Cepheid Rectal Sample Validation Study

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2014 by University of Pittsburgh
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Sharon Hillier, University of Pittsburgh
ClinicalTrials.gov Identifier:
NCT02099760
First received: March 12, 2014
Last updated: March 26, 2014
Last verified: March 2014
  Purpose

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 Intervention
Gonorrhea
Chlamydia
Trichomonas
Device: STD testing (GC/Ct/trich)

Study Type: Observational
Study Design: 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

Resource links provided by NLM:


Further study details as provided by University of Pittsburgh:

Primary Outcome Measures:
  • Rectal Gonorrhea/Chlamydia testing result [ Time Frame: approximately 7 days ] [ Designated as safety issue: No ]
    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 [ Time Frame: approximately 7 days ] [ Designated as safety issue: No ]
    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 [ Time Frame: approximately 7 days ] [ Designated as safety issue: No ]
    evaluate the prevalence of Trichomonas vaginalis in vaginal and rectal samples using both the Xpert system and AC2


Biospecimen Retention:   Samples Without DNA

Any leftover specimens including genital, rectal, pharyngeal, or urine may be retained.


Estimated Enrollment: 550
Study Start Date: December 2013
Estimated Study Completion Date: November 2014
Estimated Primary Completion Date: November 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
STD testing (GC/Ct/trich) Device: STD testing (GC/Ct/trich)
Other Name: Cepheid Xpert CT/NG

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Subjects presenting for routine clinical care in an STD Clinic and/or subjects who are aware of the study and meet the inclusion/exclusion criteria.

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02099760

Contacts
Contact: Ingrid Macio, PA-C 412-641-5455 imacio@mail.magee.edu
Contact: Jamie Haggerty 412-641-5378 jhaggerty@mail.magee.edu

Locations
United States, Pennsylvania
Magee-Womens Hospital of UPMC Recruiting
Pittsburgh, Pennsylvania, United States, 15213
Contact: Ingrid Macio, PA-C    412-641-5455    imacio@mail.magee.edu   
Contact: Jamie Haggerty    412-641-5378    jhaggerty@mail.magee.edu   
Allegheny County Health Department Sexually Transmitted Diseases Clinic Recruiting
Pittsburgh, Pennsylvania, United States, 15213
Contact: Ingrid Macio, PA-C    412-641-5455    imacio@mail.magee.edu   
Sub-Investigator: Harold C Wiesenfeld, MD         
Sponsors and Collaborators
University of Pittsburgh
Investigators
Principal Investigator: Sharon Hillier, PhD University of Pittsburgh/UPMC
  More Information

No publications provided

Responsible Party: Sharon Hillier, Professor, University of Pittsburgh
ClinicalTrials.gov Identifier: NCT02099760     History of Changes
Other Study ID Numbers: PRO13100170, 5U01AI068633-04
Study First Received: March 12, 2014
Last Updated: March 26, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by University of Pittsburgh:
gonorrhea
chlamydia
trichomonas

Additional relevant MeSH terms:
Chlamydia Infections
Gonorrhea
Trichomonas Infections
Chlamydiaceae Infections
Gram-Negative Bacterial Infections
Bacterial Infections
Sexually Transmitted Diseases, Bacterial
Sexually Transmitted Diseases
Infection
Genital Diseases, Male
Genital Diseases, Female
Neisseriaceae Infections
Protozoan Infections
Parasitic Diseases

ClinicalTrials.gov processed this record on September 18, 2014