Efficacy and Safety of Faropenem in Bangladeshi Adults With Community-Acquired Pneumonia: A Randomized Controlled Trial

Background: Community-acquired pneumonia (CAP) causes substantial morbidity, and effective singleagent oral therapies that simplify treatment are needed.Faropenem, an oral penem with broad antibacterial activity, has not previously been compared with standard combination therapy for CAP.This study aimed to evaluate the efficacy and safety of oral faropenem, compared with co-amoxiclav plus clarithromycin, in adults with mild-to-moderate CAP who did not require hospitalization.Materials and methods: In this open-label, randomized controlled trial conducted at two tertiary centers in Dhaka, Bangladesh, adults aged 18-65 years with mild-to-moderate CAP were randomly assigned in a 1:1 ratio to oral faropenem or combination therapy.Patients with severe pneumonia, recent hospitalization, or significant renal or hepatic impairment were excluded 200 mg three times daily or co-amoxiclav 625 mg three times daily plus clarithromycin 500 mg twice daily, each for 7 days with standard care.The primary efficacy outcome was clinical cure at days 10-14, and the primary safety outcome was withdrawal due to adverse events (ClinicalTrials.govNCT06804096).Results: Of 244 patients assessed, 129 were randomized (faropenem, 65; comparator, 64), and all completed follow-up.Clinical cure at days 10-14 was 98.5% with faropenem and 95.3% with the comparator (risk difference +3.1%, 95% confidence interval (CI) -2.8 to +9.1; relative risk 1.03, 95% CI 0.97-1.10).The clinical cure at day 3 was 84.6% versus 78.1%.Adverse events were infrequent (9.2% versus 12.5% in the faropenem and comparator arms, respectively), with no serious adverse events and no treatment withdrawals; altered taste occurred only in the comparator arm.Hepatic and renal parameters showed no clinically meaningful change in either arm.Conclusions: In adults with mild-to-moderate CAP, oral faropenem was non-inferior to co-amoxiclav and clarithromycin.As a single-agent oral therapy, it may offer an alternative when narrower-spectrum first-line regimens are unsuitable.However, larger, blinded, microbiologically well-characterized trials are needed to establish pathogen-specific efficacy.These findings should not be extrapolated to severe or hospitalized CAP or to patients with significant renal or hepatic impairment.