drugset / Trial / NCT05001750
Prophylactic Antibiotics Useful With Antibiotic Impregnated External Ventricular Drains (EVDs)?
RandomizedParallel-groupOpen-labelTreatment
Summary
The principal objective of this study is to compare the incidence of ventriculostomy related infections (VRIs) in patients who receive twenty-four hours of antibiotics, beginning no more than sixty minutes prior to EVD placement, to the incidence of VRIs in patients who also receive a pre-procedural dose of antibiotics with continued dosing of antibiotics for the duration of the external ventricular drain (EVD). At this time, the duration of prophylactic antibiotic use with antibiotic impregnated EVDs is unknown.
Timeline
- Start
- 2021-06-14
- Primary completion
- 2026-06
- Completion
- 2026-06
Publications
- Background Nieuwkamp DJ, Setz LE, Algra A, Linn FH, de Rooij NK, Rinkel GJ. Changes in case fatality of aneurysmal subarachnoid haemorrhage over time, according to age, sex, and region: a meta-analysis. Lancet Neurol. 2009 Jul;8(7):635-42. doi: 10.1016/S1474-4422(09)70126-7. Epub 2009 Jun 6.
- Background Lozier AP, Sciacca RR, Romagnoli MF, Connolly ES Jr. Ventriculostomy-related infections: a critical review of the literature. Neurosurgery. 2002 Jul;51(1):170-81; discussion 181-2. doi: 10.1097/00006123-200207000-00024.
- Background Foreman PM, Chua M, Harrigan MR, Fisher WS 3rd, Vyas NA, Lipsky RH, Walters BC, Tubbs RS, Shoja MM, Griessenauer CJ. Association of nosocomial infections with delayed cerebral ischemia in aneurysmal subarachnoid hemorrhage. J Neurosurg. 2016 Dec;125(6):1383-1389. doi: 10.3171/2015.10.JNS151959. Epub 2016 Feb 12.
- Background Frontera JA, Fernandez A, Schmidt JM, Claassen J, Wartenberg KE, Badjatia N, Parra A, Connolly ES, Mayer SA. Impact of nosocomial infectious complications after subarachnoid hemorrhage. Neurosurgery. 2008 Jan;62(1):80-7; discussion 87. doi: 10.1227/01.NEU.0000311064.18368.EA.
- Background Lyke KE, Obasanjo OO, Williams MA, O'Brien M, Chotani R, Perl TM. Ventriculitis complicating use of intraventricular catheters in adult neurosurgical patients. Clin Infect Dis. 2001 Dec 15;33(12):2028-33. doi: 10.1086/324492. Epub 2001 Nov 9.
- Background Aucoin PJ, Kotilainen HR, Gantz NM, Davidson R, Kellogg P, Stone B. Intracranial pressure monitors. Epidemiologic study of risk factors and infections. Am J Med. 1986 Mar;80(3):369-76. doi: 10.1016/0002-9343(86)90708-4.
- Background Mayhall CG, Archer NH, Lamb VA, Spadora AC, Baggett JW, Ward JD, Narayan RK. Ventriculostomy-related infections. A prospective epidemiologic study. N Engl J Med. 1984 Mar 1;310(9):553-9. doi: 10.1056/NEJM198403013100903.
- Background Wong GK, Poon WW. Ventriculostomy infections. J Neurosurg. 2006 Sep;105(3):506-7; author reply 507. doi: 10.3171/jns.2006.105.3.506. No abstract available.
- Background Poblete R, Zheng L, Raghavan R, Cen S, Amar A, Sanossian N, Mack W, Kim-Tenser M. Trends in Ventriculostomy-Associated Infections and Mortality in Aneurysmal Subarachnoid Hemorrhage: Data From the Nationwide Inpatient Sample. World Neurosurg. 2017 Mar;99:599-604. doi: 10.1016/j.wneu.2016.12.073. Epub 2016 Dec 27.
- Background Camacho EF, Boszczowski I, Basso M, Jeng BC, Freire MP, Guimaraes T, Teixeira MJ, Costa SF. Infection rate and risk factors associated with infections related to external ventricular drain. Infection. 2011 Feb;39(1):47-51. doi: 10.1007/s15010-010-0073-5. Epub 2011 Jan 25.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Doxycycline | Small molecule | 100 mg | — |
| Subject | nafcillin | Small molecule | 1 g | — |
| Subject | nafcillin | Small molecule | 2 g | — |