Acinetobacter baumannii. Cross infection. Pneumonia, Ventilator-Associated. Sepsis Other specified bacterial agents as the cause of diseases classified to other chapters
Conditions
Interventions
This is an open-label, non-randomized, controlled interventional clinical study with two arms. The study includes a total of 29 participants, with 11 participants allocated to the polymyxin monotherap
Sponsors
Santa Casa de Misericórdia de Limeira
Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo
Eligibility
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: Patients aged 18 years or older; both sexes; hospitalized, with identification of carbapenem-resistant Acinetobacter spp. in blood cultures or tracheal secretion cultures; who meet diagnostic criteria for ventilator-associated pneumonia (VAP) or bloodstream infection (BSI), according to definitions from the Epidemiological Surveillance Center of São Paulo (CVE-SP); who agree to participate in the study by signing the Informed Consent Form (ICF) or through a legal representative
Exclusion criteria
Exclusion criteria: Patients who do not consent to participate in the study or whose Informed Consent Form (ICF) is withdrawn; patients transferred to a non-participating institution; patients with isolation of carbapenem-susceptible Acinetobacter spp.; cases in which the isolate is considered colonization or contamination without indication for antimicrobial treatment, according to clinical evaluation; patients with insufficient clinical data for analysis
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To assess all-cause mortality within 28 days following the diagnosis of infection, verified through clinical follow-up of included patients, based on the occurrence of death within this period, expressed as the proportion of patients who died relative to the total sample. | — |
Secondary
| Measure | Time frame |
|---|---|
| It is expected to evaluate length of hospital stay in patients included in the study, verified through analysis of medical records, with the number of days between hospital admission and discharge or death being observed;It is expected to evaluate clinical response to treatment in patients included in the study, verified through the evolution of clinical signs and symptoms during hospitalization, with the percentage of patients presenting clinical improvement at the end of antimicrobial treatment being observed;It is expected to evaluate the occurrence of adverse events related to antimicrobial treatment, verified through clinical and laboratory monitoring of patients during hospitalization, with the number and frequency of adverse events during the treatment period being observed | — |
Countries
BR
Contacts
Public ContactSidnei Bertholdi Filho
Santa Casa de Misericórdia de Limeira
Outcome results
None listed