Treatment Failure of Chlamydial Infection in Males and Females in Youth Correctional Facilities
| Status: | Completed |
|---|---|
| Conditions: | Infectious Disease |
| Therapuetic Areas: | Immunology / Infectious Diseases |
| Healthy: | No |
| Age Range: | 12 - 21 |
| Updated: | 5/5/2014 |
| Start Date: | December 2009 |
| End Date: | January 2014 |
| Contact: | William M Geisler |
| Email: | wgeisler@uab.edu |
| Phone: | (205) 934-4376 |
Randomized Clinical Trial Evaluating Treatment Failure Following Recommended Therapy (Azithromycin Versus Doxycycline) for Genital Chlamydial Infection in Males and Females in Youth Correctional Facilities
Chlamydia is a common infection among youth and can be given from one person to another
during sex. Many people who have chlamydia have no signs of infection at all, but can pass
the infection to anyone they have sex with. If not treated, chlamydia can lead to serious
health problems. This study will look at how well medicines given for chlamydia infection
work. The study requires 306 evaluable subjects, chlamydia-positive, males and non-pregnant
females, ages 12-21, living in long-term, gender-segregated youth correctional facilities.
Participants will be assigned to receive either doxycycline (2 times per day, by mouth, for
7 days) or azithromycin (1 single dose by mouth). Study procedures will include collection
of at least 3 urine samples to test for chlamydia. Study visits will occur during initial
enrollment in the study, day 28 after starting treatment, and day 67. Participants will be
involved in study related procedures for up to 67 days.
during sex. Many people who have chlamydia have no signs of infection at all, but can pass
the infection to anyone they have sex with. If not treated, chlamydia can lead to serious
health problems. This study will look at how well medicines given for chlamydia infection
work. The study requires 306 evaluable subjects, chlamydia-positive, males and non-pregnant
females, ages 12-21, living in long-term, gender-segregated youth correctional facilities.
Participants will be assigned to receive either doxycycline (2 times per day, by mouth, for
7 days) or azithromycin (1 single dose by mouth). Study procedures will include collection
of at least 3 urine samples to test for chlamydia. Study visits will occur during initial
enrollment in the study, day 28 after starting treatment, and day 67. Participants will be
involved in study related procedures for up to 67 days.
Genital chlamydia is a public health concern. The World Health Organization (WHO) estimates
that 90 million of all new cases of sexually transmitted diseases (STDs) per year are caused
by Chlamydia (C.) trachomatis. In the United States alone, approximately 3 million new cases
of chlamydia are reported yearly, and the costs associated with their management and
complications exceed $2 billion. Unfortunately, at least 75 percent of females with
chlamydia are asymptomatic, and unless the infection is detected through chlamydia testing
(screening), their infection may be transmitted to others or lead to complications. The
Centers of Disease Control and Prevention (CDC) recommends either azithromycin 1 gram (gm)
by mouth (PO) once or doxycycline 100 milligrams (mg) PO twice daily (BID) for 7 days as
co-equal therapies for uncomplicated chlamydia. A secondary aim will be to determine
demographic predictors of chlamydia treatment failure following azithromycin or doxycycline
treatment, and to explore clinical parameters, which distinguish those with persistent
infection. The study design of this Phase III trial will address major limitations of prior
chlamydia efficacy studies and the findings will reveal both the true efficacy of
azithromycin and doxycycline in uncomplicated chlamydia in adolescents and the factors that
predict treatment failure. This study is designed primarily to determine the frequency of
chlamydia treatment failure following either azithromycin or doxycycline regimens and to
evaluate whether the efficacy of the azithromycin regimen is inferior to the doxycycline
regimen. Both drugs are Food and Drug Administration (FDA) approved for use in the U.S. The
study will enroll 575 males and females age 12-21 years in good health (based on vital
signs and provider's clinical evaluation documented in medical records) who are residing in
long-term gender-segregated (not co-ed) youth correctional facilities (YCFs) (usual stay >3
weeks) and who are identified as chlamydia-infected would comprise the study population
until 306 evaluable subjects are obtained . Only individuals who have a positive chlamydia
screening test are enrolled, and those with negative screening tests are excluded.
Consenting chlamydia-positive subjects at the enrollment visit (study visit 1) will be
enrolled, asked to provide demographic data, to provide a first-void urine sample (not a
mid-stream specimen) for repeat chlamydia testing with Gen-Probe (GP) AC2 (for verification
of chlamydia), and then randomized to 1 of 2 treatment arms (190 153 subjects per arm):
doxycycline 100 mg PO BID for 7 days or azithromycin 1 gm PO single dose. Both therapies are
given as directly observed, and side effects are evaluated at the first follow-up visit (day
28 after study drug initiation). If a subject who's GP AC2 from the enrollment treatment
visit returns negative for C. trachomatis, they will be categorized as unevaluable and will
be removed from the study, then the site investigator will determine whether the subject
will complete this treatment or will receive other therapy. Subjects whose GP AC2 at the
enrollment treatment visit is positive for C. trachomatis will then be asked to provide a
first-void urine sample for repeat chlamydia testing with GP AC2 at 28- and 67-days after
study drug initiation [corresponding to the first follow-up visit (study visit 2) and second
follow-up visit (study visit 3), respectively].
that 90 million of all new cases of sexually transmitted diseases (STDs) per year are caused
by Chlamydia (C.) trachomatis. In the United States alone, approximately 3 million new cases
of chlamydia are reported yearly, and the costs associated with their management and
complications exceed $2 billion. Unfortunately, at least 75 percent of females with
chlamydia are asymptomatic, and unless the infection is detected through chlamydia testing
(screening), their infection may be transmitted to others or lead to complications. The
Centers of Disease Control and Prevention (CDC) recommends either azithromycin 1 gram (gm)
by mouth (PO) once or doxycycline 100 milligrams (mg) PO twice daily (BID) for 7 days as
co-equal therapies for uncomplicated chlamydia. A secondary aim will be to determine
demographic predictors of chlamydia treatment failure following azithromycin or doxycycline
treatment, and to explore clinical parameters, which distinguish those with persistent
infection. The study design of this Phase III trial will address major limitations of prior
chlamydia efficacy studies and the findings will reveal both the true efficacy of
azithromycin and doxycycline in uncomplicated chlamydia in adolescents and the factors that
predict treatment failure. This study is designed primarily to determine the frequency of
chlamydia treatment failure following either azithromycin or doxycycline regimens and to
evaluate whether the efficacy of the azithromycin regimen is inferior to the doxycycline
regimen. Both drugs are Food and Drug Administration (FDA) approved for use in the U.S. The
study will enroll 575 males and females age 12-21 years in good health (based on vital
signs and provider's clinical evaluation documented in medical records) who are residing in
long-term gender-segregated (not co-ed) youth correctional facilities (YCFs) (usual stay >3
weeks) and who are identified as chlamydia-infected would comprise the study population
until 306 evaluable subjects are obtained . Only individuals who have a positive chlamydia
screening test are enrolled, and those with negative screening tests are excluded.
Consenting chlamydia-positive subjects at the enrollment visit (study visit 1) will be
enrolled, asked to provide demographic data, to provide a first-void urine sample (not a
mid-stream specimen) for repeat chlamydia testing with Gen-Probe (GP) AC2 (for verification
of chlamydia), and then randomized to 1 of 2 treatment arms (190 153 subjects per arm):
doxycycline 100 mg PO BID for 7 days or azithromycin 1 gm PO single dose. Both therapies are
given as directly observed, and side effects are evaluated at the first follow-up visit (day
28 after study drug initiation). If a subject who's GP AC2 from the enrollment treatment
visit returns negative for C. trachomatis, they will be categorized as unevaluable and will
be removed from the study, then the site investigator will determine whether the subject
will complete this treatment or will receive other therapy. Subjects whose GP AC2 at the
enrollment treatment visit is positive for C. trachomatis will then be asked to provide a
first-void urine sample for repeat chlamydia testing with GP AC2 at 28- and 67-days after
study drug initiation [corresponding to the first follow-up visit (study visit 2) and second
follow-up visit (study visit 3), respectively].
Inclusion Criteria:
- Males and females between the ages of 12 and 21 years
- Residing in a long-term gender-segregated (no co-ed) youth correctional facility
(YCF)
- Diagnosed with genital chlamydia as determined by a screening C. trachomatis nucleic
acid amplification test (NAAT)
- Anticipated length of stay at the YCF at the time of enrollment is > 3 weeks
- Willingness to provide written consent
- Willingness to comply with study procedures
Exclusion Criteria:
- Diagnosed with gonorrhea as determined by a screening Neisseria gonorrhoeae nucleic
acid amplification test (NAAT)
- Clinical diagnosis of pelvic inflammatory disease (PID) or epididymitis based on
review of medical records
- Known allergy to tetracyclines or macrolides
- Currently pregnant or breastfeeding
- History of photosensitivity related to doxycycline use
- Having received antimicrobial therapy with activity against C. trachomatis within 21
days of the positive chlamydia screening NAAT or in the interval between the positive
screening NAAT and study enrollment
- Any concomitant infection, which requires antimicrobial therapy with activity against
C. trachomatis
- Previously enrolled in this study
- Unable to swallow pills
- Other exclusion criteria, per clinician judgment, that prohibits subject from
enrolling in study
- Of note, current use of oral contraceptive agents (OCPs) is not an exclusion
criterion
We found this trial at
2
sites
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Los Angeles, California 90007
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