Prophylactic Antibiotics Useful With Antibiotic Impregnated External Ventricular Drains (EVDs)?

NCT05001750 | Recruiting Phase 1 DMC FDA Drug

• 1 other identifier: 2021-12680
• Study Type: interventional
• Target: 84
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Hydrocephalus; Subarachnoid Hemorrhage; Intracerebral Hemorrhage; Ventriculitis, Cerebral

Keywords

Subarachnoid hemorrhage; Intracerebral Hemorrhage; Ventriculitis; Hydrocephalus

Outcome Measures

Primary Outcomes (1)

• Number of Participants with Cerebrospinal Fluid Positive (CSF+) VRI

  A VRI will be defined as an infection of the CNS including abscess (when occurring after EVD placement), ventriculitis, or meningitis. To receive a diagnosis of meningitis or ventriculitis, NHSN criteria (1) OR (2) must be met: 1. Patient has organism(s) identified from CSF by a culture or non-culture based microbiological method (PCR) performed for purposes of clinical diagnosis or treatment OR 2. Patient has 2 or more of: 1. fever (\>38.0°C) or headache 2. meningeal sign(s) 3. cranial nerve sign(s) AND 1 or more of: 4. increased white cells, elevated protein, and decreased glucose in CSF (per reporting lab's reference range) 5. organism(s) seen on Gram stain of CSF 6. organism(s) identified from blood by a culture or non-culture based microbiologic testing method performed for purposes of clinical diagnosis or treatment (not Active Surveillance Culture/Testing) 7. diagnostic single antibody titer (IgM) or 4-fold increase in paired sera (IgG) for organism

  From EVD insertion until discharge - estimated period of time is 2 weeks

Secondary Outcomes (6)

• Class of infecting organism

  From EVD insertion until discharge - estimated period of time is 2 weeks

• Time to infection

  From EVD insertion until discharge - estimated period of time is 2 weeks

• Number of attempts at EVD catheter insertion

  From EVD insertion until discharge - estimated period of time is 2 weeks

• Incidence of nosocomial infections

  From EVD insertion until discharge - estimated period of time is 2 weeks

• Overall Morbidity

  From EVD insertion until discharge - estimated period of time is 2 weeks

Study Arms (2)

Continuous antibiotic use until the EVD is removed

EXPERIMENTAL

Continuous prophylactic antibiotic use until the EVD is removed. Antibiotics will begin no more than sixty minutes pre-procedure.

Drug: Long term (continuous) prophylactic antibiotics

Antibiotics for a total of twenty-four hours

EXPERIMENTAL

Antibiotics for a total of twenty-four hours. Antibiotics will begin no more than sixty minutes pre-procedure.

Drug: 24 hours antibiotics

Interventions

Long term (continuous) prophylactic antibiotics DRUG

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. Nafcillin 1-2 grams every 6 hours (depending on weight) until the EVD is removed. If penicillin allergic, Doxycycline 100mg every 12 hours until the EVD is removed.

Continuous antibiotic use until the EVD is removed

24 hours antibiotics DRUG

Nafcillin 1-2 grams every 6 hours (depending on weight) for a total of 24 hours. If penicillin allergic, Doxycycline 100mg every 12 hours for a total of 24 hours.

Antibiotics for a total of twenty-four hours

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• patients over the age of 18 years
• patients diagnosed with a subarachnoid hemorrhage, intracerebral hemorrhage, or acute ischemic stroke who require an EVD for management of their underlying condition. In certain cases (a small minority), an EVD must be replaced due to failure (i.e., blood clot interrupting flow). In such cases, patients will be re-dosed with antibiotics prior to catheter exchange in typical fashion and continue in their previously randomized treatment group

You may not qualify if:

• patients who were on antibiotics within the week prior to admission
• patients with leukopenia (\<5000) at baseline
• patients with signs of meningitis, ventriculitis or any other infection at presentation
• patients who are pregnant or prisoners
• patients aged \< 18 years old

Sponsors & Collaborators

• Montefiore Medical Center: lead

Study Sites (1)

Montefiore Medical Center

The Bronx, New York, 10452, United States

RECRUITING

Related Publications (10)

• 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.

  PMID: 19501022 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.

  PMID: 12182415 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.

  PMID: 26871202 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.

  PMID: 18300894 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.

  PMID: 11712094 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.

  PMID: 3953614 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.

  PMID: 6694707 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.

  PMID: 16961156 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.

  PMID: 28034809 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.

  PMID: 21264679 BACKGROUND

MeSH Terms

Conditions

Subarachnoid Hemorrhage; Cerebral Hemorrhage; Cerebral Ventriculitis; Hydrocephalus

Interventions

Anti-Bacterial Agents

Condition Hierarchy (Ancestors)

Intracranial Hemorrhages; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Central Nervous System Viral Diseases; Central Nervous System Infections; Infections; Encephalitis; Neuroinflammatory Diseases

Intervention Hierarchy (Ancestors)

Anti-Infective Agents; Therapeutic Uses; Pharmacologic Actions; Chemical Actions and Uses

Study Officials

• David C Altschul, MD

  Montefiore Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

David C Altschul, MD

CONTACT

7189204965; daltschul@montefiore.org

Genesis Liriano

CONTACT

7189202469; gliriano@montefiore.org

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: The patients will be randomized into one of two groups, either continuous antibiotic usage until the EVD is removed or antibiotics for a total of twenty-four hours; in both cases antibiotics will begin no more than sixty minutes pre-procedure.

Study Record Dates

• First Submitted: June 25, 2021
• First Posted: August 12, 2021
• Study Start: June 14, 2021
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 1, 2026
• Last Updated: February 2, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)