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

NCT ID: NCT01989130

Last Updated: 2019-08-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 70 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-10-31
• Study Completion Date: 2015-03-31

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.

Conditions

Reproductive Tract Infections

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Real-time results with Cepheid Xpert CT/NG Test

Diagnosis of +/- CT/NG within 2 hours of specimen entering laboratory

Group Type: EXPERIMENTAL

Cepheid Xpert CT/NG Test

Intervention Type: DEVICE

Batched results with Roche AMPLICOR CT/NG test

Diagnosis of +/- CT/NG within 1 to 4 days of visit to the ED

Group Type: ACTIVE_COMPARATOR

Roche AMPLICOR CT/NG

Intervention Type: DEVICE

Interventions

Roche AMPLICOR CT/NG

Intervention Type: DEVICE

Cepheid Xpert CT/NG Test

Intervention Type: DEVICE

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Cepheid

INDUSTRY

Sponsor Role: collaborator

George Washington University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Larissa May, MD

Role: PRINCIPAL_INVESTIGATOR

George Washington University

Locations

The George Washington University Hospital

Washington D.C., District of Columbia, United States

Countries

United States

References

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.

Reference Type: BACKGROUND

PMID: 23644641 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 12865101 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 23467600 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 27100764 (View on PubMed)

Other Identifiers

071346

Identifier Type: -

Identifier Source: org_study_id