Lumbar Puncture and Syphilis Outcome

NCT02031146 | Completed Results

• 2 other identifiers: STUDY00001718R01NS082120
• Study Type: interventional
• Target: 231
• Locations: 1 country
• Sites: 1

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.

Conditions

Syphilis

Outcome Measures

Primary Outcomes (2)

• 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

• 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

Study Arms (2)

LP

OTHER

Participants undergo lumbar puncture for CSF evaluation

Procedure: Lumbar puncture

No LP

NO INTERVENTION

Participants do not undergo lumbar puncture and CSF is not examined.

Interventions

Lumbar puncture PROCEDURE

LP

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• Provider plans neurosyphilis (NS) treatment regardless of whether the patient has an lumbar puncture (LP)
• 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:
• years of age or older
• Current syphilis infection
• Primary language is English or fluent in English
• No contraindications to LP
• Have not received antibiotics within one month that would treat neurosyphilis

Sponsors & Collaborators

• University of Washington: lead
• National Institute of Neurological Disorders and Stroke (NINDS): collaborator

Study Sites (1)

University of Washington Harborview Medical Center

Seattle, Washington, 98104, United States

Location

MeSH Terms

Conditions

Syphilis

Interventions

Spinal Puncture

Condition Hierarchy (Ancestors)

Treponemal Infections; Spirochaetales Infections; Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Sexually Transmitted Diseases, Bacterial; Sexually Transmitted Diseases; Communicable Diseases; Genital Diseases; Urogenital Diseases

Intervention Hierarchy (Ancestors)

Biopsy; Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Diagnostic Techniques, Neurological; Punctures; Therapeutics; Surgical Procedures, Operative; Investigative Techniques

Limitations and Caveats

Inclusion of a non-randomized group introduces risk of bias; however, the groups were comparable with regard to neurosyphilis risk factors.

Results Point of Contact

• Title: Christina Marra, MD
• Organization: University of Washington

cmarra@uw.edu

206-744-3251

Study Officials

• Christina M Marra, MD

  University of Washington

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Neurology

Study Record Dates

• First Submitted: January 6, 2014
• First Posted: January 9, 2014
• Study Start: August 1, 2013
• Primary Completion: December 1, 2020
• Study Completion: December 1, 2020
• Last Updated: May 25, 2021
• Results First Posted: May 25, 2021

Record last verified: 2021-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)