Trial Outcomes & Findings for Treatment Failure of Chlamydial Infection in Males and Females in Youth Correctional Facilities (NCT NCT00980148)
NCT ID: NCT00980148
Last Updated: 2015-03-18
Results Overview
The proportion of participants with testing by Gen-Probe Aptima Combo 2 that is positive for C. trachomatis and C. trachomatis OmpA (Major Outer Membrane Protein) genotyping reveals the baseline chlamydial strain and the repeat positive chlamydial strain to be the same genotype (i.e., concordant).
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
567 participants
Primary outcome timeframe
Study visit # 2 (Day 28 after therapy started)
Results posted on
2015-03-18
Participant Flow
Participant milestones
| Measure |
Azithromycin Arm
Azithromycin 1 gm oral single dose
|
Doxycycline Arm
Doxycycline 100 mg oral twice a day for 7 days
|
|---|---|---|
|
Overall Study
STARTED
|
284
|
283
|
|
Overall Study
COMPLETED
|
155
|
155
|
|
Overall Study
NOT COMPLETED
|
129
|
128
|
Reasons for withdrawal
| Measure |
Azithromycin Arm
Azithromycin 1 gm oral single dose
|
Doxycycline Arm
Doxycycline 100 mg oral twice a day for 7 days
|
|---|---|---|
|
Overall Study
Discharged from facility
|
89
|
96
|
|
Overall Study
Received other antichlamydia treatment
|
20
|
14
|
|
Overall Study
Negative for chlamydia at enrollment
|
12
|
9
|
|
Overall Study
Various other reasons
|
8
|
9
|
Baseline Characteristics
Treatment Failure of Chlamydial Infection in Males and Females in Youth Correctional Facilities
Baseline characteristics by cohort
| Measure |
Azithromycin Arm
n=155 Participants
Azithromycin 1 gm oral single dose
|
Doxycycline Arm
n=155 Participants
Doxycycline 100 mg oral twice a day for 7 days
|
Total
n=310 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
155 Participants
n=5 Participants
|
154 Participants
n=7 Participants
|
309 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
17.0 years
STANDARD_DEVIATION 0.9 • n=5 Participants
|
16.8 years
STANDARD_DEVIATION 1.1 • n=7 Participants
|
16.9 years
STANDARD_DEVIATION 1.0 • n=5 Participants
|
|
Sex: Female, Male
Female
|
53 Participants
n=5 Participants
|
56 Participants
n=7 Participants
|
109 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
102 Participants
n=5 Participants
|
99 Participants
n=7 Participants
|
201 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
155 participants
n=5 Participants
|
155 participants
n=7 Participants
|
310 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Study visit # 2 (Day 28 after therapy started)Population: The per protocol population is comprised of participants who completed therapy and whose failure status could be established at the day 28 visit. Participants were considered to have completed therapy if they took a single dose of azithromycin or at least 10 of the 14 doses of doxycycline.
The proportion of participants with testing by Gen-Probe Aptima Combo 2 that is positive for C. trachomatis and C. trachomatis OmpA (Major Outer Membrane Protein) genotyping reveals the baseline chlamydial strain and the repeat positive chlamydial strain to be the same genotype (i.e., concordant).
Outcome measures
| Measure |
Azithromycin Arm
n=155 Participants
Azithromycin 1 gm oral single dose
|
Doxycycline Arm
n=155 Participants
Doxycycline 100 mg oral twice a day for 7 days
|
|---|---|---|
|
Assess Microbiological Failure of Recommended Azithromycin and Doxycycline Regimens in Uncomplicated Chlamydia Trachomatis Infection in a Setting Where Repeat Exposure to Chlamydia-infected Persons Can be Minimized.
|
3.2 percentage of participants
|
0.0 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline and study visit #2 (Day 28 after therapy is started)Outcome measures
Outcome data not reported
Adverse Events
Azithromycin Arm
Serious events: 0 serious events
Other events: 11 other events
Deaths: 0 deaths
Doxycycline Arm
Serious events: 0 serious events
Other events: 18 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Azithromycin Arm
n=155 participants at risk
Azithromycin 1 gm oral single dose
|
Doxycycline Arm
n=155 participants at risk
Doxycycline 100 mg oral twice a day for 7 days
|
|---|---|---|
|
Gastrointestinal disorders
Abdominal Pain
|
3.9%
6/155 • Number of events 7 • Adverse events (AEs) that occur after study drug administration (Study Visit 1) and through the first follow-up visit (Study Visit 2, Day 28) were recorded. AEs were followed until resolution even if this extended beyond the study-reporting period.
Resolution of an AE is defined as the return to pretreatment status or stabilization of the condition with the expectation that it will remain chronic. In Sept 2010, the protocol was amended to streamline reportable AE's by limiting to GI related symptoms, vaginal irritation or itching, and dermatologic reactions.
|
6.5%
10/155 • Number of events 10 • Adverse events (AEs) that occur after study drug administration (Study Visit 1) and through the first follow-up visit (Study Visit 2, Day 28) were recorded. AEs were followed until resolution even if this extended beyond the study-reporting period.
Resolution of an AE is defined as the return to pretreatment status or stabilization of the condition with the expectation that it will remain chronic. In Sept 2010, the protocol was amended to streamline reportable AE's by limiting to GI related symptoms, vaginal irritation or itching, and dermatologic reactions.
|
|
Gastrointestinal disorders
Vomiting
|
3.9%
6/155 • Number of events 6 • Adverse events (AEs) that occur after study drug administration (Study Visit 1) and through the first follow-up visit (Study Visit 2, Day 28) were recorded. AEs were followed until resolution even if this extended beyond the study-reporting period.
Resolution of an AE is defined as the return to pretreatment status or stabilization of the condition with the expectation that it will remain chronic. In Sept 2010, the protocol was amended to streamline reportable AE's by limiting to GI related symptoms, vaginal irritation or itching, and dermatologic reactions.
|
6.5%
10/155 • Number of events 11 • Adverse events (AEs) that occur after study drug administration (Study Visit 1) and through the first follow-up visit (Study Visit 2, Day 28) were recorded. AEs were followed until resolution even if this extended beyond the study-reporting period.
Resolution of an AE is defined as the return to pretreatment status or stabilization of the condition with the expectation that it will remain chronic. In Sept 2010, the protocol was amended to streamline reportable AE's by limiting to GI related symptoms, vaginal irritation or itching, and dermatologic reactions.
|
Additional Information
Shelly Lensing, Statistician
University of Arkansas for Medical Sciences
Phone: 501-686-8203
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place