Clarithromycin to help prevent secondary infections in adults with pneumonia and sepsis

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This Phase 3 trial compares clarithromycin plus standard-of-care antibiotics versus placebo plus standard-of-care in adults with CAP and sepsis, including those with sepsis-induced immunoparalysis. The primary outcome is the incidence of new infections or worsening of CAP within 28 days. Secondary outcomes include mortality, sepsis response, timing of antimicrobial escalation, hospital readmission, quality of life, cost-effectiveness, and immune biomarkers. The trial seeks to determine if clarithromycin can modulate the immune response and reduce secondary infections in this high-risk population.

Why it matters

Who can join: the full rules

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

Where it's running

• General University Hospital of Patras, Department of Internal Medicine
  Pátrai, Achaea, Greece Recruiting
• Evaggelismos Hospital, 1st Department of Internal Medicine
  Athens, Attica, Greece Recruiting
• General Hospital of Athens Korgialenio Benakio H.R.C, Intensive Care Unit
  Athens, Attica, Greece Recruiting
• General Hospital of Athens Korgialenio Benakio H.R.C., 1st Department of Internal Medicine
  Athens, Attica, Greece Recruiting
• General Hospital of Athens G.Gennimatas, 1st Department of Internal Medicine
  Athens, Attica, Greece Recruiting
• Thoracic General Hospital of Athens I Sotiria, 3rd University Department of Internal Medicine
  Athens, Attica, Greece Recruiting

Study contacts

• Study coordinator: Evangelos J Giamarellos-Bourboulis, Professor
• Email: egiamarel@med.uoa.gr
• Phone: 2105831994

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.