Trial Outcomes & Findings for Use of a Rapid Test for Gonorrhea & Chlamydia for Women Presenting With Possible Sexually Transmitted Infections (NCT NCT03098394)
NCT ID: NCT03098394
Last Updated: 2023-08-31
Results Overview
Evaluate the effect of a rapid turnaround CT/NG test compared to standard of care on antibiotic prescription for female patients with STI.
Recruitment status
TERMINATED
Study phase
NA
Target enrollment
64 participants
Primary outcome timeframe
7 days
Results posted on
2023-08-31
Participant Flow
Participant milestones
| Measure |
Rapid Turnaround Test
Patients randomized to this arm will be tested for a sexually transmitted infection (STI) with both the rapid nucleic acid amplification test (NAAT) as well as the conventional polymerase chain reaction (PCR) test. The results from the rapid turnaround test will guide providers on treatment decisions for a possible STI. The results from the PCR test will be used to verify the results of the rapid turnaround test.
Cepheid Xpert CT/NG Rapid Turnaround Test: This diagnostic test will be used to help clinicians determine the need for antibiotic prescriptions in patients with a suspected sexually tract infection.
Polymerase chain reaction (PCR): This is the standard of care for diagnosis of a suspected sexually transmitted infection.
|
Usual Care
Patients randomized to this arm will be tested for a sexually transmitted infection (STI) using the conventional PCR test. The results from the PCR test normally take approximately 48-72 hours and these patients will likely receive treatment based on the decision of the clinical provider. The results from the PCR test will be used to verify the decision of the clinical provider to treat or withhold treatment for a possible STI.
Polymerase chain reaction (PCR): This is the standard of care for diagnosis of a suspected sexually transmitted infection.
|
|---|---|---|
|
Overall Study
STARTED
|
30
|
34
|
|
Overall Study
COMPLETED
|
30
|
33
|
|
Overall Study
NOT COMPLETED
|
0
|
1
|
Reasons for withdrawal
| Measure |
Rapid Turnaround Test
Patients randomized to this arm will be tested for a sexually transmitted infection (STI) with both the rapid nucleic acid amplification test (NAAT) as well as the conventional polymerase chain reaction (PCR) test. The results from the rapid turnaround test will guide providers on treatment decisions for a possible STI. The results from the PCR test will be used to verify the results of the rapid turnaround test.
Cepheid Xpert CT/NG Rapid Turnaround Test: This diagnostic test will be used to help clinicians determine the need for antibiotic prescriptions in patients with a suspected sexually tract infection.
Polymerase chain reaction (PCR): This is the standard of care for diagnosis of a suspected sexually transmitted infection.
|
Usual Care
Patients randomized to this arm will be tested for a sexually transmitted infection (STI) using the conventional PCR test. The results from the PCR test normally take approximately 48-72 hours and these patients will likely receive treatment based on the decision of the clinical provider. The results from the PCR test will be used to verify the decision of the clinical provider to treat or withhold treatment for a possible STI.
Polymerase chain reaction (PCR): This is the standard of care for diagnosis of a suspected sexually transmitted infection.
|
|---|---|---|
|
Overall Study
Pregnancy
|
0
|
1
|
Baseline Characteristics
Use of a Rapid Test for Gonorrhea & Chlamydia for Women Presenting With Possible Sexually Transmitted Infections
Baseline characteristics by cohort
| Measure |
Rapid Turnaround Test
n=30 Participants
Patients randomized to this arm will be tested for a sexually transmitted infection (STI) with both the rapid nucleic acid amplification test (NAAT) as well as the conventional polymerase chain reaction (PCR) test. The results from the rapid turnaround test will guide providers on treatment decisions for a possible STI. The results from the PCR test will be used to verify the results of the rapid turnaround test.
Cepheid Xpert CT/NG Rapid Turnaround Test: This diagnostic test will be used to help clinicians determine the need for antibiotic prescriptions in patients with a suspected sexually tract infection.
Polymerase chain reaction (PCR): This is the standard of care for diagnosis of a suspected sexually transmitted infection.
|
Usual Care
n=33 Participants
Patients randomized to this arm will be tested for a sexually transmitted infection (STI) using the conventional PCR test. The results from the PCR test normally take approximately 48-72 hours and these patients will likely receive treatment based on the decision of the clinical provider. The results from the PCR test will be used to verify the decision of the clinical provider to treat or withhold treatment for a possible STI.
Polymerase chain reaction (PCR): This is the standard of care for diagnosis of a suspected sexually transmitted infection.
|
Total
n=63 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
30 Participants
n=99 Participants
|
33 Participants
n=107 Participants
|
63 Participants
n=206 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Continuous
|
30.3 years
n=99 Participants
|
29 years
n=107 Participants
|
29.6 years
n=206 Participants
|
|
Sex: Female, Male
Female
|
30 Participants
n=99 Participants
|
33 Participants
n=107 Participants
|
63 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 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
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
30 Participants
n=99 Participants
|
33 Participants
n=107 Participants
|
63 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
30 participants
n=99 Participants
|
33 participants
n=107 Participants
|
63 participants
n=206 Participants
|
|
Presence of signs or symptoms of STIs
|
30 Participants
n=99 Participants
|
33 Participants
n=107 Participants
|
63 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: 7 daysPopulation: Intention to treat
Evaluate the effect of a rapid turnaround CT/NG test compared to standard of care on antibiotic prescription for female patients with STI.
Outcome measures
| Measure |
Rapid Turnaround Test
n=30 Participants
Patients randomized to this arm will be tested for a sexually transmitted infection (STI) with both the rapid nucleic acid amplification test (NAAT) as well as the conventional polymerase chain reaction (PCR) test. The results from the rapid turnaround test will guide providers on treatment decisions for a possible STI. The results from the PCR test will be used to verify the results of the rapid turnaround test.
Cepheid Xpert CT/NG Rapid Turnaround Test: This diagnostic test will be used to help clinicians determine the need for antibiotic prescriptions in patients with a suspected sexually tract infection.
Polymerase chain reaction (PCR): This is the standard of care for diagnosis of a suspected sexually transmitted infection.
|
Usual Care
n=33 Participants
Patients randomized to this arm will be tested for a sexually transmitted infection (STI) using the conventional PCR test. The results from the PCR test normally take approximately 48-72 hours and these patients will likely receive treatment based on the decision of the clinical provider. The results from the PCR test will be used to verify the decision of the clinical provider to treat or withhold treatment for a possible STI.
Polymerase chain reaction (PCR): This is the standard of care for diagnosis of a suspected sexually transmitted infection.
|
|---|---|---|
|
Number of Participants Treated With Antibiotics
|
4 Participants
|
10 Participants
|
SECONDARY outcome
Timeframe: 7 daysEvaluate the effect of utilizing a rapid turnaround CT/NG test on length of stay (minutes) in the Emergency Department.
Outcome measures
| Measure |
Rapid Turnaround Test
n=30 Participants
Patients randomized to this arm will be tested for a sexually transmitted infection (STI) with both the rapid nucleic acid amplification test (NAAT) as well as the conventional polymerase chain reaction (PCR) test. The results from the rapid turnaround test will guide providers on treatment decisions for a possible STI. The results from the PCR test will be used to verify the results of the rapid turnaround test.
Cepheid Xpert CT/NG Rapid Turnaround Test: This diagnostic test will be used to help clinicians determine the need for antibiotic prescriptions in patients with a suspected sexually tract infection.
Polymerase chain reaction (PCR): This is the standard of care for diagnosis of a suspected sexually transmitted infection.
|
Usual Care
n=33 Participants
Patients randomized to this arm will be tested for a sexually transmitted infection (STI) using the conventional PCR test. The results from the PCR test normally take approximately 48-72 hours and these patients will likely receive treatment based on the decision of the clinical provider. The results from the PCR test will be used to verify the decision of the clinical provider to treat or withhold treatment for a possible STI.
Polymerase chain reaction (PCR): This is the standard of care for diagnosis of a suspected sexually transmitted infection.
|
|---|---|---|
|
Length of Stay (Minutes)
|
200.6896552 minutes
Standard Deviation 48.12936692
|
129.6060606 minutes
Standard Deviation 60.9717862
|
SECONDARY outcome
Timeframe: 7 daysPopulation: Four patients received indeterminate results on either their RTAT or their Usual Care (PCR) tests.
Compare the congruence of test results between the rapid turnaround CT/NG test with the usual care test (send out PCR) in subjects that have both performed (Experimental Group).
Outcome measures
| Measure |
Rapid Turnaround Test
n=26 Participants
Patients randomized to this arm will be tested for a sexually transmitted infection (STI) with both the rapid nucleic acid amplification test (NAAT) as well as the conventional polymerase chain reaction (PCR) test. The results from the rapid turnaround test will guide providers on treatment decisions for a possible STI. The results from the PCR test will be used to verify the results of the rapid turnaround test.
Cepheid Xpert CT/NG Rapid Turnaround Test: This diagnostic test will be used to help clinicians determine the need for antibiotic prescriptions in patients with a suspected sexually tract infection.
Polymerase chain reaction (PCR): This is the standard of care for diagnosis of a suspected sexually transmitted infection.
|
Usual Care
Patients randomized to this arm will be tested for a sexually transmitted infection (STI) using the conventional PCR test. The results from the PCR test normally take approximately 48-72 hours and these patients will likely receive treatment based on the decision of the clinical provider. The results from the PCR test will be used to verify the decision of the clinical provider to treat or withhold treatment for a possible STI.
Polymerase chain reaction (PCR): This is the standard of care for diagnosis of a suspected sexually transmitted infection.
|
|---|---|---|
|
Percentage of Patients With Rapid Turnaround CT/NG (RPAT) Tests That Are CONSISTENT With Usual Care Test (PCR) in Subjects That Had Both Performed.
|
92.307 percentage of total RTAT + PCR patients
|
—
|
SECONDARY outcome
Timeframe: 7 daysPopulation: Heatlhcare cost data was not collected, thus could not be analyzed and reported.
Evaluate the effect of utilizing a rapid PCR test on healthcare costs.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 7 daysPopulation: Patient counts for average satisfaction with provider explanation differ from total patient counts due to difficulty contacting patients for satisfaction surveys.
Evaluate patient satisfaction with provider's explanations for the 2 diagnostic groups. Patients were asked to rate their satisfaction with their provider's explanations on a five point scale, with 0 being "not at all satisfied" and 4 being "very satisfied."
Outcome measures
| Measure |
Rapid Turnaround Test
n=26 Participants
Patients randomized to this arm will be tested for a sexually transmitted infection (STI) with both the rapid nucleic acid amplification test (NAAT) as well as the conventional polymerase chain reaction (PCR) test. The results from the rapid turnaround test will guide providers on treatment decisions for a possible STI. The results from the PCR test will be used to verify the results of the rapid turnaround test.
Cepheid Xpert CT/NG Rapid Turnaround Test: This diagnostic test will be used to help clinicians determine the need for antibiotic prescriptions in patients with a suspected sexually tract infection.
Polymerase chain reaction (PCR): This is the standard of care for diagnosis of a suspected sexually transmitted infection.
|
Usual Care
n=30 Participants
Patients randomized to this arm will be tested for a sexually transmitted infection (STI) using the conventional PCR test. The results from the PCR test normally take approximately 48-72 hours and these patients will likely receive treatment based on the decision of the clinical provider. The results from the PCR test will be used to verify the decision of the clinical provider to treat or withhold treatment for a possible STI.
Polymerase chain reaction (PCR): This is the standard of care for diagnosis of a suspected sexually transmitted infection.
|
|---|---|---|
|
Average Score for Patient Satisfaction With Provider Explanation.
|
3.346153846 score on a scale
Standard Deviation 0.745241314
|
3.24137931 score on a scale
Standard Deviation 0.872401137
|
SECONDARY outcome
Timeframe: 7 daysPopulation: Patient counts for average satisfaction with treatment effectiveness differ from total patient counts due to difficulty contacting patients for satisfaction surveys.
Evaluate patient satisfaction with treatment effectiveness for the 2 diagnostic groups. Patients were asked to rate their satisfaction with their treatment effectiveness on a five point scale, with 0 being "not at all satisfied" and 4 being "very satisfied."
Outcome measures
| Measure |
Rapid Turnaround Test
n=26 Participants
Patients randomized to this arm will be tested for a sexually transmitted infection (STI) with both the rapid nucleic acid amplification test (NAAT) as well as the conventional polymerase chain reaction (PCR) test. The results from the rapid turnaround test will guide providers on treatment decisions for a possible STI. The results from the PCR test will be used to verify the results of the rapid turnaround test.
Cepheid Xpert CT/NG Rapid Turnaround Test: This diagnostic test will be used to help clinicians determine the need for antibiotic prescriptions in patients with a suspected sexually tract infection.
Polymerase chain reaction (PCR): This is the standard of care for diagnosis of a suspected sexually transmitted infection.
|
Usual Care
n=30 Participants
Patients randomized to this arm will be tested for a sexually transmitted infection (STI) using the conventional PCR test. The results from the PCR test normally take approximately 48-72 hours and these patients will likely receive treatment based on the decision of the clinical provider. The results from the PCR test will be used to verify the decision of the clinical provider to treat or withhold treatment for a possible STI.
Polymerase chain reaction (PCR): This is the standard of care for diagnosis of a suspected sexually transmitted infection.
|
|---|---|---|
|
Average Score for Patient Satisfaction With Treatment Effectiveness.
|
3.153846154 score on a scale
Standard Deviation 0.731699812
|
3.206896552 score on a scale
Standard Deviation 0.726012118
|
SECONDARY outcome
Timeframe: 7 daysPopulation: Patient counts for average satisfaction with overall experience differ from total patient counts due to difficulty contacting patients for satisfaction surveys.
Evaluate patient satisfaction with overall experience during visit for the 2 diagnostic groups. Patients were asked to rate their satisfaction with their wait times on a five point scale, with 0 being "not at all satisfied" and 4 being "very satisfied."
Outcome measures
| Measure |
Rapid Turnaround Test
n=26 Participants
Patients randomized to this arm will be tested for a sexually transmitted infection (STI) with both the rapid nucleic acid amplification test (NAAT) as well as the conventional polymerase chain reaction (PCR) test. The results from the rapid turnaround test will guide providers on treatment decisions for a possible STI. The results from the PCR test will be used to verify the results of the rapid turnaround test.
Cepheid Xpert CT/NG Rapid Turnaround Test: This diagnostic test will be used to help clinicians determine the need for antibiotic prescriptions in patients with a suspected sexually tract infection.
Polymerase chain reaction (PCR): This is the standard of care for diagnosis of a suspected sexually transmitted infection.
|
Usual Care
n=30 Participants
Patients randomized to this arm will be tested for a sexually transmitted infection (STI) using the conventional PCR test. The results from the PCR test normally take approximately 48-72 hours and these patients will likely receive treatment based on the decision of the clinical provider. The results from the PCR test will be used to verify the decision of the clinical provider to treat or withhold treatment for a possible STI.
Polymerase chain reaction (PCR): This is the standard of care for diagnosis of a suspected sexually transmitted infection.
|
|---|---|---|
|
Average Score for Patient Satisfaction With Overall Experience.
|
3.346153846 score on a scale
Standard Deviation 0.561591146
|
3.275862069 score on a scale
Standard Deviation 0.797162455
|
SECONDARY outcome
Timeframe: 7 daysPopulation: Total number of participants for this analysis differ from total number of participants in overall study due to difficulty contacting some patients for data collection after initial hospital visit.
Compare need for additional healthcare utilization between the groups.
Outcome measures
| Measure |
Rapid Turnaround Test
n=27 Participants
Patients randomized to this arm will be tested for a sexually transmitted infection (STI) with both the rapid nucleic acid amplification test (NAAT) as well as the conventional polymerase chain reaction (PCR) test. The results from the rapid turnaround test will guide providers on treatment decisions for a possible STI. The results from the PCR test will be used to verify the results of the rapid turnaround test.
Cepheid Xpert CT/NG Rapid Turnaround Test: This diagnostic test will be used to help clinicians determine the need for antibiotic prescriptions in patients with a suspected sexually tract infection.
Polymerase chain reaction (PCR): This is the standard of care for diagnosis of a suspected sexually transmitted infection.
|
Usual Care
n=30 Participants
Patients randomized to this arm will be tested for a sexually transmitted infection (STI) using the conventional PCR test. The results from the PCR test normally take approximately 48-72 hours and these patients will likely receive treatment based on the decision of the clinical provider. The results from the PCR test will be used to verify the decision of the clinical provider to treat or withhold treatment for a possible STI.
Polymerase chain reaction (PCR): This is the standard of care for diagnosis of a suspected sexually transmitted infection.
|
|---|---|---|
|
Number of Patients That Required Follow-up Care Within 7 Days
|
4 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: 7 daysPopulation: Patient counts for average satisfaction with wait times differ from total patient counts due to difficulty contacting patients for satisfaction surveys.
Evaluate patient satisfaction with wait times during visit for the 2 diagnostic groups. Patients were asked to rate their satisfaction with their wait times on a five point scale, with 0 being "not at all satisfied" and 4 being "very satisfied."
Outcome measures
| Measure |
Rapid Turnaround Test
n=26 Participants
Patients randomized to this arm will be tested for a sexually transmitted infection (STI) with both the rapid nucleic acid amplification test (NAAT) as well as the conventional polymerase chain reaction (PCR) test. The results from the rapid turnaround test will guide providers on treatment decisions for a possible STI. The results from the PCR test will be used to verify the results of the rapid turnaround test.
Cepheid Xpert CT/NG Rapid Turnaround Test: This diagnostic test will be used to help clinicians determine the need for antibiotic prescriptions in patients with a suspected sexually tract infection.
Polymerase chain reaction (PCR): This is the standard of care for diagnosis of a suspected sexually transmitted infection.
|
Usual Care
n=30 Participants
Patients randomized to this arm will be tested for a sexually transmitted infection (STI) using the conventional PCR test. The results from the PCR test normally take approximately 48-72 hours and these patients will likely receive treatment based on the decision of the clinical provider. The results from the PCR test will be used to verify the decision of the clinical provider to treat or withhold treatment for a possible STI.
Polymerase chain reaction (PCR): This is the standard of care for diagnosis of a suspected sexually transmitted infection.
|
|---|---|---|
|
Average Score for Patient Satisfaction With Wait Times During Visit.
|
3.038461538 score on a scale
Standard Deviation 0.999230473
|
2.931034483 score on a scale
Standard Deviation 0.923155864
|
Adverse Events
Rapid Turnaround Test
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Usual Care
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Richard Gentry Wilkerson
University of Maryland School of Medicine
Phone: 4103285555
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place