Lumbar Puncture and Syphilis Outcome

Not Applicable

Completed

Brief Summary: 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.

Recruitment & Eligibility

Inclusion Criteria

Males and females age 18 years or older
Current syphilis
Primary language is English or English is a second language but patient self-describes as fluent in English
Able to provide informed consent
If treated with benzathine penicillin G (BPG), it must have occurred less than 14 days before the entry visit (before the first visit if there is more than one entry visit)

Exclusion Criteria

Provider plans neurosyphilis (NS) treatment regardless of whether the patient has an lumbar puncture (LP)
Receipt of antibiotic treatment that would be effective for NS (for example, IV or intramuscular (IM) beta-lactam antibiotics [other than BPG]) within one month before study entry; single dose of IM ceftriaxone in the last month is not exclusionary
Allergy to penicillin or lidocaine
Contraindication to LP, including untreatable coagulation disorder, use of anticoagulants that cannot be temporarily discontinued, thrombocytopenia, focal neurological examination
Other known cause of central nervous system (CNS) infection in the last year, including that due to bacterial, fungal, protozoal or viral agents, such as tuberculosis, Cryptococcus, toxoplasmosis or herpes zoster that could confound interpretation of CSF results
Unlikely to be able to comply with study requirements or complete the study, for example, planning to leave the area < 6 months after enrollment
Subjects will not be allowed to re-enroll in this study with a new episode of syphilis

Individuals who are unwilling to be randomized can choose LP or no LP. Eligibility criteria for these individuals are:

Arm && Interventions

Group	Intervention	Description
LP	Lumbar puncture	Participants undergo lumbar puncture for CSF evaluation

Primary Outcome Measures

Name	Time	Method
Appropriate Decline in Serum Rapid Plasma Reagin Test (RPR) Titer	6-12 months +/- 4 weeks	Decline in serum RPR titer by four-fold or to nonreactive at 6 months (+/- 4 weeks) in early syphilis or at 12 months (+/- 4 weeks) in late syphilis. This is the definition of treatment success according to the US Centers for Disease Control and Prevention guidelines.
Time to Improvement in Performance on CogState Battery.	6-12 months +/- 4 weeks	Assessment of cognitive impairment was based on age adjusted normative data from CogState and was categorized as none (all test scores \> -1 standard deviation \[SD\] of normative data), mild impairment (two test scores \< -1 SD, or one test score \< -2 SD), moderate impairment (two test scores \< -2 SD) or severe impairment (three test scores \< -2 SD). Participants were categorized as improved if they had any impairment at study entry and improved by at least one category.

Secondary Outcome Measures