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

University of Maryland Baltimore (UMB) logo

University of Maryland Baltimore (UMB)

Status

Terminated

Conditions

Sexually Transmitted Infection
Gonorrhea Female
Chlamydia Females

Treatments

Device: Cepheid Xpert CT/NG Rapid Turnaround Test
Device: Polymerase chain reaction (PCR)

Study type

Interventional

Funder types

Other

Identifiers

NCT03098394
HP-00072766

Details and patient eligibility

About

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.

Full 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.

Enrollment

64 patients

Sex

Female

Ages

18 to 65 years old

Volunteers

Accepts Healthy Volunteers

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.

Trial design

Primary purpose

Diagnostic

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Triple Blind

64 participants in 2 patient groups

Rapid Turnaround Test
Experimental group
Description:
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.
Treatment:
Device: Polymerase chain reaction (PCR)
Device: Cepheid Xpert CT/NG Rapid Turnaround Test
Usual Care
Active Comparator group
Description:
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.
Treatment:
Device: Polymerase chain reaction (PCR)

Trial documents
1

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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