Reproductive Tract Infections Clinical Trial
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.
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.
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