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

Not Applicable

Completed

Conditions: Reproductive Tract Infections

Interventions: Device: Roche AMPLICOR CT/NG
Device: Cepheid Xpert CT/NG Test

Registration Number: NCT01989130

Lead Sponsor: George Washington University

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 70

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Batched results with Roche AMPLICOR CT/NG test	Roche AMPLICOR CT/NG	Diagnosis of +/- CT/NG within 1 to 4 days of visit to the ED
Real-time results with Cepheid Xpert CT/NG Test	Cepheid Xpert CT/NG Test	Diagnosis of +/- CT/NG within 2 hours of specimen entering laboratory

Primary Outcome Measures

Name	Time	Method
Percentage of Participants Prescribed Antibiotic Treatment	one year	Measurement of the number and type of antibiotics prescribed to CT/NG + v. CT/NG - in both groups
Health Utilization	one year	Number of participants with visits to healthcare facilities/providers and non-ED related medications purchased in 7-10 days after enrollment
Resolution of Symptoms	one year	Number of patients that report having no symptoms 7 to 10 days after initial encounter
Healthcare Cost	one year	To quantify the amount billed to insurance companies and out of pocket expenses for initial encounter