CoChat
Sign Up
Cited by 958Cystic Fibrosis Research AdvancesChronic Obstructive Pulmonary Disease (COPD) ResearchBacterial biofilms and quorum sensing

Azithromycin in Patients With Cystic Fibrosis Chronically Infected With Pseudomonas aeruginosa: A Randomized Controlled Trial

Saiman, Lisa, Marshall, Bruce C., Mayer-Hamblett, Nicole, Burns, Jane L., Quittner, Alexandra L., Cibene, Debra A., Coquillette, Sarah, Fieberg, Ann Yunker +3 more·2003·JAMA
DOI 10.1001/jama.290.13.1749
Open this paper in CoChat — free account

Abstract

CONTEXT: Treatment strategies for cystic fibrosis (CF) lung disease include antibiotics, mucolytics, and anti-inflammatory therapies. Increasing evidence suggests that macrolide antibiotics might be beneficial in patients with CF. OBJECTIVE: To determine if an association between azithromycin use and pulmonary function exists in patients with CF. DESIGN AND SETTING: A multicenter, randomized, double-blind, placebo-controlled trial conducted from December 15, 2000, to May 2, 2002, at 23 CF care centers in the United States. PARTICIPANTS: Of the 251 screened participants with a diagnosis of CF, 185 (74%) were randomized. Eligibility criteria included age 6 years or older, infection with Pseudomonas aeruginosa for 1 or more years, and a forced expiratory volume in 1 second (FEV1) of 30% or more. Participants were stratified by FEV1 (> or =60% predicted vs <60% predicted), weight of less than 40 kg vs 40 kg or more, and CF center. INTERVENTION: The active group (n = 87) received 250 mg (weight <40 kg) or 500 mg (weight > or =40 kg) of oral azithromycin 3 days a week for 168 days; placebo group (n = 98) received identically packaged tablets. MAIN OUTCOME MEASURES: Change in FEV1 from day 0 to completion of therapy at day 168 and determination of safety. Secondary outcomes included pulmonary exacerbations and weight gain. RESULTS: The azithromycin group had a mean 0.097-L (SD, 0.26) increase in FEV1 at day 168 compared with 0.003 L (SD, 0.23) in the placebo group (mean difference, 0.094 L; 95% confidence interval [CI], 0.023-0.165; P =.009). Nausea occurred in 17% more participants in the azithromycin group (P =.01), diarrhea in 15% more (P =.009), and wheezing in 13% more (P =.007). Participants in the azithromycin group had less risk of experiencing an exacerbation than participants in the placebo group (hazard ratio, 0.65; 95% CI, 0.44-0.95; P =.03) and weighed at the end of the study an average 0.7 kg more than participants receiving placebo (95% CI, 0.1-1.4 kg; P =.02). CONCLUSION: Azithromycin treatment was associated with improvement in clinically relevant end points and should be considered for patients with CF who are 6 years or older and chronically infected with P aeruginosa.

Integrity signals

Registry

Crossref · 10.1001/jama.290.13.1749

Cites

28 of 28 references verified0 citation errors · 0 not checkable

Statistics

Recomputing p-values needs the paper’s full text.

Claims the paper makes

This paper’s full text isn’t openly available, so its claims and self-check weren’t run. The registry and citation checks still apply.

Claims other papers make about this one

Each is checked against this paper’s own text: does it say what the citing paper says it does?

  • The intervention most consistently proven to decrease exacerbation frequency in COPD, cystic fibrosis, and bronchiectasis is azithromycin.

    “The intervention most consistently proven to decrease exacerbation frequency (in COPD,143 cystic fibrosis144 and bronchiectasis145) is azithromycin, a macrolide antibiotic.”

    From The microbiome and critical illness (2016) · cites this paper as [144]

  • At the current pace of development, point-of-care community sequencing and identification of pathogens will be available and affordable within years rather than decades.

    “At the current pace of development, point-of-care community sequencing and identification of pathogens will be available and affordable within years rather than decades.”

    From The microbiome and critical illness (2016) · cites this paper as [144]

Cites

Flagged first, then by citations

Cited by

Sorted by citations

Related

Authors
Saiman, L., Marshall, B. C., Mayer-Hamblett, N., Burns, J. L., Quittner, A. L., Cibene, D. A., Coquillette, S., Fieberg, A. Y., Accurso, F. J., Campbell III, P. W., & for the Macrolide Study Group
Affiliations
  • Columbia University Irving Medical Center (US)
  • University of Utah (US)
  • University of Washington (US)
  • University of Florida (US)
  • University of Colorado Denver (US)
ORCID
Venue
JAMA
Publisher
American Medical Association (AMA)
Published
2003-10-01
Volume
290
Issue
13
Pages
1749
ISSN
  • 0002-9955 (ISSN-L)
  • 0098-7484
DOI
10.1001/jama.290.13.1749
OpenAlex
W2090648579
Cited by
958
References
28
Citations by year
2026: 7 · 2025: 20 · 2024: 24 · 2023: 21 · 2022: 35 · 2021: 34 · 2020: 42 · 2019: 38 · 2018: 36 · 2017: 40 · 2016: 38 · 2015: 62 · 2014: 44 · 2013: 61 · 2012: 62
FWCI
33.58
Type
journal article
Language
en
Open access
closed
Locations
  • JAMA (publishedVersion)
  • PubMed (publishedVersion)
Topics
  • Health Sciences › Medicine › Pulmonary and Respiratory Medicine › Cystic Fibrosis Research Advances
  • Health Sciences › Medicine › Pulmonary and Respiratory Medicine › Chronic Obstructive Pulmonary Disease (COPD) Research
  • Life Sciences › Biochemistry, Genetics and Molecular Biology › Molecular Biology › Bacterial biofilms and quorum sensing
Keywords
cystic fibrosis, azithromycin, macrolide antibiotics, Pseudomonas aeruginosa, chronic lung infection, lung function, FEV1, pulmonary exacerbations, weight gain, adverse drug reactions, nausea and diarrhea, wheezing, long-term antibiotic therapy, anti-inflammatory therapy, mucolytic agents, children and adults
MeSH terms
Adolescent, Anti-Bacterial Agents, Child, Chronic Disease, Cystic Fibrosis, Double-Blind Method, Female, Forced Expiratory Flow Rates, Hospitalization, Humans, Male, Pancreatic Elastase, Pseudomonas Infections, Quality of Life, Proportional Hazards Models, Interleukin-8, Treatment Outcome, Azithromycin

About these checks

Registry, retraction, Cites and statistics results are computed, not judged, with one exception: a printed reference that no index lists is read once by a model before it counts as a citation error. Claims are extracted by a model and kept only when their quote appears verbatim in the text; each cited source is then checked, with a model’s help, for whether it says what the claim relies on. Those verdicts can be wrong — read the claim’s quote and the cited source before relying on one.

Statistics and arithmetic are recomputed, not judged.

Confidence bands are shown only for fields calibrated on our annotated test set. None is calibrated yet, so no band is shown.

What counts as a claim ›How we measure confidence ›How we check this ›

Are you an author, or do you see a problem with this page? Request a review