Efficacy and Safety of Faropenem in Bangladeshi Adult Patients With Community-Acquired Bacterial Pneumonia (CABP): A Randomized Controlled Trial
| Registry | NCT06804096 |
|---|---|
| Status | Completed |
| Phase | Phase 4 |
| Study type | Interventional; randomized, parallel, masking: none, treatment |
| Enrollment | 129 (Actual) |
| Sponsor | Dr. Md. Alimur Reza (Industry) |
| Conditions | Pneumonia, Community-Acquired, Bacterial Pneumonia |
| Interventions | Faropenem, Co-amoxiclav, Clarithromycin 500 mg (Drug) |
| Dates | start 2025-02-20, primary completion 2026-01-12, completion 2026-01-26, first posted 2025-01-31, last updated 2026-08-04 |
| Locations | 2 sites in Bangladesh |
Related Papers Related Patents Related Grants Related Experts
All trials for Pneumonia, Community-Acquired All trials for Bacterial Pneumonia All trials of Faropenem All trials of Co-amoxiclav
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.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| Arm 1 | Experimental | Drug: Faropenem | Arm 1: Tab. Faropenem 200mg three times daily with standard care. |
| Arm 2 | Active comparator | Drug: Co-amoxiclav; Drug: Clarithromycin 500 mg | Arm 2: Tab. Co-Amoxiclav 625mg three times daily and Tab. Clarithromycin 500mg two times daily with standard care. |
Sex: All, ages: 18 Years to 65 Years
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.
| Facility | City | Country | Status |
|---|---|---|---|
| Popular Medical College & Hospital | Dhaka, Dhaka Division | Bangladesh | |
| Shaheed Suhrawardy Medical College & Hospital | Dhaka, Dhaka Division | Bangladesh |