Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Fundação de Amparo à Pesquisa do Estado de São Paulo | OTHER_GOV |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The objective of this study is to evaluate the consumption of antimicrobial therapy in patients comparing a rapid molecular test (PCR in Real-Time Multiplex) with blood cultures to identify the etiological agents of sepsis.
Patients staying more than 48 hours in hospital with clinical suspicion of sepsis could be included in the study. Blood samples for cultures and multiplex PCR will be collected immediately prior to initiation of antibiotic therapy. Patients will be randomly selected into two groups. In Group I, the PCR results will be immediately reported to the medical researcher (6-12 hours), which will change the antimicrobial regimen (De-escalation). In Group II, the Multiplex PCR results will not be informed, being focused care as a result of blood culture (at least after 72 hours). The initial empirical antimicrobial therapy will be the same in both groups, according to the standardization of the institution.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pathogen detection by Multiplex PCR | Active Comparator | Blood samples for cultures and Multiplex PCR will be collected before start the antibiotic therapy in patients with sepsis. Multiplex PCR will be immediately undertaken and its results will be reported to prompt medical researcher (6-12 hours).The medical researcher will change the antibiotic regimen (De-escalation) immediately as a result of Multiplex PCR. |
|
| Pathogen detection by blood culture | No Intervention | Blood samples for cultures and Multiplex PCR will be collected before start the antibiotic therapy in patients with sepsis. The results of multiplex PCR will be not informed to the medical researcher, being focused care as a result of blood culture (at least after 72 hours). |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Antibiotic regimen | Other | The medical researcher will change the antibiotic regimen (De-escalation) immediately as a result of Multiplex PCR (6-12 h). |
|
| Measure | Description | Time Frame |
|---|---|---|
| Evaluation of antimicrobial use in number of days comparing a rapid molecular test (PCR in Real-Time Multiplex) with blood cultures to identify the etiological agents of sepsis. | After fourteen days of antimicrobial treatment |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Tania MV Strabelli, PhD | Instituto do Coracao | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Instituto do Coracao | São Paulo | São Paulo | 05403000 | Brazil |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31367384 | Derived | Rodrigues C, Siciliano RF, Filho HC, Charbel CE, de Carvalho Sarahyba da Silva L, Baiardo Redaelli M, de Paula Rosa Passetti AP, Franco MRG, Rossi F, Zeigler R, De Backer D, Franco RA, de Almeida JP, Rizk SI, Fukushima JT, Landoni G, Uip DE, Hajjar LA, Strabelli TMV. The effect of a rapid molecular blood test on the use of antibiotics for nosocomial sepsis: a randomized clinical trial. J Intensive Care. 2019 Jul 22;7:37. doi: 10.1186/s40560-019-0391-3. eCollection 2019. |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D018805 | Sepsis |
| D016470 | Bacteremia |
| D016469 | Fungemia |
| ID | Term |
|---|---|
| D007239 | Infections |
| D018746 | Systemic Inflammatory Response Syndrome |
| D007249 | Inflammation |
| D010335 | Pathologic Processes |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| D013568 |
| Pathological Conditions, Signs and Symptoms |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
| D000072742 | Invasive Fungal Infections |
| D009181 | Mycoses |