Sepsis Clinical Trial
— PROGRESSOfficial title:
A Randomized Prospective Clinical Trial to Assess the Role of Procalcitonin-guided Antimicrobial Therapy to Reduce Long-term Infections Sequelae
NCT number | NCT03333304 |
Other study ID # | PROGRESS |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | October 24, 2017 |
Est. completion date | July 20, 2019 |
Verified date | December 2019 |
Source | Hellenic Institute for the Study of Sepsis |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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 during the next six months may be significantly decreased.
Status | Completed |
Enrollment | 266 |
Est. completion date | July 20, 2019 |
Est. primary completion date | January 20, 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - 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 Criteria: - 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. |
Country | Name | City | State |
---|---|---|---|
Greece | 1st Department of Internal Medicine, General Hospital of Athens "G. Gennimatas" | Athens | |
Greece | 1st Department of Internal Medicine, General Hospital of Elefsina "Thriasio" | Athens | |
Greece | 2nd Department of internal Medicine, General Hospital of Attiki "Sismanogleio" | Athens | |
Greece | 2nd Department of Internal Medicine, General Hospital of Elefsina "Thriasio" | Athens | |
Greece | 3rd Department of Internal Medicine, Sotiria Athens General Hospital | Athens | |
Greece | 4th Department of Internal Medicine, Attikon University Hospital | Athens | |
Greece | 2nd Department of Internal Medicine, General Hospital of Piraeus "Tzaneio" | Piraeus |
Lead Sponsor | Collaborator |
---|---|
Hellenic Institute for the Study of Sepsis |
Greece,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | The change of infection-associated adverse events rate. The infection-associated adverse events rate are any case of Clostridium Difficile Infection (CDI) or infection by MDR or infection-related death. | The change of infection-associated adverse events rate. The infection-associated adverse events rate are any case of Clostridium Difficile Infection (CDI) or infection by MDR or infection-related death. | 6 months | |
Secondary | Infection-associated adverse events rate | Time to first infection-associated adverse events rate | 6 months | |
Secondary | Clostridium difficile Infection | Rate of infections by Clostridium difficile | 6 months | |
Secondary | Infections by MDR | Rate of infections by MDR | 6 months | |
Secondary | Mortality | Mortality | 28 days | |
Secondary | Mortality | Mortality | 6 months | |
Secondary | Stool colonization by C.difficile | Rate stool positive for GDH by C.difficile | 6 months | |
Secondary | Stool colonization by MDR | Rate of stool colonization by MDR | 6 months | |
Secondary | Microbiome composition | Microbiome composition | 28 days | |
Secondary | Changes of the microbiome | Changes of the microbiome | 28 days | |
Secondary | Consumption of antimicrobials during hospitalization | Consumption of antimicrobials during hospitalization | 28 days | |
Secondary | Cost of hospitalization | Real cost of hospitalization i.e medicines administered and interventions performed, in Euro, between the two groups of treatment. | 28 days |
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