Faropenem versus co-amoxiclav plus clarithromycin for adult community-acquired bacterial pneumonia in Bangladesh

Efficacy and Safety of Faropenem in Bangladeshi Adult Patients With Community-Acquired Bacterial Pneumonia (CABP): A Randomized Controlled Trial

This trial tests whether faropenem works as well and is as safe as co-amoxiclav plus clarithromycin for adults in Bangladesh who have community-acquired bacterial pneumonia.

Quick facts

• Phase: Phase 4
• Study type: Interventional
• Enrollment: 160 (estimated)
• Ages: 18 Years to 65 Years
• Sex: All
• Sponsor: Beximco Pharmaceuticals Ltd. (Industry-sponsored)
• Drugs / interventions: chemotherapy
• Locations: 2 sites (Dhaka, Dhaka Division and 1 other locations)
• Trial ID: NCT06804096 on ClinicalTrials.gov

What this trial studies

This randomized, Phase 4, two-arm trial enrolls adults aged 18–65 with radiographically confirmed community-acquired bacterial pneumonia and symptom duration ≤7 days. Participants are randomized to receive either faropenem 200 mg three times daily for seven days or co-amoxiclav 625 mg three times daily plus clarithromycin 500 mg twice daily for seven days, with clinical follow-up over four weeks. The study excludes severe pneumonia and suspected viral, aspiration, or nosocomial pneumonia and monitors safety and clinical cure outcomes. The trial is conducted at two hospitals in Dhaka, Bangladesh, to inform local antibiotic choices and stewardship.

Who should consider this trial

Good fit: Adults 18–65 with acute (≤7 days) symptoms and radiographic findings consistent with community-acquired bacterial pneumonia who do not have severe disease or contraindications to the study drugs are ideal candidates.

Not a fit: Patients with severe pneumonia, suspected viral, aspiration or nosocomial pneumonia, known hypersensitivity to the study antibiotics, or those outside the 18–65 age range are unlikely to benefit from participation.

Why it matters

Potential benefit: If successful, faropenem could provide an effective alternative oral antibiotic regimen for adult CABP in Bangladesh and help broaden local treatment options.

How similar studies have performed: Head-to-head antibiotic comparisons and combination regimens for CABP are well established, but there is limited published phase 4 data specifically on faropenem for adult CABP in this setting.

Eligibility criteria

Inclusion Criteria:

* Male or female patients aged between 18 to 65 years.
* Have an acute illness (less than or equal to 7 days duration) with any of the following signs and symptoms consistent with a lower respiratory tract infection (new or worsening):

  1. Fever (body temperature \> 38.0 °C (100.4 °F) measured orally)
  2. Shortness of breath
  3. New onset or increased cough with or without sputum production.
  4. Chest pain.
* Have radiographically documented bacterial pneumonia:

  1. Infiltrates in a unilateral, lobar distribution
  2. Diffuse opacities or white condensed area
  3. The alveoli fill with white inflammatory fluid

Exclusion Criteria:

* Patients with severe pneumonia (Clinical \& Radiological Assessment)
* Patients with suspicion of viral pneumonia (bilateral, patchy opacities, etc., in chest radiography.)
* Patients with suspicion of nosocomial pneumonia, aspiration pneumonia, etc.
* History of hypersensitivity, known or suspected contraindications, or intolerance to any of the study drugs.
* Intake of an antibiotic within the last 48 hours before study admission.
* History of hospitalization within the last 28 days.
* Patients in pregnancy and lactational state.
* Patients with Renal impairment (screening eGFR \< 30mL/min).
* Significant hepatic impairment (Alanine aminotransferase \> three times the upper limit of normal).
* Serious diseases that affect the immune system, such as Acquired Immunodeficiency Syndrome (AIDS), cancer, etc.
* Patients who are taking steroid medications, at least 20 mg daily dose of prednisolone (or equivalent doses of other glucocorticoids).
* Patients who are accepting chemotherapy or anti-cancer therapy or plan to receive such treatment during the trial or six months prior to enrollment.
* Had epilepsy, stroke, or other central nervous system disorders or uncontrolled psychiatric history.

Where this trial is running

Dhaka, Dhaka Division and 1 other locations

• Popular Medical College & Hospital — Dhaka, Dhaka Division, Bangladesh (Recruiting)
• Shaheed Suhrawardy Medical College & Hospital — Dhaka, Dhaka Division, Bangladesh (Recruiting)

Study contacts

• Principal investigator: Prof. Khan Abul Kalam Azad — Popular Medical College Hospital
• Study coordinator: Prof. Khan Abul Kalam Azad, MBBS, FCPS, MD(Med), FACP(USA)

Conditions Pneumonia, Community-Acquired; Bacterial Pneumonia; CABP; Faropenem