CFDB - Cystic Fibrosis DataBase

primary studies published RCT

Lack of association of small-colony-variant Staphylococcus aureus strains with long-term use of azithromycin in patients with cystic fibrosis.

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

randomized, placebo-controlled multicenter trial

Participants

260 children and adolescents with CF. The study enrolled relatively healthy children and adolescents with CF but uninfected with P. aeruginosa

Interventions

Respiratory tract specimens were obtained at baseline, day 84, and day 168

Outcome measures

azithromycin

Main results

At baseline, 74% of both azithromycin and placebo participants harbored S. aureus (3) and 4.6% of participants harbored SCV S. aureus. There was no association between treatment with azithromycin and emergence of SCV S. aureus. Treatment-emergent azithromycin-resistant non-SCV strains of methicillin-susceptible and/or methicillin-resistant S. aureus were detected in 37% of azithromycin and 11% of placebo participants (P < 0.001) but there was no association between azithromycin resistance and SCVs. Among 57 participants with azithromycin-resistant non-SCV S. aureus at baseline, 4 harbored SCV strains, and among 135 participants without azithromycin resistance, 8 harbored SCV strains (difference in proportions, 0.01; 95% confidence interval [CI95], −0.06, 0.11; P = 0.75). Among 51 participants with azithromycin-resistant S. aureus at baseline, 2 had treatment-emergent SCV strains, and among 123 participants without azithromycin resistance, 3 had treatment-emergent SCV strains (difference in proportions, 0.01; CI95, −0.04, 0.11; P = 0.63). Finally, emergence of azithromycin-resistant S. aureus was not associated with treatment-emergent SCV strains; 0 SCV strains emerged among 34 participants with emergence of azithromycin resistance, and 3 SCV strains emerged among 89 participants without azithromycin resistance (difference in proportions, −0.03; CI95, −0.09, 0.07; P = 0.56).

Authors' conclusions

despite treatment-emergent azithromycin-resistant S. aureus, long-term treatment with azithromycin among children and adolescents with CF, most of whom were infected with S. aureus at baseline, was not associated with treatment-emergent SCV strains

Keywords: Bacterial Infections; Immunoregulatory; Infection; pharmacological_intervention; Respiratory Tract Diseases; Respiratory Tract Infections; Staphylococcus aureus; Azithromycin; Anti-Bacterial Agents; Macrolides; Anti-Inflammatory Agents; Anti-Inflammatory Agents - excl Steroids;