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Clarithromycin Treatment to Prevent Sepsis Progression in CAP (REACT)

ConditionCommunity-acquired Pneumonia
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorHellenic Institute for the Study of Sepsis

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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 subjects without decision-making capacity, informed consent must be obtained from a legally designated representative following the national legislation

Disqualifiers

Age below 18 years

Denial of written informed consent

Any stage IV malignancy

Any do not resuscitate decision

Trial design

Design model

Parallel

Treatments tested in this trial

  • Clarithromycin 500mg

    Drug

    Oral tablets of 500mg of clarithromycin

  • Tablets

    Drug

    Oral tablets of similar appearance to active study drug

Treatment groups

330 Participants
are divided into 2 treatment groups
Group A: PlaceboPlacebo comparator 1 intervention
Group B: ClarithromycinActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Change of baseline respiratory symptoms score

At least 50 percent (%) decrease of the sum of scoring (0-12) for the symptoms of cough (0-3), dyspnea (0-3), purulent sputum expectoration (0-3) and pleuritic chest pain (0-3) between baseline and Study Day 4

Time frame
4 Days
2

Change of baseline total sequential organ failure assessment (SOFA) score

At least 30 percent (%) decrease between baseline sequential organ failure assessment (SOFA) score and measured sequential organ failure assessment (SOFA) score at Study Day 4.

Time frame
4 Days
3

Change of baseline on both plasma PCT and plasma IL-10 or IL-8 to IL-10 ratio

Plasma PCT on visit 4 has decreased by at least 80% from baseline PCT on screening or it is below 0.25 ng/ml AND (\[plasma IL-10 on visit 4 has decreased by at least 25% from IL-10 of visit 1 or it is below the lower limit of detection\] OR \[the IL-8 to IL-10 ratio of day 4 has decreased less than 15% from the IL-8 to IL-10 ratio of visit 1\]).

Time frame
4 Days

Secondary outcomes

1

The number of patients that succeeded the resolution of CAP at the test of cure (TOC) visit.

This is also analyzed separately for patients infected or colonized by clarithromycin-susceptible and clarithromycin-resistant S.pneumoniae and it is defined as the complete resolution of RSS

Time frame
14 Days
2

Need for up-escalation of the SoC administered antibiotics.

This is considered as the change of the baseline administered SoC antibiotics into more broad-spectrum antibiotics.

Time frame
28 Days
3

Survival

Alive hospital discharge until day 28

Time frame
28 Days
4

Change of baseline sequential organ failure assessment (SOFA) score

Achievement of more than 50% decrease of baseline SOFA score at end-of-treatment (EOT) visit

Time frame
8 Days

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Hellenic Institute for the Study of Sepsis

Lead sponsor

Source ClinicalTrials.gov
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