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

Last updated: July 9, 2025
Sponsor: Dr. Md. Alimur Reza
Overall Status: Active - Recruiting

Phase

4

Condition

Pneumonia (Pediatric)

Pneumonia

Treatment

Clarithromycin 500 mg

Faropenem

Co-amoxiclav

Clinical Study ID

NCT06804096
BEX2410001
  • Ages 18-65
  • All Genders

Study Summary

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

Inclusion

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 thefollowing 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

Exclusion Criteria:

  • Patients with severe pneumonia (Clinical & Radiological Assessment)

  • Patients with suspicion of viral pneumonia (bilateral, patchy opacities, etc., inchest radiography.)

  • Patients with suspicion of nosocomial pneumonia, aspiration pneumonia, etc.

  • History of hypersensitivity, known or suspected contraindications, or intolerance toany 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 upperlimit of normal).

  • Serious diseases that affect the immune system, such as Acquired ImmunodeficiencySyndrome (AIDS), cancer, etc.

  • Patients who are taking steroid medications, at least 20 mg daily dose ofprednisolone (or equivalent doses of other glucocorticoids).

  • Patients who are accepting chemotherapy or anti-cancer therapy or plan to receivesuch treatment during the trial or six months prior to enrollment.

  • Had epilepsy, stroke, or other central nervous system disorders or uncontrolledpsychiatric history.

Study Design

Total Participants: 160
Treatment Group(s): 3
Primary Treatment: Clarithromycin 500 mg
Phase: 4
Study Start date:
February 20, 2025
Estimated Completion Date:
December 01, 2025

Connect with a study center

  • Popular Medical College & Hospital

    Dhaka, 1205
    Bangladesh

    Active - Recruiting

  • Shaheed Suhrawardy Medical College & Hospital

    Dhaka, 1205
    Bangladesh

    Active - Recruiting

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