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

Primary Purpose

Sexually Transmitted Infection, Gonorrhea Female, Chlamydia Females

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Cepheid Xpert CT/NG Rapid Turnaround Test
Polymerase chain reaction (PCR)
Sponsored by
University of Maryland, Baltimore
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Sexually Transmitted Infection focused on measuring Rapid turnaround test, RTAT, Gonorrhea, Chlamydia, STI

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)FemaleAccepts 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.

Sites / Locations

  • University of Maryland Medical Systems

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Rapid Turnaround Test

Usual Care

Arm 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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Length of Stay (Minutes)
Evaluate the effect of utilizing a rapid turnaround CT/NG test on length of stay (minutes) in the Emergency Department.
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).
Healthcare Costs.
Evaluate the effect of utilizing a rapid PCR test on healthcare costs.
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."
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."
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."
Number of Patients That Required Follow-up Care Within 7 Days
Compare need for additional healthcare utilization between the groups.
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."

Full Information

First Posted
March 27, 2017
Last Updated
August 8, 2023
Sponsor
University of Maryland, Baltimore
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1. Study Identification

Unique Protocol Identification Number
NCT03098394
Brief Title
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

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Terminated
Why Stopped
Low enrollment
Study Start Date
September 24, 2018 (Actual)
Primary Completion Date
March 25, 2022 (Actual)
Study Completion Date
June 20, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Maryland, Baltimore

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sexually Transmitted Infection, Gonorrhea Female, Chlamydia Females
Keywords
Rapid turnaround test, RTAT, Gonorrhea, Chlamydia, STI

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
This is a prospective, non-blinded, randomized clinical control trial
Masking
ParticipantCare ProviderInvestigator
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.
Allocation
Randomized
Enrollment
64 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Rapid Turnaround Test
Arm Type
Experimental
Arm 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.
Arm Title
Usual Care
Arm Type
Active Comparator
Arm 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.
Intervention Type
Device
Intervention Name(s)
Cepheid Xpert CT/NG Rapid Turnaround Test
Other Intervention Name(s)
GeneXpert
Intervention Description
This diagnostic test will be used to help clinicians determine the need for antibiotic prescriptions in patients with a suspected sexually tract infection.
Intervention Type
Device
Intervention Name(s)
Polymerase chain reaction (PCR)
Other Intervention Name(s)
PCR
Intervention Description
This is the standard of care for diagnosis of a suspected sexually transmitted infection.
Primary Outcome Measure Information:
Title
Number of Participants Treated With Antibiotics
Description
Evaluate the effect of a rapid turnaround CT/NG test compared to standard of care on antibiotic prescription for female patients with STI.
Time Frame
7 days
Secondary Outcome Measure Information:
Title
Length of Stay (Minutes)
Description
Evaluate the effect of utilizing a rapid turnaround CT/NG test on length of stay (minutes) in the Emergency Department.
Time Frame
7 days
Title
Percentage of Patients With Rapid Turnaround CT/NG (RPAT) Tests That Are CONSISTENT With Usual Care Test (PCR) in Subjects That Had Both Performed.
Description
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).
Time Frame
7 days
Title
Healthcare Costs.
Description
Evaluate the effect of utilizing a rapid PCR test on healthcare costs.
Time Frame
7 days
Title
Average Score for Patient Satisfaction With Provider Explanation.
Description
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."
Time Frame
7 days
Title
Average Score for Patient Satisfaction With Treatment Effectiveness.
Description
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."
Time Frame
7 days
Title
Average Score for Patient Satisfaction With Overall Experience.
Description
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."
Time Frame
7 days
Title
Number of Patients That Required Follow-up Care Within 7 Days
Description
Compare need for additional healthcare utilization between the groups.
Time Frame
7 days
Title
Average Score for Patient Satisfaction With Wait Times During Visit.
Description
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."
Time Frame
7 days

10. Eligibility

Sex
Female
Gender Based
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.
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Richard G Wilkerson, MD
Organizational Affiliation
University of Maryland, Baltimore
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Maryland Medical Systems
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21201
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
We do not plan on sharing any individual participant data with other researchers
Citations:
PubMed Identifier
25935930
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.
Results Reference
background
PubMed Identifier
24450867
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.
Results Reference
background
PubMed Identifier
23467600
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.
Results Reference
background
PubMed Identifier
26119905
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.
Results Reference
background
PubMed Identifier
17342672
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.
Results Reference
background
PubMed Identifier
23554203
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.
Results Reference
background
Links:
URL
https://www.cdc.gov/std/stats14/surv-2014-print.pdf
Description
Sexually transmitted disease surveillance and statistics

Learn more about this trial

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

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