Efficacy and Safety of Faropenem in Bangladeshi Adult Patients With Community-Acquired Bacterial Pneumonia (CABP): A Randomized Controlled Trial
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 129
- 试验地点
- 2
- 主要终点
- Clinical Cure Rate between two groups.
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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.
研究组 & 干预措施
Arm 2
Arm 2: Tab. Co-Amoxiclav 625mg three times daily and Tab. Clarithromycin 500mg two times daily with standard care.
干预措施: Co-amoxiclav (Drug)
Arm 2
Arm 2: Tab. Co-Amoxiclav 625mg three times daily and Tab. Clarithromycin 500mg two times daily with standard care.
干预措施: Clarithromycin 500 mg (Drug)
Arm 1
Arm 1: Tab. Faropenem 200mg three times daily with standard care.
干预措施: Faropenem (Drug)
结局指标
主要结局
Clinical Cure Rate between two groups.
时间窗: 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.
时间窗: 10-14 Days
To compare the percentage of patients withdrawn from the study due to adverse events between two groups.
次要结局
- Early Clinical Response (ECR) between two groups.(3 - 4 days)
- All-cause mortality between two groups(10-14 days)
- Number of patients who needed hospitalization in both groups(28 days)
- Number of patients who needed Intensive Care Unit (ICU) support in both groups.(28 Days)
- Frequency of Adverse Events & Serious Adverse Events between two groups.(28 Days)
研究者
Dr. Md. Alimur Reza
Director
Beximco Pharmaceuticals Ltd.