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Double-blind, placebo-controlled, randomized trial on low-dose azithromycin prophylaxis in patients with primary
Cinzia Milito1, Federica Pulvirenti1, Francesco Cinetto2
1Department of Molecular Medicine, Sapienza University of Rome, Rome, Italy.
Background:
Lacking protective antibodies, patients with primary antibody deficiencies (PADs) experience frequent respiratory tract infections, leading to chronic pulmonary damage. Macrolide prophylaxis has proved effective in patients with chronic respiratory diseases.
Objective:
We aimed to test the efficacy and safety of orally administered low-dose azithromycin prophylaxis in patients with PADs.
Methods:
We designed a 3-year, double-blind, placebo-controlled, randomized clinical trial to test whether oral azithromycin (250 mg administered once daily 3 times a week for 2 years) would reduce respiratory exacerbations in patients with PADs and chronic infection-related pulmonary diseases. The primary end point was the number of annual respiratory exacerbations. Secondary end points included time to first exacerbation, additional antibiotic courses, number of hospitalizations, and safety.
Results:
Eighty-nine patients received azithromycin (n = 44) or placebo (n = 45). The number of exacerbations was 3.6 (95% CI, 2.5-4.7) per patient-year in the azithromycin arm and 5.2 (95% CI, 4.1-6.4) per patient-year in the placebo arm (P = .02). In the azithromycin group the hazard risk for having an acute exacerbation was 0.5 (95% CI, 0.3-0.9; P = .03), and the hazard risk for hospitalization was 0.5 (95% CI, 0.2-1.1; P = .04). The rate of additional antibiotic treatment per patient-year was 2.3 (95% CI, 2.1-3.4) in the intervention group and 3.6 (95% CI, 2.9-4.3) in the placebo group (P = .004). Haemophilus influenzae and Streptococcus pneumoniae were the prevalent isolates, and they were not susceptible to macrolides in 25% of patients of both arms. Azithromycin's safety profile was comparable with that of placebo.
Conclusion:
The study reached the main outcome centered on the reduction of exacerbation episodes per patient-year, with a consequent reduction in additional courses of antibiotics and risk of hospitalization.
Insights
Low-dose azithromycin prophylaxis significantly reduced respiratory exacerbations in patients with primary antibody deficiencies (PADs). This treatment also decreased the need for additional antibiotics and lowered hospitalization risks, demonstrating its efficacy and safety.
Area of Science:
- Immunology
- Pulmonology
- Clinical Trials
Background:
- Patients with primary antibody deficiencies (PADs) are prone to recurrent respiratory infections, leading to chronic lung damage due to a lack of protective antibodies.
- Macrolide prophylaxis has shown effectiveness in managing chronic respiratory diseases.
Purpose of the Study:
- To evaluate the efficacy and safety of low-dose oral azithromycin prophylaxis in patients diagnosed with PADs.
- To determine if azithromycin reduces respiratory exacerbations in PAD patients with chronic pulmonary conditions.
Main Methods:
- A 3-year, double-blind, placebo-controlled, randomized clinical trial was conducted.
- Participants received either oral azithromycin (250 mg daily, 3 times/week for 2 years) or a placebo.
- Primary endpoint: annual respiratory exacerbations; Secondary endpoints: time to first exacerbation, additional antibiotic use, hospitalizations, and safety.
Main Results:
- Azithromycin significantly reduced annual respiratory exacerbations (3.6 vs. 5.2 per patient-year, P=.02).
- The risk of acute exacerbations (HR 0.5, P=.03) and hospitalizations (HR 0.5, P=.04) were halved in the azithromycin group.
- Additional antibiotic treatment was reduced by 36% (P=.004) in the azithromycin arm.
- No significant difference in macrolide susceptibility for prevalent pathogens (H. influenzae, S. pneumoniae) was observed between groups.
Conclusions:
- Low-dose azithromycin prophylaxis is effective in reducing respiratory exacerbations in patients with PADs and chronic pulmonary disease.
- The treatment also led to a decrease in the need for additional antibiotic courses and a reduced risk of hospitalization.
- Azithromycin exhibited a comparable safety profile to placebo in this patient population.
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