Cepheid Rectal Sample Validation Study

Sponsor

University of Pittsburgh (Other)

Overall Status

Completed

CT.gov ID

NCT02099760

Collaborator

National Institute of Allergy and Infectious Diseases (NIAID) (NIH)

402

Enrollment

Locations

Duration (Months)

201

Patients Per Site

12.6

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this study is to validate Xpert CT/NG for the detection of CT and GC in rectal samples as part of the PA DOH and CLIA requirements. The evaluation of samples obtained from the pharynx is exploratory and will provide new information on the frequency of pharyngeal infection due to CT and GC.

A secondary objective will be to evaluate the prevalence of Trichomonas vaginalis in vaginal and rectal samples using both the Xpert system and AC2 to assess whether women positive for this pathogen rectally usually or always have vaginal infection due to this pathogen.

The investigators hypothesis is that real-time PCR (polymerase chain reaction) amplification testing with the Cepheid Xpert CT/NG will have greater sensitivity than culture in detecting Neisseria gonorrhoeae in rectal samples. The investigators also hypothesize that Xpert CT/NG will be equivalent to the Gen-Probe APTIMA Combo2 (AC2) in detecting Chlamydia trachomatis and Neisseria gonorrhoeae in rectal samples.

Condition or Disease	Intervention/Treatment	Phase
Gonorrhea Chlamydia Trichomonas	Device: STD testing (GC/Ct/trich)

Detailed Description

Because of its high sensitivity and specificity, NAAT testing has largely replaced bacterial culture for the diagnosis of genital CT and GC in both males and females. NAAT assays have the greatest potential for detecting CT and GC in the rectum; however, no NAAT is currently cleared for use with extragenital specimens by the US Food and Drug Administration.

In order to comply with CLIA regulations, laboratories must perform in-house validations to use NAATs with rectal and pharyngeal specimens. There are multiple studies in the literature evaluating NAAT assays in diagnosing CT and GC in rectal and pharyngeal specimens using expanded reference standards, which includes positive culture result and secondary confirmatory NAAT assays. The proposed validation study is intended to provide data to support the use of NAAT for rectal and pharyngeal specimens.

Study Design

Study Type:

Observational

Actual Enrollment :

402 participants

Observational Model:

Case-Only

Time Perspective:

Cross-Sectional

Official Title:

A Validation Study of the Cepheid Xpert CT/NG for Detecting Chlamydia Trachomatis and Neisseria Gonorrhoeae in Rectal Samples

Study Start Date :

Dec 1, 2013

Actual Primary Completion Date :

Apr 1, 2015

Actual Study Completion Date :

Apr 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
STD testing (GC/Ct/trich)	Device: STD testing (GC/Ct/trich) Other Names: Cepheid Xpert CT/NG

Arm

Intervention/Treatment

STD testing (GC/Ct/trich)

Device: STD testing (GC/Ct/trich)

Other Names:

Cepheid Xpert CT/NG

Outcome Measures

Primary Outcome Measures

Rectal Gonorrhea/Chlamydia testing result [approximately 7 days]
Compare the sensitivity and specificity of the Xpert NG to the AC2 and culture in detecting GC in rectal samples Compare the sensitivity and specificity of the Xpert CT to AC2 (and as necessary, for discrepant results, to Aptima CT assay) in detecting CT in rectal samples

Secondary Outcome Measures

pharyngeal GC/Ct result [approximately 7 days]
The evaluation of samples obtained from the pharynx is exploratory and will provide new information on the frequency of pharyngeal infection due to CT and GC.
Trichomonas Testing Results [approximately 7 days]
evaluate the prevalence of Trichomonas vaginalis in vaginal and rectal samples using both the Xpert system and AC2

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

Male and female participants aged 18 and older
Women or men who have a history of engaging in receptive anal intercourse
Willing to provide written informed consent for participation in this study

Exclusion Criteria:

Use of oral antibiotics in the past 7 days
Use of rectal douche or other rectal product in the past 24 hours
If female, use of a vaginal douche or vaginal product in the past 24 hours

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Allegheny County Health Department Sexually Transmitted Diseases Clinic	Pittsburgh	Pennsylvania	United States	15213
2	Magee-Womens Hospital of UPMC	Pittsburgh	Pennsylvania	United States	15213