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
Dr. Md. Alimur Reza
160 participants
Feb 20, 2025
INTERVENTIONAL
Conditions
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
Inclusion Criteria10
- 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):
- Fever (body temperature > 38.0 °C (100.4 °F) measured orally)
- Shortness of breath
- New onset or increased cough with or without sputum production.
- Chest pain.
- Have radiographically documented bacterial pneumonia:
- Infiltrates in a unilateral, lobar distribution
- Diffuse opacities or white condensed area
- The alveoli fill with white inflammatory fluid
Exclusion Criteria13
- 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.
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Interventions
Tab. Faropenem 200mg three times daily
Tab. Co-Amoxiclav 625mg three times daily
Tab. Clarithromycin 500mg two times daily
Locations(2)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06804096