Infections Following NeuroSurgery (INS)

NCT03857295 | Unknown

• 1 other identifier: IDAO_1
• Study Type: observational
• Target: 150
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Infections Nervous System; Nosocomial Infection; Bacterial Infections; Antibiotic Resistant Infection

Keywords

infections; neurosurgery; multi drug resistance; spondylodiscitis; sepsis

Outcome Measures

Primary Outcomes (3)

• 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

  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

  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.

  30-days

Secondary Outcomes (2)

• Correlation of the antimicrobial treatment regimens with the observed outcomes of I-NS

  6-months

• Number of participants with Recurrence of infection

  6-months

Interventions

No interventions OTHER

No intervention

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

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.

You may qualify if:

• Patients hospitalized at IRCCS Neuromed between 2016-2018
• Patients with at least 1 infective episode
• Patients receiving antimicrobial therapy

You may not qualify if:

• Patients with incomplete data

Sponsors & Collaborators

• Neuromed IRCCS: lead

Related Publications (10)

• 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.

  PMID: 29758368 BACKGROUND

• Riordan 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.

  PMID: 26721616 BACKGROUND

• Conen 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.

  PMID: 27910709 BACKGROUND

• Chen 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.

  PMID: 30718963 BACKGROUND

• McClelland 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.

  PMID: 17554701 BACKGROUND

• Lener 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.

  PMID: 29356895 BACKGROUND

• Rutges 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.

  PMID: 26585975 BACKGROUND

• Li 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.

  PMID: 30223785 BACKGROUND

• Horan 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.

  PMID: 18538699 BACKGROUND

• Singer 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.

  PMID: 26903338 BACKGROUND

MeSH Terms

Conditions

Cross Infection; Bacterial Infections; Infections; Discitis; Sepsis

Condition Hierarchy (Ancestors)

Iatrogenic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Bacterial Infections and Mycoses; Spondylitis; Bone Diseases, Infectious; Bone Diseases; Musculoskeletal Diseases; Spinal Diseases; Systemic Inflammatory Response Syndrome; Inflammation

Study Officials

• Alessandra Oliva, MD, PhD

  IRCCS Neuromed

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Alessandra Oliva, MD, PhD

CONTACT

0039-3291264636; alessandra.oliva81@gmail.com

Giuseppe De Benedictis, MD

CONTACT

giuse.debenedictis@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 22, 2019
• First Posted: February 27, 2019
• Study Start: March 11, 2019
• Primary Completion: September 30, 2019
• Study Completion: December 31, 2019
• Last Updated: February 27, 2019

Record last verified: 2019-02