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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT02207647
Other study ID # 12H-770352
Secondary ID U01CK000176
Status Terminated
Phase
First received
Last updated
Start date April 2014
Est. completion date December 2021

Study information

Verified date April 2022
Source Olive View-UCLA Education & Research Institute
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Recruitment information / eligibility

Status Terminated
Enrollment 1000
Est. completion date December 2021
Est. primary completion date July 2016
Accepts healthy volunteers No
Gender All
Age group 3 Months and older
Eligibility Inclusion Criteria: - Age > or = 3 months old - Receiving a Lumbar Puncture in the emergency department as part of their standard care. Exclusion Criteria: - No CSF available

Study Design


Related Conditions & MeSH terms


Intervention

Other:
no intervention


Locations

Country Name City State
United States Olive View-UCLA Medical Center Sylmar California

Sponsors (2)

Lead Sponsor Collaborator
Olive View-UCLA Education & Research Institute Centers for Disease Control and Prevention

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
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