RECRUITING Phase 3 ClinicalTrials.gov

CLARITHROMYCIN TO PREVENT SECONDARY INFECTIONS IN PATIENTS WITH SEPSIS FOLLOWING LOWER RESPIRATORY TRACT INFECTIONS: THE CLASSIFY TRIAL

Sponsor: Hellenic Institute for the Study of Sepsis • ClinicalTrials.gov ID: NCT07834346

Registry updated: 2026-10-16

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Description

The goal of this clinical trial is to assess whether clarithromycin, given as an adjunct to standard-of-care antibiotic therapy, can reduce the risk of new infections and secondary sepsis in adult patients hospitalized with community-acquired pneumonia (CAP), sepsis, and sepsis-induced immunoparalysis (SII). The primary objective is to evaluate the effect of clarithromycin on the incidence of new infection, including worsening or recurrence of the initial CAP episode, new infections at other sites, and secondary sepsis during the 28-day follow-up period. Secondary objectives are to investigate the impact of clarithromycin on mortality, sepsis response, type of secondary infection, time to antimicrobial escalation, hospital readmission, quality of life, cost-effectiveness, and biomarkers of sepsis-induced immunoparalysis. Researchers will compare clarithromycin plus standard-of-care antibiotic therapy to placebo plus standard-of-care antibiotic therapy. Participants will: * Receive clarithromycin or placebo, administered orally or intravenously, in addition to standard-of-care antibiotic therapy for up to 7 days. * Be evaluated during treatment and follow-up through Day 28, with additional assessment of mortality, hospital readmission, and health status through Day 90.

Interventions

Placebo (Drug)
There is no other intervention in this clinical study and participation in another clinical study is an exclusion criterion.
clarithromycin (Drug)
There is no other intervention in this clinical study and participation in another clinical study is an exclusion criterion.

Eligibility criteria

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

Conditions

Sepsis

Locations

General University Hospital of Patras, Department of Internal Medicine — Pátrai, Achaea, Greece
Evaggelismos Hospital, 1st Department of Internal Medicine — Athens, Attica, Greece
General Hospital of Athens Korgialenio Benakio H.R.C, Intensive Care Unit — Athens, Attica, Greece
General Hospital of Athens Korgialenio Benakio H.R.C., 1st Department of Internal Medicine — Athens, Attica, Greece
General Hospital of Athens G.Gennimatas, 1st Department of Internal Medicine — Athens, Attica, Greece
Thoracic General Hospital of Athens I Sotiria, 3rd University Department of Internal Medicine — Athens, Attica, Greece
Thoracic General Hospital of Athens I Sotiria, 6th Department of Pulmonary Medicine — Athens, Attica, Greece
General Hospital of Athens Alexandra, Ηigh Dependency Unit of Department of Clinical Therapeutics — Athens, Attica, Greece
University General Hospital Attikon-General Hospital of West Attica H Agia Varvara, 2nd Department of Propaedeutic Medicine — Athens, Attica, Greece
University General Hospital Attikon-General Hospital of West Attica H Agia Varvara, 4th Department of Internal Medicine — Athens, Attica, Greece
General Oncological Hospital of Kifisia Agioi Anargyroi, Intensive Care Unit — Athens, Attica, Greece
University General Hospital of Ioannina, 1st Department of Internal Medicine — Ioannina, Ioannina, Greece
University General Hospital of Thessaloniki Ahepa, Intensive Care Unit — Thessaloniki, Thessaloniki, Greece
Ippokratio General Hospital of Thessaloniki, 2nd Propaedeutic Department of Internal Medicine — Thessaloniki, Thessaloniki, Greece
General Hospital of Thessaloniki Papageorgiou, Department of Internal Medicine — Thessaloniki, Thessaloniki, Greece
Geniko Nosokomeio Thessalonikis George Papanikolaou, Intensive Care Unit — Thessaloniki, Thessaloniki, Greece
University General Hospital of Alexandroupolis, 2nd Department of Internal Medicine — Alexandroupoli, Thrace, Greece
General Hospital of Eleusina Thriasio, 1st Department of Internal Medicine — Elefsina, West Attica, Greece
General Hospital of Eleusina Thriasio, 2nd Department of Internal Medicine — Elefsina, West Attica, Greece

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