Chlamydia Infection, Gonococcal Infection, Sexually Transmitted Diseases
Conditions
Keywords
Chlamydia trachomatis, Neisseria gonorrhoeae, Sexually Transmitted Diseases
Brief 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.
Detailed 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.
Interventions
None listed
Sponsors
Abbott Molecular
University of California, San Francisco
Study design
Observational model
COHORT
Time perspective
CROSS_SECTIONAL
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* A subject must be MSM. Subjects must provide verbal consent, must be able to submit all required specimens and must not have urinated within 1 hr prior to providing a study urine specimen.
Exclusion criteria
* Subjects are excluded if they do not have sex with men, refuse to give verbal consent or refuse to allow such consent to be documented in their chart, are unable to provide all required specimens and minimum specimen volume, have been on antibiotic therapy within the last 21 days, have urinated within 1 hr prior to submitting study specimens, and have already been evaluated as part of this trial. Subjects will be excluded if specimens are mishandled or inappropriately stored.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Subject's Infected-status as Determined by the Nucleic Acid Amplification Assays Performed. | 1 day - (At clinic visit) | This is a single-point prevalence assessment done when subjects present at the STD clinic for routine STD screening. Subjects are not followed beyond the clinic visit. |
Countries
United States
Participant flow
Recruitment details
Recruitment dates were 06/06/12 to 09/19/12. Study was done at the San Francisco City STD Clinic.
Participants by arm
| Arm | Count |
|---|---|
| Men Who Have Sex With Men The study population consisted of asymptomatic and symptomatic MSM that could provide approximately 25 ml of first catch urine (FCU), and two clinician-collected pharyngeal and rectal swabs. | 260 |
| Total | 260 |
Baseline characteristics
| Characteristic | Men Who Have Sex With Men |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 260 Participants |
| Sex: Female, Male Female | 0 Participants |
| Sex: Female, Male Male | 260 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 |
Outcome results
Primary
Subject's Infected-status as Determined by the Nucleic Acid Amplification Assays Performed.
This is a single-point prevalence assessment done when subjects present at the STD clinic for routine STD screening. Subjects are not followed beyond the clinic visit.
Time frame: 1 day - (At clinic visit)
Population: per protocol
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Men Who Have Sex With Men | Subject's Infected-status as Determined by the Nucleic Acid Amplification Assays Performed. | Rectum tested by AC2 for NG | 20 Positive test result |
| Men Who Have Sex With Men | Subject's Infected-status as Determined by the Nucleic Acid Amplification Assays Performed. | Oropharynx tested by RealTime for NG | 11 Positive test result |
| Men Who Have Sex With Men | Subject's Infected-status as Determined by the Nucleic Acid Amplification Assays Performed. | Oropharynx tested by AC2 for NG | 12 Positive test result |
| Men Who Have Sex With Men | Subject's Infected-status as Determined by the Nucleic Acid Amplification Assays Performed. | Rectum tested by RealTime for NG | 16 Positive test result |
| Men Who Have Sex With Men | Subject's Infected-status as Determined by the Nucleic Acid Amplification Assays Performed. | FCU tested by RealTime for NG | 11 Positive test result |
| Men Who Have Sex With Men | Subject's Infected-status as Determined by the Nucleic Acid Amplification Assays Performed. | FCU tested by AC2 for NG | 12 Positive test result |
| Men Who Have Sex With Men | Subject's Infected-status as Determined by the Nucleic Acid Amplification Assays Performed. | Oropharynx tested by RealTime for CT | 0 Positive test result |
| Men Who Have Sex With Men | Subject's Infected-status as Determined by the Nucleic Acid Amplification Assays Performed. | Oropharynx tested by AC2 for CT | 0 Positive test result |
| Men Who Have Sex With Men | Subject's Infected-status as Determined by the Nucleic Acid Amplification Assays Performed. | Rectum tested by RealTime for CT | 17 Positive test result |
| Men Who Have Sex With Men | Subject's Infected-status as Determined by the Nucleic Acid Amplification Assays Performed. | Rectum tested by AC2 for CT | 17 Positive test result |
| Men Who Have Sex With Men | Subject's Infected-status as Determined by the Nucleic Acid Amplification Assays Performed. | FCU tested by RealTime for CT | 9 Positive test result |
| Men Who Have Sex With Men | Subject's Infected-status as Determined by the Nucleic Acid Amplification Assays Performed. | FCU tested by AC2 for CT | 8 Positive test result |