Trial Outcomes & Findings for Lumbar Puncture and Syphilis Outcome (NCT NCT02031146)
NCT ID: NCT02031146
Last Updated: 2021-05-25
Results Overview
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.
COMPLETED
NA
231 participants
6-12 months +/- 4 weeks
2021-05-25
Participant Flow
The protocol section asks how many participants were enrolled. 219 unique participants were enrolled, but 12 had two enrollments. Thus there are 231 enrollment visits.
Participant milestones
| Measure |
Randomized, Lumbar Puncture (LP)
Randomized to lumbar puncture (LP) arm
|
Reenrolled, Randomized, LP
Randomised after a second enrollment, underwent LP
|
Randomized, no LP
Randomized and did not undergo LP. Includes one person for whom LP was unsuccessful.
|
Not Randomized, LP
Not randomized and underwent LP.
|
Not Randomized, no LP
Not randomized and did not undergo LP.
|
Reenrolled, Not Randomized, no LP
Not randomized during another episode of syphilis. Did not undergo LP.
|
Reenrolled, Not Randomized, LP
Not randomized with a new episode of syphilis, underwent LP
|
|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
11
|
3
|
18
|
148
|
42
|
4
|
5
|
|
Overall Study
Considered in Analysis
|
11
|
3
|
18
|
48
|
16
|
0
|
0
|
|
Overall Study
COMPLETED
|
11
|
3
|
18
|
48
|
16
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
100
|
26
|
4
|
5
|
Reasons for withdrawal
| Measure |
Randomized, Lumbar Puncture (LP)
Randomized to lumbar puncture (LP) arm
|
Reenrolled, Randomized, LP
Randomised after a second enrollment, underwent LP
|
Randomized, no LP
Randomized and did not undergo LP. Includes one person for whom LP was unsuccessful.
|
Not Randomized, LP
Not randomized and underwent LP.
|
Not Randomized, no LP
Not randomized and did not undergo LP.
|
Reenrolled, Not Randomized, no LP
Not randomized during another episode of syphilis. Did not undergo LP.
|
Reenrolled, Not Randomized, LP
Not randomized with a new episode of syphilis, underwent LP
|
|---|---|---|---|---|---|---|---|
|
Overall Study
Did not meet criteria for inclusion in data analysis
|
0
|
0
|
0
|
100
|
26
|
4
|
5
|
Baseline Characteristics
Lumbar Puncture and Syphilis Outcome
Baseline characteristics by cohort
| Measure |
Lumbar Puncture Group
n=62 Participants
Underwent lumbar puncture
|
No Lumbar Puncture Group
n=34 Participants
Did not undergo lumbar puncture
|
Total
n=96 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
36 years
n=99 Participants
|
34 years
n=107 Participants
|
35 years
n=206 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
61 Participants
n=99 Participants
|
34 Participants
n=107 Participants
|
95 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
6 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
10 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
45 Participants
n=99 Participants
|
26 Participants
n=107 Participants
|
71 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
9 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
10 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Serum Rapid Plasma Reagin test (RPR) titer
|
128 titer
n=99 Participants
|
128 titer
n=107 Participants
|
128 titer
n=206 Participants
|
|
Impaired on CogState Battery
|
42 participants
n=99 Participants
|
20 participants
n=107 Participants
|
62 participants
n=206 Participants
|
PRIMARY outcome
Timeframe: 6-12 months +/- 4 weeksDecline 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.
Outcome measures
| Measure |
Lumbar Puncture (LP), Treatment Based on Cerebrospinal Fluid (CSF ) Results
n=42 Participants
Underwent lumbar puncture and treatment based on the results of cerebrospinal fluid findings. Specifically, those with abnormal CSF were treated for neurosyphilis and those without CSF abnormalities were treated for uncomplicated syphilis. The number of participants with late syphilis was too small to allow for separate analysis of early and late stages.
|
No Lumbar Puncture Group
n=31 Participants
Did not undergo lumbar puncture. All were treated for uncomplicated syphilis. The number of participants with late syphilis was too small to allow for separate analysis of early and late stages.
|
|---|---|---|
|
Appropriate Decline in Serum Rapid Plasma Reagin Test (RPR) Titer
|
38 Participants
|
30 Participants
|
PRIMARY outcome
Timeframe: 6-12 months +/- 4 weeksAssessment 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.
Outcome measures
| Measure |
Lumbar Puncture (LP), Treatment Based on Cerebrospinal Fluid (CSF ) Results
n=34 Participants
Underwent lumbar puncture and treatment based on the results of cerebrospinal fluid findings. Specifically, those with abnormal CSF were treated for neurosyphilis and those without CSF abnormalities were treated for uncomplicated syphilis. The number of participants with late syphilis was too small to allow for separate analysis of early and late stages.
|
No Lumbar Puncture Group
n=20 Participants
Did not undergo lumbar puncture. All were treated for uncomplicated syphilis. The number of participants with late syphilis was too small to allow for separate analysis of early and late stages.
|
|---|---|---|
|
Time to Improvement in Performance on CogState Battery.
|
11.3 months
Interval 7.5 to 15.2
|
12.2 months
Interval 3.0 to 21.3
|
POST_HOC outcome
Timeframe: 6-12 months +/- 4 weeksPopulation: Time to decline in performance on the CogState battery by log rank test.
Participants were categorized as declined if they were not severely impaired at entry and declined by at least one category. The impairment categories are: 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).
Outcome measures
| Measure |
Lumbar Puncture (LP), Treatment Based on Cerebrospinal Fluid (CSF ) Results
n=20 Participants
Underwent lumbar puncture and treatment based on the results of cerebrospinal fluid findings. Specifically, those with abnormal CSF were treated for neurosyphilis and those without CSF abnormalities were treated for uncomplicated syphilis. The number of participants with late syphilis was too small to allow for separate analysis of early and late stages.
|
No Lumbar Puncture Group
n=55 Participants
Did not undergo lumbar puncture. All were treated for uncomplicated syphilis. The number of participants with late syphilis was too small to allow for separate analysis of early and late stages.
|
|---|---|---|
|
Time to Decline in Performance on the CogState Battery
|
NA months
Less than 50% of individuals worsened, so no median time can be reported.
|
12.3 months
Interval 4.1 to 20.5
|
Adverse Events
Underwent Lumbar Puncture
Did Not Undergo Lumbar Puncture
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place