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Antibiotic combo tested to block secondary infections in sepsis

NCT ID NCT07834346

Prevention 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Sep 22, 2026 · Last updated Oct 16, 2026 · Updated 9 times

Summary

Researchers are testing whether adding the antibiotic clarithromycin to standard antibiotic therapy can prevent new infections and secondary sepsis in adults hospitalized with community-acquired pneumonia and sepsis. The trial enrolls 252 adults who receive either clarithromycin or a placebo alongside standard antibiotics for up to 7 days. Participants are followed for 28 days to track new infections, and up to 90 days for mortality and hospital readmission.

What this could mean

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

Active substance
clarithromycin, an antibiotic
What this could lead to
If it works, adding clarithromycin to standard antibiotics could become a way to prevent new infections and secondary sepsis in people hospitalized with pneumonia and sepsis.
What could go wrong
This is a Phase 3 trial, so it is still testing whether clarithromycin helps. Antibiotics can cause side effects, and the results may not show a clear benefit or may not apply to all patients with sepsis.

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 252 people

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

Expected to start

Sep 2026

An estimate. Start dates often move.

Expected to finish

Dec 2029

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 * Patients of either gender * Written informed consent provided by the patient. For patients without decision-making capacity, informed consent must be obtained from a legally designated representative following the national legislation. * Negative (blood or urinary) pregnancy test for female patients of reproductive age * For female patients of reproductive age, willingness to use highly effective contraception during and seven days after the administration of the IMP. * Presence of Community-acquired pneumonia (CAP) * Presence of sepsis as defined by the Sepsis-3 classification criteria (at least 2 points increase of the total SOFA-1 score from the baseline score of the specific patient). The SOFA score which will be used for the definition of sepsis has recently been renamed SOFA-1. * Absolute lymphocyte count (ALC) less than 1000/mm³. Exclusion Criteria: * Age below 18 years * Denial of written informed consent * Pregnancy (confirmed by blood or urinary pregnancy test) or lactation for female patients * Unwillingness to receive contraception during and seven days after the administration of the IMPstudy drug (for Female patients) * Known HIV infection with known CD4 cell count \<200/mm³ * Solid organ or bone marrow transplantation * Corticosteroid oral or intravenous intake greater than 0.4mg/kg of equivalent prednisone daily over the last 15 days or other immunosuppressive therapy. However, corticosteroids received as adjunctive treatment for the current septic/infectious episode are allowed * Intake of a biological agent in the last month * Known active neoplasms or other conditions unrelated to sepsis that compromise short-term survival less than 6 months * Neutropenia \< 500/mm³ * Intake of any macrolide for the current episode of CAP under study * QTc interval at rest in the ECG ≥500 msec or history of known long QT syndrome * Medical history of allergy to macrolides * Concomitant use of medicinal products contraindicated with clarithromycin, including CYP3A substrates associated with QT prolongation (e.g., astemizole, cisapride, domperidone, pimozide, terfenadine, ivabradine), ergot alkaloids (e.g., ergotamine, dihydroergotamine), oral midazolam, HMG-CoA reductase inhibitors primarily metabolised by CYP3A4 (e.g., lovastatin, simvastatin), colchicine, ticagrelor, and ranolazine. This criterion applies to all medicinal products within these classes, not only the specific examples listed, in accordance with the SmPC for clarithromycin. Patients may be enrolled provided that such medications are discontinued prior to or at the time of trial participation. Given their short half-life, no wash-out period is required * Medical history of torsades de pointes arrhythmia * Severe hypokalemia or hypomagnesemia; patients may be enrolled once these electrolyte abnormalities are corrected. * Any contradictions for macrolide uptake * Previous participation in the CLASSIFY study * Participation in any other interventional trial within the last 30 days * Severe hepatic failure in combination with renal impairment

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Conditions

The condition(s) this trial relates to.

Community-Acquired Pneumonia infectious disease with sepsis pneumonia Sepsis

As listed by the trial registrant

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

Sepsis

How to take part

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

  1. The places running it

    19 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

  • Evaggelismos Hospital, 1st Department of Internal Medicine

    RECRUITING

    Athens, Attica, 106 76, Greece

  • General Hospital of Athens Alexandra, Ηigh Dependency Unit of Department of Clinical Therapeutics

    RECRUITING

    Athens, Attica, 115 28, Greece

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

    RECRUITING

    Athens, Attica, 115 27, Greece

  • General Hospital of Athens Korgialenio Benakio H.R.C, Intensive Care Unit

    RECRUITING

    Athens, Attica, 115 26, Greece

  • General Hospital of Athens Korgialenio Benakio H.R.C., 1st Department of Internal Medicine

    RECRUITING

    Athens, Attica, 115 26, Greece

  • General Hospital of Eleusina Thriasio, 1st Department of Internal Medicine

    NOT_YET_RECRUITING

    Elefsina, West Attica, 190 18, Greece

  • General Hospital of Eleusina Thriasio, 2nd Department of Internal Medicine

    NOT_YET_RECRUITING

    Elefsina, West Attica, 190 18, Greece

  • General Hospital of Thessaloniki Papageorgiou, Department of Internal Medicine

    RECRUITING

    Thessaloniki, Thessaloniki, 564 29, Greece

  • General Oncological Hospital of Kifisia Agioi Anargyroi, Intensive Care Unit

    RECRUITING

    Athens, Attica, 145 64, Greece

  • General University Hospital of Patras, Department of Internal Medicine

    RECRUITING

    Pátrai, Achaea, 265 04, Greece

  • Geniko Nosokomeio Thessalonikis George Papanikolaou, Intensive Care Unit

    RECRUITING

    Thessaloniki, Thessaloniki, 570 10, Greece

  • Ippokratio General Hospital of Thessaloniki, 2nd Propaedeutic Department of Internal Medicine

    RECRUITING

    Thessaloniki, Thessaloniki, 546 42, Greece

  • Thoracic General Hospital of Athens I Sotiria, 3rd University Department of Internal Medicine

    RECRUITING

    Athens, Attica, 115 27, Greece

  • Thoracic General Hospital of Athens I Sotiria, 6th Department of Pulmonary Medicine

    RECRUITING

    Athens, Attica, 115 27, Greece

  • University General Hospital Attikon-General Hospital of West Attica H Agia Varvara, 2nd Department of Propaedeutic Medicine

    RECRUITING

    Athens, Attica, 124 61, Greece

  • University General Hospital Attikon-General Hospital of West Attica H Agia Varvara, 4th Department of Internal Medicine

    RECRUITING

    Athens, Attica, 124 61, Greece

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

    RECRUITING

    Alexandroupoli, Thrace, 681 00, Greece

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

    RECRUITING

    Ioannina, Ioannina, 455 00, Greece

  • University General Hospital of Thessaloniki Ahepa, Intensive Care Unit

    RECRUITING

    Thessaloniki, Thessaloniki, 546 36, Greece

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