6/30/23, 2:20 AM TRAP-LRTI Pathway Feedback Search Clinical Topics Home Studies TRAP LRTI TRAP LRTI Disease Acute bronchitis Trial question Is placebo noninferior to azithromycin in adults with lower respiratory tract infection associated with low procalcitonin concentration? Study design Multi-center Double blinded RCT Population 499 patients Inclusion criteria: adults with clinically suspected non-pneumonia lower respiratory tract infection and symptom duration from 24 hours to 28 days Key exclusion criteria: long-term invasive mechanical ventilation for any indication, cystic fibrosis or chronic bronchiectasis, infection at any other anatomic site requiring antibacterial therapy, immunosuppression Interventions N=250 placebo (matching placebo for 5 days) N=249 azithromycin (an oral dose of 250 mg; 2 capsules on day 1 followed by one capsule daily for 4 days) Primary outcome Clinical improvement at day 5 69.0 % 69 63 51.8 % 34.5 % https://web.pathway.md/studies/recGpKvldvqEZ6Myj 1/2 6/30/23, 2:20 AM TRAP-LRTI Pathway 17.3 % Difference exceeding nonferiority margin 0.0 % Placebo Azithromycin Difference exceeding nonferiority margin in clinical improvement at day 5 (63% vs. 69%; ARD -6, 95% CI -15 to 2) Secondary outcomes No significant difference in abdominal pain at day 5 (16% vs. 23%; ARD -7, 95% CI -14.47 to 0.47) Conclusion In adults with clinically suspected non-pneumonia lower respiratory tract infection and symptom duration from 24 hours to 28 days, placebo was not noninferior to azithromycin with respect to clinical improvement at day 5. Reference Ephraim L Tsalik, Nadine G Rouphael, Ruxana T Sadikot et al. Efficacy and safety of azithromycin versus placebo to treat lower respiratory tract infections associated with low procalcitonin: a randomised, placebo-controlled, double-blind, non-inferiority trial. Lancet Infect Dis. 2023 Apr;23(4):484-495. Open reference URL https://web.pathway.md/studies/recGpKvldvqEZ6Myj 2/2