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primary studies published RCT

Azithromycin in patients with cystic fibrosis chronically infected with Pseudomonas aeruginosa: a randomized controlled trial.

  • Year: 2003
  • Date: 2003
  • Author: Saiman L
Source

JAMA. 2003 Oct 1;290(13):1749-56.

Study design (if review, criteria of inclusion for studies)

Multicentre randomised placebo-controlled trial.

Participants

185 participants: adults and children with CF (> 6 years) with chronic P. aeruginosa chest infection (> 1 year) and an FEV1 >30% predicted.

Interventions

Azithromycin, 500 mg (250 mg if weight <40 kg) 3 days a week versus placebo.

Outcome measures

Primary: relative change in FEV1 (% predicted).

Main 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).

Authors' conclusions

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.

Keywords: Adolescent; Anti-Bacterial Agents; Azithromycin; Bacterial Infections; Child; Hospitalization; Hospital care; Infection; pharmacological_intervention; Pseudomonas aeruginosa; Pseudomonas; Respiratory Tract Diseases; Respiratory Tract Infections; Macrolides; Anti-Inflammatory Agents; Anti-Inflammatory Agents - excl Steroids;