Clinical Trials Logo

Clinical Trial 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.


Clinical Trial 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:

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) ;


Study Design


Related Conditions & MeSH terms


NCT number NCT03857295
Study type Observational
Source Neuromed IRCCS
Contact Alessandra Oliva, MD, PhD
Phone 0039-3291264636
Email alessandra.oliva81@gmail.com
Status Not yet recruiting
Phase
Start date March 11, 2019
Completion date December 31, 2019

See also
  Status Clinical Trial Phase
Completed NCT03726216 - Xydalba Utilization Registry in France
Completed NCT03605498 - OR PathTrac (Tracking Intra-operative Bacterial Transmission)
Withdrawn NCT05269121 - Bacteriophage Therapy in First Time Chronic Prosthetic Joint Infections Phase 1/Phase 2
Completed NCT02541695 - Characterization of Resistance Against Live-attenuated Diarrhoeagenic E. Coli N/A
Recruiting NCT02074865 - Children's Antibiotic Resistant Infections in Low Income Countries N/A
Completed NCT01932034 - Prospective Study to Optimize Vancomycin Dosing in Children and Adults Using Computer Software N/A
Completed NCT01689207 - To Investigate the Safety and Tolerability of Aztreonam-Avibactam (ATM-AVI) Phase 1
Completed NCT01412801 - Magnitude of the Antibody Response to and Safety of a GBS Trivalent Vaccine in HIV Positive and HIV Negative Pregnant Women and Their Offsprings Phase 2
Not yet recruiting NCT01159470 - The Rate of C-reactive Protein (CRP) Increase as a Marker for Bacterial Infections in Children N/A
Completed NCT00983255 - Ascending Dose Pharmacokinetic (PK) and Absolute Bioavailability (BA) Phase 1
Completed NCT00678106 - Study Of Dalbavancin Drug Levels Achieved In Hospitalized Adolescents Who Are Receiving Antibiotic Therapy For Bacterial Infections Phase 1
Completed NCT00799591 - French Study In ICU Patients Treated With Tigecycline N/A
Completed NCT00478855 - Tazocin Intervention Study Phase 4
Completed NCT01074775 - Human Innate Immune Responses To Mycobacterial Aerodigestive Tract Infection N/A
Terminated NCT00431028 - Sub-Tenon's Injection of Triamcinolone and Ciprofloxacin in a Controlled-Release System for Cataract Surgery Phase 1/Phase 2
Not yet recruiting NCT03634904 - Serum Ceftazidime Concentrations in Hemodialysis Patients N/A
Recruiting NCT05684705 - Study to Investigate the Penetration of Rifabutin Into the Lung After Multiple Intravenous Administrations of BV100 Phase 1
Recruiting NCT03858387 - PK/PD and Clinial Outcomes of Beta-lactams in ICU Patients
Enrolling by invitation NCT04764058 - Efficacy and Safety of Colistin Based Antibiotic Therapy Phase 1/Phase 2
Recruiting NCT06319235 - Clinical Trial to Demonstrate the Safety and Efficacy of DUOFAG® Phase 1/Phase 2