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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
160
Tab. Faropenem 200mg three times daily
Tab. Co-Amoxiclav 625mg three times daily
Tab. Clarithromycin 500mg two times daily
Popular Medical College & Hospital
Dhaka, Dhaka Division, Bangladesh
RECRUITINGShaheed Suhrawardy Medical College & Hospital
Dhaka, Dhaka Division, Bangladesh
RECRUITINGClinical Cure Rate between two groups.
The clinical cure rate will be defined as significant improvement of clinical signs and symptoms at the end of treatment or follow-up, without new onset of symptoms, any complications, or the need for further antimicrobial therapy.
Time frame: 10-14 days
Percentage of patients withdrawn from the study due to adverse events between two groups.
To compare the percentage of patients withdrawn from the study due to adverse events between two groups.
Time frame: 10-14 Days
Early Clinical Response (ECR) between two groups.
ECR will be defined as at least one improvement in the symptom mentioned below within 3 ± 1 days after the first dose of the study drug. 1. Fever 2. Decreased shortness of breath. 3. Decreased chest pain. 4. Decreased cough. 5. Decreased sputum/mucous production. 6. Sense of wellbeing.\]
Time frame: 3 - 4 days
All-cause mortality between two groups
To compare the all-cause mortality rate between two groups
Time frame: 10-14 days
Number of patients who needed hospitalization in both groups
Time frame: 28 days
Number of patients who needed Intensive Care Unit (ICU) support in both groups.
Time frame: 28 Days
Frequency of Adverse Events & Serious Adverse Events between two groups.
Time frame: 28 Days
Prof. Khan Abul Kalam Azad, MBBS, FCPS, MD(Med), FACP(USA)
CONTACT
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