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Efficacy and Safety of Faropenem in Bangladeshi Adult Patients With Community-Acquired Bacterial Pneumonia (CABP) | Clinical Trials | Clareo Health

RECRUITINGPHASE4

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

Efficacy and Safety of Faropenem in Bangladeshi Adult Patients With Community-Acquired Bacterial Pneumonia (CABP): A Randomized Controlled Trial

NCT06804096•Dr. Md. Alimur Reza

View on ClinicalTrials.gov

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

Age

18 - 65 years

Sex

ALL

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.
+3 more criteria

Locations (2)

Popular Medical College & Hospital

Dhaka, Dhaka Division, Bangladesh

Shaheed Suhrawardy Medical College & Hospital

Dhaka, Dhaka Division, Bangladesh

Key Dates

Start Date

February 20, 2025

Primary Completion Date

September 30, 2025

Completion Date

December 1, 2025

Last Updated

July 11, 2025

Enrollment

160

ESTIMATED participants

Conditions

Pneumonia, Community-AcquiredBacterial Pneumonia

Interventions

Faropenem

DRUG

Co-amoxiclav

DRUG

Clarithromycin 500 mg

DRUG

Contacts

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

CONTACT

+880-1727271414 prof.kakazad@gmail.com

Optimising TREATment for Severe Gram-Negative Bacterial Infections

NCT07004049

Bloodstream InfectionVentilator Associated Bacterial Pneumonia+3 more

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RECRUITINGPHASE3

A Phase 3b Randomized, Double-blind, Multi-center Study to Compare the Safety and Efficacy of Omadacycline to Moxifloxacin for Treating Adult Subjects With CABP

NCT06162286

Community-acquired Bacterial Pneumonia

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: July 11, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

Optimising TREATment for Severe Gram-Negative Bacterial Infections

A Phase 3b Randomized, Double-blind, Multi-center Study to Compare the Safety and Efficacy of Omadacycline to Moxifloxacin for Treating Adult Subjects With CABP

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