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

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 4
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 65
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Bangladesh
Popular Medical College & Hospital
RECRUITING
Dhaka
Shaheed Suhrawardy Medical College & Hospital
RECRUITING
Dhaka
Contact Information
Primary
Prof. Khan Abul Kalam Azad, MBBS, FCPS, MD(Med), FACP(USA)
prof.kakazad@gmail.com
+880-1727271414
Time Frame
Start Date: 2025-02-20
Estimated Completion Date: 2025-12-01
Participants
Target number of participants: 160
Treatments
Experimental: Arm 1
Arm 1: Tab. Faropenem 200mg three times daily with standard care.
Active_comparator: Arm 2
Arm 2: Tab. Co-Amoxiclav 625mg three times daily and Tab. Clarithromycin 500mg two times daily with standard care.
Related Therapeutic Areas
Sponsors
Leads: Dr. Md. Alimur Reza

This content was sourced from clinicaltrials.gov

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