Evaluation of Immediate v. Delayed CT/NG Test for Treatment in the ED

Study Overview
=================
Brief 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.

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.

Official Title
-----------------
Evaluation of the Cepheid Xpert CT/NG For Management of STI in the ED: Immediate V. Delayed Test Results

Conditions
-----------------
Reproductive Tract Infections

Intervention / Treatment
-----------------
* Device: Roche AMPLICOR CT/NG
* Device: Cepheid Xpert CT/NG Test


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: greater than 18 years clinical suspicion of CT/NG able to give informed consent willingness to wait for test result Exclusion Criteria: less than 18 years pregnancy prisoners unable to give informed consent

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Real-time results with Cepheid Xpert CT/NG Test<br>Diagnosis of +/- CT/NG within 2 hours of specimen entering laboratory | Device: Cepheid Xpert CT/NG Test<br> <br> |
| Active Comparator: Batched results with Roche AMPLICOR CT/NG test<br>Diagnosis of +/- CT/NG within 1 to 4 days of visit to the ED | Device: Roche AMPLICOR CT/NG<br> <br> |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
antimicrobial stewardship, Cepheid Xpert CT/NG, chlamydia, gonorrhea, emergency department, Diagnostic Techniques, Obstetrical and Gynecological, Diagnostic Techniques, Urological