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

NCT06334874 | Recruiting Phase 4

• 1 other identifier: REC-FPFUE-32/2023
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Community-acquired Pneumonia

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (3)

• 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

• Length of hospital and ICU stay.

  from time of randomization till seven days

Study Arms (2)

intervention

ACTIVE COMPARATOR

Drug: Astaxanthin Oral Capsule

placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

Astaxanthin Oral Capsule DRUG

12 mg of astaxanthin oral capsule

intervention

Placebo DRUG

starch placebo capsule

placebo

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Future University in Egypt: lead

Study Sites (1)

Elmatarya Teaching Hospital

Cairo, 4650201, Egypt

RECRUITING

Related Publications (1)

• Youssef FM, Ateyya H, Hanna Samy AE, Elmokadem EM. The anti-inflammatory and antioxidant effects of astaxanthin as an adjunctive therapy in community-acquired pneumonia: a randomized controlled trial. Front Pharmacol. 2025 Aug 7;16:1621308. doi: 10.3389/fphar.2025.1621308. eCollection 2025.

  PMID: 40852606 DERIVED

MeSH Terms

Conditions

Community-Acquired Pneumonia

Interventions

astaxanthine

Condition Hierarchy (Ancestors)

Community-Acquired Infections; Infections; Pneumonia; Respiratory Tract Infections; Respiratory Tract Diseases

Central Study Contacts

fatma makram

CONTACT

01015000329; fatma.aboelhassan@fue.edu.eg

eman elmokadam

CONTACT

Eman.abdellatif@fue.edu.eg

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: teaching assistant, pharmacy practice & clinical pharmacy department

Study Record Dates

• First Submitted: March 2, 2024
• First Posted: March 28, 2024
• Study Start: April 1, 2024
• Primary Completion: July 1, 2024
• Study Completion: August 1, 2024
• Last Updated: April 12, 2024

Record last verified: 2024-03

Locations

EG (1)