Study of the Efficacy and Safety of Antioxidants Astaxanthin as an Adjuvant Therapy for Community Acquired Pneumonia Patients.

Study of the Efficacy and Safety of Astaxanthin as an Adjuvant Therapy for Community Acquired Pneumonia Patients.

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.

Study Overview

• Status: Recruiting
• Conditions: Community-acquired Pneumonia
• Intervention / Treatment: Drug: Astaxanthin Oral Capsule; Drug: Placebo

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 (> 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:

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:

2.1 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.

2.2 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 study.[3] D. Radiological Assessment of CAP: computed tomography will be carried out before enrollment to confirm pneumonia diagnosis.

• Study Type: Interventional
• Enrollment (Estimated): 80
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: fatma makram; Phone Number: 01015000329; Email: fatma.aboelhassan@fue.edu.eg
• Study Contact Backup: Name: eman elmokadam; Email: Eman.abdellatif@fue.edu.eg

Study Locations

• Egypt
  • Cairo, Egypt, 4650201
    • Recruiting
    • Elmatarya Teaching Hospital
    • Contact: fatma makram; Phone Number: 01015000329; Email: fatma.aboelhassan@fue.edu.eg
    • Contact: eman elmokadam; Email: Eman.abdellatif@fue.edu.eg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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).

Exclusion 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: placebo	Drug: Placebo; starch placebo capsule
Active Comparator: intervention	Drug: Astaxanthin Oral Capsule; 12 mg of astaxanthin oral capsule

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
change in IL-6 after treatment in the ASX group compared with those in the control group.	The primary endpoint indicators is the change in IL-6 after treatment in the ASX group compared with those in the control group.	from time of randomization till seven days
change in IL-10 after treatment in the ASX group compared with those in the control group.	the primary endpoint indicators is the change in IL-10 after treatment in the ASX group compared with those in the control group.	from time of randomization till seven days
change in tumor necrosis alpha after treatment in the ASX group compared with those in the control group.	the primary endpoint indicators is the change in tumor necrosis alpha after treatment in the ASX group compared with those in the control group.	from time of randomization till seven days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
difference in CURB 65 scores after treatment in the ASX group compared with the control group.	CURB-65, also known as the CURB criteria, is a clinical prediction rule that has been validated for predicting mortality in pneumonia. The score is an acronym for each of the risk factors measured. Each risk factor scores one point, for a maximum score of 5: Confusion of new onset (defined as an AMTS of 8 or less) Blood Urea nitrogen greater than 7 mmol/L (19 mg/dL) Respiratory rate of 30 breaths per minute or greater Blood pressure less than 90 mmHg systolic or diastolic blood pressure 60 mmHg or less Age 65 or older	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.	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
Length of hospital and ICU stay.	Length of hospital and ICU stay.	from time of randomization till seven days

Collaborators and Investigators

• Sponsor: Future University in Egypt

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2024
• Primary Completion (Estimated): July 1, 2024
• Study Completion (Estimated): August 1, 2024

Study Registration Dates

• First Submitted: March 2, 2024
• First Submitted That Met QC Criteria: March 21, 2024
• First Posted (Actual): March 28, 2024

Study Record Updates

• Last Update Posted (Actual): April 12, 2024
• Last Update Submitted That Met QC Criteria: April 11, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Lung Diseases; Pneumonia
• Other Study ID Numbers: REC-FPFUE-32/2023

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No