Study of the Efficacy and Safety of Astaxanthin as an Adjuvant Therapy for Community Acquired Pneumonia Patients.
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- change in IL-6 after treatment in the ASX group compared with those in the control group.
研究概览
简要总结
Community acquired pneumonia (CAP) is one of the most common and morbid conditions encountered in clinical practice, which causes serious morbidity worldwide. In CAP, oxidative stress is linked to inflammation, demonstrated by increased production of interleukin (IL)-6 and tumor necrosis factor (TNF)-α, which attract inflammatory cells and increase oxidant production by these cells. Attenuation of oxidative stress via antioxidants would be expected to result in reduced pulmonary damage. Antioxidants have been found to be effective in alleviating lung injury and protecting against damage of other organs.
详细描述
The study will be randomized controlled trial, that will be carried out at ICU at El Matarya Teaching Hospital.
Prior to participation in the study, written informed consent will be obtained from the patients or their family.
Patients with the following criteria will be enrolled: age ≥ 18 year, having clinical symptoms suggestive of CAP such as cough (with or without sputum), fever (> 38.5°C), pleuritic chest pain or dyspnea and consolidations on computed Tomography (CT). Patients will be excluded from the study if having one of the following criteria: advanced age (≥70 years old), presence of severe immunosuppression (HIV infection, use of immune suppressants), malignancy, other concurrent infections, obstruction pneumonia (e.g., because of lung cancer), pneumonia developed within two weeks after hospital discharge, use of ASX before study entry, hypersensitivity to ASX, taking warfarin, taking other antioxidants such as vitamin C, vitamin E, glutathione, granulocytopenia (<1000 neutrophils/mm3), renal failure, liver failure, pregnant and lactating women, hemodynamically unstable patients.
Eligible CAP patients at El Matarya Teaching Hospital will be randomly assigned to either ASX group or control group. The ASX group will receive ASX (12mg/d) orally or enterally in addition to conventional therapy for CAP. [1,2] The control group will receive placebo orally or enterally in addition to conventional therapy for CAP. [2] The treatment duration will be from hospital admission till time of discharge for each CAP patient.
All patients will be subjected to the following:
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
- Triple (Participant, Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 18 year
- •Clinical: Having symptoms suggestive of CAP such as cough (with or without sputum), fever (> 38.5°C), pleuritic chest pain or dyspnea.
- •Radiologic: consolidations on computed Tomography (CT).
排除标准
- •Advanced age (≥70 years old). Presence of severe immunosuppression (HIV infection, use of immune suppressants).
- •Malignancy. Other concurrent infections, obstruction pneumonia (e.g., because of lung cancer).
- •Pneumonia developed within two weeks after hospital discharge. Use of ASX before study entry. Hypersensitivity to ASX. Taking warfarin.
- •Taking other antioxidants such as vitamin C, vitamin E, glutathione.
- •Granulocytopenia (<1000 neutrophils/mm3).
- •Renal failure.
- •Liver failure.
- •Pregnant and lactating women.
- •Hemodynamically unstable patients.
研究组 & 干预措施
intervention
干预措施: Astaxanthin Oral Capsule (Drug)
placebo
干预措施: Placebo (Drug)
结局指标
主要结局
change in IL-6 after treatment in the ASX group compared with those in the control group.
时间窗: from time of randomization till seven days
The primary endpoint indicators is the change in IL-6 after treatment in the ASX group compared with those in the control group.
change in IL-10 after treatment in the ASX group compared with those in the control group.
时间窗: from time of randomization till seven days
the primary endpoint indicators is the change in IL-10 after treatment in the ASX group compared with those in the control group.
change in tumor necrosis alpha after treatment in the ASX group compared with those in the control group.
时间窗: from time of randomization till seven days
the primary endpoint indicators is the change in tumor necrosis alpha after treatment in the ASX group compared with those in the control group.
次要结局
- Length of hospital and ICU stay.(from time of randomization till seven days)
- difference in CURB 65 scores after treatment in the ASX group compared with the control group.(from time of randomization till seven days)
- o Adverse drug reactions related to ASX as increase bowel movement, stomach pain and increase PT and APTT will be assessed.(from time of randomization till seven days)
研究者
Fatma Makram Youssef
teaching assistant, pharmacy practice & clinical pharmacy department
Future University in Egypt