Efficacy and Safety of Faropenem in Bangladeshi Adult Patients With Community-Acquired Bacterial Pneumonia (CABP)

Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18-65
SponsorDr. Md. Alimur Reza

About this trial

The goal of this clinical trial is to evaluate the efficacy and safety of faropenem in comparison to co-amoxiclav and clarithromycin in Bangladeshi adults diagnosed with community-acquired bacterial pneumonia (CABP). Eligible participants will be randomly assigned to one of two treatment arms. The first arm will receive faropenem at a dosage of 200 mg administered three times daily for a duration of seven days. The second arm will receive co-amoxiclav 625 mg, also three times daily, along with clarithromycin 500 mg, administered twice daily for seven days. All participants included in the study will undergo follow-up assessments over a period of four weeks. This research aims to provide valuable insights regarding the potential role of faropenem, thereby enhancing clinical outcomes and informing antibiotic stewardship in a region significantly burdened by CABP and characterized by limited treatment alternatives.

Eligibility criteria

Qualifiers

Male or female patients aged between 18 to 65 years.

Fever (body temperature > 38.0 °C (100.4 °F) measured orally)

Shortness of breath

New onset or increased cough with or without sputum production.

Disqualifiers

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.

Trial design

Treatments tested in this trial

  • Faropenem
  • Co-amoxiclav
  • Clarithromycin 500 mg

Treatment groups

160 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Dr. Md. Alimur Reza

Lead sponsor

Beximco Pharmaceuticals Ltd.

Sponsor institution