Bacterial Infections Clinical Trial
— INSOfficial 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.
Status | Not yet recruiting |
Enrollment | 150 |
Est. completion date | December 31, 2019 |
Est. primary completion date | September 30, 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | N/A and older |
Eligibility |
Inclusion Criteria: - Patients hospitalized at IRCCS Neuromed between 2016-2018 - Patients with at least 1 infective episode - Patients receiving antimicrobial therapy Exclusion Criteria: - Patients with incomplete data |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Neuromed IRCCS |
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. — View Citation
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. Review. — View Citation
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. Erratum in: Am J Infect Control. 2008 Nov;36(9):655. — View Citation
Lener S, Hartmann S, Barbagallo GMV, Certo F, Thomé 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. Review. — View Citation
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. — View Citation
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. Epub 2007 May 21. — View Citation
Renz N, Özdirik 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. — View Citation
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. — View Citation
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. Review. — View Citation
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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | |
Primary | 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 | |
Primary | mortality | Evaluation of mortality of patient with infection. | 30-days | |
Secondary | 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 | 6-months | |
Secondary | Number of participants with Recurrence of infection | Return of the same infection after an infection-free period | 6-months |
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