Evidence map›Paper›PMID 16809416›Full record

Trial reportThorax2006

Long term effects of azithromycin in patients with cystic fibrosis: A double blind, placebo controlled trial.

A Clement, A Tamalet, E Leroux, S Ravilly, B Fauroux, J-P Jais

Open access · bronzeAbstract readMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in Thorax, 2006. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 88 papers, 11 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
88citing papers in PubMed, 11 pooled it
20.4field-weighted citation impact, top 1% 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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

88 citing papers in PubMed, 11 syntheses or guidelines pooled it, 289 citations in OpenAlex.

  1. Pooled it
  2. Macrolide antibiotics (including azithromycin) for cystic fibrosis.The Cochrane database of systematic reviews · 2024
    Pooled it
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  11. Macrolide antibiotics for cystic fibrosis.The Cochrane database of systematic reviews · 2012
    Pooled it
  12. Trial
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  16. Inhaled aztreonam lysine for chronic airway Pseudomonas aeruginosa in cystic fibrosis.American journal of respiratory and critical care medicine · 2008
    Trial
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  19. Review
  20. Article

28 more citing papers are in PubMed but not listed here.

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

6 authors at 1 institution in 1 country.

A ClementAP-HP, Hôpital Trousseau, Pediatric Pulmonary Department, Inserm, U719, Université Pierre et Marie Curie-Paris 6, 26 Avenue du Docteur Arnold Netter, 75571 Paris cedex 12, France.
A Tamalet
E Leroux
S Ravilly
B Fauroux
J-P Jais
Inserm · FR

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundMacrolides display immunomodulatory effects that may be beneficial in chronic inflammatory pulmonary diseases. The aim of the study was to document whether long term use of azithromycin may be associated with respiratory benefits in young patients with cystic fibrosis.

methodsA multicentre, randomised, double blind, placebo controlled trial was conducted from October 2001 to June 2003. The criteria for enrollment were age older than 6 years and forced expiratory volume in 1 second (FEV1) of 40% or more. The active group received either 250 mg or 500 mg (body weight < or > or =40 kg) of oral azithromycin three times a week for 12 months. The primary end point was change in FEV1.

resultsEighty two patients of mean (SD) age 11.0 (3.3) years and mean (SD) FEV1 85 (22)% predicted were randomised: 40 in the azithromycin group and 42 in the placebo group. Nineteen patients were infected with Pseudomonas aeruginosa. The relative change in FEV1 at month 12 did not differ significantly between the two groups. The number of pulmonary exacerbations (count ratio 0.50 (95% CI 0.32 to 0.79), p < 0.005), the time elapsed before the first pulmonary exacerbation (hazard ratio 0.37 (95% CI 0.22 to 0.63), p < 0.0001), and the number of additional courses of oral antibiotics were significantly reduced in the azithromycin group regardless of the infectious status (count ratio 0.55 (95% CI 0.36 to 0.85), p < 0.01). No severe adverse events were reported.

conclusionLong term use of low dose azithromycin in young patients with cystic fibrosis has a beneficial effect on lung disease expression, even before infection with Pseudomonas aeruginosa.

Indexed as

AdolescentAdultAnti-Bacterial AgentsAzithromycinChildCystic FibrosisDouble-Blind MethodFemaleForced Expiratory VolumeHumansLong-Term CareMalePseudomonas aeruginosaPseudomonas InfectionsTreatment OutcomeAnti-Bacterial AgentsAzithromycin

Identifiers

PMID16809416
PMCPMC2104771
OpenAlexW2116960191

What OpenQuestion holds

Textmetadata
Read underepoch 390

Registered trials

None linked

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.