Ignite Creation Date:
2024-05-05 @ 12:09 PM
Last Modification Date:
2024-10-26 @ 9:20 AM
Study NCT ID:
NCT00252096
Status:
COMPLETED
Last Update Posted:
2012-09-27
First Post:
2005-11-10
Brief Title:
Nucleic Acid Amplification Tests NAATs for the Diagnosis of Pharyngeal and Rectal Chlamydia and Gonorrhea Infections
Sponsor:
Centers for Disease Control and Prevention
Organization:
Centers for Disease Control and Prevention
Study Overview
Official Title:
Nucleic Acid Amplification Tests for the Diagnosis of Pharyngeal and Rectal Chlamydia Trachomatis and Neisseria Gonorrhoeae Infections
Status:
COMPLETED
Status Verified Date:
2012-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Investigators at the University of Alabama in Birmingham in collaboration with investigators from the Centers for Disease Control in Atlanta are evaluating the performance of three commercial nucleic acid amplification tests for the detection of Chlamydia trachomatis and Neisseria gonorrhoeae in pharyngeal and rectal swab specimens Cultures for C trachomatis and N gonorrhoeae are performed as additional reference tests Study subjects are men and women attending sexually transmitted disease STD and HIV care clinics in Birmingham Alabama who report sexual behaviors that place them at risk for pharyngeal or rectal sexually transmitted infections
Detailed Description:
In the latter part of the 1990s 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 ie 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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| ASPH S2070-2222 | None | None | None |
| CA U36CCU300430 PA05048 | None | None | None |