long term prophylactic antibiotics for Subarachnoid Hemorrhage

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Montefiore Medical center, Bronx, NY
Subarachnoid Hemorrhage+5 More
long term prophylactic antibiotics - Drug
Eligibility
18+
All Sexes
Eligible conditions
Select

Study Summary

This study is evaluating whether a shorter course of antibiotics is as effective as a longer course of antibiotics for preventing infection in patients with an EVD.

See full description

Eligible Conditions

  • Subarachnoid Hemorrhage
  • Cerebral Hemorrhage
  • Hydrocephalus
  • Ventriculitis, Cerebral

Treatment Effectiveness

Effectiveness Progress

1 of 3

Other trials for Subarachnoid Hemorrhage

Study Objectives

This trial is evaluating whether long term prophylactic antibiotics will improve 1 primary outcome and 5 secondary outcomes in patients with Subarachnoid Hemorrhage. Measurement will happen over the course of EVD insertion until discharge- estimated period of time is 2 weeks.

Week 2
Class of infecting organism
Incidence of nosocomial infections
Time to infection
Ventriculitis extending from EVD insertion until discharge
overall morbidity which is morbidity from all causes
Week 3
Mortality

Trial Safety

Safety Progress

1 of 3

Other trials for Subarachnoid Hemorrhage

Trial Design

2 Treatment Groups

antibiotics for a total of twenty-four hours
1 of 2
continuous antibiotic use until the EVD is removed
1 of 2
Active Control
Experimental Treatment

This trial requires 150 total participants across 2 different treatment groups

This trial involves 2 different treatments. Long Term Prophylactic Antibiotics is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are in Phase 1 and are in the first stage of evaluation with people.

continuous antibiotic use until the EVD is removedcontinuous 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.
antibiotics for a total of twenty-four hoursantibiotics 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.

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: evd insertion until discharge- estimated period of time is 3 weeks
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly evd insertion until discharge- estimated period of time is 3 weeks for reporting.

Who is running the study

Principal Investigator
D. A.
David Altschul, Surgical Director of Comprehensive Stroke Center
Montefiore Medical Center

Closest Location

Montefiore Medical center - Bronx, NY

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. There are 2 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
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.

Patient Q&A Section

How many people get hemorrhage a year in the United States?

"The total estimated rate of hemorrhage from all sources was 940 events per 10,000 person-years in the United States in 1998. In the United States, hemorrhage is thought to account for about 19 percent of all deaths." - Anonymous Online Contributor

Unverified Answer

What causes hemorrhage?

"Heparin therapy may increase hemorrhagic complications during orthotopic liver transplantation. Patient characteristics and surgical type seem to be the best predictors of hemorrhage in this procedure." - Anonymous Online Contributor

Unverified Answer

What is hemorrhage?

"Hemorrhagic shock is a life-threatening condition in which significant blood loss can occur. It can lead to organ damage, and, in the severe and refractory cases, may result in blood transfusion. Bleeding is an important cause of mortality in patients admitted to a Level I trauma center." - Anonymous Online Contributor

Unverified Answer

How does long term prophylactic antibiotics work?

"Results from a recent clinical trial provide additional circumstantial evidence that there are no absolute contraindications to this strategy in the setting of elective primary prophylactic antibiotic therapy for open abdominal aortic surgery." - Anonymous Online Contributor

Unverified Answer

Can hemorrhage be cured?

"A simple and efficient method for closing venous puncture sites without use of suturing agents is developed. The method works well in the treatment of intra-abdominal and external hemorrhages and reduces the occurrence of complications while maintaining the effectiveness of treatment." - Anonymous Online Contributor

Unverified Answer

What are the signs of hemorrhage?

"Signs of traumatic hemorrhage often involve signs of shock and loss of consciousness. In less severe cases, hemorrhage may be detected through signs of a change in consciousness, blood or pleural pressures, or pulmonary changes. In severe cases, hemorrhage may be detected through signs such as anemia or abnormal coagulation tests. These signs are not necessarily limited to traumatic hemorrhage, because a change in consciousness could also be a sign of seizures or other causes of traumatic hemorrhage." - Anonymous Online Contributor

Unverified Answer

What are common treatments for hemorrhage?

"A patient presenting with a gunshot wound, a patient with a fractured femoral neck, or a patient who has a pericardial effusion usually need operative intervention." - Anonymous Online Contributor

Unverified Answer

How serious can hemorrhage be?

"These 4 cases emphasize the fact that any case can become potentially very serious and often fatal, even in the presence of an otherwise complete health plan. The first case had two of the most severe clinical manifestations seen in pediatric traumatic brain injury: 1) severe trauma-induced focal neurological impairment/death 2) a "brain dead" patient with multisystem organ disruption requiring resuscitation. The second case illustrates the need for early neurosurgical intervention in addition to other therapeutic measures. The third case illustrates the need to maintain a closed head CT at admission in adults with severe neurologic deficits." - Anonymous Online Contributor

Unverified Answer

Have there been other clinical trials involving long term prophylactic antibiotics?

"The current data has been accumulating since 1999. There are not sufficient results (evidence) about the superiority over other types of antibiotics. It is not possible to draw conclusions about their superiority over others." - Anonymous Online Contributor

Unverified Answer

What is the average age someone gets hemorrhage?

"The average age of someone suffering a hemorrhage is 72.9. Hemorrhage is often a traumatic issue at some point in everyone's life, so it is imperative that all members of the pediatric population are aware of the signs and symptoms of bleeding. If someone notices any signs of bruising in combination with hemorrhage, they should seek medical help immediately to avoid a catastrophic outcome. The goal of medical professionals is to ensure the quickest, safest, and most favorable healing process. In a medical setting, you are likely to notice symptoms such as swelling, tenderness, a dull ache, or the tingling sensation in the extremities. Other symptoms could include sudden dizziness, extreme fatigue, low energy, and fever." - Anonymous Online Contributor

Unverified Answer

Does hemorrhage run in families?

"In this population, patients with a positive family history of intracranial hemorrhage had 2.3 times the odds of having hemorrhage history compared with the general population. Patients with a positive family history of intracranial hemorrhage were 2.2 times more likely to have had a catastrophic hemorrhage, but 2.4 times less likely to have developed epilepsy. Patients with a positive family history of intracranial hemorrhage may be at increased risk for catastrophic hemorrhage and/or epilepsy." - Anonymous Online Contributor

Unverified Answer

What are the common side effects of long term prophylactic antibiotics?

"Long term prophylactic antibiotics can cause side effects. Some may be avoided by starting the antibiotic under a new treatment and monitoring the patient. This strategy increases the time over which the antibiotic will produce therapeutic effects, and thus, is more cost effective." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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