Actively Recruiting
Clarithromycin Treatment to Prevent Sepsis Progression in CAP (REACT)
Led by Hellenic Institute for the Study of Sepsis · Updated on 2025-12-16
330
Participants Needed
24
Research Sites
128 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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. The secondary objectives of REACT are to investigate the impact of early adjunctive treatment with clarithromycin on the resolution of CAP at the test-of-cure (TOC) visit.
CONDITIONS
Official Title
Clarithromycin Treatment to Prevent Sepsis Progression in CAP (REACT)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age equal to or above 18 years
- Male or female gender
- Women of reproductive age must be willing to use dual contraception during the study
- Provide written informed consent or consent from a legal representative
- Diagnosed with community-acquired pneumonia (CAP)
- Presence of at least two of these signs: cough, purulent sputum, difficulty breathing, or chest pain
- Procalcitonin (PCT) level of 0.25 ng/ml or higher
- suPAR level of 6 ng/ml or higher
You will not qualify if you...
- Under 18 years of age
- Decline to provide written informed consent
- Have any stage IV cancer
- Have a do-not-resuscitate order
- Require non-invasive or mechanical ventilation
- Currently hospitalized in an Intensive Care Unit
- Infected with SARS-CoV-2 (COVID-19)
- Taking oral or intravenous corticosteroids at doses of 0.4 mg/kg prednisone or higher for more than 15 days
- Have taken any macrolide antibiotic for the current pneumonia episode
- Known HIV infection
- Receiving chronic anti-cytokine treatment for more than two months
- QTc interval of 500 msec or more or history of long QT syndrome
- Allergic to macrolides
- Taking certain medications such as astemizole, cizapride, doperidone, pimozide, terfenadine, midazolam, ranolazine, ergot alkaloids, lomitapide, colchicine unless stopped during the trial
- History of torsades de pointes arrhythmia
- Taking lovastatin or simvastatin unless stopped during the trial
- Have end-stage liver or renal failure
- Severe low potassium or magnesium levels unless corrected
- Any contraindications to macrolide antibiotics
- Pregnant or breastfeeding women
- Participated in another interventional trial within the last 30 days
AI-Screening
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Trial Site Locations
Total: 24 locations
1
5th Pulmonary Department, SOTIRIA Athens General Hospital of Chest Diseases
Athens, Athens, Greece, 115 27
Actively Recruiting
2
1st Department of Internal Medicine - General Hospital of Athens "Sismanogleio-Amalia Fleming"
Athens, Greece, Greece
Not Yet Recruiting
3
1st Department of Internal Medicine, AHEPA University General Hospital of Thessaloniki
Athens, Greece, Greece
Actively Recruiting
4
1st Department of Internal Medicine, EVANGELISMOS Athens General Hospital
Athens, Greece, Greece
Actively Recruiting
5
1st Department of Internal Medicine, G. GENNIMATAS Athens General Hospital
Athens, Greece, Greece
Actively Recruiting
6
1st Department of Internal Medicine, General University Hospital of Ioannina
Athens, Greece, Greece
Actively Recruiting
7
1st Department of Internal Medicine, KORGIALENEIO-BENAKEIO E.E.S. Athens General Hospital
Athens, Greece, Greece
Actively Recruiting
8
1st Department of Internal Medicine, THRIASIO General Hospital of Elefsis
Athens, Greece, Greece
Actively Recruiting
9
1st University Department of Pulmonary Medicine, SOTIRIA General Hospital of Chest Diseases of Athens
Athens, Greece, Greece
Actively Recruiting
10
2nd Department of Internal Medicine, Attikon University Hospital
Athens, Greece, Greece
Actively Recruiting
11
2nd Department of Internal Medicine, THRIASIO General Hospital of Elefsis
Athens, Greece, Greece
Actively Recruiting
12
2nd Department of Internal Medicine, TZANEIO Piraeus General Hospital
Athens, Greece, Greece
Actively Recruiting
13
2nd Department of Internal Medicine, University General Hospital of Alexandroupolis
Athens, Greece, Greece
Actively Recruiting
14
3rd Department of Internal Medicine - General State Hospital of Nikaia "Saint Panteleimon" - West Attica General Hospital
Athens, Greece, Greece
Actively Recruiting
15
3rd Department of Internal Medicine, General Hospital of Athens KORGIALENEIO- BENAKEIO E.E.S.
Athens, Greece, Greece
Actively Recruiting
16
3rd University Department of Internal Medicine, SOTIRIA Athens General Hospital of Chest Diseases
Athens, Greece, Greece
Actively Recruiting
17
4th Department of Internal Medicine, Attikon University Hospital
Athens, Greece, Greece
Actively Recruiting
18
6th Pulmonary Medicine Department, SOTIRIA General Hospital of Chest Diseases of Athens
Athens, Greece, Greece
Actively Recruiting
19
Department of Chest Medicine, EVANGELISMOS Athens General Hospital
Athens, Greece, Greece
Actively Recruiting
20
Department of Internal Medicine, Larissa University General Hospital
Athens, Greece, Greece
Actively Recruiting
21
Department of Internal Medicine, Patras University General Hospital
Athens, Greece, Greece
Actively Recruiting
22
Department of Pulmonary Medicine, General Hospital of Kerkira
Athens, Greece, Greece
Actively Recruiting
23
Emergency Department, TZANEIO Piraeus General Hospital
Athens, Greece, Greece
Actively Recruiting
24
3rd Department of Internal Medicine, PAPAGEORGIOU General Hospital of Thessaloniki
Thessaloniki, Thessaloniki, Greece, 564 29
Actively Recruiting
Research Team
E
Evangelos J Giamarellos-Bourboulis, MD, Phd
CONTACT
A
Athanasia Chatzianastasiou, Phd
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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