Trial Outcomes & Findings for Use of Abbott RealTime CT/NG to Detect Chlamydia Trachomatis [CT] & Neisseria Gonorrhoeae [NG] in Men Who Have Sex With Men [MSM] (NCT NCT01291264)
NCT ID: NCT01291264
Last Updated: 2014-03-04
Results Overview
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.
Recruitment status
TERMINATED
Target enrollment
260 participants
Primary outcome timeframe
1 day - (At clinic visit)
Results posted on
2014-03-04
Participant Flow
Recruitment dates were 06/06/12 to 09/19/12. Study was done at the San Francisco City STD Clinic.
Participant milestones
| Measure |
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.
|
|---|---|
|
Overall Study
STARTED
|
260
|
|
Overall Study
COMPLETED
|
260
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Use of Abbott RealTime CT/NG to Detect Chlamydia Trachomatis [CT] & Neisseria Gonorrhoeae [NG] in Men Who Have Sex With Men [MSM]
Baseline characteristics by cohort
| Measure |
Men Who Have Sex With Men
n=260 Participants
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.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
260 Participants
n=99 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=99 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
260 Participants
n=99 Participants
|
PRIMARY outcome
Timeframe: 1 day - (At clinic visit)Population: per protocol
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.
Outcome measures
| Measure |
Men Who Have Sex With Men
n=260 Participants
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.
|
|---|---|
|
Subject's Infected-status as Determined by the Nucleic Acid Amplification Assays Performed.
Oropharynx tested by RealTime for NG
|
11 Positive test result
|
|
Subject's Infected-status as Determined by the Nucleic Acid Amplification Assays Performed.
Oropharynx tested by AC2 for NG
|
12 Positive test result
|
|
Subject's Infected-status as Determined by the Nucleic Acid Amplification Assays Performed.
Rectum tested by RealTime for NG
|
16 Positive test result
|
|
Subject's Infected-status as Determined by the Nucleic Acid Amplification Assays Performed.
Rectum tested by AC2 for NG
|
20 Positive test result
|
|
Subject's Infected-status as Determined by the Nucleic Acid Amplification Assays Performed.
FCU tested by RealTime for NG
|
11 Positive test result
|
|
Subject's Infected-status as Determined by the Nucleic Acid Amplification Assays Performed.
FCU tested by AC2 for NG
|
12 Positive test result
|
|
Subject's Infected-status as Determined by the Nucleic Acid Amplification Assays Performed.
Oropharynx tested by RealTime for CT
|
0 Positive test result
|
|
Subject's Infected-status as Determined by the Nucleic Acid Amplification Assays Performed.
Oropharynx tested by AC2 for CT
|
0 Positive test result
|
|
Subject's Infected-status as Determined by the Nucleic Acid Amplification Assays Performed.
Rectum tested by RealTime for CT
|
17 Positive test result
|
|
Subject's Infected-status as Determined by the Nucleic Acid Amplification Assays Performed.
Rectum tested by AC2 for CT
|
17 Positive test result
|
|
Subject's Infected-status as Determined by the Nucleic Acid Amplification Assays Performed.
FCU tested by RealTime for CT
|
9 Positive test result
|
|
Subject's Infected-status as Determined by the Nucleic Acid Amplification Assays Performed.
FCU tested by AC2 for CT
|
8 Positive test result
|
Adverse Events
Men Who Have Sex With Men
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr. Julius Schachter, Professor of Laboratory Medicine
University of California, San Francisco
Phone: 415 824 5115
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place