Lumbar Puncture and Syphilis Outcome

Age Range:18 - Any
Start Date:August 2013
End Date:June 2021
Contact:Christina M Marra, MD

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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.

Inclusion Criteria:

1. Males and females age 18 years or older

2. Current syphilis

3. Primary language is English or English is a second language but patient self-describes
as fluent in English

4. Able to provide informed consent

5. 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:

1. Provider plans neurosyphilis (NS) treatment regardless of whether the patient has an
lumbar puncture (LP)

2. 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

3. Allergy to penicillin or lidocaine

4. Contraindication to LP, including untreatable coagulation disorder, use of
anticoagulants that cannot be temporarily discontinued, thrombocytopenia, focal
neurological examination

5. 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

6. Unlikely to be able to comply with study requirements or complete the study, for
example, planning to leave the area < 6 months after enrollment

7. 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:

1. 18 years of age or older

2. Current syphilis infection

3. Primary language is English or fluent in English

4. No contraindications to LP

5. Have not received antibiotics within one month that would treat neurosyphilis
We found this trial at
Seattle, Washington 98104
Phone: 206-394-9096
Seattle, WA
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