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Use of a Rapid Turnaround Test for NG/CT to Improve Treatment of Women Presenting With Possible STIs

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ClinicalTrials.gov Identifier: NCT03098394
Recruitment Status : Recruiting
First Posted : March 31, 2017
Last Update Posted : October 17, 2018
Sponsor:
Information provided by (Responsible Party):
Richard Gentry Wilkerson, University of Maryland

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.

Condition or disease Intervention/treatment Phase
Sexually Transmitted Infection Gonorrhea Female Chlamydia Females Device: Cepheid Xpert CT/NG Rapid Turnaround Test Device: Polymerase chain reaction (PCR) Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: This is a prospective, non-blinded, randomized clinical control trial
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.
Primary Purpose: Diagnostic
Official Title: Use of a Rapid Turnaround Test for Gonorrhea & Chlamydia to Improve Treatment of Women Presenting With Possible Sexually Transmitted Infections
Actual Study Start Date : September 24, 2018
Estimated Primary Completion Date : June 2019
Estimated Study Completion Date : October 2019

Resource links provided by the National Library of Medicine


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.
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 Name: GeneXpert

Device: Polymerase chain reaction (PCR)
This is the standard of care for diagnosis of a suspected sexually transmitted infection.
Other Name: 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 Name: PCR




Primary Outcome Measures :
  1. Rate of Overtreatment with Antibiotics [ Time Frame: One year ]
    Evaluate the effect of a rapid turnaround CT/NG test compared to standard of care on antibiotic prescription for female patients with STI.


Secondary Outcome Measures :
  1. Length of Stay [ Time Frame: One year ]
    Evaluate the effect of utilizing a rapid turnaround CT/NG test on length of stay in the Emergency Department.

  2. Test congruence [ Time Frame: One year ]
    Compare the congruence of test results between the rapid turnaround CT/NG test with the usual care test (send out PCR) in those subjects that have both performed (Experimental Group).

  3. Healthcare costs. [ Time Frame: One year ]
    Evaluate the effect of utilizing a rapid PCR test on healthcare costs.

  4. Patient and provider satisfaction [ Time Frame: One year ]
    Evaluate patient and provider satisfaction with the 2 diagnostic groups.

  5. Need for additional healthcare [ Time Frame: One year ]
    Compare need for additional healthcare utilization between the groups.



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Participant eligibility is not based on self-representation of gender identity. All participants in this study will receive a pelvic exam in the emergency department as well as a cervical swab for diagnostic testing.
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03098394


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

Locations
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United States, Maryland
University of Maryland Medical Systems Recruiting
Baltimore, Maryland, United States, 21201
Contact: R. Gentry Wilkerson, MD    410-328-4237    gwilkerson@som.umaryland.edu   
Sponsors and Collaborators
University of Maryland

Additional Information:
Publications:

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Responsible Party: Richard Gentry Wilkerson, Assistant Professor, University of Maryland
ClinicalTrials.gov Identifier: NCT03098394     History of Changes
Other Study ID Numbers: HP-00072766
First Posted: March 31, 2017    Key Record Dates
Last Update Posted: October 17, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: We do not plan on sharing any individual participant data with other researchers

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: Yes

Keywords provided by Richard Gentry Wilkerson, University of Maryland:
Rapid turnaround test
RTAT
Gonorrhea
Chlamydia
STI

Additional relevant MeSH terms:
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Sexually Transmitted Diseases
Sexually Transmitted Diseases, Bacterial
Genital Diseases, Male
Genital Diseases, Female
Virus Diseases
Infection
Chlamydia Infections
Gonorrhea
Chlamydiaceae Infections
Gram-Negative Bacterial Infections
Bacterial Infections
Neisseriaceae Infections