Pneumonia, Community-Acquired, Bacterial Pneumonia
Conditions
Keywords
CABP, Faropenem
Brief 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.
Interventions
DRUGFaropenem
Tab. Faropenem 200mg three times daily
DRUGCo-amoxiclav
Tab. Co-Amoxiclav 625mg three times daily
Tab. Clarithromycin 500mg two times daily
Sponsors
Dr. Md. Alimur Reza
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Clinical Cure Rate between two groups. | 10-14 days | 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. |
| Percentage of patients withdrawn from the study due to adverse events between two groups. | 10-14 Days | To compare the percentage of patients withdrawn from the study due to adverse events between two groups. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of patients who needed hospitalization in both groups | 28 days | — |
| Early Clinical Response (ECR) between two groups. | 3 - 4 days | 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.\] |
| Frequency of Adverse Events & Serious Adverse Events between two groups. | 28 Days | — |
| Number of patients who needed Intensive Care Unit (ICU) support in both groups. | 28 Days | — |
| All-cause mortality between two groups | 10-14 days | To compare the all-cause mortality rate between two groups |
Countries
Bangladesh
Contacts
Primary ContactProf. Khan Abul Kalam Azad, MBBS, FCPS, MD(Med), FACP(USA)
Outcome results
None listed