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

Phase 4

Not yet recruiting

• Conditions: Pneumonia, Community-Acquired; Bacterial Pneumonia
• Interventions: Drug: Faropenem; Drug: Co-amoxiclav; Drug: Clarithromycin 500 mg

• Registration Number: NCT06804096
• Lead Sponsor: Dr. Md. Alimur Reza

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2025-01-26
• Study First Submitted QC: 2025-01-30
• Study First Posted: 2025-01-31
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-01
• Last Update Posted: 2025-02-05
• Study Start: 2025-02-20
• Primary Completion: 2025-06-01
• Study Completion: 2025-11-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 160

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm 1	Faropenem	Arm 1: Tab. Faropenem 200mg three times daily with standard care.
Arm 2	Co-amoxiclav	Arm 2: Tab. Co-Amoxiclav 625mg three times daily and Tab. Clarithromycin 500mg two times daily with standard care.
Arm 2	Clarithromycin 500 mg	Arm 2: Tab. Co-Amoxiclav 625mg three times daily and Tab. Clarithromycin 500mg two times daily with standard care.

Primary Outcome Measures

Name	Time	Method
Clinical Cure Rate between two groups.	10-14 days	The clinical cure rate will be defined as significant improvement of clinical signs and symptoms at the end of treatment or follow-up, without new onset of symptoms, any complications, or the need for further antimicrobial therapy.
Percentage of patients withdrawn from the study due to adverse events between two groups.	10-14 Days	To compare the percentage of patients withdrawn from the study due to adverse events between two groups.

Secondary Outcome Measures

Name	Time	Method
Early Clinical Response (ECR) between two groups.	3 - 4 days	ECR will be defined as at least one improvement in the symptom mentioned below within 3 ± 1 days after the first dose of the study drug.; 1. Fever; 2. Decreased shortness of breath.; 3. Decreased chest pain.; 4. Decreased cough.; 5. Decreased sputum/mucous production.; 6. Sense of wellbeing.\]
All-cause mortality between two groups	10-14 days	To compare the all-cause mortality rate between two groups
Number of patients who needed hospitalization in both groups	28 days
Number of patients who needed Intensive Care Unit (ICU) support in both groups.	28 Days
Frequency of Adverse Events & Serious Adverse Events between two groups.	28 Days

Trial Locations

Locations (2)

Popular Medical College & Hospital; 🇧🇩 Dhaka, Bangladesh

Shaheed Suhrawardy Medical College & Hospital; 🇧🇩 Dhaka, Bangladesh