- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00252096
Nucleic Acid Amplification Tests (NAATs) for the Diagnosis of Pharyngeal and Rectal Chlamydia and Gonorrhea Infections
Nucleic Acid Amplification Tests for the Diagnosis of Pharyngeal and Rectal Chlamydia Trachomatis and Neisseria Gonorrhoeae Infections
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
In the latter part of the 1990's, testing for Chlamydia trachomatis and Neisseria gonorrhoeae infections was revolutionized by the introduction of nucleic acid amplification tests (NAATs) which achieve greater sensitivity than traditional culture methods by exponentially replicating the nucleic acid of these organisms. The specimens collected for NAATs are easier to transport and NAATs permit collection of less invasive specimens for testing (i.e. voided urine or patient-collected vaginal swabs for women rather than urethral or endocervical swabs). Despite their somewhat higher costs, these tests have been found to be preferred by patients (because specimens can be collected less invasively), by clinicians (because of both their ease of collection and increased sensitivity), and to permit expanded screening both in traditional clinical settings and at outreach sites where testing has not typically been done in the past.
NAATs have been cleared by FDA for testing of genital specimens (cervical and male urethral swabs and urine), but the performance of NAATs has not been adequately evaluated for diagnosis of C. trachomatis and N. gonorrhoeae infections occurring at rectal or pharyngeal sites of sexual exposure. Increasing numbers of heterosexual individuals might be engaging in orogenital or rectal sexual activity, especially adolescents and young adults who might view such exposures as less risky with respect to pregnancy and sexually transmitted diseases (STD) than penile-vaginal intercourse. Pharyngeal and rectal exposures, often without use of condoms, are relatively common among MSM. Recent demonstration of resurgent sexually transmitted diseases and unsafe sexual practices among men-who-have-sex-with-men (MSM), including those who are infected with the human immunodeficiency virus (HIV), provides an especially strong public health imperative to the need for careful evaluation of NAATs with pharyngeal and rectal specimens.
The primary aim of this study is to compare the performance of the three NAATs that are available commercially to test pharyngeal and rectal specimens for C. trachomatis and N. gonorrhoeae infections with culture, the current method of choice, and with each other. In order to enroll adequate numbers of individuals with such infections, the study will be conducted during a 3-year period in a STD clinic and two HIV care clinics located in Birmingham, AL. Enrollment will be confined to individuals who are at high risk for genital C. trachomatis or N. gonorrhoeae infection, or who give a history of orogenital or rectal sexual exposures. An effort will be made to balance enrollment of heterosexual individuals and MSM, but resource limitations require that sample sizes be based on combining these subgroups.
No adequate criterion-standard for pharyngeal or rectal infections exists due to the probable, but poorly defined, low sensitivity of the current standard, culture. Fortunately, the 3 NAATs employ different C. trachomatis and N. gonorrhoeae molecular targets and methods of nucleic acid amplification. By including all 3 NAATs plus culture in the study, combinations of the results of culture and a NAAT or of two NAATs can be utilized to take advantage of the likely independence of testing errors among truly uninfected subjects to construct more satisfactory criterion standards for infection for the purpose of estimating and comparing their sensitivities and specificities. A secondary aim of the study will be to compare this methodological approach, utilizing a traditional statistical and clinical epidemiological approach, with alternative methods that have been more widely used but strongly criticized by statisticians and clinical epidemiologists and with newer methods designed to meet these criticisms and to be more efficient than the traditional statistical approaches.
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Alabama
-
Birmingham, Alabama, United States, 35294
- University of Alabama at Birmingham
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Age greater than 15 years.
- If male, history of fellatio, cunnilingus, or receptive anal sex within the last two months.
- If female, presenting for treatment of N. gonorrhoeae and/or C. trachomatis or contact to N. gonorrhoeae, C. trachomatis, or nongonococcal urethritis.
- If female, history of fellatio or history of anal sex within the last two months.
Exclusion Criteria:
- Declines to participate.
- History of receipt of antimicrobial agents active against N. gonorrhoeae or C. trachomatis in the preceding 30 days.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
---|
Detection of Chlamydia trachomatis or Neisseria gonorrhoeae infections
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Laura H. Bachmann, MD, MPH, University of Alabama at Birmingham
- Principal Investigator: Edward W. Hook, III, MD, University of Alabama at Birmingham
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Pathologic Processes
- Sexually Transmitted Diseases
- Disease Attributes
- Gram-Negative Bacterial Infections
- Bacterial Infections
- Bacterial Infections and Mycoses
- Neisseriaceae Infections
- Chlamydiaceae Infections
- Sexually Transmitted Diseases, Bacterial
- Infections
- Communicable Diseases
- Chlamydia Infections
- Gonorrhea
Other Study ID Numbers
- CDC-NCHSTP-3881
- CA U36/CCU300430 PA05048
- ASPH S2070-22/22
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Gonorrhea
-
Melinta Therapeutics, Inc.National Institute of Allergy and Infectious Diseases (NIAID)CompletedUncomplicated Urogenital GonorrheaUnited States, Australia
-
Melinta Therapeutics, Inc.CompletedUncomplicated Urogenital GonorrheaUnited States
-
University of WashingtonCompleted
-
University of North Carolina, Chapel HillNational Institute of Allergy and Infectious Diseases (NIAID)RecruitingGonorrhea MaleUnited States
-
University of North Carolina, Chapel HillLondon School of Hygiene and Tropical Medicine; National Institute of Allergy... and other collaboratorsCompleted
-
University of California, Los AngelesEmory University; University of California, San Francisco; Asociacion Civil Via...Active, not recruitingChlamydia | HIV-1-infection | Partner Communication | Gonorrhea MalePeru
-
University of California, Los AngelesRecruitingMethamphetamine-dependence | Rectal Gonorrhea | Rectal ChlamydiaUnited States
-
University of Maryland, BaltimoreTerminatedSexually Transmitted Infection | Gonorrhea Female | Chlamydia FemalesUnited States
-
Population CouncilBill and Melinda Gates Foundation; Centers for Disease Control and Prevention; Ministry of Health, Thailand and other collaboratorsCompletedHIV Infections | Syphilis | Trichomonas Vaginitis | Chlamydia Trachomatis | Nesseria GonorrheaThailand
-
Global Antibiotics Research and Development PartnershipActive, not recruitingGonorrheaUnited States, Belgium, South Africa, Netherlands, Thailand
Clinical Trials on Nucleic acid amplification test
-
Duke UniversityNational Institute of Allergy and Infectious Diseases (NIAID)CompletedSexually Transmitted Infections | Chlamydia Trachomatis Infection | Neisseria Gonorrhoeae InfectionUnited States
-
Taipei Medical University WanFang HospitalBuddhist Tzu Chi General Hospital; Taichung Veterans General Hospital; Chang-Hua... and other collaboratorsActive, not recruitingPulmonary Tuberculosis Confirmation by CultureTaiwan
-
University of California, DavisBioFire Diagnostics, LLCCompletedRespiratory Tract Infections | Influenza, Human | Common ColdUnited States
-
Centers for Disease Control and PreventionUS Department of Veterans AffairsCompletedTuberculosisUganda, United States, Canada, South Africa
-
University of California, San DiegoNational Institutes of Health (NIH); Centers for Disease Control and PreventionCompletedAcute HIV InfectionUnited States
-
Mayo ClinicDepartment of Health and Human ServicesCompleted
-
Riccardo SerrainoSocieta' Italiana Di Malattie Infettive E TropicaliRecruitingSexually Transmitted DiseasesUganda
-
Children's Oncology GroupNational Cancer Institute (NCI)Completed
-
Institute of Tropical Medicine, BelgiumUniversity Hospital, Geneva; Institut National de Recherche Biomédicale. Kinshasa...CompletedNeurological Disorders | Bacterial Meningitis | Cryptococcal Meningitis | Neurosyphilis | Cerebral Malaria | Central Nervous System TuberculosisCongo, The Democratic Republic of the
-
Massachusetts General HospitalCompletedMRSA ColonizationUnited States