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Lumbar Puncture and Syphilis Outcome

Primary Purpose

Syphilis

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Lumbar puncture
Sponsored by
University of Washington
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Syphilis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Washington Harborview Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

No Intervention

Arm Label

LP

No LP

Arm Description

Participants undergo lumbar puncture for CSF evaluation

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

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

Full Information

First Posted
January 6, 2014
Last Updated
May 20, 2021
Sponsor
University of Washington
Collaborators
National Institute of Neurological Disorders and Stroke (NINDS)
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1. Study Identification

Unique Protocol Identification Number
NCT02031146
Brief Title
Lumbar Puncture and Syphilis Outcome
Official Title
Lumbar Puncture and Syphilis Outcome
Study Type
Interventional

2. Study Status

Record Verification Date
May 2021
Overall Recruitment Status
Completed
Study Start Date
August 2013 (undefined)
Primary Completion Date
December 2020 (Actual)
Study Completion Date
December 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Washington
Collaborators
National Institute of Neurological Disorders and Stroke (NINDS)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Syphilis

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
231 (Actual)

8. Arms, Groups, and Interventions

Arm Title
LP
Arm Type
Other
Arm Description
Participants undergo lumbar puncture for CSF evaluation
Arm Title
No LP
Arm Type
No Intervention
Arm Description
Participants do not undergo lumbar puncture and CSF is not examined.
Intervention Type
Procedure
Intervention Name(s)
Lumbar puncture
Primary Outcome Measure Information:
Title
Appropriate Decline in Serum Rapid Plasma Reagin Test (RPR) Titer
Description
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 Frame
6-12 months +/- 4 weeks
Title
Time to Improvement in Performance on CogState Battery.
Description
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.
Time Frame
6-12 months +/- 4 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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: 18 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christina M Marra, MD
Organizational Affiliation
University of Washington
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Washington Harborview Medical Center
City
Seattle
State/Province
Washington
ZIP/Postal Code
98104
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Lumbar Puncture and Syphilis Outcome

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