Clinical trial NCT02031146: Lumbar Puncture and Syphilis Outcome
Official title: Lumbar Puncture and Syphilis Outcome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Syphilis
Lead sponsor: University of Washington
Sponsor class: OTHER
Collaborators: name: National Institute of Neurological Disorders and Stroke (NINDS)
First posted: 2014-01-09
Enrollment: 231
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.


Eligibility criteria: 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

Primary outcomes:
measure: Appropriate Decline in Serum Rapid Plasma Reagin Test (RPR) Titer
timeFrame: 6-12 months +/- 4 weeks
measure: Time to Improvement in Performance on CogState Battery.
timeFrame: 6-12 months +/- 4 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Seattle
country: United States
facility: University of Washington Harborview Medical Center
state: Washington
Study officials:
affiliation: University of Washington
name: Christina M Marra, MD
role: PRINCIPAL_INVESTIGATOR
References: