Purpose

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.

Conditions

Eligibility

Eligible Ages
Between 18 Years and 65 Years
Eligible Genders
Female
Accepts Healthy Volunteers
Yes

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 Design

Phase
N/A
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Intervention Model Description
This is a prospective, non-blinded, randomized clinical control trial
Primary Purpose
Diagnostic
Masking
Triple (Participant, Care Provider, Investigator)
Masking Description
Participants, investigators, and care providers will be masked to the experimental or control arm prior to enrollment in the study. Once the participant has been enrolled in the study, they will be randomized to either the control arm or the experimental arm. Once randomization has occurred, participants, care providers, and the investigators will know which group the participants are in.

Arm Groups

ArmDescriptionAssigned Intervention
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.
  • 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.
    Other names:
    • GeneXpert
  • Device: Polymerase chain reaction (PCR)
    This is the standard of care for diagnosis of a suspected sexually transmitted infection.
    Other names:
    • PCR
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.
  • Device: Polymerase chain reaction (PCR)
    This is the standard of care for diagnosis of a suspected sexually transmitted infection.
    Other names:
    • PCR

Recruiting Locations

University of Maryland Medical Systems
Baltimore, Maryland 21201
Contact:
R. Gentry Wilkerson, MD
410-328-4237
gwilkerson@som.umaryland.edu

More Details

NCT ID
NCT03098394
Status
Recruiting
Sponsor
University of Maryland

Study Contact

Thomas del Ninno, MD
410-328-4237
tdelninno@em.umaryland.edu

Detailed Description

All females ages 18-55 presenting to the UMMC 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.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.