Prophylactic Antibiotics for Hydrocephalus

Recruiting at 1 trial location

Overseen By Erida C Rivas

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Montefiore Medical Center

Must be taking: Antibiotics

Disqualifiers: Recent surgery, Recent antibiotics, Infection, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 2 weeks

84 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but it excludes those who were on antibiotics within the week prior to admission.

What evidence supports the effectiveness of using prophylactic antibiotics like Nafcillin or Doxycycline for preventing infections in hydrocephalus patients?

Research suggests that using prophylactic antibiotics, such as Nafcillin, can reduce infection rates in hydrocephalus shunt surgeries, as seen in studies where short-term antibiotic use lowered infection rates. However, the effectiveness of long-term prophylactic use remains uncertain due to a lack of controlled studies. ^{1 2 3 4 5}

Is long-term prophylactic antibiotic use safe for humans?

Research shows that using antibiotics like Unasyn for a longer period can reduce infections in patients with ventricular catheters, but it may lead to resistant infections like MRSA and Candida. Short-term use of antibiotics like nafcillin in shunt surgeries has been recommended for reducing infection risk, with no major safety issues reported. ^{1 2 3 6 7}

How does the drug used in prophylactic antibiotics for hydrocephalus differ from other treatments?

Prophylactic antibiotics for hydrocephalus, such as nafcillin, are used to prevent infections during shunt surgery by reducing the risk of bacteria entering the cerebrospinal fluid. This approach is different from standard treatments that focus on treating infections after they occur, often involving intravenous antibiotics and surgical interventions. ^{1 2 3 4 7}

What is the purpose of this trial?

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

Research Team

David J Altschul, MD

Principal Investigator

Montefiore Medical Center

Eligibility Criteria

This trial is for adults over 18 with subarachnoid hemorrhage, intracerebral hemorrhage, or acute ischemic stroke needing an EVD. It's not for those who had brain procedures within the last month, were on antibiotics recently, have low white blood cell counts, are pregnant or imprisoned.

Inclusion Criteria

If my EVD fails, I will be given antibiotics before it's replaced and stay in my treatment group.

Exclusion Criteria

I have not had any brain surgery in the last 30 days.

Prisoners

Pregnant patients

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants receive either 24 hours of prophylactic antibiotics or continuous antibiotics until EVD removal

2 weeks

In-person visits for EVD management

Follow-up

Participants are monitored for safety and effectiveness after treatment

3 weeks

Treatment Details

Interventions

• long term prophylactic antibiotics
• long term prophylactic antibiotics (Nafcillin or Doxycycline)

Trial Overview The study tests if long-term prophylactic antibiotics (Nafcillin or Doxycycline) are beneficial alongside antibiotic-coated EVDs. Participants will either receive antibiotics for 24 hours or throughout their entire EVD treatment duration.

Participant Groups

Group I: continuous antibiotic use until the EVD is removed Experimental Treatment 1 Intervention

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.

Group II: antibiotics for a total of twenty-four hours Active Control 1 Intervention

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.

Who Is Running the Clinical Trial?

Montefiore Medical Center

Lead Sponsor

Trials

468

Recruited

599,000+

Findings from Research

Nafcillin is recommended over methicillin for prophylactic use in shunt surgeries due to its better penetration into cerebrospinal fluid (CSF), although both antibiotics showed low levels in CSF.

The study suggests that while a preoperative dose of 25 mg/kg of nafcillin may reduce infection risk, higher doses should be considered for patients with significantly dilated ventricles, as nafcillin levels were found to be inversely related to ventricular size.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Antibiotic prophylaxis in ventricular shunt surgery. II. Antibiotic concentrations in cerebrospinal fluid. McCullough, DC., Kane, JG., Harleman, G., et al.[2019]

A trial was conducted to assess the efficacy of intraventricular vancomycin as antimicrobial prophylaxis during shunt surgery for hydrocephalus, but it failed to enroll the necessary number of patients (only 158 out of the required 712) to provide statistically valid results.

While the trial did not demonstrate significant toxicity from the vancomycin treatment, it reported fewer infections in the test group (2 infections) compared to the control group (5 infections), indicating a potential benefit, but the small sample size limited the ability to draw definitive conclusions about efficacy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A prospective randomised controlled trial of antimicrobial prophylaxis in hydrocephalus shunt surgery. Bayston, R., Bannister, C., Boston, V., et al.[2019]

The use of short-term prophylactic antibiotics, specifically methicillin, during cerebrospinal fluid (CSF) shunt surgery has been associated with a reduction in case infection rates from 10.9% to 8.9% and operative infections from 8% to 2.6%, based on data from a study spanning 1969 to 1978.

The findings suggest that further improvements in preventing shunt sepsis could be achieved by selecting other semisynthetic penicillins that provide higher concentrations in the CSF, indicating a potential for enhanced efficacy in infection prevention.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Antibiotic prophylaxis in ventricular shunt surgery. I. Reduction of operative infection rates with methicillin. McCullough, DC., Kane, JG., Presper, JH., et al.[2013]

Cerebrospinal fluid (CSF) shunt infections are common complications following neurosurgery for hydrocephalus, typically occurring within the first two months post-surgery, with Staphylococcus epidermidis being the most frequent cause.

The standard treatment involves intravenous antibiotics, removal of the infected shunt, and placement of a new shunt after ensuring the CSF is sterile, with vancomycin being the preferred initial antibiotic, especially for methicillin-resistant infections.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Treatment and prevention of infections of cerebrospinal fluid shunts. Fan-Havard, P., Nahata, MC.[2004]

In a study involving six patients with cerebro-spinal fluid shunt infections, daily intrashunt injections of vancomycin combined with systemic antibiotics led to a 67% cure rate without the need for shunt surgery.

The treatment was effective against common organisms like Staphylococcus epidermidis, but two patients required surgery due to shunt malfunction, highlighting the importance of monitoring for complications during antibiotic therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Infection of the valves of CSF shunts. Results of local and general antibiotic treatment in 6 cases]. Roualdes, G., Lartigue, C., Boudigue, MD., et al.[2006]

In a study of 18 neonates with Flavobacterium meningitis, those who received effective antibiotic treatment within 8 days of infection had better outcomes, with normal or mildly dilated ventricles, while those treated later developed progressive hydrocephalus and associated complications.

The combination of intravenous rifampicin, moxalactam, and piperacillin was effective in treating patients with normal or mildly dilated ventricles, highlighting the importance of timely intervention and monitoring through daily ultrasound to prevent severe complications like hydrocephalus.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Management of Flavobacterium meningitis in the neonates: experience with 18 consecutive cases. Boo, NY., Lim, VK., Yakin, FM., et al.[2004]

Prolonged antibiotic prophylaxis in patients with ventricular catheters significantly reduced the incidence of cerebrospinal fluid (CSF) infections (3% vs 11%) and extracranial infections (20% vs 42%) compared to those receiving only perioperative antibiotics, based on a study of 228 patients.

While the extended use of antibiotics was effective in lowering infection rates, it also led to the selection of resistant pathogens like MRSA and Candida, highlighting a potential safety concern with this approach.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

CSF antibiotic prophylaxis for neurosurgical patients with ventriculostomy: a randomised study. Poon, WS., Ng, S., Wai, S.[2022]

References

1. Switzerland pubmed.ncbi.nlm.nih.gov

Antibiotic prophylaxis in ventricular shunt surgery. II. Antibiotic concentrations in cerebrospinal fluid. [2019]

2. Germany pubmed.ncbi.nlm.nih.gov

A prospective randomised controlled trial of antimicrobial prophylaxis in hydrocephalus shunt surgery. [2019]

3. Switzerland pubmed.ncbi.nlm.nih.gov

Antibiotic prophylaxis in ventricular shunt surgery. I. Reduction of operative infection rates with methicillin. [2013]

4. United States pubmed.ncbi.nlm.nih.gov

Treatment and prevention of infections of cerebrospinal fluid shunts. [2004]

5. France pubmed.ncbi.nlm.nih.gov

[Infection of the valves of CSF shunts. Results of local and general antibiotic treatment in 6 cases]. [2006]

6. India pubmed.ncbi.nlm.nih.gov

Management of Flavobacterium meningitis in the neonates: experience with 18 consecutive cases. [2004]

7. Austria pubmed.ncbi.nlm.nih.gov

CSF antibiotic prophylaxis for neurosurgical patients with ventriculostomy: a randomised study. [2022]