Infections Following NeuroSurgery (INS)

Sponsor

Neuromed IRCCS (Other)

Overall Status

Unknown status

CT.gov ID

NCT03857295

Collaborator

(none)

150

Enrollment

9.7

Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Infections Nervous System Nosocomial Infection Bacterial Infections Antibiotic Resistant Infection	Other: No interventions

Detailed Description

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:

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)

Study Design

Study Type:

Observational

Anticipated Enrollment :

150 participants

Observational Model:

Cohort

Time Perspective:

Retrospective

Official Title:

Clinical and Microbiological Analyses of Infections Following NeuroSurgery: a Retrospective, Single-center Study

Anticipated Study Start Date :

Mar 11, 2019

Anticipated Primary Completion Date :

Sep 30, 2019

Anticipated Study Completion Date :

Dec 31, 2019

Outcome Measures

Primary Outcome Measures

Number of participants with sepsis/septic shock [From the date of inclusion until the date of sepsis/septic shock diagnosis, assessed up to 6 months]
Sepsis or septic shock at the onset of infection Sepsis includes a life-threatening condition and organ dysfunction induced by a disregulated host response to infection (change ≥2 points in SOFA) and septic shock includes persisting hypotension requiring vasopressors to maintain MAP≥65 mmHg AND serum lactate levels ≥2mmol/L despite adequate liquid support. Collected measurement data will be aggregated as follows: no sepsis/sepsis/septic shock
Number of participants with multi-drug resistant microorganisms [From the date of inclusion until the date of antimicrobial susceptibility report availability, assessed up to 6 months]
Presence of resistance to >3 class of antimicrobials, as it appears in the antimicrobial susceptibility report. Collected measurement data will be aggregated as follows: presence/absence of multi-drug resistance
mortality [30-days]
Evaluation of mortality of patient with infection.

Secondary Outcome Measures

Correlation of the antimicrobial treatment regimens with the observed outcomes of I-NS [6-months]
Correlation of the antimicrobial treatment regimens with the observed outcomes of I-NS
Number of participants with Recurrence of infection [6-months]
Return of the same infection after an infection-free period