Use of a Rapid Test for Gonorrhea & Chlamydia for Women Presenting With Possible Sexually Transmitted Infections

Sexually Transmitted Infection Clinical Trial

Official title:

Use of a Rapid Turnaround Test for Gonorrhea & Chlamydia to Improve Treatment of Women Presenting With Possible Sexually Transmitted Infections

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03098394
• Other study ID #: HP-00072766
• Status: Terminated
• Phase: N/A
• Start date: September 24, 2018
• Est. completion date: June 20, 2023

Study information

• Verified date: August 2023
• Source: University of Maryland, Baltimore
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 64
• Est. completion date: June 20, 2023
• Est. primary completion date: March 25, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Chlamydia Females
• Chlamydia Infections
• Communicable Diseases
• Gonorrhea
• Gonorrhea Female
• Infections
• Sexually Transmitted Diseases
• Sexually Transmitted Infection

Intervention

Device:
• 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.

Locations

Country	Name	City	State
United States	University of Maryland Medical Systems	Baltimore	Maryland

Sponsors (1)

Lead Sponsor	Collaborator
University of Maryland, Baltimore

Country where clinical trial is conducted

United States, 

References & Publications (6)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants Treated With Antibiotics	Evaluate the effect of a rapid turnaround CT/NG test compared to standard of care on antibiotic prescription for female patients with STI.	7 days
Secondary	Length of Stay (Minutes)	Evaluate the effect of utilizing a rapid turnaround CT/NG test on length of stay (minutes) in the Emergency Department.	7 days
Secondary	Percentage of Patients With Rapid Turnaround CT/NG (RPAT) Tests That Are CONSISTENT With Usual Care Test (PCR) in Subjects That Had Both Performed.	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).	7 days
Secondary	Healthcare Costs.	Evaluate the effect of utilizing a rapid PCR test on healthcare costs.	7 days
Secondary	Average Score for Patient Satisfaction With Provider Explanation.	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."	7 days
Secondary	Average Score for Patient Satisfaction With Treatment Effectiveness.	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."	7 days
Secondary	Average Score for Patient Satisfaction With Overall Experience.	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."	7 days
Secondary	Number of Patients That Required Follow-up Care Within 7 Days	Compare need for additional healthcare utilization between the groups.	7 days
Secondary	Average Score for Patient Satisfaction With Wait Times During Visit.	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."	7 days

External Links

•   Sexually transmitted disease surveillance and statistics