Use of Abbott RealTime CT/NG to Detect Chlamydia Trachomatis [CT] &

Status Terminated

Clinical Trial Summary

Julius Schachter, PhD, (Department of Laboratory Medicine, University of California, San Francisco) and Susan S. Philip, MD MPH (Department of Medicine, University of California, San Francisco) are conducting a study to evaluate the Abbott RealTime CT/NG polymerase chain reaction [PCR] assay (which is a nucleic acid amplification test [NAAT]) for detecting two sexually transmitted bacteria, Chlamydia trachomatis [CT] and Neisseria gonorrhoeae [NG], using urine samples and swabs from the throat and rectum of men who have sex with men [MSM]. Using this test on these swabs is experimental because it has not been approved by the Food & Drug Administration.

Clinical Trial Description

For each subject enrolled in the study, the following clinical data information will be obtained: 1) reason for exam, 2) subject's signs and symptoms and 3) clinical assessment.

For each subject enrolled in the study, two clinician-collected pharyngeal swabs, two clinician-collected rectal swabs, and a first catch urine specimen (approximately 25 ml) will be obtained. The collection order of the clinician-collected swabs will be randomized.

Two pharyngeal swabs will be tested at the research laboratory using: 1) APTIMA COMBO 2® [AC2](Gen-Probe Inc, San Diego, CA); and 2) Abbott RealTime CT/NG [RealTime](Abbott Molecular, Des Plains, IL). Two rectal swabs will be tested at the research laboratory using: 1) AC2; and 2) RealTime.

A first-catch urine [FCU] specimen will be split out at San Francisco Department of Public Health laboratory and sent to the Chlamydia Research Laboratory for analysis using: 1)AC2; and 2) RealTime.

All NAAT specimens are collected in the manufacturer's recommended NAAT transport medium. After specimen processing, samples will be frozen at -70ºC for discrepant analysis. ;

Study Design

Observational Model: Cohort, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT01291264
Study type	Observational
Source	University of California, San Francisco
Contact
Status	Terminated
Phase	Phase 4
Start date	June 2012
Completion date	May 2013

View Details

See also
Status	Clinical Trial	Phase
Completed	`NCT02579135` - Reducing HIV Risk Among Adolescents: Evaluating Project HEART	N/A
Enrolling by invitation	`NCT06127277` - Next4You: A Fully Mobile Relationships Based Program for Youth in Foster Care	N/A
Recruiting	`NCT05889689` - Evaluation of an Adolescent Pregnancy Prevention Program; Relationship Smarts+ With Lessons From Mind Matters	N/A
Completed	`NCT02516930` - A Non-inferiority Randomized Controlled Trial to Evaluate Promoting Condom Use Among MSM and Transgender Individuals in China	N/A
Completed	`NCT03063385` - Puerto Rico Cuidalos Parent-adolescent Program	N/A
Completed	`NCT01411878` - Louisville Teen Pregnancy Prevention Project	N/A
Completed	`NCT02009046` - Randomized Evaluation of a Multi-Component, Rights-Based Sexuality Education Initiative for High School Students	N/A
Completed	`NCT01303575` - Internet-Based Sexual Health Education for Middle School Native American Youth	N/A
Completed	`NCT00167505` - All About Youth: Evaluation of Sexual Risk Avoidance and Risk Reduction Programs for Middle School Students	N/A
Completed	`NCT00183456` - A Peer-Oriented HIV Prevention Outreach Program for Individuals at High Risk for HIV and Other STIs	Phase 2
Completed	`NCT00336180` - Adolescent Drug and HIV Prevention in South Africa	Phase 2/Phase 3
Completed	`NCT00710060` - Effectiveness of a Community-level HIV/STD Prevention Intervention in Promoting Safer Sexual Behaviors in High-risk Populations	Phase 3
Completed	`NCT01084395` - Reducing HIV Risk Among Mexican Youth	N/A
Completed	`NCT00161382` - Development and Evaluation of an HIV, STD, and Pregnancy Prevention Program for Middle School Students	N/A
Completed	`NCT00640653` - Efficacy of an Abstinence-Only HIV Risk-Reduction Intervention for Young African-American Adolescents	N/A
Completed	`NCT00289939` - Reducing HIV & Domestic Violence Risk in Women Offenders	Phase 3
Completed	`NCT00137943` - Parents Matter!: Interventions to Promote Effective Parent-Child Communication	Phase 1
Completed	`NCT03408743` - Engineering an Online STI Prevention Program: CSE2	N/A
Completed	`NCT06104813` - Evaluation of Deaf Men's Knowledge About Sexual Health
Not yet recruiting	`NCT05910580` - Improving Alcohol and Substance Use Care Access, Outcome, Equity During the Reproductive Years	N/A

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Use of Abbott RealTime CT/NG to Detect Chlamydia Trachomatis [CT] & Neisseria Gonorrhoeae [NG] in Men Who Have Sex With Men [MSM]

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms