- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03098394
Use of a Rapid Test for Gonorrhea & Chlamydia for Women Presenting With Possible Sexually Transmitted Infections
August 8, 2023 updated by: Richard Gentry Wilkerson, University of Maryland, Baltimore
Use of a Rapid Turnaround Test for Gonorrhea & Chlamydia to Improve Treatment of Women Presenting With Possible Sexually Transmitted Infections
The purpose of this study is to evaluate the effect of utilizing a rapid turnaround CT/NG test on treatment of female patients in the emergency department or urgent care setting with possible STIs.
Study Overview
Status
Terminated
Intervention / Treatment
Detailed Description
All females ages 18-55 presenting to the University of Maryland Medical Center Emergency Department or Urgent Care whose provider suspects sexually transmitted infection will be offered study enrollment and be randomly assigned to either the control or the experimental group.
Both groups will have a urinalysis, a pregnancy test, a pelvic exam, and an endocervical sample collected, but the experimental group's urine will be used to run the rapid turnaround test (RTAT) instead of the standard PCR.
Data will be collected regarding provider decision making, length of stay in the emergency department, patient satisfaction, clinician satisfaction, further healthcare sought by patient, and cost surrounding each treatment.
Study Type
Interventional
Enrollment (Actual)
64
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Maryland
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Baltimore, Maryland, United States, 21201
- University of Maryland Medical Systems
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- Female patients age 18-55
- Signs or symptoms consistent with sexually transmitted infection
- Medical provider willing to consider the result of the rapid turnaround test in decision to treat for gonorrhea/chlamydia
- Must have a urine specimen obtained and a pelvic exam performed as part of the anticipated standard of care evaluation
- Provides informed consent
Exclusion Criteria:
- Signs of systemic infection
- Patient in whom the provider is unwilling to consider the result of the rapid turnaround test
- Patient who reports being treated for either gonorrhea or chlamydia in the preceding 3 months
- Patients undergoing evaluation for sexual assault
- Patients that are known to be pregnant or express concern that they may be pregnant
- Incarcerated patients
- Students/Employees of the facility
- Presence of any other condition(s) that the investigator feels makes the patient unsuitable for study inclusion.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 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.
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This diagnostic test will be used to help clinicians determine the need for antibiotic prescriptions in patients with a suspected sexually tract infection.
Other Names:
This is the standard of care for diagnosis of a suspected sexually transmitted infection.
Other Names:
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Active Comparator: 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.
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This is the standard of care for diagnosis of a suspected sexually transmitted infection.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of Participants Treated With Antibiotics
Time Frame: 7 days
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Evaluate the effect of a rapid turnaround CT/NG test compared to standard of care on antibiotic prescription for female patients with STI.
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7 days
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Length of Stay (Minutes)
Time Frame: 7 days
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Evaluate the effect of utilizing a rapid turnaround CT/NG test on length of stay (minutes) in the Emergency Department.
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7 days
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Percentage of Patients With Rapid Turnaround CT/NG (RPAT) Tests That Are CONSISTENT With Usual Care Test (PCR) in Subjects That Had Both Performed.
Time Frame: 7 days
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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).
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7 days
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Healthcare Costs.
Time Frame: 7 days
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Evaluate the effect of utilizing a rapid PCR test on healthcare costs.
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7 days
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Average Score for Patient Satisfaction With Provider Explanation.
Time Frame: 7 days
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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."
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7 days
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Average Score for Patient Satisfaction With Treatment Effectiveness.
Time Frame: 7 days
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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."
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7 days
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Average Score for Patient Satisfaction With Overall Experience.
Time Frame: 7 days
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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."
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7 days
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Number of Patients That Required Follow-up Care Within 7 Days
Time Frame: 7 days
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Compare need for additional healthcare utilization between the groups.
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7 days
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Average Score for Patient Satisfaction With Wait Times During Visit.
Time Frame: 7 days
|
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."
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7 days
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Richard G Wilkerson, MD, University of Maryland School of Medicine
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Newman LM, Moran JS, Workowski KA. Update on the management of gonorrhea in adults in the United States. Clin Infect Dis. 2007 Apr 1;44 Suppl 3:S84-101. doi: 10.1086/511422.
- Brook G. The performance of non-NAAT point-of-care (POC) tests and rapid NAAT tests for chlamydia and gonorrhoea infections. An assessment of currently available assays. Sex Transm Infect. 2015 Dec;91(8):539-44. doi: 10.1136/sextrans-2014-051997. Epub 2015 May 2.
- Gaydos CA. Review of use of a new rapid real-time PCR, the Cepheid GeneXpert(R) (Xpert) CT/NG assay, for Chlamydia trachomatis and Neisseria gonorrhoeae: results for patients while in a clinical setting. Expert Rev Mol Diagn. 2014 Mar;14(2):135-7. doi: 10.1586/14737159.2014.871495. Epub 2014 Jan 23.
- Gaydos CA, Van Der Pol B, Jett-Goheen M, Barnes M, Quinn N, Clark C, Daniel GE, Dixon PB, Hook EW 3rd; CT/NG Study Group. Performance of the Cepheid CT/NG Xpert Rapid PCR Test for Detection of Chlamydia trachomatis and Neisseria gonorrhoeae. J Clin Microbiol. 2013 Jun;51(6):1666-72. doi: 10.1128/JCM.03461-12. Epub 2013 Mar 6.
- Holley CE, Van Pham T, Mezzadra HM, Willis GC, Witting MD. Overtreatment of gonorrhea and chlamydial infections in 2 inner-city emergency departments. Am J Emerg Med. 2015 Sep;33(9):1265-8. doi: 10.1016/j.ajem.2015.06.009. Epub 2015 Jun 12.
- Tabrizi SN, Unemo M, Golparian D, Twin J, Limnios AE, Lahra M, Guy R; TTANGO Investigators. Analytical evaluation of GeneXpert CT/NG, the first genetic point-of-care assay for simultaneous detection of Neisseria gonorrhoeae and Chlamydia trachomatis. J Clin Microbiol. 2013 Jun;51(6):1945-7. doi: 10.1128/JCM.00806-13. Epub 2013 Apr 3.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
September 24, 2018
Primary Completion (Actual)
March 25, 2022
Study Completion (Actual)
June 20, 2023
Study Registration Dates
First Submitted
March 27, 2017
First Submitted That Met QC Criteria
March 27, 2017
First Posted (Actual)
March 31, 2017
Study Record Updates
Last Update Posted (Actual)
August 31, 2023
Last Update Submitted That Met QC Criteria
August 8, 2023
Last Verified
August 1, 2023
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Pathologic Processes
- Disease Attributes
- Gram-Negative Bacterial Infections
- Bacterial Infections
- Bacterial Infections and Mycoses
- Neisseriaceae Infections
- Chlamydiaceae Infections
- Sexually Transmitted Diseases, Bacterial
- Urogenital Diseases
- Genital Diseases
- Infections
- Communicable Diseases
- Chlamydia Infections
- Gonorrhea
- Sexually Transmitted Diseases
Other Study ID Numbers
- HP-00072766
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
IPD Plan Description
We do not plan on sharing any individual participant data with other researchers
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
Yes
product manufactured in and exported from the U.S.
Yes
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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