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CLARITHROMYCIN TO PREVENT SECONDARY INFECTIONS IN PATIENTS WITH SEPSIS FOLLOWING LOWER RESPIRATORY TRACT INFECTIONS: THE CLASSIFY TRIAL
EU CTIS ID: 2025-525058-20-00
What this study is testing
The CLASSIFY trial is designed to determine whether adjunctive clarithromycin, administered IV or orally, can reduce the incidence of secondary infection episodes including sepsis within 28 days among patients with CAP-related sepsis and evidence of SII.
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 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 contraception during and seven days after the administration of the study drug.
- Presence of Community-acquired pneumonia (CAP)
You likely can't join if
- Age below 18 years
- Unwillingness to receive contraception during and seven days after the administration of the study 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 0.4 mg/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
See the full eligibility 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 contraception during and seven days after the administration of the study drug.
- 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.
- Age below 18 years
- Unwillingness to receive contraception during and seven days after the administration of the study 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 0.4 mg/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 to less than 6 months.
- Severe hypokalemia or severe hypomagnesemia; a patient may be enrolled one any of these electrolyte disturbances are restored.
- Any contraindications for macrolide uptake
- Participation in any other interventional trial within the last 30 days
- Previous participation in the CLASSIFY study
- Neutropenia defined as an absolute neutrophil count less than 500/mm³
- Patients with severe hepatic failure or severe renal dysfunction may be excluded at the discretion of the attending physician
- Intake of macrolide for the current episode of CAP under study
- Corrected QT 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
- Denial of written informed consent
- Pregnancy (confirmed by blood or urinary pregnancy test) or lactation for female patients
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.