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NCT02031146 · ClinicalTrials.gov registry record · NA

Lumbar Puncture and Syphilis Outcome

A NA study, sponsored by University of Washington.

Completed
Registry status
NA
Development phase
231
Enrollment target

NCT02031146: Completed NA study, sponsored by University of Washington.

NCT02031146 is a NA study that has completed, run by University of Washington. The registered enrollment target is 231 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (84% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT02031146, a NA study, has completed, sponsored by University of Washington.

COMPLETED
Registry status
NA
Development phase
231 participants
Enrollment target

Study 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.

Primary Outcome

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.

Interventions

  • PROCEDURE Lumbar puncture

Trial Details

FieldValue
Enrollment Target 231 participants
Start Date 2013-08
Est. Completion 2020-12
Phase NA
University of Washington

1,048 total trials

What the finished NCT02031146 record still lists

NCT02031146 is an interventional study that assigns participants to a tested intervention. The registered 231 participants enrollment target is mid-sized for trials with a published cap, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (84% lower).

The record links to 0 conditions, and to 1 intervention - of which Lumbar puncture is the first listed.

NCT02031146 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT02031146 about?

NCT02031146 is a clinical study titled "Lumbar Puncture and Syphilis Outcome". 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 an...

What is the current status of trial NCT02031146?

This trial is currently completed. It is a NA study. The enrollment target is 231 participants. The study started on 2013-08. Estimated completion is 2020-12.

What interventions are being tested in trial NCT02031146?

The interventions under investigation include: Lumbar puncture (PROCEDURE).

Who is sponsoring clinical trial NCT02031146?

This trial is sponsored by University of Washington, which has 1,048 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT02031146's enrollment target sits among peer trials

231 465th of 2000 higher than 1,536 of 2,000 other NA trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT02031146, the US trial registry maintained by the National Library of Medicine. NCT02031146 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.