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

ConditionsPneumonia, Community-AcquiredBacterial Pneumonia
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18-65
SponsorDr. Md. Alimur Reza

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

Male or female patients aged between 18 to 65 years.

Fever (body temperature > 38.0 °C (100.4 °F) measured orally)

Shortness of breath

New onset or increased cough with or without sputum production.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Faropenem

    Drug

    Tab. Faropenem 200mg three times daily

  • Co-amoxiclav

    Drug

    Tab. Co-Amoxiclav 625mg three times daily

  • Clarithromycin 500 mg

    Drug

    Tab. Clarithromycin 500mg two times daily

Treatment groups

160 Participants
are divided into 2 treatment groups
Group A: Arm 1Experimental treatment 1 intervention
Group B: Arm 2Active comparator 2 interventions

Trial outcomes

Primary outcomes

1

Clinical 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
2

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

Secondary outcomes

1

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
2

All-cause mortality between two groups

To compare the all-cause mortality rate between two groups

Time frame
10-14 days
3

Number of patients who needed hospitalization in both groups

Time frame
28 days
4

Number of patients who needed Intensive Care Unit (ICU) support in both groups.

Time frame
28 Days

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Dr. Md. Alimur Reza

Lead sponsor

Beximco Pharmaceuticals Ltd.

Sponsor institution

Source ClinicalTrials.gov
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