Cepheid Rectal Sample Validation Study

Gonorrhea Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02099760
• Other study ID #: PRO13100170
• Secondary ID: 5U01AI068633-04
• Status: Completed
• Start date: December 2013
• Est. completion date: April 2015

Study information

• Verified date: February 2019
• Source: University of Pittsburgh
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 402
• Est. completion date: April 2015
• Est. primary completion date: April 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Male and female participants aged 18 and older

2. Women or men who have a history of engaging in receptive anal intercourse

3. Willing to provide written informed consent for participation in this study

Exclusion Criteria:

1. Use of oral antibiotics in the past 7 days

2. Use of rectal douche or other rectal product in the past 24 hours

3. If female, use of a vaginal douche or vaginal product in the past 24 hours

Related Conditions & MeSH terms

• Chlamydia
• Chlamydia Infections
• Gonorrhea
• Trichomonas
• Trichomonas Infections

Intervention

Device:
• STD testing (GC/Ct/trich)

Locations

Country	Name	City	State
United States	Allegheny County Health Department Sexually Transmitted Diseases Clinic	Pittsburgh	Pennsylvania
United States	Magee-Womens Hospital of UPMC	Pittsburgh	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
University of Pittsburgh	National Institute of Allergy and Infectious Diseases (NIAID)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rectal Gonorrhea/Chlamydia testing result	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	approximately 7 days
Secondary	pharyngeal GC/Ct result	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.	approximately 7 days
Secondary	Trichomonas Testing Results	evaluate the prevalence of Trichomonas vaginalis in vaginal and rectal samples using both the Xpert system and AC2	approximately 7 days