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

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2013 by George Washington University
Sponsor:
Collaborator:
Cepheid
Information provided by (Responsible Party):
George Washington University
ClinicalTrials.gov Identifier:
NCT01989130
First received: November 6, 2013
Last updated: November 14, 2013
Last verified: November 2013
  Purpose

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.


Condition Intervention
Reproductive Tract Infections
Device: Roche AMPLICOR CT/NG
Device: Cepheid Xpert CT/NG Test

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Evaluation of the Cepheid Xpert CT/NG For Management of STI in the ED: Immediate V. Delayed Test Results

Resource links provided by NLM:


Further study details as provided by George Washington University:

Primary Outcome Measures:
  • Antibiotic Prescription [ Time Frame: one year ] [ Designated as safety issue: No ]
    Measurement of the number and type of antibiotics prescribed to CT/NG + v. CT/NG - in both groups

  • Health Utilization [ Time Frame: one year ] [ Designated as safety issue: No ]
    Quantify the number of visits to healthcare facilities/providers and non-ED related medications purchased in 7-10 days after enrollment

  • Healthcare Cost [ Time Frame: one year ] [ Designated as safety issue: No ]
    To quantify the amount billed to insurance companies and out of pocket expenses for initial encounter

  • Resolution of Symptoms [ Time Frame: one year ] [ Designated as safety issue: No ]
    Number of patients that report having no symptoms 7 to 10 days after initial encounter


Estimated Enrollment: 150
Study Start Date: October 2013
Estimated Primary Completion Date: April 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Real-time results with Cepheid Xpert CT/NG Test
Diagnosis of +/- CT/NG within 2 hours of specimen entering laboratory
Device: Cepheid Xpert CT/NG Test
Active Comparator: Batched results with Roche AMPLICOR CT/NG test
Diagnosis of +/- CT/NG within 1 to 4 days of visit to the ED
Device: Roche AMPLICOR CT/NG

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01989130

Locations
United States, District of Columbia
The George Washington University Hospital Recruiting
Washington, District of Columbia, United States, 20036
Contact: Catherine Zatorski, BA    202-677-6422    czatorski@mfa.gwu.edu   
Contact: Gillian Brooks, BA    202-677-6423    gbrooks@mfa.gwu.edu   
Principal Investigator: Larissa May, MD, MSPH, MSHS         
Sponsors and Collaborators
George Washington University
Cepheid
  More Information

Publications:
Responsible Party: George Washington University
ClinicalTrials.gov Identifier: NCT01989130     History of Changes
Other Study ID Numbers: 071346
Study First Received: November 6, 2013
Last Updated: November 14, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by George Washington University:
antimicrobial stewardship
Cepheid Xpert CT/NG
chlamydia
gonorrhea
emergency department
Diagnostic Techniques, Obstetrical and Gynecological
Diagnostic Techniques, Urological
Antimicrobial stewardship

Additional relevant MeSH terms:
Reproductive Tract Infections
Infection
Genital Diseases, Male
Genital Diseases, Female

ClinicalTrials.gov processed this record on September 30, 2014