Ignite Creation Date:
2024-05-06 @ 8:19 PM
Last Modification Date:
2024-10-26 @ 3:25 PM
Study NCT ID:
NCT06334874
Status:
RECRUITING
Last Update Posted:
2024-04-12
First Post:
2024-03-02
Brief Title:
Study of the Efficacy and Safety of Antioxidants Astaxanthin as an Adjuvant Therapy for Community Acquired Pneumonia Patients
Sponsor:
Future University in Egypt
Organization:
Future University in Egypt
Study Overview
Official Title:
Study of the Efficacy and Safety of Astaxanthin as an Adjuvant Therapy for Community Acquired Pneumonia Patients
Status:
RECRUITING
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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
Detailed Description:
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 385C 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 eg 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 neutrophilsmm3 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 12mgd orally or enterally in addition to conventional therapy for CAP 12 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
A Patient Data Collection
1 Baseline characteristics demographic data of the participants including age gender weight height and body mass index BMI
2 Medication History complete history of medication will be recorded for each patient including medications for comorbidities and past medication history as well as concomitant medications
3 Medical History patient history will be recorded including history of present illness as well as comorbidities
B Clinical Assessment
1 Physical Examination daily records of ABGS body temperature pulse blood pressure and respiratory rate will be collected baseline and final readings will be used for analysis
2 Biochemical Investigations
21 The biochemical parameters include complete blood count with differential counts of total leukocyte count lymphocytic count liver function renal functions albumin level creatinine level alkaline phosphatase level ferritin level C-reactive protein Prothrombin time PT activated partial thromboplastin time APTT lipid profile and blood sugar level baseline and final readings will be used for analysis
22 Cytokine storm parameters interleukin-6 tumor necrosis factor-α and interleukin10 will be assessed at baseline and at the end of the study
C Severity Assessment CURB-65 severity score that has been validated for predicting mortality of CAP will be assessed at baseline and at the end of the study3 D Radiological Assessment of CAP computed tomography will be carried out before enrollment to confirm pneumonia diagnosis
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 385C 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 eg 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 neutrophilsmm3 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 12mgd orally or enterally in addition to conventional therapy for CAP 12 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
A Patient Data Collection
1 Baseline characteristics demographic data of the participants including age gender weight height and body mass index BMI
2 Medication History complete history of medication will be recorded for each patient including medications for comorbidities and past medication history as well as concomitant medications
3 Medical History patient history will be recorded including history of present illness as well as comorbidities
B Clinical Assessment
1 Physical Examination daily records of ABGS body temperature pulse blood pressure and respiratory rate will be collected baseline and final readings will be used for analysis
2 Biochemical Investigations
21 The biochemical parameters include complete blood count with differential counts of total leukocyte count lymphocytic count liver function renal functions albumin level creatinine level alkaline phosphatase level ferritin level C-reactive protein Prothrombin time PT activated partial thromboplastin time APTT lipid profile and blood sugar level baseline and final readings will be used for analysis
22 Cytokine storm parameters interleukin-6 tumor necrosis factor-α and interleukin10 will be assessed at baseline and at the end of the study
C Severity Assessment CURB-65 severity score that has been validated for predicting mortality of CAP will be assessed at baseline and at the end of the study3 D Radiological Assessment of CAP computed tomography will be carried out before enrollment to confirm pneumonia diagnosis
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None