Sexually Transmitted InfectionNCT03098394

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

A study testing Cepheid Xpert CT/NG Rapid Turnaround Test and Polymerase chain reaction (PCR) in people with Sexually Transmitted Infection and Gonorrhea Female, run by University of Maryland, Baltimore at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 18 to 65 years, women onlyHealthy volunteers can take part
Conditions the study is for: Sexually Transmitted Infection, Gonorrhea Female, Chlamydia Females
What is being tested?: Cepheid Xpert CT/NG Rapid Turnaround Test and Polymerase chain reaction (PCR)
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 64 participants
Where: 1 siteUnited States
Study dates: 24 Sep 2018to 20 Jun 2023
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 65 years
Women only
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

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

Who cannot join

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 locations and contacts

1 site in 1 country.

United States1 site

University of Maryland Medical Systems
Baltimore, Maryland, 21201

Other trials in United States

About this study

Official title: Use of a Rapid Turnaround Test for Gonorrhea & Chlamydia to Improve Treatment of Women Presenting With Possible Sexually Transmitted Infections

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.

Read the 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.

Conditions: Sexually Transmitted Infection, Gonorrhea Female, Chlamydia Females
Being tested: Cepheid Xpert CT/NG Rapid Turnaround Test, Polymerase chain reaction (PCR)
Keywords: Rapid turnaround test, RTAT, Gonorrhea, Chlamydia, STI
Medical subject headings: Sexually Transmitted Diseases, Gonorrhea, Chlamydia Infections

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Cepheid Xpert CT/NG Rapid Turnaround TestDevice
Also called GeneXpert
This diagnostic test will be used to help clinicians determine the need for antibiotic prescriptions in patients with a suspected sexually tract infection.
Polymerase chain reaction (PCR)Device
Also called PCR
This is the standard of care for diagnosis of a suspected sexually transmitted infection.

Study groups in NCT03098394
Study group	Role	What they receive
Rapid Turnaround Test	Experimental	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. Receives: Device: Cepheid Xpert CT/NG Rapid Turnaround Test; Device: Polymerase chain reaction (PCR)
Usual Care	Active comparator	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. Receives: Device: Polymerase chain reaction (PCR)

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 7 days

Secondary outcomes (8)

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

24 Sep 201820 Jun 2023

First posted31 Mar 2017
Study start24 Sep 2018
Primary completion25 Mar 2022
Study completion20 Jun 2023

Why it stopped: Low enrollment

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (6)Papers the sponsor has linked to this study.
Other trials for Sexually Transmitted InfectionStudies of the same condition, open and under way.
More trials run by University of Maryland, BaltimoreThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Diagnosis
Allocation: Randomised
Intervention model: Parallel groups
Model description: This is a prospective, non-blinded, randomized clinical control trial
Masking: Triple blind
Who is masked: Participant, Care provider, Investigator
Enrolment: 64 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03098394
Sponsor's protocol ID: HP-00072766
Status last verified: Aug 2023
First submitted: 27 Mar 2017
Last updated: 31 Aug 2023
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: Yes
Individual data sharing: No: We do not plan on sharing any individual participant data with other researchers

Publications

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.
PubMed 25935930
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.
PubMed 24450867
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.
PubMed 23467600
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.
PubMed 26119905
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.
PubMed 17342672
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.
PubMed 23554203

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Sexually Transmitted Infection trials

Study at a glance

From the registry record, last updated by the sponsor on 31 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Use of a Rapid Turnaround Test for Gonorrhea & Chlamydia to Improve Treatment of Women Presenting With Possible Sexually Transmitted Infections
ClinicalTrials.gov ID: NCT03098394
Acronym / sponsor ID: HP-00072766
Conditions: Sexually Transmitted Infection, Gonorrhea Female, Chlamydia Females
Keywords: Rapid turnaround test, RTAT, Gonorrhea, Chlamydia, STI
Study type: Interventional
Recruitment status: TerminatedReason stopped: Low enrollment
Enrolment: 64 participants (actual)
Lead sponsor: University of Maryland, BaltimoreUniversity, hospital or other
Study start: 24 Sep 2018 (actual)
Primary completion: 25 Mar 2022 (actual)
Study completion: 20 Jun 2023 (actual)
First posted: 31 Mar 2017 (actual)
Results: Posted 31 Aug 2023

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

Study design

Primary purpose: Diagnosis
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, care provider, investigator)
Number of arms: 2
Model description: This is a prospective, non-blinded, randomized clinical control trial

Arm	Type	Receives
Rapid Turnaround Test	Experimental	Device: Cepheid Xpert CT/NG Rapid Turnaround Test, Device: Polymerase chain reaction (PCR)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.
Usual Care	Active comparator	Device: Polymerase chain reaction (PCR)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.

Who may qualify

Ages: 18 to 65 years
Sex: Female only
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

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

Key exclusion criteria (8 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Cepheid Xpert CT/NG Rapid Turnaround TestAlso: GeneXpertThis diagnostic test will be used to help clinicians determine the need for antibiotic prescriptions in patients with a suspected sexually tract infection.	Device	Rapid Turnaround Test
Polymerase chain reaction (PCR)Also: PCRThis is the standard of care for diagnosis of a suspected sexually transmitted infection.	Device	Rapid Turnaround Test, Usual Care

Primary outcome

Number of Participants Treated With Antibiotics
Time frame: 7 days
Evaluate the effect of a rapid turnaround CT/NG test compared to standard of care on antibiotic prescription for female patients with STI.

8 secondary outcomes

Length of Stay (Minutes)
Time frame: 7 days
Percentage of Patients With Rapid Turnaround CT/NG (RPAT) Tests That Are CONSISTENT With Usual Care Test (PCR) in Subjects That Had Both Performed.
Time frame: 7 days
Healthcare Costs.
Time frame: 7 days
Average Score for Patient Satisfaction With Provider Explanation.
Time frame: 7 days
Average Score for Patient Satisfaction With Treatment Effectiveness.
Time frame: 7 days
Average Score for Patient Satisfaction With Overall Experience.
Time frame: 7 days
Number of Patients That Required Follow-up Care Within 7 Days
Time frame: 7 days
Average Score for Patient Satisfaction With Wait Times During Visit.
Time frame: 7 days

Results and safety

Results posted to the registry on 31 Aug 2023, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Rapid Turnaround Test	30	30
Usual Care	34	33

Primary outcome: Number of Participants Treated With Antibiotics

Time frame: 7 days. Count of participants. Unit: Participants

Measure	Rapid Turnaround Test n = 30	Usual Care n = 33
Value	4	10

Population analysed: Intention to treat

8 secondary outcomes are reported in the full results.

Adverse events

Time frame: 7 Days. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Rapid Turnaround Test	0 of 30 (0%)	0 of 30 (0%)	0 of 30
Usual Care	0 of 33 (0%)	0 of 33 (0%)	0 of 33

Limitations and caveats (from the sponsor): Early termination leading to small numbers of subjects enrolled

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 31 Aug 2023.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 25935930Brook 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.
Background: PubMed 24450867Gaydos 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.
Background: PubMed 23467600Gaydos 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.
Background: PubMed 26119905Holley 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.
Background: PubMed 17342672Newman 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.
Background: PubMed 23554203Tabrizi 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.
Individual participant dataSharing planned: No. We do not plan on sharing any individual participant data with other researchers

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Richard G Wilkerson, MD principal investigator

University of Maryland, Baltimore

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 31 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 31 Aug 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants Treated With Antibiotics (time frame: 7 days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03098394, which also lists 6 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Aug 2023.