Efficacy and Safety of Faropenem in Bangladeshi Adults With Community-Acquired Pneumonia: A Randomized Controlled Trial
4 affiliations
- 1Department of Medicine, Popular Medical College, Dhaka, BGD
- 2Department of Medicine, Shaheed Suhrawardy Medical College, Dhaka, BGD
- 3Department of Internal Medicine, LABAID Specialized Hospital, Dhaka, BGD
- 4Department of Medical Affairs, Beximco Pharmaceuticals PLC, Dhaka, BGD
Abstract
Background: Community-acquired pneumonia (CAP) causes substantial morbidity, and effective single-agent 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.gov NCT06804096).
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.
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BibTeX
@article{azad2026efficacy,
title = {{Efficacy and Safety of Faropenem in Bangladeshi Adults With Community-Acquired Pneumonia: A Randomized Controlled Trial}},
author = {Khan Abul Kalam Azad and Quazi Tarikul Islam and H A M Nazmul Ahasan and Mohammad Zahiruddin and Mohammad Rafiqul Islam and Rubina Yasmin and Syed Ghulam Mogni Mowla and K M Ashik Elahi and Samia Tahnin Reza and Mohammed Alimur Reza},
journal = {Cureus},
year = {2026},
month = nov,
doi = {10.7759/cureus.118941},
url = {https://europepmc.org/article/PMC/PMC13725548},
note = {CC BY},
}
RIS
TY - JOUR
TI - Efficacy and Safety of Faropenem in Bangladeshi Adults With Community-Acquired Pneumonia: A Randomized Controlled Trial
AU - Khan Abul Kalam Azad
AU - Quazi Tarikul Islam
AU - H A M Nazmul Ahasan
AU - Mohammad Zahiruddin
AU - Mohammad Rafiqul Islam
AU - Rubina Yasmin
AU - Syed Ghulam Mogni Mowla
AU - K M Ashik Elahi
AU - Samia Tahnin Reza
AU - Mohammed Alimur Reza
PY - 2026
DA - 2026/11/01
JO - Cureus
DO - 10.7759/cureus.118941
UR - https://europepmc.org/article/PMC/PMC13725548
AB - Background: Community-acquired pneumonia (CAP) causes substantial morbidity, and effective single-agent 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.gov NCT06804096). 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.
SN - 2168-8184
ER -