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

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01989130
• Other study ID #: 071346
• Status: Completed
• Phase: N/A
• Start date: October 2013
• Est. completion date: March 2015

Study information

• Verified date: July 2019
• Source: George Washington University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 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 information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: March 2015
• Est. primary completion date: March 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Reproductive Tract Infections

Intervention

Device:
• Roche AMPLICOR CT/NG

• Cepheid Xpert CT/NG Test

Locations

Country	Name	City	State
United States	The George Washington University Hospital	Washington	District of Columbia

Sponsors (2)

Lead Sponsor	Collaborator
George Washington University	Cepheid

Country where clinical trial is conducted

United States, 

References & Publications (3)

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	Healthcare Cost	To quantify the amount billed to insurance companies and out of pocket expenses for initial encounter	one year
Primary	Resolution of Symptoms	Number of patients that report having no symptoms 7 to 10 days after initial encounter	one year