Status:
COMPLETED
A Clinical Trial of Procalcitonin-guided Antimicrobial Therapy in Sepsis
Lead Sponsor:
Hellenic Institute for the Study of Sepsis
Conditions:
Sepsis
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The aim of the study is to demonstrate if using one procalcitonin (PCT)-guided rule of stop of antimicrobials, the incidence of infections by C.difficile and by Multi-Drug-Resistant (MDR) bacteria dur...
Detailed Description
Early administration of antimicrobials remains the mainstay of treatment of severe infections. Current guidelines of management of severe sepsis suggest that initial therapy of a patient should be rev...
Eligibility Criteria
Inclusion
- Male or female
- In case of women, unwillingness to remain pregnant during the study period.
- Age more than or equal to 18 years
- Sequential Organ Failure Assessment (SOFA) score more than or equal to 2 points for patients admitted in the emergencies and with a more than or equal to a 2-point increase of admission SOFA score for hospitalized patients.
- Presence of one of the following infections: community-acquired pneumonia, hospital-acquired pneumonia, ventilator-associated pneumonia, bacteremia and acute pyelonephritis. Any infection with onset more than 48 hours post hospital admission is considered one hospital-acquired infection.
Exclusion
- Failure to obtain written consent to participate
- Patients in pregnancy or breastfeeding. Women of child-bearing potential will be screened by a urine pregnancy test before inclusion in the study
- Patients receiving prolonged antibiotic therapies ( e.g. endocarditis, implantable device-associated infection, cerebral/hepatic abscess, osteomyelitis, meningitis)
- Patients with severe infections due to viruses or parasites (e.g. Dengue, Toxoplasma gondii, Plasmodium spp.)
- Patients infected with Mycobacterium tuberculosis.
Key Trial Info
Start Date :
October 24 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 20 2019
Estimated Enrollment :
266 Patients enrolled
Trial Details
Trial ID
NCT03333304
Start Date
October 24 2017
End Date
July 20 2019
Last Update
December 17 2019
Active Locations (7)
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1
1st Department of Internal Medicine, General Hospital of Athens "G. Gennimatas"
Athens, Greece, 11527
2
3rd Department of Internal Medicine, Sotiria Athens General Hospital
Athens, Greece, 11527
3
4th Department of Internal Medicine, Attikon University Hospital
Athens, Greece, 12462
4
2nd Department of internal Medicine, General Hospital of Attiki "Sismanogleio"
Athens, Greece, 15126