NCT02099760

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
402

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Dec 2013

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2013

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

March 12, 2014

Completed
19 days until next milestone

First Posted

Study publicly available on registry

March 31, 2014

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2015

Completed
Last Updated

February 7, 2019

Status Verified

February 1, 2019

Enrollment Period

1.3 years

First QC Date

March 12, 2014

Last Update Submit

February 6, 2019

Conditions

GonorrheaChlamydiaTrichomonas

Keywords

gonorrheachlamydiatrichomonas

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • pharyngeal GC/Ct result

    approximately 7 days

  • Trichomonas Testing Results

    approximately 7 days

Study Arms (1)

STD testing (GC/Ct/trich)

Device: STD testing (GC/Ct/trich)

Interventions

STD testing (GC/Ct/trich)DEVICE
Also known as: Cepheid Xpert CT/NG
STD testing (GC/Ct/trich)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Allegheny County Health Department Sexually Transmitted Diseases Clinic

Pittsburgh, Pennsylvania, 15213, United States

Location

Magee-Womens Hospital of UPMC

Pittsburgh, Pennsylvania, 15213, United States

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

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

MeSH Terms

Conditions

GonorrheaChlamydia InfectionsTrichomonas Infections

Condition Hierarchy (Ancestors)

Neisseriaceae InfectionsGram-Negative Bacterial InfectionsBacterial InfectionsBacterial Infections and MycosesInfectionsSexually Transmitted Diseases, BacterialSexually Transmitted DiseasesCommunicable DiseasesGenital DiseasesUrogenital DiseasesChlamydiaceae InfectionsProtozoan InfectionsParasitic Diseases

Study Officials

  • Sharon Hillier, PhD

    University of Pittsburgh/UPMC

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

March 12, 2014

First Posted

March 31, 2014

Study Start

December 1, 2013

Primary Completion

April 1, 2015

Study Completion

April 1, 2015

Last Updated

February 7, 2019

Record last verified: 2019-02

Locations

US(2)