Actively Recruiting

Phase 4
Age: 18Years - 65Years
All Genders
NCT06804096

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

Led by Dr. Md. Alimur Reza · Updated on 2025-07-11

160

Participants Needed

2

Research Sites

40 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years - 65Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Male or female patients aged between 18 to 65 years
  • Acute illness lasting 7 days or less with symptoms such as fever over 38.0 6C, shortness of breath, new or increased cough, or chest pain
  • Radiographically confirmed bacterial pneumonia showing unilateral lobar infiltrates, diffuse opacities, or alveoli filled with inflammatory fluid
Not Eligible

You will not qualify if you...

  • Severe pneumonia based on clinical and radiological assessment
  • Suspected viral pneumonia or other types like nosocomial or aspiration pneumonia
  • Known allergy or intolerance to study drugs
  • Antibiotic use within 48 hours before study admission
  • Hospitalization within the last 28 days
  • Pregnancy or lactation
  • Renal impairment with eGFR less than 30 mL/min
  • Significant liver impairment with ALT more than three times the normal limit
  • Serious immune system diseases such as AIDS or cancer
  • Use of steroids at doses of 20 mg prednisolone daily or equivalent
  • Receiving or planning chemotherapy or anti-cancer therapy within six months
  • History of epilepsy, stroke, central nervous system disorders, or uncontrolled psychiatric illness

AI-Screening

AI-Powered Screening

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Trial Site Locations

Total: 2 locations

1

Popular Medical College & Hospital

Dhaka, Dhaka Division, Bangladesh, 1205

Actively Recruiting

2

Shaheed Suhrawardy Medical College & Hospital

Dhaka, Dhaka Division, Bangladesh, 1205

Actively Recruiting

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Research Team

P

Prof. Khan Abul Kalam Azad, MBBS, FCPS, MD(Med), FACP(USA)

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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