Prevalence of Pathogens in Cerebrospinal Fluid Obtained From Emergency Department Patients

NCT02207647 | Terminated

• 2 other identifiers: 12H-770352U01CK000176
• Study Type: observational
• Target: 1,000
• Locations: 1 country
• Sites: 1

Brief Summary

Of all emergency room patients, persons presenting with encephalitis/meningitis syndrome of a potentially infectious nature are among those of greatest concern. Routine clinical and laboratory evaluation of such patients involves screening for known infectious disease agents, selection of which is nonstandardized. Progress in diagnostic technologies, especially molecular techniques based on genetic characteristics of potential pathogens, has greatly expanded the investigators capacity to evaluate specimens from patients for a much wider range of potential pathogens (bacterial, viral, fungal and parasitic agents). Use of Polymerase Chain Reaction (PCR) technology offers the possibility of identifying causative agents for the approximately 50% of all such presentations which go un-diagnosed. The investigators propose a study involving a collaboration between the EMERGEncy ID NET, a network of 10 geographically diverse university-affiliated urban emergency departments (coordinated by Olive View-UCLA Medical Center) and the Centers for Disease Control and Prevention (CDC), to use these new technologies to address this issue.

Conditions

Meningoencephalitis; Other Syndromes Requiring Lumbar Puncture in Emergency Department

Outcome Measures

Primary Outcomes (1)

• prevalence of pathogens

  We will describe the range and proportion of pathogens found in CSF among patients enrolled over a 2 year period.

  2 years

Study Arms (1)

Patients with syndromes requiring lumbar puncture

Other: no intervention

Interventions

no intervention OTHER

Patients with syndromes requiring lumbar puncture

Eligibility Criteria

• Age: 3 Months+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

This study will be conducted by the Emergency ID Net Study group (P.I. David Talan), which consists of a network of 10 emergency departments in university-affiliated hospitals throughout the United States.

You may qualify if:

• Age \> or = 3 months old
• Receiving a Lumbar Puncture in the emergency department as part of their standard care.

You may not qualify if:

• No CSF available

Sponsors & Collaborators

• Olive View-UCLA Education & Research Institute: lead
• Centers for Disease Control and Prevention: collaborator

Study Sites (1)

Olive View-UCLA Medical Center

Sylmar, California, 91342, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

Cerebrospinal fluid and blood serum are being collected.

MeSH Terms

Conditions

Meningoencephalitis

Condition Hierarchy (Ancestors)

Central Nervous System Viral Diseases; Central Nervous System Infections; Infections; Encephalitis; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neuroinflammatory Diseases; Meningitis

Study Design

• Study Type: observational
• Observational Model: ECOLOGIC OR COMMUNITY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 31, 2014
• First Posted: August 4, 2014
• Study Start: April 1, 2014
• Primary Completion: July 1, 2016
• Study Completion: December 1, 2021
• Last Updated: April 20, 2022

Record last verified: 2022-04

Locations

US (1)