Community-acquired PneumoniaPhase 4NCT06334874
Study of the Efficacy and Safety of Antioxidants Astaxanthin as an Adjuvant Therapy for Community Acquired Pneumonia Patients.
A Phase 4 study testing Astaxanthin Oral Capsule in people with Community-acquired Pneumonia, run by Future University in Egypt at 1 site in Egypt.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Community-acquired Pneumonia
- What is being tested?
- Astaxanthin Oral Capsule
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Apr 2024to 1 Aug 2024
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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.
Show all 9Show fewer
- Liver failure.
- Pregnant and lactating women.
- Hemodynamically unstable patients.
Trial locations and contacts
1 site in 1 country.
eman elmokadam contact
Egypt1 site, 1 recruiting
- Recruiting
Elmatarya Teaching Hospital
Cairo, 4650201
fatma makram, 01015000329, fatma.aboelhassan@fue.edu.eg
eman elmokadam, Eman.abdellatif@fue.edu.eg
About this study
Official title: 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.
Read the 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:
- Patient Data Collection:
- Baseline characteristics: demographic data of the participants including: age, gender, weight, height, and body mass index (BMI).
- 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.
- Medical History: patient history will be recorded including history of present illness as well as comorbidities.
- Clinical Assessment:
- 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.
- 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.
- 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.
- Conditions
- Community-acquired Pneumonia
- Being tested
- Astaxanthin Oral Capsule, Placebo
- Medical subject headings
- Community-Acquired Pneumonia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Astaxanthin Oral CapsuleDrug
12 mg of astaxanthin oral capsule
PlaceboDrug
starch placebo capsule
| Study group | Role | What they receive |
|---|---|---|
| intervention | Active comparator | Not described Receives: Drug: Astaxanthin Oral Capsule |
| placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
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
Measured: 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.
- Adverse drug reactions related to ASX as increase bowel movement, stomach pain and increase PT and APTT will be assessed.
Measured: from time of randomization till seven days
Length of hospital and ICU stay.
Length of hospital and ICU stay.
Measured: from time of randomization till seven days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Mar 2024
- Study start1 Apr 2024
- Primary completion1 Jul 2024 (estimated)
- Study completion1 Aug 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Community-acquired PneumoniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Future University in Egypt
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fatma Makram Youssef, Future University in Egypt
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06334874
- Sponsor's protocol ID
- REC-FPFUE-32/2023
- Status last verified
- Mar 2024
- First submitted
- 2 Mar 2024
- Last updated
- 12 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 40852606
Study at a glance
From the registry record, last updated by the sponsor on 12 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of the Efficacy and Safety of Astaxanthin as an Adjuvant Therapy for Community Acquired Pneumonia Patients.
- ClinicalTrials.gov ID
- NCT06334874
- Acronym / sponsor ID
- REC-FPFUE-32/2023
- Conditions
- Community-acquired Pneumonia
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Future University in EgyptUniversity, hospital or other
- Study start
- 1 Apr 2024 (actual)
- Primary completion
- 1 Jul 2024 (estimated)
- Study completion
- 1 Aug 2024 (estimated)
- First posted
- 28 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 (> 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:
- Patient Data Collection:
- Baseline characteristics: demographic data of the participants including: age, gender, weight, height, and body mass index (BMI).
- 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.
- Medical History: patient history will be recorded including history of present illness as well as comorbidities.
- Clinical Assessment:
- 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.
- 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.
- 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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| intervention | Active comparator | Drug: Astaxanthin Oral Capsule |
| placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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).
Key exclusion criteria (9 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Astaxanthin Oral Capsule12 mg of astaxanthin oral capsule | Drug | intervention |
| Placebostarch placebo capsule | Drug | placebo |
Primary outcome
change in IL-6 after treatment in the ASX group compared with those in the control group.
Time frame: 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.
Time frame: 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.
Time frame: 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.
3 secondary outcomes
difference in CURB 65 scores after treatment in the ASX group compared with the control group.
Time frame: 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.
Time frame: from time of randomization till seven days
Length of hospital and ICU stay.
Time frame: from time of randomization till seven days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Apr 2024.
- Derived from this study: PubMed 40852606Youssef 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
eman elmokadam contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Astaxanthin Oral Capsule in people with Community-acquired Pneumonia, run by Future University in Egypt at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 12 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact fatma makram (01015000329, fatma.aboelhassan@fue.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
change in IL-6 after treatment in the ASX group compared with those in the control group. (time frame: from time of randomization till seven days). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06334874, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Apr 2024.