Phase
Condition
Soft Tissue Infections
Treatment
Standard of Care
Change of antimicrobials based on BCID2 and Reveal Rapid AST tests. Stop of antimicrobials based on PCT results.
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Male or female
For women of child-bearing potential, willingness to avoid pregnancy during thestudy and agreement to notify investigator if pregnancy occurs.
Age more than or equal to 18 years
Patients who have completed their participation in another study for more than 30days can be included in this study.
Written informed consent provided by the patient or by their legal representative incase of patients unable to consent due to sepsis onset affecting their mentalcapacity.
Sepsis defined by the Sepsis-3 definition; this is defined separately forcommunity-acquired sepsis and for hospital-acquired sepsis. Community-acquiredsepsis is defined as any SOFA score 2 points or more for patients admitted inhospital emergencies with community-acquired pneumonia (CAP), community-acquiredacute pyelonephritis (AP) or community-acquired primary bacteremia (BSI). CAP, APand BSI are considered community-acquired for patients who have no history ofhospitalization lasting more than 2 days the last 90 days or who are not underhemodialysis or who are not residents of long-term care facilities.Hospital-acquired sepsis is defined as any SOFA score increase by 2 points or morefrom the admission SOFA score for patients with onset of hospital-acquired pneumonia (HAP), ventilator-associated pneumonia (VAP), acute pyelonephritis (AP) or primarybacteremia (BSI) at least 48 hours after hospital admission. For patients withhistory of hospitalization lasting more than 2 days the last 90 days or who areunder hemodialysis or who are residents of long-term care facilities and areadmitted to hospital with HAP, VAP, AP and BSI the definition of hospital-acquiredsepsis applies. In this case, the baseline SOFA score is considered as the knownSOFA score before infection onset.
Presence of one of the following infections: community-acquired pneumonia (CAP),hospital-acquired pneumonia (HAP), ventilator-associated pneumonia (VAP), acutepyelonephritis (AP) and primary bacteremia (BSI).
Positive blood culture
Exclusion
Exclusion Criteria:
Failure to obtain written consent to participate
Previous enrollment in this study within the past 90 days. Patients enrolled inanother study will not be accepted.
Patients in pregnancy or breastfeeding. Women of child-bearing potential will bescreened by a urine pregnancy test before inclusion in the study
Patients receiving prolonged antibiotic therapies (e.g. endocarditis, implantabledevice-associated infection, cerebral/hepatic abscess, osteomyelitis, meningitis)
Patients with severe infections due to viruses or parasites (e.g. Dengue, Toxoplasmagondii, Plasmodium spp.)
Patients with infection due to Mycobacterium tuberculosis.
Patients suffering from cystic fibrosis
Severely immunocompromised patients such as a) patients with infection by the humanimmunodeficiency virus and with a CD4 count of less than 200 cells/mm3; b)neutropenic patients with less than 500 neutrophils/mm3; and c) patients with solidorgan transplantation.
Study Design
Study Description
Connect with a study center
2nd Propaedeutic Department of Internal Medicine, Attikon University Hospital
Athens, Chaidari 12462
GreeceActive - Recruiting
4th Department of Internal Medicine, Attikon University Hospital
Athens, Chaidari 12462
GreeceActive - Recruiting
1st Department of Internal Medicine, General Hospital of Elefsina "Thriasio"
Athens, Elefsina 19600
GreeceActive - Recruiting
2nd Department of Internal Medicine, University General Hospital of Alexandroupolis
Alexandroupolis,
GreeceSite Not Available
1st Department of Internal Medicine - General Hospital of Athens Sismanoglio- Amalia Fleming
Athens, 15126
GreeceActive - Recruiting
1st Department of Internal Medicine, General Hospital of Athens KORGIALENIO-BENAKIO E.E.S.
Athens, 11526
GreeceActive - Recruiting
1st Department of Internal Medicine- General Hospital of Athens GENNIMATAS
Athens, 11527
GreeceActive - Recruiting
3rd Department of Internal Medicine - General State Hospital of Nikaia "Saint Panteleimon" - West Attica General Hospital "Agia Varvara"
Athens, 18454
GreeceActive - Recruiting
3rd University Department of Internal Medicine, Sotiria Athens General Hospital
Athens, 11527
GreeceActive - Recruiting
2nd Department of Internal Medicine, General Hospital of Piraeus "Tzaneio"
Piraeus, 18536
GreeceActive - Recruiting
1st University Department of Internal Medicine, AHEPA University General Hospital of Thessaloniki
Thessaloníki, 54636
GreeceSite Not Available
Intensive Care Unit, Ippokrateion General Hospital
Thessaloníki, 54642
GreeceSite Not Available
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