Trial Outcomes & Findings for Trial of Azithromycin vs. Doxycycline for the Treatment of Rectal Chlamydia in MSM (NCT NCT03608774)
NCT ID: NCT03608774
Last Updated: 2021-01-07
Results Overview
Microbiologic cure was based on rectal CT (Chlamydia trachomatis) NAAT (nucleic acid amplification test) result. The proportion of subjects with microbiologic cure in each study arm at Day 29 is reported in this outcome measure.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
177 participants
Primary outcome timeframe
Day 29
Results posted on
2021-01-07
Participant Flow
Participants recruited for the study were men who have sex with men diagnosed with rectal chlamydia based on a positive rectal Chlamydia trachomatis (CT) nucleic acid amplification test (NAAT) result. The first participant was enrolled on 13 July 2018, and the last participant was enrolled in January 2020.
Participant milestones
| Measure |
Azithromycin + Doxycycline Placebo
1 gram of Azithromycin (4 capsules of 250 mg) administered orally as a single dose on Day 1, and Doxycycline placebo (1 capsule) administered orally twice daily for 7 days starting on Day 1. N=89
Azithromycin: Azithromycin monohydrate is a macrolide antibacterial drug, FDA-approved in the US for the treatment of Chlamydia trachomatis (CT) in dose 1 gram (4 capsules of 250 mg), administered orally as a single dose.
Placebo: Doxycycline placebo (1 capsule), administered orally twice daily for 7 days.
|
Doxycycline + Azithromycin Placebo
100 mg of Doxycycline (1 capsule) administered orally twice daily for 7 days starting on Day 1, and Azithromycin placebo (4 capsules) administered orally as a single dose on Day 1. N=88
Doxycycline: Doxycycline hyclate is an antibacterial drug synthetically derived from oxytetracycline, FDA-approved in the US for the treatment of Chlamydia trachomatis (CT) as a course of 100 mg (1 capsule), administered orally twice daily for 7 days.
Placebo: Azithromycin placebo (4 capsules), administered orally as a single dose.
|
|---|---|---|
|
Overall Study
STARTED
|
89
|
88
|
|
Overall Study
COMPLETED
|
82
|
81
|
|
Overall Study
NOT COMPLETED
|
7
|
7
|
Reasons for withdrawal
| Measure |
Azithromycin + Doxycycline Placebo
1 gram of Azithromycin (4 capsules of 250 mg) administered orally as a single dose on Day 1, and Doxycycline placebo (1 capsule) administered orally twice daily for 7 days starting on Day 1. N=89
Azithromycin: Azithromycin monohydrate is a macrolide antibacterial drug, FDA-approved in the US for the treatment of Chlamydia trachomatis (CT) in dose 1 gram (4 capsules of 250 mg), administered orally as a single dose.
Placebo: Doxycycline placebo (1 capsule), administered orally twice daily for 7 days.
|
Doxycycline + Azithromycin Placebo
100 mg of Doxycycline (1 capsule) administered orally twice daily for 7 days starting on Day 1, and Azithromycin placebo (4 capsules) administered orally as a single dose on Day 1. N=88
Doxycycline: Doxycycline hyclate is an antibacterial drug synthetically derived from oxytetracycline, FDA-approved in the US for the treatment of Chlamydia trachomatis (CT) as a course of 100 mg (1 capsule), administered orally twice daily for 7 days.
Placebo: Azithromycin placebo (4 capsules), administered orally as a single dose.
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
5
|
5
|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
|
Overall Study
Protocol Violation
|
1
|
0
|
|
Overall Study
Not eligible at enrollment
|
0
|
1
|
|
Overall Study
Health related event
|
0
|
1
|
Baseline Characteristics
Trial of Azithromycin vs. Doxycycline for the Treatment of Rectal Chlamydia in MSM
Baseline characteristics by cohort
| Measure |
Azithromycin + Doxycycline Placebo
n=89 Participants
1 gram of Azithromycin (4 capsules of 250 mg) administered orally as a single dose on Day 1, and Doxycycline placebo (1 capsule) administered orally twice daily for 7 days starting on Day 1. N=89
Azithromycin: Azithromycin monohydrate is a macrolide antibacterial drug, FDA-approved in the US for the treatment of Chlamydia trachomatis (CT) in dose 1 gram (4 capsules of 250 mg), administered orally as a single dose.
Placebo: Doxycycline placebo (1 capsule), administered orally twice daily for 7 days.
|
Doxycycline + Azithromycin Placebo
n=88 Participants
100 mg of Doxycycline (1 capsule) administered orally twice daily for 7 days starting on Day 1, and Azithromycin placebo (4 capsules) administered orally as a single dose on Day 1. N=88
Doxycycline: Doxycycline hyclate is an antibacterial drug synthetically derived from oxytetracycline, FDA-approved in the US for the treatment of Chlamydia trachomatis (CT) as a course of 100 mg (1 capsule), administered orally twice daily for 7 days.
Placebo: Azithromycin placebo (4 capsules), administered orally as a single dose.
|
Total
n=177 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
33.6 years
STANDARD_DEVIATION 10.8 • n=99 Participants
|
33.9 years
STANDARD_DEVIATION 11.6 • n=107 Participants
|
33.7 years
STANDARD_DEVIATION 11.2 • n=206 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
89 Participants
n=99 Participants
|
88 Participants
n=107 Participants
|
177 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
16 Participants
n=99 Participants
|
21 Participants
n=107 Participants
|
37 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
71 Participants
n=99 Participants
|
67 Participants
n=107 Participants
|
138 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
10 Participants
n=99 Participants
|
12 Participants
n=107 Participants
|
22 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
2 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
3 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
8 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
54 Participants
n=99 Participants
|
58 Participants
n=107 Participants
|
112 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
16 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
22 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
3 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
8 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
89 participants
n=99 Participants
|
88 participants
n=107 Participants
|
177 participants
n=206 Participants
|
|
Rectal CT Symptomatic Status
Symptomatic
|
18 Participants
n=99 Participants
|
13 Participants
n=107 Participants
|
31 Participants
n=206 Participants
|
|
Rectal CT Symptomatic Status
Asymptomatic
|
71 Participants
n=99 Participants
|
74 Participants
n=107 Participants
|
145 Participants
n=206 Participants
|
|
Rectal CT Symptomatic Status
Not Available
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Inguinal Lymphadenopathy
Yes
|
3 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
7 Participants
n=206 Participants
|
|
Inguinal Lymphadenopathy
No
|
86 Participants
n=99 Participants
|
83 Participants
n=107 Participants
|
169 Participants
n=206 Participants
|
|
Inguinal Lymphadenopathy
Not Available
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: Day 29Population: The Complete Case population included randomized subjects who met all inclusion/exclusion criteria at enrollment, had a positive baseline rectal CT NAAT result, and had a Day 29 microbiologic result available.
Microbiologic cure was based on rectal CT (Chlamydia trachomatis) NAAT (nucleic acid amplification test) result. The proportion of subjects with microbiologic cure in each study arm at Day 29 is reported in this outcome measure.
Outcome measures
| Measure |
Azithromycin + Doxycycline Placebo
n=65 Participants
1 gram of Azithromycin (4 capsules of 250 mg) administered orally as a single dose on Day 1, and Doxycycline placebo (1 capsule) administered orally twice daily for 7 days starting on Day 1. N=89
Azithromycin: Azithromycin monohydrate is a macrolide antibacterial drug, FDA-approved in the US for the treatment of Chlamydia trachomatis (CT) in dose 1 gram (4 capsules of 250 mg), administered orally as a single dose.
Placebo: Doxycycline placebo (1 capsule), administered orally twice daily for 7 days.
|
Doxycycline + Azithromycin Placebo
n=70 Participants
100 mg of Doxycycline (1 capsule) administered orally twice daily for 7 days starting on Day 1, and Azithromycin placebo (4 capsules) administered orally as a single dose on Day 1. N=88
Doxycycline: Doxycycline hyclate is an antibacterial drug synthetically derived from oxytetracycline, FDA-approved in the US for the treatment of Chlamydia trachomatis (CT) as a course of 100 mg (1 capsule), administered orally twice daily for 7 days.
Placebo: Azithromycin placebo (4 capsules), administered orally as a single dose.
|
|---|---|---|
|
The Proportion of Subjects With Microbiologic Cure (Negative Rectal CT NAAT Result) at Day 29
|
0.74 proportion of participants
Interval 0.56 to 0.86
|
1.00 proportion of participants
Interval 0.9 to 1.0
|
SECONDARY outcome
Timeframe: Day 15Population: The Complete Case population included randomized subjects who met all inclusion/exclusion criteria at enrollment, had a positive baseline rectal CT NAAT result, and had a Day 15 microbiologic result available.
Microbiologic cure was based on rectal CT (Chlamydia trachomatis) NAAT (nucleic acid amplification test) result. The proportion of subjects with microbiologic cure in each study arm at Day 15 is reported in this outcome measure.
Outcome measures
| Measure |
Azithromycin + Doxycycline Placebo
n=67 Participants
1 gram of Azithromycin (4 capsules of 250 mg) administered orally as a single dose on Day 1, and Doxycycline placebo (1 capsule) administered orally twice daily for 7 days starting on Day 1. N=89
Azithromycin: Azithromycin monohydrate is a macrolide antibacterial drug, FDA-approved in the US for the treatment of Chlamydia trachomatis (CT) in dose 1 gram (4 capsules of 250 mg), administered orally as a single dose.
Placebo: Doxycycline placebo (1 capsule), administered orally twice daily for 7 days.
|
Doxycycline + Azithromycin Placebo
n=70 Participants
100 mg of Doxycycline (1 capsule) administered orally twice daily for 7 days starting on Day 1, and Azithromycin placebo (4 capsules) administered orally as a single dose on Day 1. N=88
Doxycycline: Doxycycline hyclate is an antibacterial drug synthetically derived from oxytetracycline, FDA-approved in the US for the treatment of Chlamydia trachomatis (CT) as a course of 100 mg (1 capsule), administered orally twice daily for 7 days.
Placebo: Azithromycin placebo (4 capsules), administered orally as a single dose.
|
|---|---|---|
|
The Proportion of Subjects With Microbiologic Cure (Negative Rectal CT NAAT Result) at Day 15
|
0.84 proportion of participants
Interval 0.73 to 0.91
|
0.94 proportion of participants
Interval 0.86 to 0.98
|
SECONDARY outcome
Timeframe: Day 15Population: The Complete Case population included randomized subjects who met all inclusion/exclusion criteria at enrollment, had a positive baseline rectal CT NAAT result, had a baseline LGV infection status result, and had a post-baseline microbiologic result available. Furthermore, participants in this subgroup analyses were non-LGV infected at baseline.
Microbiologic cure was based on rectal CT (Chlamydia trachomatis) NAAT (nucleic acid amplification test) result. The proportion of subjects with microbiologic cure in each study arm at Day 15 is reported in this outcome measure. LGV strains of CT were identified via multiplex PCR (Polymerase Chain Reaction) on positive CT NAAT specimens.
Outcome measures
| Measure |
Azithromycin + Doxycycline Placebo
n=63 Participants
1 gram of Azithromycin (4 capsules of 250 mg) administered orally as a single dose on Day 1, and Doxycycline placebo (1 capsule) administered orally twice daily for 7 days starting on Day 1. N=89
Azithromycin: Azithromycin monohydrate is a macrolide antibacterial drug, FDA-approved in the US for the treatment of Chlamydia trachomatis (CT) in dose 1 gram (4 capsules of 250 mg), administered orally as a single dose.
Placebo: Doxycycline placebo (1 capsule), administered orally twice daily for 7 days.
|
Doxycycline + Azithromycin Placebo
n=66 Participants
100 mg of Doxycycline (1 capsule) administered orally twice daily for 7 days starting on Day 1, and Azithromycin placebo (4 capsules) administered orally as a single dose on Day 1. N=88
Doxycycline: Doxycycline hyclate is an antibacterial drug synthetically derived from oxytetracycline, FDA-approved in the US for the treatment of Chlamydia trachomatis (CT) as a course of 100 mg (1 capsule), administered orally twice daily for 7 days.
Placebo: Azithromycin placebo (4 capsules), administered orally as a single dose.
|
|---|---|---|
|
The Proportion of Subjects With Microbiologic Cure (Negative Rectal CT NAAT Result) Within the Subgroup of Non-LGV (Lymphogranuloma Venereum) Infected at Baseline
|
0.84 proportion of participants
Interval 0.73 to 0.91
|
0.94 proportion of participants
Interval 0.85 to 0.98
|
SECONDARY outcome
Timeframe: Day 29Population: The Complete Case population included randomized subjects who met all inclusion/exclusion criteria at enrollment, had a positive baseline rectal CT NAAT result, had a baseline LGV infection status result, and had a post-baseline microbiologic result available. Furthermore, participants in this subgroup analyses were non-LGV infected at baseline.
Microbiologic cure was based on rectal CT (Chlamydia trachomatis) NAAT (nucleic acid amplification test) result. The proportion of subjects with microbiologic cure in each study arm at Day 29 is reported in this outcome measure. LGV strains of CT were identified via multiplex PCR (Polymerase Chain Reaction) on positive CT NAAT specimens.
Outcome measures
| Measure |
Azithromycin + Doxycycline Placebo
n=61 Participants
1 gram of Azithromycin (4 capsules of 250 mg) administered orally as a single dose on Day 1, and Doxycycline placebo (1 capsule) administered orally twice daily for 7 days starting on Day 1. N=89
Azithromycin: Azithromycin monohydrate is a macrolide antibacterial drug, FDA-approved in the US for the treatment of Chlamydia trachomatis (CT) in dose 1 gram (4 capsules of 250 mg), administered orally as a single dose.
Placebo: Doxycycline placebo (1 capsule), administered orally twice daily for 7 days.
|
Doxycycline + Azithromycin Placebo
n=66 Participants
100 mg of Doxycycline (1 capsule) administered orally twice daily for 7 days starting on Day 1, and Azithromycin placebo (4 capsules) administered orally as a single dose on Day 1. N=88
Doxycycline: Doxycycline hyclate is an antibacterial drug synthetically derived from oxytetracycline, FDA-approved in the US for the treatment of Chlamydia trachomatis (CT) as a course of 100 mg (1 capsule), administered orally twice daily for 7 days.
Placebo: Azithromycin placebo (4 capsules), administered orally as a single dose.
|
|---|---|---|
|
The Proportion of Subjects With Microbiologic Cure (Negative Rectal CT NAAT Result) Within the Subgroup of Non-LGV (Lymphogranuloma Venereum) Infected at Baseline
|
0.74 proportion of participants
Interval 0.62 to 0.83
|
1.00 proportion of participants
Interval 0.94 to 1.0
|
SECONDARY outcome
Timeframe: Day 15Population: The Complete Case population included randomized subjects who met all inclusion/exclusion criteria at enrollment, had a positive baseline rectal CT NAAT result, had a baseline LGV infection status result, and had a post-baseline microbiologic result available. Furthermore, participants in this subgroup analyses were LGV infected at baseline.
Microbiologic cure was based on rectal CT (Chlamydia trachomatis) NAAT (nucleic acid amplification test) result. The proportion of subjects with microbiologic cure in each study arm at Day 15 is reported in this outcome measure. LGV strains of CT were identified via multiplex PCR (Polymerase Chain Reaction) on positive CT NAAT specimens.
Outcome measures
| Measure |
Azithromycin + Doxycycline Placebo
n=4 Participants
1 gram of Azithromycin (4 capsules of 250 mg) administered orally as a single dose on Day 1, and Doxycycline placebo (1 capsule) administered orally twice daily for 7 days starting on Day 1. N=89
Azithromycin: Azithromycin monohydrate is a macrolide antibacterial drug, FDA-approved in the US for the treatment of Chlamydia trachomatis (CT) in dose 1 gram (4 capsules of 250 mg), administered orally as a single dose.
Placebo: Doxycycline placebo (1 capsule), administered orally twice daily for 7 days.
|
Doxycycline + Azithromycin Placebo
n=4 Participants
100 mg of Doxycycline (1 capsule) administered orally twice daily for 7 days starting on Day 1, and Azithromycin placebo (4 capsules) administered orally as a single dose on Day 1. N=88
Doxycycline: Doxycycline hyclate is an antibacterial drug synthetically derived from oxytetracycline, FDA-approved in the US for the treatment of Chlamydia trachomatis (CT) as a course of 100 mg (1 capsule), administered orally twice daily for 7 days.
Placebo: Azithromycin placebo (4 capsules), administered orally as a single dose.
|
|---|---|---|
|
The Proportion of Subjects With Microbiologic Cure (Negative Rectal CT NAAT Result) Within the Subgroup of LGV (Lymphogranuloma Venereum) Infected at Baseline
|
0.75 proportion of participants
Interval 0.3 to 0.95
|
1.00 proportion of participants
Interval 0.51 to 1.0
|
SECONDARY outcome
Timeframe: Day 29Population: The Complete Case population included randomized subjects who met all inclusion/exclusion criteria at enrollment, had a positive baseline rectal CT NAAT result, had a baseline LGV infection status result, and had a post-baseline microbiologic result available. Furthermore, participants in this subgroup analyses were LGV infected at baseline.
Microbiologic cure was based on rectal CT (Chlamydia trachomatis) NAAT (nucleic acid amplification test) result. The proportion of subjects with microbiologic cure in each study arm at Day 29 is reported in this outcome measure. LGV strains of CT were identified via multiplex PCR (Polymerase Chain Reaction) on positive CT NAAT specimens.
Outcome measures
| Measure |
Azithromycin + Doxycycline Placebo
n=4 Participants
1 gram of Azithromycin (4 capsules of 250 mg) administered orally as a single dose on Day 1, and Doxycycline placebo (1 capsule) administered orally twice daily for 7 days starting on Day 1. N=89
Azithromycin: Azithromycin monohydrate is a macrolide antibacterial drug, FDA-approved in the US for the treatment of Chlamydia trachomatis (CT) in dose 1 gram (4 capsules of 250 mg), administered orally as a single dose.
Placebo: Doxycycline placebo (1 capsule), administered orally twice daily for 7 days.
|
Doxycycline + Azithromycin Placebo
n=4 Participants
100 mg of Doxycycline (1 capsule) administered orally twice daily for 7 days starting on Day 1, and Azithromycin placebo (4 capsules) administered orally as a single dose on Day 1. N=88
Doxycycline: Doxycycline hyclate is an antibacterial drug synthetically derived from oxytetracycline, FDA-approved in the US for the treatment of Chlamydia trachomatis (CT) as a course of 100 mg (1 capsule), administered orally twice daily for 7 days.
Placebo: Azithromycin placebo (4 capsules), administered orally as a single dose.
|
|---|---|---|
|
The Proportion of Subjects With Microbiologic Cure (Negative Rectal CT NAAT Result) Within the Subgroup of LGV (Lymphogranuloma Venereum) Infected at Baseline
|
0.75 proportion of participants
Interval 0.3 to 0.95
|
1.00 proportion of participants
Interval 0.51 to 1.0
|
Adverse Events
Azithromycin + Doxycycline Placebo
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Doxycycline + Azithromycin Placebo
Serious events: 1 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Azithromycin + Doxycycline Placebo
n=89 participants at risk
1 gram of Azithromycin (4 capsules of 250 mg) administered orally as a single dose on Day 1, and Doxycycline placebo (1 capsule) administered orally twice daily for 7 days starting on Day 1. N=89
Azithromycin: Azithromycin monohydrate is a macrolide antibacterial drug, FDA-approved in the US for the treatment of Chlamydia trachomatis (CT) in dose 1 gram (4 capsules of 250 mg), administered orally as a single dose.
Placebo: Doxycycline placebo (1 capsule), administered orally twice daily for 7 days.
|
Doxycycline + Azithromycin Placebo
n=87 participants at risk
100 mg of Doxycycline (1 capsule) administered orally twice daily for 7 days starting on Day 1, and Azithromycin placebo (4 capsules) administered orally as a single dose on Day 1. N=88
Doxycycline: Doxycycline hyclate is an antibacterial drug synthetically derived from oxytetracycline, FDA-approved in the US for the treatment of Chlamydia trachomatis (CT) as a course of 100 mg (1 capsule), administered orally twice daily for 7 days.
Placebo: Azithromycin placebo (4 capsules), administered orally as a single dose.
|
|---|---|---|
|
Infections and infestations
Large intestine infection
|
0.00%
0/89 • SAEs that occurred during the subject's participation in the trial (Day 1 through Day 29) were collected.
Due to the safety profile of both drugs used in this trial, only SAEs (not non-serious AEs) that occurred after the first dose of treatment through Visit 3 (target at Day 29, visit window Day 25-31) were collected. SAEs included any untoward medical occurrence that resulted in death; was life threatening; required inpatient hospitalization or prolongation; or was a persistent/significant disability/incapacity. Participants considered at risk were restricted to those who received study product.
|
1.1%
1/87 • Number of events 1 • SAEs that occurred during the subject's participation in the trial (Day 1 through Day 29) were collected.
Due to the safety profile of both drugs used in this trial, only SAEs (not non-serious AEs) that occurred after the first dose of treatment through Visit 3 (target at Day 29, visit window Day 25-31) were collected. SAEs included any untoward medical occurrence that resulted in death; was life threatening; required inpatient hospitalization or prolongation; or was a persistent/significant disability/incapacity. Participants considered at risk were restricted to those who received study product.
|
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60