Trial Outcomes & Findings for Rapid Diagnostic Assay for Gonorrhea and Chlamydia (NCT NCT05564299)
NCT ID: NCT05564299
Last Updated: 2025-09-23
Results Overview
The investigators will compare the mean antibiotic days of therapy (DOT) administered per patient at the time of initial ciinical visit when evaluated with either point-of-care gram stain or rapid 30-minute desktop test.
COMPLETED
NA
98 participants
Day 1
2025-09-23
Participant Flow
Participant milestones
| Measure |
Standard of Care
Point-of-care gram stain
|
Rapid STI Test
30-minute point of care test for gonorrhea/chlamydia
|
|---|---|---|
|
Overall Study
STARTED
|
49
|
49
|
|
Overall Study
COMPLETED
|
49
|
49
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Rapid Diagnostic Assay for Gonorrhea and Chlamydia
Baseline characteristics by cohort
| Measure |
Standard of Care
n=49 Participants
Point-of-care gram stain
|
Rapid STI Test
n=49 Participants
Rapid 30-minute Desktop Assay: Participants will undergo routine evaluation and specimen collection per current clinic protocols. Specimens will be processed by the rapid 30-minute desktop assay. Concurrently, specimens will be used to create a point-of-care gram stain, to be read by the clinician following the clinical encounter.
Treatment for urethritis and cervicitis will be provided based on results from the 30-minute assay.
Specimens will also be plated for Gonorrhea culture and sent to the Massachusetts Department of Public Health for additional Gonorrhea and Chlamydia polymerase chain reaction testing, as per clinic protocols.
|
Total
n=98 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
28 years
n=93 Participants
|
31 years
n=4 Participants
|
29.5 years
n=27 Participants
|
|
Sex/Gender, Customized
Cisgender male
|
34 Participants
n=93 Participants
|
28 Participants
n=4 Participants
|
62 Participants
n=27 Participants
|
|
Sex/Gender, Customized
Cisgender female
|
13 Participants
n=93 Participants
|
19 Participants
n=4 Participants
|
32 Participants
n=27 Participants
|
|
Sex/Gender, Customized
Transgender/nonbinary
|
1 Participants
n=93 Participants
|
2 Participants
n=4 Participants
|
3 Participants
n=27 Participants
|
|
Sex/Gender, Customized
Other
|
1 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
10 Participants
n=93 Participants
|
7 Participants
n=4 Participants
|
17 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
30 Participants
n=93 Participants
|
35 Participants
n=4 Participants
|
65 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
9 Participants
n=93 Participants
|
7 Participants
n=4 Participants
|
16 Participants
n=27 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=93 Participants
|
5 Participants
n=4 Participants
|
7 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Black or African American
|
8 Participants
n=93 Participants
|
12 Participants
n=4 Participants
|
20 Participants
n=27 Participants
|
|
Race (NIH/OMB)
White
|
26 Participants
n=93 Participants
|
18 Participants
n=4 Participants
|
44 Participants
n=27 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=93 Participants
|
3 Participants
n=4 Participants
|
4 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
12 Participants
n=93 Participants
|
11 Participants
n=4 Participants
|
23 Participants
n=27 Participants
|
PRIMARY outcome
Timeframe: Day 1The investigators will compare the mean antibiotic days of therapy (DOT) administered per patient at the time of initial ciinical visit when evaluated with either point-of-care gram stain or rapid 30-minute desktop test.
Outcome measures
| Measure |
Standard of Care
n=49 Participants
Point-of-care gram stain
|
Rapid STI Test
n=49 Participants
Rapid 30-minute Desktop Assay: Participants will undergo routine evaluation and specimen collection per current clinic protocols. Specimens will be processed by the rapid 30-minute desktop assay. Concurrently, specimens will be used to create a point-of-care gram stain, to be read by the clinician following the clinical encounter.
Treatment for urethritis and cervicitis will be provided based on results from the 30-minute assay.
Specimens will also be plated for Gonorrhea culture and sent to the Massachusetts Department of Public Health for additional Gonorrhea and Chlamydia polymerase chain reaction testing, as per clinic protocols.
|
|---|---|---|
|
Mean Antibiotic Days of Therapy (DOT) Administered Per Patient With Symptomatic Urethritis or Cervicitis
|
7 Antibiotic days of therapy (DOT)
Interval 0.0 to 8.0
|
1 Antibiotic days of therapy (DOT)
Interval 0.0 to 7.0
|
SECONDARY outcome
Timeframe: Day 1The investigators will compare visit duration between participants randomized to the point-of-care test and those to the 30-minute desktop test. Participant visit duration will be calculated as the difference between when the participant enters the exam room and when they check out of the clinic, in minutes.
Outcome measures
| Measure |
Standard of Care
n=49 Participants
Point-of-care gram stain
|
Rapid STI Test
n=49 Participants
Rapid 30-minute Desktop Assay: Participants will undergo routine evaluation and specimen collection per current clinic protocols. Specimens will be processed by the rapid 30-minute desktop assay. Concurrently, specimens will be used to create a point-of-care gram stain, to be read by the clinician following the clinical encounter.
Treatment for urethritis and cervicitis will be provided based on results from the 30-minute assay.
Specimens will also be plated for Gonorrhea culture and sent to the Massachusetts Department of Public Health for additional Gonorrhea and Chlamydia polymerase chain reaction testing, as per clinic protocols.
|
|---|---|---|
|
Participant Visit Duration
|
57 Minutes
Interval 45.0 to 69.0
|
87 Minutes
Interval 72.0 to 97.0
|
SECONDARY outcome
Timeframe: Day 1Population: This outcome measure was not collected. At the start of the study, it was determined that staff would not be able to accurately document the sample processing time in the clinical context, as stopping between sample processing and running or reading the test was not feasible and disrupted the providers' workflow, thus potentially altering the outcomes of other process measures. This change was made after the start of the study but not amended specifically in the protocol.
The investigators will compare the time taken to process clinical specimen using either the point-of-care gram stain or rapid 30-minute desktop test. The provider processing the samples will record the start and end times on a time sheet, and the sample processing time will be calculated as the difference between those entries, in minutes.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Day 1The investigators will compare time from specimen collection to availability of test result between the point-of-care gram stain or rapid 30-minute desktop test. Providers will record time of specimen collection and time of result (for point of care gram stain), time of result for the rapid desktop platform will be extracted from the platform; time to result will be calculated as the difference between those times, in minutes.
Outcome measures
| Measure |
Standard of Care
n=49 Participants
Point-of-care gram stain
|
Rapid STI Test
n=49 Participants
Rapid 30-minute Desktop Assay: Participants will undergo routine evaluation and specimen collection per current clinic protocols. Specimens will be processed by the rapid 30-minute desktop assay. Concurrently, specimens will be used to create a point-of-care gram stain, to be read by the clinician following the clinical encounter.
Treatment for urethritis and cervicitis will be provided based on results from the 30-minute assay.
Specimens will also be plated for Gonorrhea culture and sent to the Massachusetts Department of Public Health for additional Gonorrhea and Chlamydia polymerase chain reaction testing, as per clinic protocols.
|
|---|---|---|
|
Time to Result
|
6.5 Minutes
Interval 5.0 to 9.0
|
34 Minutes
Interval 33.0 to 36.0
|
SECONDARY outcome
Timeframe: Day 1Proportion of participants in each arm who recevied gonorrhea-active antibiotics if PCR-based testing (rapid test or MDPH) was positive for gonorrhea, or who did not receive gonorrhea-active antibiotics if PCR-based testing (rapid test or MDPH) was negative for gonorrhea
Outcome measures
| Measure |
Standard of Care
n=49 Participants
Point-of-care gram stain
|
Rapid STI Test
n=49 Participants
Rapid 30-minute Desktop Assay: Participants will undergo routine evaluation and specimen collection per current clinic protocols. Specimens will be processed by the rapid 30-minute desktop assay. Concurrently, specimens will be used to create a point-of-care gram stain, to be read by the clinician following the clinical encounter.
Treatment for urethritis and cervicitis will be provided based on results from the 30-minute assay.
Specimens will also be plated for Gonorrhea culture and sent to the Massachusetts Department of Public Health for additional Gonorrhea and Chlamydia polymerase chain reaction testing, as per clinic protocols.
|
|---|---|---|
|
Test-concordant Antibiotic Use for Gonorrhea
|
41 Participants
|
46 Participants
|
SECONDARY outcome
Timeframe: Day 1Proportion of participants in each arm who were prescribed an antibiotic with activity against gonorrhea on the day of clinic visit, either for a positive test result or for a clinical syndrome for which the antibiotics are indicated (e.g., a clinical diagnosis of pelvic inflammatory disease, a diagnosis of non-gonococcal urethritis) as determined by study PI; or who were not prescribed an antibiotic with activity against gonorrhea on the day of clinic visit in the absence of a positive test result for gonorrhea or clinical syndrome for which the antibiotics are indicated.
Outcome measures
| Measure |
Standard of Care
n=49 Participants
Point-of-care gram stain
|
Rapid STI Test
n=49 Participants
Rapid 30-minute Desktop Assay: Participants will undergo routine evaluation and specimen collection per current clinic protocols. Specimens will be processed by the rapid 30-minute desktop assay. Concurrently, specimens will be used to create a point-of-care gram stain, to be read by the clinician following the clinical encounter.
Treatment for urethritis and cervicitis will be provided based on results from the 30-minute assay.
Specimens will also be plated for Gonorrhea culture and sent to the Massachusetts Department of Public Health for additional Gonorrhea and Chlamydia polymerase chain reaction testing, as per clinic protocols.
|
|---|---|---|
|
Diagnosis-concordant Antibiotic Use for Gonorrhea
|
43 Participants
|
48 Participants
|
SECONDARY outcome
Timeframe: Day 1The proportion of point of care gram stain results (control arm) or rapid test results (intervention arm) that were unavailable or invalid (unable to be read or provided an error message) at the time of the clinic visit.
Outcome measures
| Measure |
Standard of Care
n=49 Participants
Point-of-care gram stain
|
Rapid STI Test
n=49 Participants
Rapid 30-minute Desktop Assay: Participants will undergo routine evaluation and specimen collection per current clinic protocols. Specimens will be processed by the rapid 30-minute desktop assay. Concurrently, specimens will be used to create a point-of-care gram stain, to be read by the clinician following the clinical encounter.
Treatment for urethritis and cervicitis will be provided based on results from the 30-minute assay.
Specimens will also be plated for Gonorrhea culture and sent to the Massachusetts Department of Public Health for additional Gonorrhea and Chlamydia polymerase chain reaction testing, as per clinic protocols.
|
|---|---|---|
|
Proportion of Participants With Invalid or Unavailable Point of Care Gram Stain or Rapid STI Test Results
|
4 Participants
|
0 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: at study completion: 12 monthsClinic provider perspectives will be elicited during a focus group discussion at the conclusion of the clinical study.
Outcome measures
Outcome data not reported
Adverse Events
Standard of Care
Rapid STI Test
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