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| Name | Class |
|---|---|
| Cepheid | INDUSTRY |
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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.
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 \
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Real-time results with Cepheid Xpert CT/NG Test | Experimental | Diagnosis of +/- CT/NG within 2 hours of specimen entering laboratory |
|
| Batched results with Roche AMPLICOR CT/NG test | Active Comparator | Diagnosis of +/- CT/NG within 1 to 4 days of visit to the ED |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Roche AMPLICOR CT/NG | Device |
| ||
| Cepheid Xpert CT/NG Test |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Prescribed Antibiotic Treatment | Measurement of the number and type of antibiotics prescribed to CT/NG + v. CT/NG - in both groups | 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 | one year |
| Healthcare Cost | To quantify the amount billed to insurance companies and out of pocket expenses for initial encounter | one year |
| Resolution of Symptoms | Number of patients that report having no symptoms 7 to 10 days after initial encounter | one year |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Larissa May, MD | George Washington University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The George Washington University Hospital | Washington D.C. | District of Columbia | 20036 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23644641 | Background | 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. | |
| 12865101 | Background | Levitt 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Real-time Results With Cepheid Xpert CT/NG Test | Diagnosis of +/- CT/NG within 2 hours of specimen entering laboratory Cepheid Xpert CT/NG Test |
| FG001 | Batched Results With Roche AMPLICOR CT/NG Test | Diagnosis of +/- CT/NG within 1 to 4 days of visit to the ED Roche AMPLICOR CT/NG |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Real-time Results With Cepheid Xpert CT/NG Test | Diagnosis of +/- CT/NG within 2 hours of specimen entering laboratory Cepheid Xpert CT/NG Test |
| BG001 | Batched Results With Roche AMPLICOR CT/NG Test |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Percentage of Participants Prescribed Antibiotic Treatment | Measurement of the number and type of antibiotics prescribed to CT/NG + v. CT/NG - in both groups | Posted | Number | percentage of 70 participants | one year |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Real-time Results With Cepheid Xpert CT/NG Test | Diagnosis of +/- CT/NG within 2 hours of specimen entering laboratory Cepheid Xpert CT/NG Test |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Larissa May, MD | University of California-Davis | 916-736-5010 | lsmay@ucdavis.edu |
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| ID | Term |
|---|---|
| D060737 | Reproductive Tract Infections |
| D002690 | Chlamydia Infections |
| D006069 | Gonorrhea |
| D004630 | Emergencies |
| ID | Term |
|---|---|
| D007239 | Infections |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
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| Device |
|
| 23467600 | Background | 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. |
| 27100764 | Derived | May 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. |
Diagnosis of +/- CT/NG within 1 to 4 days of visit to the ED
Roche AMPLICOR CT/NG
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Units | Counts |
|---|
| Participants |
|
|
| Primary | Health Utilization | Number of participants with visits to healthcare facilities/providers and non-ED related medications purchased in 7-10 days after enrollment | Analysis included patients that responded to the 7-10 day follow-up phone call. | Posted | Count of Participants | Participants | one year |
|
|
|
| Primary | Healthcare Cost | To quantify the amount billed to insurance companies and out of pocket expenses for initial encounter | This outcome measure was not measured, as insurance coverage for hospital and physician charges was unavailable. | Posted | one year |
|
|
| Primary | Resolution of Symptoms | Number of patients that report having no symptoms 7 to 10 days after initial encounter | Analysis of patients who completed the 7-10 day follow-up phone call | Posted | Count of Participants | Participants | one year |
|
|
|
| 0 |
| 70 |
| 0 |
| 70 |
| EG001 | Batched Results With Roche AMPLICOR CT/NG Test | Diagnosis of +/- CT/NG within 1 to 4 days of visit to the ED Roche AMPLICOR CT/NG | 0 | 70 | 0 | 70 |
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| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
| D005832 | Genital Diseases, Male |
| D052801 | Male Urogenital Diseases |
| D002694 | Chlamydiaceae Infections |
| D016905 | Gram-Negative Bacterial Infections |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
| D015231 | Sexually Transmitted Diseases, Bacterial |
| D012749 | Sexually Transmitted Diseases |
| D003141 | Communicable Diseases |
| D016870 | Neisseriaceae Infections |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| new prescription drugs |
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