Infections Nervous SystemINSNCT03857295
Infections Following NeuroSurgery (INS)
An observational study of Infections Nervous System and Nosocomial Infection, run by Neuromed IRCCS.
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Infections Nervous System, Nosocomial Infection, Bacterial Infections
- How many people
- 150 participants
- Where
- No sites listed yet
- Study dates
- 11 Mar 2019to 31 Dec 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: 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 anonimously registered in an electronic database.
Who may be able to join
- Patients hospitalized at IRCCS Neuromed between 2016-2018
- Patients with at least 1 infective episode
- Patients receiving antimicrobial therapy
Who cannot join
- Patients with incomplete data
Trial locations and contacts
No sites are listed yet.
Giuseppe De Benedictis, MD contact
About this study
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).
Read more
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.
Read the 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)
- Conditions
- Infections Nervous System, Nosocomial Infection, Bacterial Infections, Antibiotic Resistant Infection
- Being tested
- No interventions
- Keywords
- infections, neurosurgery, multi drug resistance, spondylodiscitis, sepsis
- Medical subject headings
- Cross Infection, Bacterial Infections, Infections, Discitis, Sepsis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionsOther
No intervention
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with sepsis/septic shock
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
Measured: From the date of inclusion until the date of sepsis/septic shock diagnosis, assessed up to 6 months
Number of participants with multi-drug resistant microorganisms
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
Measured: From the date of inclusion until the date of antimicrobial susceptibility report availability, assessed up to 6 months
mortality
Evaluation of mortality of patient with infection.
Measured: 30-days
Secondary outcomes (2)
Correlation of the antimicrobial treatment regimens with the observed outcomes of I-NS
Correlation of the antimicrobial treatment regimens with the observed outcomes of I-NS
Measured: 6-months
Number of participants with Recurrence of infection
Return of the same infection after an infection-free period
Measured: 6-months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2019
- Study start11 Mar 2019 (estimated)
- Primary completion30 Sep 2019 (estimated)
- Study completion31 Dec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Infections Nervous SystemStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Neuromed IRCCS
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alessandra Oliva, Neuromed IRCCS
- Investigators
- Alessandra Oliva, MD, PhD, Principal investigator, IRCCS Neuromed
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03857295
- Sponsor's protocol ID
- IDAO_1
- Acronym
- INS
- Status last verified
- Feb 2019
- First submitted
- 22 Feb 2019
- Last updated
- 27 Feb 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Renz N, Ozdirik B, Finger T, Vajkoczy P, Trampuz A. Infections After Cranial Neurosurgery: Prospective Cohort of 103 Episodes Treated According to a Standardized Algorithm. World Neurosurg. 2018 Aug;116:e491-e499. doi: 10.1016/j.wneu.2018.05.017. Epub 2018 May 30.
PubMed 29758368Riordan MA, Simpson VM, Hall WA. Analysis of Factors Contributing to Infections After Cranioplasty: A Single-Institution Retrospective Chart Review. World Neurosurg. 2016 Mar;87:207-13. doi: 10.1016/j.wneu.2015.11.070. Epub 2015 Dec 22.
PubMed 26721616Conen A, Fux CA, Vajkoczy P, Trampuz A. Management of infections associated with neurosurgical implanted devices. Expert Rev Anti Infect Ther. 2017 Mar;15(3):241-255. doi: 10.1080/14787210.2017.1267563. Epub 2016 Dec 13.
PubMed 27910709Chen F, Deng X, Wang Z, Wang L, Wang K, Gao L. Treatment of severe ventriculitis caused by extensively drug-resistant Acinetobacter baumannii by intraventricular lavage and administration of colistin. Infect Drug Resist. 2019 Jan 21;12:241-247. doi: 10.2147/IDR.S186646. eCollection 2019.
PubMed 30718963McClelland S 3rd, Hall WA. Postoperative central nervous system infection: incidence and associated factors in 2111 neurosurgical procedures. Clin Infect Dis. 2007 Jul 1;45(1):55-9. doi: 10.1086/518580. Epub 2007 May 21.
PubMed 17554701Lener S, Hartmann S, Barbagallo GMV, Certo F, Thome C, Tschugg A. Management of spinal infection: a review of the literature. Acta Neurochir (Wien). 2018 Mar;160(3):487-496. doi: 10.1007/s00701-018-3467-2. Epub 2018 Jan 22.
PubMed 29356895Rutges JP, Kempen DH, van Dijk M, Oner FC. Outcome of conservative and surgical treatment of pyogenic spondylodiscitis: a systematic literature review. Eur Spine J. 2016 Apr;25(4):983-99. doi: 10.1007/s00586-015-4318-y. Epub 2015 Nov 19.
PubMed 26585975Li YD, Wong CB, Tsai TT, Lai PL, Niu CC, Chen LH, Fu TS. Appropriate duration of post-surgical intravenous antibiotic therapy for pyogenic spondylodiscitis. BMC Infect Dis. 2018 Sep 17;18(1):468. doi: 10.1186/s12879-018-3377-1.
PubMed 30223785Horan TC, Andrus M, Dudeck MA. CDC/NHSN surveillance definition of health care-associated infection and criteria for specific types of infections in the acute care setting. Am J Infect Control. 2008 Jun;36(5):309-32. doi: 10.1016/j.ajic.2008.03.002. No abstract available.
PubMed 18538699Singer M, Deutschman CS, Seymour CW, Shankar-Hari M, Annane D, Bauer M, Bellomo R, Bernard GR, Chiche JD, Coopersmith CM, Hotchkiss RS, Levy MM, Marshall JC, Martin GS, Opal SM, Rubenfeld GD, van der Poll T, Vincent JL, Angus DC. The Third International Consensus Definitions for Sepsis and Septic Shock (Sepsis-3). JAMA. 2016 Feb 23;315(8):801-10. doi: 10.1001/jama.2016.0287.
PubMed 26903338
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical and Microbiological Analyses of Infections Following NeuroSurgery: a Retrospective, Single-center Study
- ClinicalTrials.gov ID
- NCT03857295
- Acronym / sponsor ID
- INS / IDAO_1
- Conditions
- Infections Nervous System, Nosocomial Infection, Bacterial Infections, Antibiotic Resistant Infection
- Keywords
- infections, neurosurgery, multi drug resistance, spondylodiscitis, sepsis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Neuromed IRCCSUniversity, hospital or other
- Study start
- 11 Mar 2019 (estimated)
- Primary completion
- 30 Sep 2019 (estimated)
- Study completion
- 31 Dec 2019 (estimated)
- First posted
- 27 Feb 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- 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 anonimously registered in an electronic database.
Key inclusion criteria (3 listed)
- Patients hospitalized at IRCCS Neuromed between 2016-2018
- Patients with at least 1 infective episode
- Patients receiving antimicrobial therapy
Key exclusion criteria (1 listed)
- Patients with incomplete data
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No interventionsNo intervention | Other | – |
Primary outcome
Number of participants with sepsis/septic shock
Time frame: 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
Time frame: 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
Time frame: 30-days
Evaluation of mortality of patient with infection.
2 secondary outcomes
Correlation of the antimicrobial treatment regimens with the observed outcomes of I-NS
Time frame: 6-months
Number of participants with Recurrence of infection
Time frame: 6-months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2019.
- Background: PubMed 29758368Renz N, Ozdirik B, Finger T, Vajkoczy P, Trampuz A. Infections After Cranial Neurosurgery: Prospective Cohort of 103 Episodes Treated According to a Standardized Algorithm. World Neurosurg. 2018 Aug;116:e491-e499. doi: 10.1016/j.wneu.2018.05.017. Epub 2018 May 30.
- Background: PubMed 26721616Riordan MA, Simpson VM, Hall WA. Analysis of Factors Contributing to Infections After Cranioplasty: A Single-Institution Retrospective Chart Review. World Neurosurg. 2016 Mar;87:207-13. doi: 10.1016/j.wneu.2015.11.070. Epub 2015 Dec 22.
- Background: PubMed 27910709Conen A, Fux CA, Vajkoczy P, Trampuz A. Management of infections associated with neurosurgical implanted devices. Expert Rev Anti Infect Ther. 2017 Mar;15(3):241-255. doi: 10.1080/14787210.2017.1267563. Epub 2016 Dec 13.
- Background: PubMed 30718963Chen F, Deng X, Wang Z, Wang L, Wang K, Gao L. Treatment of severe ventriculitis caused by extensively drug-resistant Acinetobacter baumannii by intraventricular lavage and administration of colistin. Infect Drug Resist. 2019 Jan 21;12:241-247. doi: 10.2147/IDR.S186646. eCollection 2019.
- Background: PubMed 17554701McClelland S 3rd, Hall WA. Postoperative central nervous system infection: incidence and associated factors in 2111 neurosurgical procedures. Clin Infect Dis. 2007 Jul 1;45(1):55-9. doi: 10.1086/518580. Epub 2007 May 21.
- Background: PubMed 29356895Lener S, Hartmann S, Barbagallo GMV, Certo F, Thome C, Tschugg A. Management of spinal infection: a review of the literature. Acta Neurochir (Wien). 2018 Mar;160(3):487-496. doi: 10.1007/s00701-018-3467-2. Epub 2018 Jan 22.
- Background: PubMed 26585975Rutges JP, Kempen DH, van Dijk M, Oner FC. Outcome of conservative and surgical treatment of pyogenic spondylodiscitis: a systematic literature review. Eur Spine J. 2016 Apr;25(4):983-99. doi: 10.1007/s00586-015-4318-y. Epub 2015 Nov 19.
- Background: PubMed 30223785Li YD, Wong CB, Tsai TT, Lai PL, Niu CC, Chen LH, Fu TS. Appropriate duration of post-surgical intravenous antibiotic therapy for pyogenic spondylodiscitis. BMC Infect Dis. 2018 Sep 17;18(1):468. doi: 10.1186/s12879-018-3377-1.
- Background: PubMed 18538699Horan TC, Andrus M, Dudeck MA. CDC/NHSN surveillance definition of health care-associated infection and criteria for specific types of infections in the acute care setting. Am J Infect Control. 2008 Jun;36(5):309-32. doi: 10.1016/j.ajic.2008.03.002. No abstract available.
- Background: PubMed 26903338Singer M, Deutschman CS, Seymour CW, Shankar-Hari M, Annane D, Bauer M, Bellomo R, Bernard GR, Chiche JD, Coopersmith CM, Hotchkiss RS, Levy MM, Marshall JC, Martin GS, Opal SM, Rubenfeld GD, van der Poll T, Vincent JL, Angus DC. The Third International Consensus Definitions for Sepsis and Septic Shock (Sepsis-3). JAMA. 2016 Feb 23;315(8):801-10. doi: 10.1001/jama.2016.0287.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Giuseppe De Benedictis, MD contact
Alessandra Oliva, MD, PhD principal investigator
IRCCS Neuromed
Questions about this trial
What is this clinical trial studying?
An observational study of Infections Nervous System and Nosocomial Infection, run by Neuromed IRCCS.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 27 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Alessandra Oliva, MD, PhD (0039-3291264636, alessandra.oliva81@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with sepsis/septic shock (time frame: From the date of inclusion until the date of sepsis/septic shock diagnosis, assessed up to 6 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03857295, which also lists 10 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Feb 2019.