Trial Outcomes & Findings for YCFM (Youth Correctional Facilities Males) (NCT NCT03249935)

Last Updated: 2019-10-28

Results Overview

Test positive for Chlamydia trachomatis with Aptima Combo 2® Assay (AC2) and having enrollment and follow-up CT strains that had concordant genotyping of the CT major outer membrane protein (ompA) sequences or, if genotyping was unsuccessful on urine from both visits (i.e., due to insufficient number of ompA copies), then participants could not have unsupervised furloughs or report interim sex to be categorized as a treatment failure.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

100 participants

Primary outcome timeframe

Day 28-follow-up visit

Results posted on

2019-10-28

Participant Flow

Participant milestones

Participant milestones
Measure	Azithromycin Azithromycin 1 gm PO single dose given as directly observed Azithromycin: Azithromycin 1 gm PO single dose given as directly observed
Overall Study STARTED	100
Overall Study COMPLETED	55
Overall Study NOT COMPLETED	45

Reasons for withdrawal

Reasons for withdrawal
Measure	Azithromycin Azithromycin 1 gm PO single dose given as directly observed Azithromycin: Azithromycin 1 gm PO single dose given as directly observed
Overall Study Discharged from facility early	36
Overall Study Negative for chlamydia at enrollment	4
Overall Study Protocol Violation	5

Baseline Characteristics

YCFM (Youth Correctional Facilities Males)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Azithromycin n=96 Participants Azithromycin 1 gm PO single dose given as directly observed Azithromycin: Azithromycin 1 gm PO single dose given as directly observed
Age, Continuous	17.0 years n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants
Sex: Female, Male Male	96 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	46 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	50 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race/Ethnicity, Customized American Indian or Alaska Native	3 Participants n=5 Participants
Race/Ethnicity, Customized Asian	0 Participants n=5 Participants
Race/Ethnicity, Customized Native Hawaiian or Other Pacific Islander	2 Participants n=5 Participants
Race/Ethnicity, Customized Black or African American	38 Participants n=5 Participants
Race/Ethnicity, Customized White	11 Participants n=5 Participants
Race/Ethnicity, Customized Other	42 Participants n=5 Participants
Race/Ethnicity, Customized More than one race	0 Participants n=5 Participants
Race/Ethnicity, Customized Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	96 participants n=5 Participants

PRIMARY outcome

Timeframe: Day 28-follow-up visit

Population: Per protocol population, which included all participants who tested positive for CT at enrollment and were evaluable at day 28.

Outcome measures

Outcome measures
Measure	Symptomatic n=12 Participants Symptomatic was defined as urethral discharge and/or dysuria at baseline.	Asymptomatic n=43 Participants Asymptomatic was defined as not having urethral discharge or dysuria at baseline.
Proportion of Participants Experiencing Treatment Failure After Treatment With Azithromycin for Uncomplicated Chlamydia Trachomatis (CT) in Males With and Without Urethral Symptoms	1 Participants	3 Participants

SECONDARY outcome

Timeframe: Day 28-follow-up visit

Population: Per protocol population, which included all participants who tested positive for CT at enrollment and were evaluable for treatment failure at day 28.

Odds ratios for the outcome of treatment failure calculated for laboratory findings (enrollment chlamydia load and OmpA genotype) and other participant characteristics (demographics, sexual behaviors, etc.). Note that samples were not run for OmpA genotype.

Outcome measures

Outcome measures
Measure	Symptomatic n=55 Participants Symptomatic was defined as urethral discharge and/or dysuria at baseline.	Asymptomatic Asymptomatic was defined as not having urethral discharge or dysuria at baseline.
Evaluate the Association of Laboratory Findings and Other Participant Characteristics to Chlamydia Treatment Failure in Males After Azithromycin Treatment	4 Participants	—

Adverse Events

Azithromycin

Serious events: 0 serious events

Other events: 5 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Azithromycin n=100 participants at risk Azithromycin 1 gm PO single dose given as directly observed Azithromycin: Azithromycin 1 gm PO single dose given as directly observed
Gastrointestinal disorders Nausea	1.0% 1/100 • Number of events 1 • After study drug administration (Study Visit 1) through the Day 28 follow-up visit (Study Visit 2). Gastrointestinal AEs that occur after study drug administration (Study Visit 1) and through the Day 28 follow-up visit (Study Visit 2) will be recorded. AEs which cause a participant to discontinue from the study after study drug administration (Study Visit 1) and through the Day 28 follow-up visit (Study Visit 2) will also be recorded.
Gastrointestinal disorders Abdominal pain	2.0% 2/100 • Number of events 2 • After study drug administration (Study Visit 1) through the Day 28 follow-up visit (Study Visit 2). Gastrointestinal AEs that occur after study drug administration (Study Visit 1) and through the Day 28 follow-up visit (Study Visit 2) will be recorded. AEs which cause a participant to discontinue from the study after study drug administration (Study Visit 1) and through the Day 28 follow-up visit (Study Visit 2) will also be recorded.
Gastrointestinal disorders Vomiting	1.0% 1/100 • Number of events 1 • After study drug administration (Study Visit 1) through the Day 28 follow-up visit (Study Visit 2). Gastrointestinal AEs that occur after study drug administration (Study Visit 1) and through the Day 28 follow-up visit (Study Visit 2) will be recorded. AEs which cause a participant to discontinue from the study after study drug administration (Study Visit 1) and through the Day 28 follow-up visit (Study Visit 2) will also be recorded.
Gastrointestinal disorders Constipation	1.0% 1/100 • Number of events 1 • After study drug administration (Study Visit 1) through the Day 28 follow-up visit (Study Visit 2). Gastrointestinal AEs that occur after study drug administration (Study Visit 1) and through the Day 28 follow-up visit (Study Visit 2) will be recorded. AEs which cause a participant to discontinue from the study after study drug administration (Study Visit 1) and through the Day 28 follow-up visit (Study Visit 2) will also be recorded.

Additional Information

Jeannette Lee

University of Arkansas for Medical Sciences

Phone: 501-526-6712

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place