Lumbar Puncture and Syphilis Outcome
Treponema pallidum, the bacterium that causes syphilis, invades the central nervous system in about 40% of patients with syphilis. This happens early after infection. Patients with neuroinvasion are at risk of developing serious neurological complications, including vision or hearing loss, stroke and dementia. Because neuroinvasion can happen without symptoms, the only way to identify it is by performing a lumbar puncture (LP) to examine cerebrospinal fluid (CSF).The overall hypothesis to be tested in this study is that a strategy of immediate LP, followed by therapy based on CSF evaluation, results in better serological and functional outcomes in patients with syphilis who are at high risk for neuroinvasion.
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
|Official Title:||Lumbar Puncture and Syphilis Outcome|
- Serum RPR titer [ Time Frame: 6-12 months ] [ Designated as safety issue: No ]Decline in serum RPR titer by four-fold or to nonreactive at 6 months in early syphilis or at 12 months in late syphilis.
|Study Start Date:||August 2013|
|Estimated Primary Completion Date:||June 2019 (Final data collection date for primary outcome measure)|
Participants undergo lumbar puncture for CSF evaluation
|Procedure: Lumbar puncture|
No Intervention: No LP
Participants do not undergo lumbar puncture and CSF is not examined.
Please refer to this study by its ClinicalTrials.gov identifier: NCT02031146
|Contact: Christina M Marra, MD||206-897-5400|
|United States, Washington|
|University of Washington Harborview Medical Center||Recruiting|
|Seattle, Washington, United States, 98104|
|Contact: Christina M Marra, MD 206-394-9096 firstname.lastname@example.org|
|Principal Investigator:||Christina M Marra, MD||University of Washington|