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

July 9, 2025 updated by: Dr. Md. Alimur Reza

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

160

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Prof. Khan Abul Kalam Azad, MBBS, FCPS, MD(Med), FACP(USA)
  • Phone Number: +880-1727271414
  • Email: prof.kakazad@gmail.com

Study Locations

  • Bangladesh
      • Dhaka, Bangladesh, 1205
        • Recruiting
        • Popular Medical College & Hospital
        • Contact:
          • Prof. Khan Abul Kalam Azad, FCPS(Med), MD (Med), FACP(USA)
          • Phone Number: +880-1727271414
          • Email: prof.kakazad@gmail.com
        • Sub-Investigator:
          • Prof. Quazi Tarikul Islam, FCPS (Med), FACP (USA), FRCP
        • Sub-Investigator:
          • Prof. H.A.M. Nazmul Ahasan, MBBS, FCPS, FRCP
        • Sub-Investigator:
          • Prof. Md. Mujibur Rahman, MBBS, FCPS, MD, FACP (USA)
        • Sub-Investigator:
          • Prof. Mohammed Zahir Uddin, MBBS, FCPS, MD, FACP (USA)
        • Sub-Investigator:
          • Prof. Syed Ghulam Mogni Mowla, MBBS, FCPS, FRCPE, FACP (USA)
        • Principal Investigator:
          • Prof. Khan Abul Kalam Azad, FCPS(Med), MD (Med), FACP(USA)
      • Dhaka, Bangladesh, 1205
        • Recruiting
        • Shaheed Suhrawardy Medical College & Hospital
        • Contact:
          • Prof. Mohammad Rafiqul Islam, MBBS(DU), FCPS, FACP . FRCP
          • Phone Number: +880-1753199796
          • Email: drrafiq73@yahoo.com
        • Sub-Investigator:
          • Prof. Mohammad Rafiqul Islam, MBBS(DU), FCPS, FACP . FRCP

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Arm 1
Arm 1: Tab. Faropenem 200mg three times daily with standard care.
Drug: Faropenem
Tab. Faropenem 200mg three times daily
Active Comparator: Arm 2
Arm 2: Tab. Co-Amoxiclav 625mg three times daily and Tab. Clarithromycin 500mg two times daily with standard care.
Drug: Co-amoxiclav
Tab. Co-Amoxiclav 625mg three times daily
Drug: Clarithromycin 500 mg
Tab. Clarithromycin 500mg two times daily

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Clinical Cure Rate between two groups.
Time Frame: 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.
10-14 days
Percentage of patients withdrawn from the study due to adverse events between two groups.
Time Frame: 10-14 Days
To compare the percentage of patients withdrawn from the study due to adverse events between two groups.
10-14 Days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Early Clinical Response (ECR) between two groups.
Time Frame: 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.]
3 - 4 days
Number of patients who needed hospitalization in both groups
Time Frame: 28 days
28 days
Number of patients who needed Intensive Care Unit (ICU) support in both groups.
Time Frame: 28 Days
28 Days
Frequency of Adverse Events & Serious Adverse Events between two groups.
Time Frame: 28 Days
28 Days
All-cause mortality between two groups
Time Frame: 10-14 days
To compare the all-cause mortality rate between two groups
10-14 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Dr. Md. Alimur Reza

Investigators

  • Principal Investigator: Prof. Khan Abul Kalam Azad, Popular Medical College Hospital
  • Study Director: Prof. Quazi Tarikul Islam, MBBS, FCPS, FACP (USA), FRCP,, Popular Medical College Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 20, 2025

Primary Completion (Estimated)

September 30, 2025

Study Completion (Estimated)

December 1, 2025

Study Registration Dates

First Submitted

January 26, 2025

First Submitted That Met QC Criteria

January 30, 2025

First Posted (Actual)

January 31, 2025

Study Record Updates

Last Update Posted (Actual)

July 11, 2025

Last Update Submitted That Met QC Criteria

July 9, 2025

Last Verified

July 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BEX2410001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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