Prophylactic Antibiotics for Hydrocephalus
Recruiting in Palo Alto (17 mi)
+1 other location
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 1
Recruiting
Sponsor: Montefiore Medical Center
Must be taking: Antibiotics
Disqualifiers: Recent surgery, Recent antibiotics, Infection, others
No Placebo Group
Trial Summary
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
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.
12345Is 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.
12367How 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.
12346Eligibility 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
I am over 18 and need an EVD for my stroke or brain hemorrhage.
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
+4 more
Trial 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
Participant Groups
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.
2Treatment groups
Experimental Treatment
Active Control
Group I: continuous antibiotic use until the EVD is removedExperimental Treatment1 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 hoursActive Control1 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.
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Montefiore Medical CenterBronx, NY
Montefiore Medical centerBronx, NY
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Who Is Running the Clinical Trial?
Montefiore Medical CenterLead Sponsor
References
Antibiotic prophylaxis in ventricular shunt surgery. II. Antibiotic concentrations in cerebrospinal fluid. [2019]Investigation of cerebrospinal fluid (CSF) antibiotic levels from patients operated upon under short-term prophylactic protocols for shunt insertions or revisions revealed low-level CSF penetration by nafcillin and virtually no methicillin activity. Nafcillin levels were not influenced by route of injection or CSF sampling time, but were inversely proportional to ventricular size. The authors recommend nafcillin over methicillin as the preferred prophylactic agent in shunt surgery. Although the 25 mg/kg preoperative dose may be adequate for reducing infection risk, higher dosages should be considered when the ventricles are markedly dilated.
A prospective randomised controlled trial of antimicrobial prophylaxis in hydrocephalus shunt surgery. [2019]Despite attempts to reduce their incidence, shunt infections remain a major complication of the treatment of hydrocephalus. Various forms of antimicrobial prophylaxis are in use, but no controlled, statistically valid trial has been conducted to assess their efficacy. Such a trial was therefore carried out and its design is described here. After a 1-year retrospective and prospective study by members of the United Kingdom Hydrocephalus Group to establish feasibility and infection rates, a statistical study showed that at least 712 patients would be required. Six centres were enrolled to fulfil these requirements, and ethical committee approval was obtained at each. The chosen prophylactic regimen was 10 mg vancomycin administered into the ventricular system during surgery. Adults and children undergoing insertion or revision of ventriculoperitoneal shunts were included unless they were receiving therapeutic antimicrobials. Randomisation was by computer-generated numbers. Controls received the antimicrobial regimen, if any, currently used in that centre, the only difference between the two groups being intraventricular vancomycin in the test group. Diagnosis of shunt infection included accepted clinical and microbiological criteria reinforced by measurement of serum C-reactive protein levels. Follow-up was for at least six months. After 2.5 years only 158 patients had been enrolled in the trial, 80 controls and 78 tests. There were 5 preventable infections in the control group and 2 in the test group. In view of the small total the planned statistical analysis was not possible. Therefore, while no problems were encountered with toxicity, the trial failed to enroll enough patients to answer the question of efficacy of antimicrobial prophylaxis in shunt surgery and the reasons for this are discussed.
Antibiotic prophylaxis in ventricular shunt surgery. I. Reduction of operative infection rates with methicillin. [2013]Administration of prophylactic antibiotics is not a proven or universal practice in cerebrospinal fluid (CSF) shunt surgery although case and operative infection rates in hydrocephalic patients average 20 and 8%, respectively. In sequential series from 1969 through 1978 the authors achieved a reduction in case infection rates from 10.9 to 8.9% and in operative infections from 8 to 2.6% with the use of short-term prophylactic methicillin. Comparison of these results to those of other reported series supports the case for short-term prophylactic antibiotics in shunt surgery. Further reduction in shunt sepsis may be possible with the appropriate selection of other semisynthetic penicillins which achieve higher levels in CSF.
Treatment and prevention of infections of cerebrospinal fluid shunts. [2004]The etiology, pathogenesis, clinical manifestations, diagnosis, and treatment of cerebrospinal fluid (CSF) shunt infections are reviewed. Infection is a frequent complication of neurosurgical procedures performed for the treatment of hydrocephalus. Shunt infections generally occur within the first two months after surgery. Staphylococcus epidermidis is the most common cause of infections of both ventriculoatrial and ventriculoperitoneal shunts. The preferred treatment of CSF shunt infections involves intravenous antimicrobial therapy, surgical removal of the infected shunt, installation of an extraventricular drainage device, and placement of a new shunt once the CSF is sterile. However, many aspects of therapy are controversial because few controlled, comparative studies have been reported. Intravenous vancomycin is the drug of choice for empiric treatment of shunt infections. Nafcillin is recommended for infections caused by methicillin-sensitive strains of staphylococci. Vancomycin should be used for infections caused by methicillin-resistant strains of staphylococci or in patients who are allergic to penicillin. The addition of rifampin has eradicated infections that failed to respond to monotherapy with vancomycin or nafcillin. Intraventricular antimicrobial therapy is indicated if the risks associated with surgery are high or if ventriculitis is persistent and refractory to systemic antimicrobial therapy. The role of prophylactic antimicrobial therapy is controversial. Infection continues to be an important complication of CSF shunt placement; many aspects of treatment are controversial.
[Infection of the valves of CSF shunts. Results of local and general antibiotic treatment in 6 cases]. [2006]Infection of six cerebro-spinal fluid shunts in six patients were treated with daily intrashunt injections of antibiotics plus combination of intravenous or oral systemic antibiotic therapy. Three organisms were involved in the shunt infection: staphylococcus epidermidis in five, staphylococcus capitis and micrococcus varians. One patient had mixed shunt infection with micrococcus varians and staphylococcus épidermidis. All six patients received daily intrashunt injections of vancomycin and oral rifampin with a combination of trimethoprim/sulfamethoxazole (three patients), or intravenous fosfomycin (two patients), or intravenous vancomycin (one patient). Four of six cases were considered cured of their infection without shunt surgery. Their hydrocephalus will be well controlled during antibiotic therapy. Surgery was necessary for two patients with associated shunt malfunction, one of them was considered a treatment failure of antibiotic therapy.
CSF antibiotic prophylaxis for neurosurgical patients with ventriculostomy: a randomised study. [2022]The value of prophylactic antibiotics for patients with ventricular catheter for monitoring and CSF drainage is uncertain. 228 patients were randomised to receive perioperative antibiotics only (Unasyn, Group I) or prolonged antibiotics for the presence of the ventricular catheter (Unasyn and Aztreonam, Group II). The incidence of intracranial and extracranial infection was documented prospectively. Group II patients had a significantly reduced incidence of CSF infection [3/115 (3%) vs 12/113 (11%), p = 0.01] and extracranial infections [23/115 (20%) vs 48/113 (42%), p = 0.002]. CSF pathogens in Group II patients were MRSA and Candida, whereas in Group I, Staphylococci, E coli and Klebsiella. Although prolonged antibiotic prophylaxis significantly reduced the incidence of serious CSF infection as well as extracranial infections, this policy did select resistant or opportunistic pathogens such as Candida and MRSA.
Management of Flavobacterium meningitis in the neonates: experience with 18 consecutive cases. [2004]18 neonates with bacteriologically confirmed Flavobacterium meningitis and ventriculitis were treated with various antibiotic regimens, including the use of intraventricular antibiotics. During the course of treatment, four patients died. 8/14 patients developed progressive hydrocephalus which required insertion of ventriculo-peritoneal shunts. The remainder 6/14 patients had normal ventricles or only mild ventriculomegaly. 5/8 patients with progressive hydrocephalus and 5/6 patients with normal or mildly dilated ventricles were followed up for at least 24 months. 4/5 of the patients with progressive hydrocephalus had severe bilateral hearing loss and delayed milestones. All the 5 patients with normal or mildly dilated ventricles had normal hearing although 2 of them had gross motor delay due to spastic paraplegia. Patients with progressive hydrocephalus received effective antibiotic treatment more than 8 days after the onset of infection while those with normal or mildly dilated ventricles within 8 days of infection. Onset of ventricular dilatation was associated with ventriculitis. Daily ultrasound scanning of the ventricles in the early stage helped to determine the need for early instillation of intraventricular antibiotics. Combined use of intravenous rifampicin, moxalactam and piperacillin showed promise as an effective antibiotic regimen in treating patients with normal or mildly dilated ventricles. Once significant ventriculomegaly has occurred, concomitant intravenous and intraventricular administration of antibiotics, to which the organisms were sensitive, was necessary to eradicate the infection.