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

Montefiore Medicine Academic Health System

Status and phase: Enrolling; Phase 1

Conditions: Hydrocephalus; Subarachnoid Hemorrhage; Ventriculitis, Cerebral; Intracerebral Hemorrhage

Treatments: Drug: long term prophylactic antibiotics (Nafcillin or Doxycycline)

Study type: Interventional

Funder types: Other

Identifiers

NCT05001750

2021-12680

Details and patient eligibility

About

The length of prophylactic antibiotic use with antibiotic impregnated External Ventricular Drains (EVD)s is unknown. This study is a randomized clinical trial with two arms:

1. twenty four hours of prophylactic antibiotic use or
2. prophylactic antibiotic use for entire duration of EVD

Full description

The principle 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).

Enrollment: 84 estimated patients

Sex: All

Ages: 18 to 99 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• patients over the age of 18 years and 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 criteria

• patients who underwent any intracranial procedure in the 30 days prior,
• 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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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84 participants in 2 patient groups

continuous antibiotic use until the EVD is removed

Experimental group

Description:

continuous antibiotic use until the EVD is removed. 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.

Treatment:

Drug: long term prophylactic antibiotics (Nafcillin or Doxycycline)

antibiotics for a total of twenty-four hours

No Intervention group

Description:

antibiotics for a total of twenty-four hours 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.