Reproductive Tract InfectionsNCT01989130
Evaluation of Immediate v. Delayed CT/NG Test for Treatment in the ED
A study testing Roche AMPLICOR CT/NG and Cepheid Xpert CT/NG Test in people with Reproductive Tract Infections, run by George Washington University at 1 site in United States.
Trial summary
The purpose of this study is to determine if immediate availability of GeneXpert® CT/NG test results reduces the overtreatment rate for ED patients with suspected gonorrhea or chlamydia and to assess changes in clinician management decisions with real-time test results. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Reproductive Tract Infections
- What is being tested?
- Roche AMPLICOR CT/NG and Cepheid Xpert CT/NG Test
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2013to Mar 2015
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- greater than 18 years
- clinical suspicion of CT/NG
- able to give informed consent
- willingness to wait for test result
Who cannot join
- less than 18 years
- pregnancy
- prisoners
- unable to give informed consent
Trial locations and contacts
1 site in 1 country.
United States1 site
The George Washington University Hospital
Washington D.C., District of Columbia, 20036
About this study
Official title: Evaluation of the Cepheid Xpert CT/NG For Management of STI in the ED: Immediate V. Delayed Test Results
The purpose of this study is to determine if immediate availability of GeneXpert® CT/NG test results reduces the overtreatment rate for ED patients with suspected gonorrhea or chlamydia and to assess changes in clinician management decisions with real-time test results.
Read the detailed description
The investigators will conduct a randomized controlled trial in patients aged 18 and older where the treating clinician is ordering a CT/NG test. Clinicians will be approached by a research assistant while they are in the ED and asked whether a CT/NG swab will be ordered and if CT/NG is in the differential diagnosis. Then, potentially eligible patients will be approached and asked for consent to enroll. For patients that consent, simple randomization procedure (i.e. random number generator) will be used to assign patients to either immediate test results or delayed test results. Typically, in the ED these tests are ordered for diagnostic rather than screening purposes (symptoms of vaginal discharge, abdominal pain, etc). Patients will be randomized to batched testing with the Roche AMPLICOR CT/NG (standard of care, control group) or immediate testing of clinical specimens with Cepheid CT/NG with real-time result reporting (within 90 minutes) to the treating clinician in the ED. Patient interview and clinician survey will be conducted to ascertain perceptions of illness and the test. A follow up interview will be conducted with the patient to determine clinical and public health outcomes.
A validation of the Cepheid CT/NG test will be conducted against the hospital standard of care on </= 40 pilot participants. Pilot participants will be asked to provide 2 endocervical swabs and a urine specimen. All surveys and interviews will be conducted on pilot patients.
While many outcomes can be measured in this study, the investigators will power this study to reduce the overtreatment rate with antibiotics. Assuming a baseline overtreatment rate of 88% (# treated with antibiotics/# without disease), to reduce this rate by 50% (to 44%), at a power of 80% and alpha of 0.05, the investigators will need to enroll 42 patients (21 controls and 21 study patients) with negative tests. Given an estimated positive rate of 6%, and that approximately 50% of patients who receive these tests for any reason will be treated empirically with antibiotics, the investigators think that enrolling a total of 70 patients with full data (enrollment survey, clinician survey, and follow up survey) would be sufficient to identify trends with this subject matter. Due to the sensitive nature of the subject matter and the high percentages of lost-to-follow up with ED patients, the investigators estimate approximately 50% will have incomplete data. Therefore, the investigators request to enroll 150 patients in the study.
- Conditions
- Reproductive Tract Infections
- Being tested
- Roche AMPLICOR CT/NG, Cepheid Xpert CT/NG Test
- Keywords
- antimicrobial stewardship, Cepheid Xpert CT/NG, chlamydia, gonorrhea, emergency department, Diagnostic Techniques, Obstetrical and Gynecological, Diagnostic Techniques, Urological
- Medical subject headings
- Reproductive Tract Infections, Chlamydia Infections, Gonorrhea, Emergencies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Roche AMPLICOR CT/NGDevice
Cepheid Xpert CT/NG TestDevice
| Study group | Role | What they receive |
|---|---|---|
| Real-time results with Cepheid Xpert CT/NG Test | Experimental | Diagnosis of +/- CT/NG within 2 hours of specimen entering laboratory Receives: Device: Cepheid Xpert CT/NG Test |
| Batched results with Roche AMPLICOR CT/NG test | Active comparator | Diagnosis of +/- CT/NG within 1 to 4 days of visit to the ED Receives: Device: Roche AMPLICOR CT/NG |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants Prescribed Antibiotic Treatment
Measurement of the number and type of antibiotics prescribed to CT/NG + v. CT/NG - in both groups
Measured: one year
Health Utilization
Number of participants with visits to healthcare facilities/providers and non-ED related medications purchased in 7-10 days after enrollment
Measured: one year
Healthcare Cost
To quantify the amount billed to insurance companies and out of pocket expenses for initial encounter
Measured: one year
Resolution of Symptoms
Number of patients that report having no symptoms 7 to 10 days after initial encounter
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2013 (estimated)
- Study startOct 2013
- Primary completionMar 2015
- Study completionMar 2015
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 (4)Papers the sponsor has linked to this study.
- Other trials for Reproductive Tract InfectionsStudies of the same condition, open and under way.
- 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
- Masking
- None (open label)
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- George Washington University
- Sponsor type
- University, hospital or other
- Collaborators
- Cepheid
- Responsible party
- Sponsor
- Investigators
- Larissa May, MD, Principal investigator, George Washington University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01989130
- Sponsor's protocol ID
- 071346
- Status last verified
- Jul 2019
- First submitted
- 6 Nov 2013
- Last updated
- 13 Aug 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Andric B, Drowos J, Trepka MJ, Suciu G, Alonso A, Hennekens CH. High frequencies of negative pretreatment results following presumptive antibiotic treatment for chlamydia and gonorrhea. South Med J. 2013 May;106(5):321-6. doi: 10.1097/SMJ.0b013e318291b3c2.
PubMed 23644641Levitt MA, Johnson S, Engelstad L, Montana R, Stewart S. Clinical management of chlamydia and gonorrhea infection in a county teaching emergency department--concerns in overtreatment, undertreatment, and follow-up treatment success. J Emerg Med. 2003 Jul;25(1):7-11. doi: 10.1016/s0736-4679(03)00131-8.
PubMed 12865101Gaydos 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 23467600May L, Ware CE, Jordan JA, Zocchi M, Zatorski C, Ajabnoor Y, Pines JM. A Randomized Controlled Trial Comparing the Treatment of Patients Tested for Chlamydia and Gonorrhea After a Rapid Polymerase Chain Reaction Test Versus Standard of Care Testing. Sex Transm Dis. 2016 May;43(5):290-5. doi: 10.1097/OLQ.0000000000000438.
PubMed 27100764
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Cepheid Xpert CT/NG For Management of STI in the ED: Immediate V. Delayed Test Results
- ClinicalTrials.gov ID
- NCT01989130
- Acronym / sponsor ID
- 071346
- Conditions
- Reproductive Tract Infections
- Keywords
- antimicrobial stewardship, Cepheid Xpert CT/NG, chlamydia, gonorrhea, emergency department, Diagnostic Techniques, Obstetrical and Gynecological, Diagnostic Techniques, Urological
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- George Washington UniversityUniversity, hospital or other
- Collaborators
- Cepheid
- Study start
- Oct 2013
- Primary completion
- Mar 2015 (actual)
- Study completion
- Mar 2015 (actual)
- First posted
- 20 Nov 2013 (estimated)
- Results
- Posted 21 Apr 2017
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 determine if immediate availability of GeneXpert® CT/NG test results reduces the overtreatment rate for ED patients with suspected gonorrhea or chlamydia and to assess changes in clinician management decisions with real-time test results.
Detailed description
The investigators will conduct a randomized controlled trial in patients aged 18 and older where the treating clinician is ordering a CT/NG test. Clinicians will be approached by a research assistant while they are in the ED and asked whether a CT/NG swab will be ordered and if CT/NG is in the differential diagnosis. Then, potentially eligible patients will be approached and asked for consent to enroll. For patients that consent, simple randomization procedure (i.e. random number generator) will be used to assign patients to either immediate test results or delayed test results. Typically, in the ED these tests are ordered for diagnostic rather than screening purposes (symptoms of vaginal discharge, abdominal pain, etc). Patients will be randomized to batched testing with the Roche AMPLICOR CT/NG (standard of care, control group) or immediate testing of clinical specimens with Cepheid CT/NG with real-time result reporting (within 90 minutes) to the treating clinician in the ED. Patient interview and clinician survey will be conducted to ascertain perceptions of illness and the test. A follow up interview will be conducted with the patient to determine clinical and public health outcomes.
A validation of the Cepheid CT/NG test will be conducted against the hospital standard of care on </= 40 pilot participants. Pilot participants will be asked to provide 2 endocervical swabs and a urine specimen. All surveys and interviews will be conducted on pilot patients.
While many outcomes can be measured in this study, the investigators will power this study to reduce the overtreatment rate with antibiotics. Assuming a baseline overtreatment rate of 88% (# treated with antibiotics/# without disease), to reduce this rate by 50% (to 44%), at a power of 80% and alpha of 0.05, the investigators will need to enroll 42 patients (21 controls and 21 study patients) with negative tests. Given an estimated positive rate of 6%, and that approximately 50% of patients who receive these tests for any reason will be treated empirically with antibiotics, the investigators think that enrolling a total of 70 patients with full data (enrollment survey, clinician survey, and follow up survey) would be sufficient to identify trends with this subject matter. Due to the sensitive nature of the subject matter and the high percentages of lost-to-follow up with ED patients, the investigators estimate approximately 50% will have incomplete data. Therefore, the investigators request to enroll 150 patients in the study.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Real-time results with Cepheid Xpert CT/NG Test | Experimental | Device: Cepheid Xpert CT/NG TestDiagnosis of +/- CT/NG within 2 hours of specimen entering laboratory |
| Batched results with Roche AMPLICOR CT/NG test | Active comparator | Device: Roche AMPLICOR CT/NGDiagnosis of +/- CT/NG within 1 to 4 days of visit to the ED |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- greater than 18 years
- clinical suspicion of CT/NG
- able to give informed consent
- willingness to wait for test result
Key exclusion criteria (4 listed)
- less than 18 years
- pregnancy
- prisoners
- unable to give informed consent
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 |
|---|---|---|
| Roche AMPLICOR CT/NG | Device | Batched results with Roche AMPLICOR CT/NG test |
| Cepheid Xpert CT/NG Test | Device | Real-time results with Cepheid Xpert CT/NG Test |
Primary outcome
Percentage of Participants Prescribed Antibiotic Treatment
Time frame: one year
Measurement of the number and type of antibiotics prescribed to CT/NG + v. CT/NG - in both groups
Health Utilization
Time frame: one year
Number of participants with visits to healthcare facilities/providers and non-ED related medications purchased in 7-10 days after enrollment
Healthcare Cost
Time frame: one year
To quantify the amount billed to insurance companies and out of pocket expenses for initial encounter
Resolution of Symptoms
Time frame: one year
Number of patients that report having no symptoms 7 to 10 days after initial encounter
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 23644641Andric B, Drowos J, Trepka MJ, Suciu G, Alonso A, Hennekens CH. High frequencies of negative pretreatment results following presumptive antibiotic treatment for chlamydia and gonorrhea. South Med J. 2013 May;106(5):321-6. doi: 10.1097/SMJ.0b013e318291b3c2.
- Background: PubMed 12865101Levitt MA, Johnson S, Engelstad L, Montana R, Stewart S. Clinical management of chlamydia and gonorrhea infection in a county teaching emergency department--concerns in overtreatment, undertreatment, and follow-up treatment success. J Emerg Med. 2003 Jul;25(1):7-11. doi: 10.1016/s0736-4679(03)00131-8.
- 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.
- Derived from this study: PubMed 27100764May L, Ware CE, Jordan JA, Zocchi M, Zatorski C, Ajabnoor Y, Pines JM. A Randomized Controlled Trial Comparing the Treatment of Patients Tested for Chlamydia and Gonorrhea After a Rapid Polymerase Chain Reaction Test Versus Standard of Care Testing. Sex Transm Dis. 2016 May;43(5):290-5. doi: 10.1097/OLQ.0000000000000438.
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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.
Larissa May, MD principal investigator
George Washington University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Roche AMPLICOR CT/NG and Cepheid Xpert CT/NG Test in people with Reproductive Tract Infections, run by George Washington University at 1 site in United States.
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 4 inclusion and 4 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: finished, as of the sponsor's last update on 13 Aug 2019. 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 21 Apr 2017). 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?
Percentage of Participants Prescribed Antibiotic Treatment (time frame: one year). The study lists 4 primary outcomes in all. 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 NCT01989130, which also lists 4 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 13 Aug 2019.