Lumbar Puncture and Syphilis Outcome

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2014 by University of Washington
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Christina Marra, University of Washington
ClinicalTrials.gov Identifier:
NCT02031146
First received: January 6, 2014
Last updated: September 11, 2014
Last verified: September 2014
  Purpose

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.


Condition Intervention
Syphilis
Procedure: Lumbar puncture

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Official Title: Lumbar Puncture and Syphilis Outcome

Resource links provided by NLM:


Further study details as provided by University of Washington:

Primary Outcome Measures:
  • Serum RPR titer [ Time Frame: 6-12 months ] [ Designated as safety issue: No ]
    Decline in serum RPR titer by four-fold or to nonreactive at 6 months in early syphilis or at 12 months in late syphilis.


Estimated Enrollment: 280
Study Start Date: August 2013
Estimated Primary Completion Date: June 2019 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
LP
Participants undergo lumbar puncture for CSF evaluation
Procedure: Lumbar puncture
No Intervention: No LP
Participants do not undergo lumbar puncture and CSF is not examined.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Males and females age 18 years or older
  2. Current syphilis defined as:

    • Reactive serum Rapid Plasma Reagin (RPR) test with a) no history of syphilis; or b) last recorded serum RPR or Venereal Diseases Research Laboratory (VDRL) test nonreactive; or c) a 4-fold increase in RPR titer relative to most recent lowest titer, and d) a reactive treponemal serological test

  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 for gonorrhea 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02031146

Contacts
Contact: Christina M Marra, MD 206-897-5400

Locations
United States, Washington
University of Washington Harborview Medical Center Recruiting
Seattle, Washington, United States, 98104
Contact: Christina M Marra, MD    206-394-9096    cmarra@uw.edu   
Sponsors and Collaborators
University of Washington
Investigators
Principal Investigator: Christina M Marra, MD University of Washington
  More Information

No publications provided

Responsible Party: Christina Marra, Professor, Neurology, University of Washington
ClinicalTrials.gov Identifier: NCT02031146     History of Changes
Other Study ID Numbers: 45122-A, R01NS082120
Study First Received: January 6, 2014
Last Updated: September 11, 2014
Health Authority: United States: Federal Government

Additional relevant MeSH terms:
Syphilis
Treponemal Infections
Gram-Negative Bacterial Infections
Bacterial Infections
Sexually Transmitted Diseases, Bacterial
Spirochaetales Infections
Sexually Transmitted Diseases
Infection
Genital Diseases, Male
Genital Diseases, Female

ClinicalTrials.gov processed this record on September 22, 2014