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

Launched by DR. MD. ALIMUR REZA · Jan 30, 2025

Keywords

ClinConnect Summary

This clinical trial is looking at a new antibiotic called faropenem to see how well it works and how safe it is for treating community-acquired bacterial pneumonia (CABP) in adults in Bangladesh. CABP is a type of lung infection that people can get outside of hospitals. Participants in the study will be randomly divided into two groups: one group will receive faropenem for seven days, while the other group will take a combination of two other antibiotics, co-amoxiclav and clarithromycin, for the same duration. After treatment, all participants will have follow-up check-ups for four weeks to monitor their progress.

To be eligible for this trial, participants need to be between 18 and 65 years old and have symptoms like fever, cough, or trouble breathing, along with a confirmed diagnosis of bacterial pneumonia through chest imaging. However, patients with severe infections or certain health issues, such as recent hospitalization or significant liver or kidney problems, will not be included. This trial aims to provide important information on how effective faropenem could be, especially in a region where there are limited treatment options for pneumonia. Participants will play a vital role in helping researchers understand and improve treatment for this condition.

Gender

ALL

Eligibility criteria

• 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.