Urogential Chlamydia Trachomatis Infection
Conditions
Keywords
Chlamydia
Brief summary
Evaluate the clinical efficacy and safety of WC2031 200 mg tablets taken orally once a day for 7 days versus Vibramycin (doxycycline) 100 mg capsules taken orally twice a day for 7 days, for the treatment of uncomplicated urogenital Chlamydia trachomatis infection. Primary efficacy endpoint is microbiological cure at Day 28. Safety assessments are adverse events, changes in vital signs and laboratory test results.
Interventions
DRUGDoxycyline Hyclate tablet
200 mg tablet, once daily for 7 days
DRUGVibramycin (doxycyline hyclate) capsule
100 mg capsule, twice daily for 7 days, over-encapsulated
Sponsors
Warner Chilcott
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
19 Years to 45 Years
Healthy volunteers
No
Inclusion criteria
* 19-45 years of age, male or female * presumed diagnosis of urogenital C. trachomatis infection * use condoms during sexual activity during study (enrollment thru day 28)
Exclusion criteria
* Clinical diagnosis pelvic inflammatory disease or epididymitis at baseline * Diagnosis of N. gonorrhoea * HIV infection * Active Hepatitis B or C infection * Prior hysterectomy (partial or total) * Treatment with antimicrobial therapy with known activity against urogenital C. trachomatis within 28 days of enrollment
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Microbiological Cure Rate | Day 28 | Percentage of Subjects in mITT Population with Microbiological Cure defined as a negative result for C. trachomatis as determined by GP AC2 NAAT (Gen-Probe Aptima Combo 2 Nucleic Acid Amplification Test) at Day 28 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Microbiological Cure and Clinical Cure of C. Trachomatis, Day 28, Clinically Evaluable Population, Percentage Participants Cured | End of Study (Day 28) | Microbiological cure (defined as a negative result for urogenital C. trachomatis, determined by GP AC2 NAAT/Gen-Probe Aptima Combo 2 Nucleic Acid Amplification Test and clinical cure (for males defined as resolution of baseline signs/symptoms of dysuria, urethral pruritus and urethral discharge, and resolution of exam finding of urethral discharge; for females resolution of exam finding of endocervical discharge) at Day 28 |
| Microbiological Cure C. Trachomatis and M. Genitalium, M. Genitalium Coinfected Population, Day 28, Percentage Participants Cured | End of Study (Day 28) | Percentage Subjects Cured of both M. genitalium and C. trachomatis M. genitalium co-infected population: microbiological cure for both at Day 28, defined as negative PCR (polymerase chain reaction) for M. genitalium and negative GP AC2 NAAT (Gen-Probe Aptima Combo 2 Nucleic Acid Amplification test) for C. trachomatis at Day 28 |
| Microbiological Cure C. Trachomatis, N. Gonorrhoea Negative Population, Day 28, Percentage Participants Cured | Day 28 | Percentage Participants cured in N. gonorrhoea Negative Population: cured defined as both microbiological cure (negative result for urogenital C. trachomatis, determined by GP AC2 NAAT/Gen-Probe Aptima Combo 2 Nucleic Acid Amplification test) and clinical cure (males defined as resolution of baseline signs/symptoms of dysuria, urethral pruritis and urethral discharge, and resolution of exam finding of urethral discharge; females - resolution of exam finding of endocervical discharge) at Day 28 |
Countries
United States
Participant flow
Recruitment details
Enrollment period began 7 Apr '10
Participants by arm
| Arm | Count |
|---|---|
| Doxycycline Hyclate Morning: 1 200 mg tablet doxycycline hyclate and 1 placebo Vibramycin capsule, Evening: 1 placebo Vibramycin capsule | 247 |
| Vibramycin Morning: 1 over-encapsulated 100 mg Vibramycin tablet and 1 placebo doxycycline hyclate table, Evening: 1 over-encapsulated 100 mg Vibramycin tablet | 248 |
| Total | 495 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 2 | 2 |
| Overall Study | Lost to Follow-up | 12 | 9 |
| Overall Study | Physician Decision | 0 | 2 |
| Overall Study | Various | 2 | 4 |
| Overall Study | Withdrawal by Subject | 3 | 0 |
Baseline characteristics
| Characteristic | Doxycycline Hyclate | Vibramycin | Total |
|---|---|---|---|
| Age Continuous | 24.1 years STANDARD_DEVIATION 4.9 | 23.9 years STANDARD_DEVIATION 4.9 | 24.0 years STANDARD_DEVIATION 4.9 |
| Age, Customized <30 years | 163 participants | 170 participants | 333 participants |
| Age, Customized >40 years | 3 participants | 2 participants | 5 participants |
| Age, Customized Between 30 and 40 years | 22 participants | 18 participants | 40 participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 33 Participants | 44 Participants | 77 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 155 Participants | 146 Participants | 301 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Gender Female | 115 participants | 118 participants | 233 participants |
| Gender Male | 73 participants | 72 participants | 145 participants |
| Race (NIH/OMB) American Indian or Alaska Native | 2 Participants | 1 Participants | 3 Participants |
| Race (NIH/OMB) Asian | 3 Participants | 1 Participants | 4 Participants |
| Race (NIH/OMB) Black or African American | 109 Participants | 104 Participants | 213 Participants |
| Race (NIH/OMB) More than one race | 10 Participants | 10 Participants | 20 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 3 Participants | 1 Participants | 4 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 61 Participants | 73 Participants | 134 Participants |
| Region of Enrollment United States | 247 participants | 248 participants | 495 participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 84 / 246 | 129 / 248 |
| serious Total, serious adverse events | 0 / 246 | 0 / 248 |
Outcome results
Primary
Microbiological Cure Rate
Percentage of Subjects in mITT Population with Microbiological Cure defined as a negative result for C. trachomatis as determined by GP AC2 NAAT (Gen-Probe Aptima Combo 2 Nucleic Acid Amplification Test) at Day 28
Time frame: Day 28
Population: mITT Population - all randomized subjects who had positive NAAT for C. trachomatis at Baseline and took at least one dose of study drug.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Doxycycline Hyclate | Microbiological Cure Rate | 94.9 percentage of participants cured |
| Vibramycin | Microbiological Cure Rate | 94.6 percentage of participants cured |
Comparison: The planned sample size of 480 randomized subjects ensured that approximately 200 subjects per group were included in the primary efficacy analyses. The 20% rate of exclusion was to account for subjects who had a negative test for urogenital C. trachomatis at the Baseline visit.95% CI: [-4.6, 5.1]
Secondary
Microbiological Cure and Clinical Cure of C. Trachomatis, Day 28, Clinically Evaluable Population, Percentage Participants Cured
Microbiological cure (defined as a negative result for urogenital C. trachomatis, determined by GP AC2 NAAT/Gen-Probe Aptima Combo 2 Nucleic Acid Amplification Test and clinical cure (for males defined as resolution of baseline signs/symptoms of dysuria, urethral pruritus and urethral discharge, and resolution of exam finding of urethral discharge; for females resolution of exam finding of endocervical discharge) at Day 28
Time frame: End of Study (Day 28)
Population: Clinically Evaluable Population
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Doxycycline Hyclate | Microbiological Cure and Clinical Cure of C. Trachomatis, Day 28, Clinically Evaluable Population, Percentage Participants Cured | 80.0 Percentage Particpants Cured |
| Vibramycin | Microbiological Cure and Clinical Cure of C. Trachomatis, Day 28, Clinically Evaluable Population, Percentage Participants Cured | 68.6 Percentage Particpants Cured |
Secondary
Microbiological Cure C. Trachomatis and M. Genitalium, M. Genitalium Coinfected Population, Day 28, Percentage Participants Cured
Percentage Subjects Cured of both M. genitalium and C. trachomatis M. genitalium co-infected population: microbiological cure for both at Day 28, defined as negative PCR (polymerase chain reaction) for M. genitalium and negative GP AC2 NAAT (Gen-Probe Aptima Combo 2 Nucleic Acid Amplification test) for C. trachomatis at Day 28
Time frame: End of Study (Day 28)
Population: M. genitalium Coinfected Population
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Doxycycline Hyclate | Microbiological Cure C. Trachomatis and M. Genitalium, M. Genitalium Coinfected Population, Day 28, Percentage Participants Cured | 38.5 Percentage Participants Cured |
| Vibramycin | Microbiological Cure C. Trachomatis and M. Genitalium, M. Genitalium Coinfected Population, Day 28, Percentage Participants Cured | 18.2 Percentage Participants Cured |
Secondary
Microbiological Cure C. Trachomatis, N. Gonorrhoea Negative Population, Day 28, Percentage Participants Cured
Percentage Participants cured in N. gonorrhoea Negative Population: cured defined as both microbiological cure (negative result for urogenital C. trachomatis, determined by GP AC2 NAAT/Gen-Probe Aptima Combo 2 Nucleic Acid Amplification test) and clinical cure (males defined as resolution of baseline signs/symptoms of dysuria, urethral pruritis and urethral discharge, and resolution of exam finding of urethral discharge; females - resolution of exam finding of endocervical discharge) at Day 28
Time frame: Day 28
Population: N. gonorrhoea Population. Only subjects with an evaluable outcome are included in the analysis.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Doxycycline Hyclate | Microbiological Cure C. Trachomatis, N. Gonorrhoea Negative Population, Day 28, Percentage Participants Cured | 94.9 Percentage Participants Cured |
| Vibramycin | Microbiological Cure C. Trachomatis, N. Gonorrhoea Negative Population, Day 28, Percentage Participants Cured | 94.6 Percentage Participants Cured |
Comparison: The planned sample size of 480 randomized subjects ensured that approximately 200 subjects per group were included in the primary efficacy analyses. The 20% rate of exclusion was to account for subjects who had a negative test for urogenital C. trachomatis at the Baseline visit.95% CI: [-4.6, 5.1]