Evaluation of efficacy and safety of adjuvant Pentoxifylline therapy in adults with community acquired pneumonia: An Open label, Randomized-controlled trial.
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Time to overall clinical stability (TCS) defined as temperature less than or equall to 37·8 degree celsius, heart rate below 100 beats per minute, respiratory rate below 24 breaths per minute, arterial oxygen saturation of 90 percentage or higher on room air, systolic blood pressure of 90 mm Hg or higher, and baseline mental status. TCS is defined as the first day after the starting of study drug all the 5 vital signs fulfill the above criteria on same day and eating and mental status are stable.
研究概览
简要总结
· Severe CAP has a complicated and diverse aetiology. Although antibiotics are essential for battling the infectious agent, lung damage and the emergence of systemic consequences are mostly dependent on the concomitant hyperinflammatory response. Pentoxifylline has the potential to mitigate the cytokine storm linked to severe CAP by regulating the inflammatory response by inhibiting proinflammatory cytokines such as tumor necrosis factor-alpha (TNF-α). This modulation has the potential to improve oxygenation, reduce lung injury, and eventually improve clinical results. This study aims to evaluate the efficacy and safety of PENTOXIFYLLINE as an adjuvant in hospitalized adults with CAP.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 75.00 Year(s)（—）
- 性别
- All
入选标准
- •At least one acute clinical sign compatible with pneumonia (dyspnea, cough, purulent sputum, crackles) 2)Infiltrate on chest X-ray or CT scan suggestive of pneumonia 3)Diagnosis of CAP at or during the 48 hours post-hospital admission.
- •Informed consent signed by the patient, his/her legally authorized representative.
排除标准
- •Patient on invasive mechanical ventilation.
- •Patients with creatinine clearance less than 30 ml per minute 3)Patient on vasopressors at the time of inclusion 4)Any contraindications to the study drug 5)Patient requiring corticosteroids (except for nebulized corticosteroids) for any reason.
- •Patient treated with antibiotics for more than 7 days prior to admission.
- •Suspicion of aspiration or heath care associated pneumonia.
- •Active tuberculosis 9)On immunosuppressive therapy or malignancy 10)Pregnancy or lactating women.
结局指标
主要结局
Time to overall clinical stability (TCS) defined as temperature less than or equall to 37·8 degree celsius, heart rate below 100 beats per minute, respiratory rate below 24 breaths per minute, arterial oxygen saturation of 90 percentage or higher on room air, systolic blood pressure of 90 mm Hg or higher, and baseline mental status. TCS is defined as the first day after the starting of study drug all the 5 vital signs fulfill the above criteria on same day and eating and mental status are stable.
时间窗: Over 7 days
次要结局
- To evaluate the change in inflammatory markers in terms of change in serum CRP and TNF alpha level between the groups.(To evaluate the length of hospital stay (LOS) between the groups.)
研究者
DR DHRITI SUNDAR DAS
AIIMS BHUBANESWAR