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Could a common antibiotic stop pneumonia from turning deadly?

NCT ID NCT06294600

Disease control Sponsor: Hellenic Institute for the Study of Sepsis 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tests whether giving the antibiotic clarithromycin early, guided by a blood test (suPAR), can prevent pneumonia from worsening into sepsis. About 330 adults with community-acquired pneumonia will receive either clarithromycin or a placebo. The goal is to see if this approach improves symptoms, organ function, and immune markers within four days.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Clarithromycin
What this could lead to
If successful, this could provide a simple, early treatment to stop pneumonia from turning into sepsis, reducing hospital stays and deaths.
What could go wrong
This is a Phase 3 trial, but previous results were mixed. The benefit may be small or not apply to all patients, and clarithromycin can cause side effects like stomach upset or heart rhythm issues.

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 330 people

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

Started

Feb 2024

Expected to finish

Jul 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 years and older

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: * Age equal to or above 18 years * Male or female gender * In case of women of reproductive age, willingness to use dual contraceptive method during the study period * Written informed consent provided by the patient. For subjects without decision-making capacity, informed consent must be obtained from a legally designated representative following the national legislation * Community-acquired pneumonia (CAP) * Presence of at least two of the following signs: i) cough; ii) purulent sputum expectoration; iii) dyspnea; and/or iv) pleuritic chest pain * PCT ≥0.25 ng/ml * suPAR ≥6 ng/ml Exclusion Criteria: * Age below 18 years * Denial of written informed consent * Any stage IV malignancy * Any do not resuscitate decision * Patients necessitating non-invasive ventilation or mechanical ventilation * Hospitalization in Intensive Care Unit * Infection by SARS-CoV-2 * Oral or IV intake of corticosteroids at a daily dose equal to or greater than 0.4 mg/kg prednisone for a period greater than the last 15 days * Intake of any macrolide for the current episode of CAP under study * Known infection by the human immunodeficiency virus * Any chronic anti-cytokine treatment for more than two months * QTc interval at rest in the ECG ≥500 msec or history of know long QT syndrome * Medical history of allergy to macrolides * Concomitant oral intake of astemizole, cizapride, doperidone, pimozide, terfenadine, midazolam, ranolazine, ergot alkaloids (e.g. ergotamine and dihydroergotamine), lomitapide and colchicine; patients may be enrolled in the trial if they stop these drugs during trial participation. * Medical history of torsades de pointes arrhythmia * Concomitant intake of lovostatin or simvastatin; patients may be enrolled in the trial if they stop these drugs during trial participation. * Concomitant presence of end-stage liver failure and end-stage renal failure. * Severe hypokalemia or severe hypomagnesemia; a patient may be enrolled one any of these electrolyte disturbances are restored. * Any contradictions for macrolide uptake * Pregnancy or lactation. Women of child-bearing potential will be screened by a urine pregnancy test before inclusion in the study * Participation in any other interventional trial within the last 30 days

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Conditions

The condition(s) this trial relates to.

Community-Acquired Pneumonia pneumonia Sepsis infectious disease with sepsis prevention target

As listed by the trial registrant

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

Community-acquired pneumonia

How to take part

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

  1. The places running it

    24 sites. 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

  • 1st Department of Internal Medicine - General Hospital of Athens "Sismanogleio-Amalia Fleming"

    NOT_YET_RECRUITING

    Athens, Greece, Greece

  • 1st Department of Internal Medicine, AHEPA University General Hospital of Thessaloniki

    RECRUITING

    Athens, Greece, Greece

  • 1st Department of Internal Medicine, EVANGELISMOS Athens General Hospital

    RECRUITING

    Athens, Greece, Greece

  • 1st Department of Internal Medicine, G. GENNIMATAS Athens General Hospital

    RECRUITING

    Athens, Greece, Greece

  • 1st Department of Internal Medicine, General University Hospital of Ioannina

    RECRUITING

    Athens, Greece, Greece

  • 1st Department of Internal Medicine, KORGIALENEIO-BENAKEIO E.E.S. Athens General Hospital

    RECRUITING

    Athens, Greece, Greece

  • 1st Department of Internal Medicine, THRIASIO General Hospital of Elefsis

    RECRUITING

    Athens, Greece, Greece

  • 1st University Department of Pulmonary Medicine, SOTIRIA General Hospital of Chest Diseases of Athens

    RECRUITING

    Athens, Greece, Greece

  • 2nd Department of Internal Medicine, Attikon University Hospital

    RECRUITING

    Athens, Greece, Greece

  • 2nd Department of Internal Medicine, THRIASIO General Hospital of Elefsis

    RECRUITING

    Athens, Greece, Greece

  • 2nd Department of Internal Medicine, TZANEIO Piraeus General Hospital

    RECRUITING

    Athens, Greece, Greece

  • 2nd Department of Internal Medicine, University General Hospital of Alexandroupolis

    RECRUITING

    Athens, Greece, Greece

  • 3rd Department of Internal Medicine - General State Hospital of Nikaia "Saint Panteleimon" - West Attica General Hospital

    RECRUITING

    Athens, Greece, Greece

  • 3rd Department of Internal Medicine, General Hospital of Athens KORGIALENEIO- BENAKEIO E.E.S.

    RECRUITING

    Athens, Greece, Greece

  • 3rd Department of Internal Medicine, PAPAGEORGIOU General Hospital of Thessaloniki

    RECRUITING

    Thessaloniki, Thessaloniki, 564 29, Greece

  • 3rd University Department of Internal Medicine, SOTIRIA Athens General Hospital of Chest Diseases

    RECRUITING

    Athens, Greece, Greece

  • 4th Department of Internal Medicine, Attikon University Hospital

    RECRUITING

    Athens, Greece, Greece

  • 5th Pulmonary Department, SOTIRIA Athens General Hospital of Chest Diseases

    RECRUITING

    Athens, Athens, 115 27, Greece

  • 6th Pulmonary Medicine Department, SOTIRIA General Hospital of Chest Diseases of Athens

    RECRUITING

    Athens, Greece, Greece

  • Department of Chest Medicine, EVANGELISMOS Athens General Hospital

    RECRUITING

    Athens, Greece, Greece

  • Department of Internal Medicine, Larissa University General Hospital

    RECRUITING

    Athens, Greece, Greece

  • Department of Internal Medicine, Patras University General Hospital

    RECRUITING

    Athens, Greece, Greece

  • Department of Pulmonary Medicine, General Hospital of Kerkira

    RECRUITING

    Athens, Greece, Greece

  • Emergency Department, TZANEIO Piraeus General Hospital

    RECRUITING

    Athens, Greece, Greece

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