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

NCT ID: NCT06804096

Last Updated: 2025-07-11

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE4
• Total Enrollment: 160 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-02-20
• Study Completion Date: 2025-12-01

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.

Conditions

Pneumonia, Community-Acquired; Bacterial Pneumonia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Arm 1

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

Group Type: EXPERIMENTAL

Faropenem

Intervention Type: DRUG

Tab. Faropenem 200mg three times daily

Arm 2

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

Group Type: ACTIVE_COMPARATOR

Co-amoxiclav

Intervention Type: DRUG

Tab. Co-Amoxiclav 625mg three times daily

Clarithromycin 500 mg

Intervention Type: DRUG

Tab. Clarithromycin 500mg two times daily

Interventions

Faropenem

Tab. Faropenem 200mg three times daily

Intervention Type: DRUG

Co-amoxiclav

Tab. Co-Amoxiclav 625mg three times daily

Intervention Type: DRUG

Clarithromycin 500 mg

Tab. Clarithromycin 500mg two times daily

Intervention Type: DRUG

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Dr. Md. Alimur Reza

INDUSTRY

Sponsor Role: lead

Responsible Party

Dr. Md. Alimur Reza

Director

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Prof. Khan Abul Kalam Azad

Role: PRINCIPAL_INVESTIGATOR

Popular Medical College Hospital

Prof. Quazi Tarikul Islam, MBBS, FCPS, FACP (USA), FRCP,

Role: STUDY_DIRECTOR

Popular Medical College Hospital

Locations

Popular Medical College & Hospital

Dhaka, Dhaka Division, Bangladesh

Site Status: RECRUITING

Shaheed Suhrawardy Medical College & Hospital

Dhaka, Dhaka Division, Bangladesh

Site Status: RECRUITING

Countries

Bangladesh

Central Contacts

Prof. Khan Abul Kalam Azad, MBBS, FCPS, MD(Med), FACP(USA)

Role: CONTACT

prof.kakazad@gmail.com

+880-1727271414

Facility Contacts

Prof. Khan Abul Kalam Azad, FCPS(Med), MD (Med), FACP(USA)

Role: primary

prof.kakazad@gmail.com

+880-1727271414

Prof. Mohammad Rafiqul Islam, MBBS(DU), FCPS, FACP . FRCP

Role: primary

drrafiq73@yahoo.com

+880-1753199796

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Other Identifiers

BEX2410001

Identifier Type: -

Identifier Source: org_study_id