Clinical trial NCT03098394: Use of a Rapid Test for Gonorrhea & Chlamydia for Women Presenting With Possible Sexually Transmitted Infections
Official title: Use of a Rapid Turnaround Test for Gonorrhea & Chlamydia to Improve Treatment of Women Presenting With Possible Sexually Transmitted Infections
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Sexually Transmitted Infection
Gonorrhea Female
Chlamydia Females
Keywords: Rapid turnaround test
RTAT
Gonorrhea
Chlamydia
STI
Lead sponsor: University of Maryland, Baltimore
Sponsor class: OTHER
First posted: 2017-03-31
Enrollment: 64
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This is a prospective, non-blinded, randomized clinical control trial
Primary purpose: DIAGNOSTIC

Brief 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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Number of Participants Treated With Antibiotics
timeFrame: 7 days
Secondary outcomes:
measure: Length of Stay (Minutes)
timeFrame: 7 days
measure: Percentage of Patients With Rapid Turnaround CT/NG (RPAT) Tests That Are CONSISTENT With Usual Care Test (PCR) in Subjects That Had Both Performed.
timeFrame: 7 days
measure: Healthcare Costs.
timeFrame: 7 days
measure: Average Score for Patient Satisfaction With Provider Explanation.
timeFrame: 7 days
measure: Average Score for Patient Satisfaction With Treatment Effectiveness.
timeFrame: 7 days
measure: Average Score for Patient Satisfaction With Overall Experience.
timeFrame: 7 days
measure: Number of Patients That Required Follow-up Care Within 7 Days
timeFrame: 7 days
measure: Average Score for Patient Satisfaction With Wait Times During Visit.
timeFrame: 7 days
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: University of Maryland Medical Systems
state: Maryland
Study officials:
affiliation: University of Maryland, Baltimore
name: Richard G Wilkerson, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
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.
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.
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.
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.
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.