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Completed

NCT Number: NCT02099760

Cepheid Rectal Sample Validation Study

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.

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Key information

Conditions

Gonorrhea Bacterial Infections Bacterial Infections and Mycoses Chlamydia Chlamydia Infections Chlamydiaceae Infections Communicable Diseases Genital Diseases Gram-Negative Bacterial Infections Infections Neisseriaceae Infections Parasitic Diseases Protozoan Infections Sexually Transmitted Diseases Sexually Transmitted Diseases, Bacterial Trichomonas Trichomonas Infections Urogenital Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Allegheny County Health Department Sexually Transmitted Diseases Clinic, Pittsburgh, Pennsylvania, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

STD testing (GC/Ct/trich)

Device

Other names: Cepheid Xpert CT/NG

Primary outcomes

  1. Rectal Gonorrhea/Chlamydia testing result

    Time frame: 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 outcomes

  1. pharyngeal GC/Ct result

    Time frame: 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.

  2. Trichomonas Testing Results

    Time frame: approximately 7 days

    evaluate the prevalence of Trichomonas vaginalis in vaginal and rectal samples using both the Xpert system and AC2

Sponsors and collaborators

Lead sponsor

University of Pittsburgh

Other

Collaborators

  • National Institute of Allergy and Infectious Diseases (NIAID)

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2015
Study completion
2015
First posted
Mar 31, 2014
Registry last updated
Feb 7, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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