary DysplasiaFemaleHumansInfant, Extremely Low Birth WeightInfant, NewbornInfant, PrematureInfant, Premature, DiseasesMaleRespiration, ArtificialUreaplasmaUreaplasma InfectionsAzithromycin

Identifiers

PMID21098694
PMCPMC4240745
OpenAlexW1975088105

What OpenQuestion holds

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.