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

Efficacy and Safety of Faropenem in Bangladeshi Adult Patients With Community-Acquired Bacterial Pneumonia (CABP) (NCT06804096) is a Phase 4 interventional studying Pneumonia, Community-Acquired and Bacterial Pneumonia, sponsored by Dr. Md. Alimur Reza. RECRUITING as of the most recent ClinicalTrials.gov update. Talk to your doctor before contacting the trial site.

About This 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.

What Stage of Research Is This?

Phase 4 studies happen after a treatment has been approved by the FDA. They monitor long-term safety, real-world effectiveness, and any rare side effects that only emerge in larger populations over longer periods. Phase 4 results sometimes lead to label changes, additional warnings, or — rarely — withdrawal of approval.

This trial is currently recruiting participants. The sponsor has registered the study with ClinicalTrials.gov as actively enrolling, which means new applicants who meet the eligibility criteria can be considered for screening. Trial status can change between updates — confirm current recruiting status with the study contact before traveling for a screening visit.

Target enrollment of 160 participants puts this in the typical range for a Phase 2-style efficacy study or a moderate Phase 3 trial in a focused Pneumonia, Community-Acquired subpopulation. At this scale, the study has enough statistical power to detect a clear treatment effect but is not the largest cohort in the field.

Who May Be Eligible (Plain English)

Who May Qualify: - 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 Who Should NOT Join This Trial: - 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 weakened immune system 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. Always talk to your doctor about whether this trial is right for you.

These are translations of the protocol\'s inclusion and exclusion criteria, simplified for patients and caregivers. The original clinical text appears below. Eligibility is ultimately confirmed by the trial site\'s screening process — this summary is a starting point for a conversation with your doctor, not a final determination.

Original Eligibility Criteria

View original clinical language

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.

Treatments Being Tested

DRUG

Faropenem

Tab. Faropenem 200mg three times daily

DRUG

Co-amoxiclav

Tab. Co-Amoxiclav 625mg three times daily

DRUG

Clarithromycin 500 mg

Tab. Clarithromycin 500mg two times daily

Locations (2)

Trial sites listed on ClinicalTrials.gov for this study. Site activation status can vary — confirm with the specific site before traveling for a screening visit.

Popular Medical College & Hospital

Dhaka, Dhaka Division, Bangladesh

Shaheed Suhrawardy Medical College & Hospital

Dhaka, Dhaka Division, Bangladesh

How to Talk to Your Doctor About This Trial

Bring the printable summary of this trial — including the NCT ID (NCT06804096), the sponsor (Dr. Md. Alimur Reza), and the key eligibility criteria — to your next appointment. Your doctor can review the inclusion and exclusion criteria against your medical history, lab values, and current treatments to assess whether you are likely to qualify. They can also help you weigh whether trial participation makes sense alongside your existing care plan.

Useful questions to walk through together: What does the trial protocol require beyond standard care? How long is the active treatment phase, and how long is follow-up? Are there study visits at sites I can reach? Who pays for the trial-specific procedures, and who pays for standard-of-care portions? See our 25 questions to ask about clinical trials guide for a more complete checklist.

Authoritative Sources

The official record for this trial lives on ClinicalTrials.gov — the federal registry maintained by the National Library of Medicine at NIH. For background on how this trial fits into the FDA approval pathway, see the FDA drug approval process. For oncology-specific guidance for patients considering trials, the National Cancer Institute publishes patient-oriented overviews. International trial registries are aggregated by the WHO ICTRP.

Frequently Asked Questions

What is the NCT06804096 clinical trial studying?

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 stud… The full protocol is registered on ClinicalTrials.gov and includes the primary outcome measures, eligibility criteria, and study endpoints.

Who can participate in NCT06804096?

Eligibility for this trial depends on the specific inclusion and exclusion criteria set by the sponsor. The plain-English summary above translates the most important criteria into accessible language; the official clinical text is preserved in the collapsible section underneath. Whether you fit any specific trial is a medical decision your doctor needs to confirm — bring the trial information to your treating physician for a full review against your medical history.

How do I contact the trial site for NCT06804096?

Contact information registered with ClinicalTrials.gov is shown in the sidebar of this page. Before reaching out, confirm with your treating physician that this trial is appropriate for your situation. The trial site will then walk you through the screening process to determine final eligibility.

Is participating in a clinical trial safe?

Clinical trials in the United States are regulated by the FDA and overseen by Institutional Review Boards (IRBs) that review the protocol for safety. Risk varies by trial — Phase 1 studies test new treatments in humans for the first time, while Phase 3 trials use treatments that have already passed earlier safety screening. The informed consent document for any specific trial details the known risks and what to expect. Discuss those risks with your physician before deciding whether to participate.

Where can I verify the data on this page?

Every detail on this page comes directly from the ClinicalTrials.gov API. Click "View on ClinicalTrials.gov" in the sidebar to see the official, unmodified record. The federal record is always authoritative; this page is a structured presentation with a plain-English eligibility translation. For background on how clinical trials are regulated, see the FDA drug approval process documentation.

How This Page Is Built

Every field on this page is pulled directly from the ClinicalTrials.gov API v2 — no estimates, no proxies. The plain-English eligibility translation is generated from the original protocol text and reviewed for fidelity to the underlying clinical criteria. The original clinical text remains visible in the collapsible section above so users and clinicians can verify the translation. Read the full methodology for the data pipeline and known limitations.

Source: ClinicalTrials.gov API v2 record for NCT06804096. Maintained by the National Library of Medicine at NIH. Public domain. Cite as: "TrialFinderData. NCT06804096. Data: ClinicalTrials.gov."

Medical disclaimer: This page is informational, not medical advice. Talk to your doctor about whether a clinical trial is right for you.

Last updated 2026-05-08 · Data from ClinicalTrials.gov.