RecruitingPhase 1NCT05001750

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

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


Sponsor

Montefiore Medical Center

Enrollment

84 participants

Start Date

Jun 14, 2021

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Inclusion Criteria2

  • 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

Exclusion Criteria5

  • 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

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Interventions

DRUGLong term (continuous) prophylactic antibiotics

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.

DRUG24 hours antibiotics

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.


Locations(1)

Montefiore Medical Center

The Bronx, New York, United States

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NCT05001750


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