Lumbar Puncture and Syphilis Outcome

Syphilis Clinical Trial

Official title:

Lumbar Puncture and Syphilis Outcome

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02031146
• Other study ID #: STUDY00001718
• Secondary ID: R01NS082120
• Status: Completed
• Phase: N/A
• Start date: August 2013
• Est. completion date: December 2020

Study information

• Verified date: May 2021
• Source: University of Washington
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 information / eligibility

• Status: Completed
• Enrollment: 231
• Est. completion date: December 2020
• Est. primary completion date: December 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Syphilis

Intervention

Procedure:
• Lumbar puncture

Locations

Country	Name	City	State
United States	University of Washington Harborview Medical Center	Seattle	Washington

Sponsors (2)

Lead Sponsor	Collaborator
University of Washington	National Institute of Neurological Disorders and Stroke (NINDS)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Appropriate Decline in Serum Rapid Plasma Reagin Test (RPR) Titer	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.	6-12 months +/- 4 weeks
Primary	Time to Improvement in Performance on CogState Battery.	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.	6-12 months +/- 4 weeks