Treatment of Pseudomonas and Staphylococcus Bronchopulmonary Infection in Patients with Cystic Fibrosis

Table 4

Summary of azithromycin trials.

Author	Study design	Subjects	Dose used	Outcomes	Main results
Wolter et al. [20]	RCT	𝑁=60.; Age = 27.9 (±6.5) years.; Inclusion criteria: chronic P. aeruginosa infection	Azithromycin 250 mg OD for 3 months	% change in FEV1 (FVC), weight, quality of life (QOL), respiratory; exacerbations	Improved QOL, reduced number of exacerbations, and reduced rate of decline in lung function
Equi et al. [21]	Crossover study	𝑁=41.; Age = 8–18 years.; Inclusion criteria: chronic P. aeruginosa infection and with a median FEV1 of 61%	Azithromycin 250 mg (500 mg if weight >40 kg) OD for 6 months	% change in FEV1 (FVC and MEF), exercise tolerance, and subjective wellbeing	FEV1 improved by ≥13% and fewer courses of antibiotics were required in the treatment group. Rest of other parameters did not improve.
Saiman et al. [22]	Multicenter, RCT	𝑁=185.; Age = ≥6 years.; Inclusion criteria: FEV1 of ≥30%	Azithromycin 250 mg (500 mg if weight >40 kg) 3 days/week for 168 days	% change in FEV1, weight, respiratory; exacerbations	Significant improvement in the FEV1%, weight, and reduced exacerbations
Clement et al. [23]	Multicenter, RCT	𝑁=82.; Age = 6–21 years.; Inclusion criteria: FEV1 of ≥40%	Azithromycin 250 mg (500 mg if weight > 40 kg) 3 days/week for 12 months	% change in FEV1 (FVC), weight, respiratory exacerbations, additional antibiotic treatment	FEV1% change did not differ significantly, but the numbers of pulmonary exacerbations and the additional courses of antibiotics were significantly reduced in the treatment group
Steinkamp et al. [24]	Multicenter, RCT	𝑁=38.; Age = 24.8 (±10) years.; Inclusion criteria: chronic P. aeruginosa infection	Azithromycin (<30 kg: 500 mg, 30–39 kg: 750 mg, 40–49 kg: 1000 mg, and ≥50 kg: 1250 mg) once/week for 8 weeks	% change in FEV1 (FVC), weight, quality of life (QOL), respiratory; exacerbations	Pulmonary function declined in both the groups, but QOL was improved in the treatment group.
Saiman et al. [25]	Multicenter, RCT	𝑁=260.; Age = 6–18 years.; Inclusion criteria: FEV1 of at least 50% predicted and negative respiratory tract cultures for P. aeruginosa for at least 1 year	Azithromycin 250 mg (500 mg if weight > 36 kg) 3 days/week for 6 months	% change in FEV1, weight, respiratory; Exacerbations, treatment requirements	No significant change in the FEV1%, rate of hospitalizations, and use of additional antibiotics. But reduced exacerbations and increased weight in treatment group