Lumbar Puncture and Syphilis Outcome

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT02031146
Recruitment Status : Recruiting
First Posted : January 9, 2014
Last Update Posted : December 14, 2017
National Institute of Neurological Disorders and Stroke (NINDS)
Information provided by (Responsible Party):
Christina Marra, University of Washington

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.

Condition or disease Intervention/treatment Phase
Syphilis Procedure: Lumbar puncture Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 280 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Lumbar Puncture and Syphilis Outcome
Study Start Date : August 2013
Estimated Primary Completion Date : June 2019
Study Completion Date : June 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Syphilis
U.S. FDA Resources

Arm Intervention/treatment
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.

Primary Outcome Measures :
  1. Serum RPR titer [ Time Frame: 6-12 months ]
    Decline in serum RPR titer by four-fold or to nonreactive at 6 months in early syphilis or at 12 months in late syphilis.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02031146

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

United States, Washington
University of Washington Harborview Medical Center Recruiting
Seattle, Washington, United States, 98104
Contact: Christina M Marra, MD    206-394-9096   
Sponsors and Collaborators
University of Washington
National Institute of Neurological Disorders and Stroke (NINDS)
Principal Investigator: Christina M Marra, MD University of Washington

Responsible Party: Christina Marra, Professor, Neurology, University of Washington Identifier: NCT02031146     History of Changes
Other Study ID Numbers: STUDY00001718
R01NS082120 ( U.S. NIH Grant/Contract )
First Posted: January 9, 2014    Key Record Dates
Last Update Posted: December 14, 2017
Last Verified: December 2017

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

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