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Flu shot study probes hidden inflammation clues in High-Risk patients

NCT ID NCT07604103

Knowledge-focused Sponsor: University of Brawijaya Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study looks at 60 adult male smokers under 65 who have both heart disease (acute coronary syndrome) and pneumonia along with COPD. Researchers want to see if certain blood markers (GDF-15, MR proADM, and Presepsin) change after getting a flu shot. The goal is to understand how vaccination might affect inflammation in these very sick patients.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 60 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jan 2026

Expected to finish

Oct 2026

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 65 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Adult male patients (\< 65 years old). * History of being an active smoker. * Confirmed diagnosis of Acute Coronary Syndrome (ACS) and Pneumonia based on clinical, laboratory, and radiological criteria. * Demonstrated clinical improvement (stabilization) after receiving standard ACS and Pneumonia therapy in the acute intrahospital phase. * Willing to undergo all study procedures and sign the Informed Consent form. Exclusion Criteria: * Presence of absolute contraindications to pneumococcal and influenza vaccination (history of anaphylactic reactions to vaccine components). * Patients with malignancies (cancer), systemic autoimmune diseases, or those currently on long-term immunosuppressant therapy. * Patients with End-Stage Renal Disease (ESRD) or severe liver dysfunction that could confound inflammatory biomarker values. * Patients with persistently unstable hemodynamic conditions or unresolved cardiogenic shock during the acute care phase. * Patient death before the observation period (up to post-vaccination) is completed. * Patient unilaterally resigns or withdraws consent during the study. * Lost to follow-up during scheduled outpatient clinic visits or scheduled follow-up biomarker evaluations.

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Conditions

The condition(s) this trial relates to.

acute coronary syndrome chronic obstructive pulmonary disease COPD, severe early onset influenza pneumonia

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Acute coronary syndromes (ACS) COPD (chronic obstructive pulmonary disease) Pneumonia

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • RSUD Dr. Saiful Anwar

    RECRUITING

    Malang, East Java, 65111, Indonesia

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