Evidence map›Paper›PMID 22595153›Full record

Trial reportChest2012

Effect of azithromycin on systemic markers of inflammation in patients with cystic fibrosis uninfected with Pseudomonas aeruginosa.

Felix Ratjen, Lisa Saiman, Nicole Mayer-Hamblett, Larry C Lands, Margaret Kloster, Valeria Thompson, Peggy Emmett, Bruce Marshall, Frank Accurso, Scott Sagel and 1 more

2 registry-linked trialsOpen access · bronzeAbstract readRandomized Controlled Trial
In one paragraph

Trial report in Chest, 2012. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 53 papers, 5 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
53citing papers in PubMed, 5 pooled it
8.1field-weighted citation impact, top 2% 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.

NCT00431964 phase4completednot on this map

Multi-center, Multi-national, Randomized, Placebo-Controlled Trial of Azithromycin in Subjects With Cystic Fibrosis 6-18 Years Old, Culture Negative for Pseudomonas Aeruginosa

TypeinterventionalSponsorCF Therapeutics Development Network Coordinating CenterRan2007 to 2009Enrolled263ConditionsCystic FibrosisArmsazithromycin 250 mg tablets, placebo tablets
NCT02630394 phase1withdrawnnot on this mapstarted 2015, after this paper: background citation

A Pilot Study of Azithromycin Prophylaxis for Acute Chest Syndrome in Sickle Cell Disease

TypeinterventionalSponsorUniversity of Mississippi Medical CenterRan2015 to 2017Enrolled0ConditionsSickle Cell Disease, Acute Chest SyndromeArmsAzithromycin
3 · Its place in the literature

Who cites it

53 citing papers in PubMed, 5 syntheses or guidelines pooled it, 120 citations in OpenAlex.

  1. Pooled it
  2. Macrolide antibiotics (including azithromycin) for cystic fibrosis.The Cochrane database of systematic reviews · 2024
    Pooled it
  3. Pooled it
  4. Macrolide antibiotics for cystic fibrosis.The Cochrane database of systematic reviews · 2012
    Pooled it
  5. Pooled it
  6. Trial
  7. Trial
  8. Azithromycin for Early Pseudomonas Infection in Cystic Fibrosis. The OPTIMIZE Randomized Trial.American journal of respiratory and critical care medicine · 2018
    Trial
  9. Trial
  10. Impact of azithromycin on the clinical and antimicrobial effectiveness of tobramycin in the treatment of cystic fibrosis.Journal of cystic fibrosis : official journal of the European Cystic Fibrosis Society · 2017
    Trial
  11. Trial
  12. Trial
  13. Article
  14. Frontiers in immunology · 2024
    Review
  15. Review
  16. Article
  17. Article
  18. Review
  19. Review
  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

11 authors at 8 institutions in 2 countries.

Felix RatjenDivision of Respiratory Medicine, Department of Pediatrics, and Program in Physiology and Experimental Medicine, SickKids Research Institute, The Hospital for Sick Children, and University of Toronto, Toronto, ON, Canada. Electronic address: felix.ratjen@sickkids.ca.
Lisa SaimanDepartment of Pediatrics, Columbia University, New York, NY.
Nicole Mayer-HamblettUniversity of Washington, Seattle, WA.
Larry C LandsDepartment of Pediatrics, McGill University, Montreal, QC, Canada.
Margaret KlosterUniversity of Washington, Seattle, WA.
Valeria ThompsonUniversity of Washington, Seattle, WA.
Peggy EmmettUniversity of Colorado School of Medicine, Children's Hospital Colorado, Aurora, CO.
Bruce MarshallCystic Fibrosis Foundation, Bethesda, MD.
Frank AccursoUniversity of Colorado School of Medicine, Children's Hospital Colorado, Aurora, CO.
Scott SagelUniversity of Colorado School of Medicine, Children's Hospital Colorado, Aurora, CO.
Michael AnsteadChildren's Hospital, Lexington, KY.
University of Washington · USUniversity of Colorado Denver · USChildren's Hospital Colorado · USColumbia University · USCystic Fibrosis Foundation · USMcGill University · CAShriners Hospitals for Children Medical Center - Lexington · USUniversity of Toronto · CA

Funding

CTSA INFRASTRUCTURE FOR PEDIATRIC RESEARCHUL1RR025780 · NCRR · UNIVERSITY OF COLORADO DENVER · PI SOKOL, RONALD J. · 2008 to 2011
$61.3M
LABORATORY COREU01HL081335 · NHLBI · UNIVERSITY OF COLORADO DENVER · PI ABMAN, STEVEN HERBERT · 2005 to 2008
$4.1M
CIHRNCRR NIH HHS 1 UL1 RR025780NCRR NIH HHS UL1 RR025780NHLBI NIH HHS 1 U01HL081335-01NHLBI NIH HHS U01 HL081335
6 · The paper itself

Abstract

backgroundWhile the mechanism of action by which azithromycin exerts positive effects inpatients with cystic fibrosis remains unclear, evidence suggests that azithromycin may act as an immunomodulatory agent. We examined changes in systemic inflammatory markers in a doubleblind, randomized, controlled trial of oral azithromycin in patients 6-18 years of age with cystic fibrosis who were uninfected with Pseudomonas aeruginosa.

methodsWBC counts and differential, serum myeloperoxidase (MPO), high-sensitivity C reactive protein (hsCRP), intracellular adhesion molecule 1, IL-6, calprotectin, serum amyloid A (SAA),and granulocyte colony-stimulating factor (G-CSF) were measured at baseline and after 28 and 168 days of treatment in patients receiving either oral azithromycin or placebo.

resultsInflammatory markers were similar in both groups at baseline. HsCRP, MPO, SAA, calprotectin,and the absolute neutrophil count (ANC) significantly decreased from baseline today 28 in the azithromycin group compared with the placebo group ( P < .05). This treatment effect was sustained at day 168 for ANC, calprotectin, and SAA ( P < .05). Changes in hsCRP, calprotectin,and SAA at day 28 were negatively correlated with changes in FEV 1 (L) and FEV 1(% predicted), as well as both absolute and relative changes in weight ( P < .05). Except for weight (%),the associations remained significant for calprotectin; FEV 1 (L) and weight (%) remained significantly correlated with the 168-day change in hsCRP. The 168-day change in ANC was significantly correlated with changes in lung function, but not in weight; the change in G-CSF was significantly correlated with the change in weight (%) only.

conclusionsIn patients not infected with P aeruginosa , oral azithromycin significantly reduced neutrophil counts and serum inflammatory markers within 28 days of initiating treatment. TRIAL REGISTRY: ClinicalTrials.gov; No.: NCT00431964; URL: www.clinicaltrials.gov

Indexed as

AdolescentAzithromycinBiomarkersChildC-Reactive ProteinCystic FibrosisDouble-Blind MethodFemaleGranulocyte Colony-Stimulating FactorHumansIntercellular Adhesion Molecule-1Interleukin-6Leukocyte CountLeukocyte L1 Antigen ComplexMalePeroxidaseAzithromycinBiomarkersC-Reactive ProteinGranulocyte Colony-Stimulating FactorIntercellular Adhesion Molecule-1Interleukin-6Leukocyte L1 Antigen ComplexPeroxidasePlacebosSerum Amyloid A Protein

Identifiers

PMID22595153
PMCPMC3610595
OpenAlexW2132861283

What OpenQuestion holds

Textmetadata
Read underepoch 390

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.