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New treatment option for Community-acquired Pneumonia
Official title Clarithromycin Treatment to Prevent Sepsis Progression in CAP (REACT)
ClinicalTrials.gov ID: NCT06294600
What this study is testing
What is Clarithromycin 500mg?
Clarithromycin 500mg is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for community-acquired pneumonia.
Also referred to as A β-lactam/β-lactamase inhibitor or a 3rd generation cephalosporin or a fluoroquinolone.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The primary objective of the REACT randomized clinical trial (RCT) is to optimize the clinical benefit from adjunctive clarithromycin treatment shown in the ACCESS trial and to provide evidence for the clinical benefit of early start of adjunctive oral clarithromycin guided by suPAR to prevent the progression into sepsis in patients with community-acquired pneumonia (CAP) at risk. This can be achieved by endpoints incorporating clinical benefit with the effect of treatment on the improvement of the immune dysregulation of CAP.
- Phase 3: a large, late-stage study
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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 people without decision-making capacity, informed consent must be obtained from a legally...
- Community-acquired pneumonia (CAP)
You likely can't join if
- 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
See the full eligibility 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 people 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
- 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...
- 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 treatment trial within the last 30 days
The study team makes the final eligibility decision.
Where it's taking place
- Athens, Athens, Greece
- Athens, Greece, Greece
- Thessaloniki, Thessaloniki, Greece
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
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, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Athens, Athens, Greece; Athens, Greece, Greece; Thessaloniki, Thessaloniki, Greece. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.