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

Beximco

Status and phase: Enrolling; Phase 4

Conditions: Bacterial Pneumonia; Pneumonia, Community-Acquired

Treatments: Drug: Faropenem; Drug: Clarithromycin 500 mg; Drug: Co-amoxiclav

Study type: Interventional

Funder types: Industry

Identifiers

NCT06804096

BEX2410001

Details and patient eligibility

About

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.

Enrollment: 160 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

160 participants in 2 patient groups

Arm 1

Experimental group

Description:

Arm 1: Tab. Faropenem 200mg three times daily with standard care.

Treatment:

Drug: Faropenem

Arm 2

Active Comparator group

Description:

Arm 2: Tab. Co-Amoxiclav 625mg three times daily and Tab. Clarithromycin 500mg two times daily with standard care.

Treatment:

Drug: Co-amoxiclav

Drug: Clarithromycin 500 mg