Bacterial Infections Clinical Trial
Official title:
Clinical and Microbiological Analyses of Infections Following NeuroSurgery: a Retrospective, Single-center Study
Neurosurgery (NS) is essential for the treatment of various diseases such as malignant
tumors, vascular conditions, spinal stenosis or trauma. However, NS can be complicated by the
onset of infections, directly related to surgery or to hospitalization.
Little is known regarding the epidemiology, the optimal treatment regimens and the outcome of
infections following NS (I-NS).
The study aims at investigating the clinical and microbiological characteristics as well as
the outcomes of I-NS occurring at a single Institution (IRCCS Neuromed, Pozzilli, Italy)
during the period 2016-2018.
Patients with at least 1 infective episode requiring antimicrobial therapy are included in
this retrospective observational study.
Neurosurgery (NS) is essential for the treatment of various diseases such as malignant
tumors, vascular conditions, spinal stenosis or trauma. However, one of the major
complication is the occurrence of infections following NS (I-NS), with reported rate between
0.5% and 15% depending on the type of NS and the presence/absence of foreign bodies (i.e
ventricular shunts, brain stimulators, spinal fixation systems).
I-NS might be related to NS and include meningitis, brain abscesses or spinal infections;
I-NS might be also related to the hospitalization and include nosocomial pneumonia,
bloodstream and urinary tract infections, especially in elder and frail patients.
While risk factors have been investigated in several studies, little is known about the
epidemiology, the optimal treatment regimens and the outcomes of I-NS.
The knowledge of the causative agents of I-NS and the local epidemiology might lead to an
early initiation of an appropriate and definite antimicrobial therapy, with obvious
consequences in terms of treatment failure and mortality reduction, in line with
antimicrobial stewardship principles. Moreover, being aware of the outcomes of I-NS might
allow the comprehension of the risk factors associated with clinical cure, recurrence or
mortality.
Based on these premises, the principal aim of this single-center, retrospective,
observational study is to evaluate the clinical and microbiological characteristics as well
as the outcomes of I-NS observed at IRCCS Neuromed (Pozzilli, Italy) over the 2016-2018
period.
Secondary aims are:
i) to analyze the clinical and microbiological characteristics based on the different types
of I-NS (i.e. meningitis, brain abscesses, spinal infections, nosocomial pneumonia,
bloodstream infections, urinary tract infections); ii) to investigate the presence of
multi-drug resistance of the causative agents of I-NS; iii) to correlate the antimicrobial
treatment regimens with the observed outcomes of I-NS (i.e. clinical cure, recurrence of
infections at 6 months, 30-days mortality).
Patients hospitalized at IRCCS Neuromed with at least 1 infective episode requiring
antimicrobial therapy between 2016-2018 will be included in the study. Data will be collected
from patient records and will be anonymously registered in an electronic database.
The following data will be collected: type of infection (defined in in accordance with
international guidelines); general characteristics of patients (age, gender, type and number
of NS, reason for NS, comorbidities); clinical presentation of I-NS (sepsis/septic shock);
laboratory and radiological data; microbiological characteristics of I-NS (causative agents;
antimicrobial susceptibility profile); antimicrobial therapy (type and number of
antimicrobials, length of therapy, empiric versus definite therapy); outcome (30-days
mortality, clinical cure, 6-months recurrence of infection)
;
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