Chlamydia Trachomatis Clinical Trial
Official title:
Study of Time to Eradication of Mycoplasma Genitalium and Chlamydia Trachomatis After Antibiotic Treatment
The purpose of this on-going study is to study the number of days after antibiotic treatment has commenced (due to infection caused by the sexually transmitted bacteria Chlamydia trachomatis (CT) and Mycoplasma genitalium(Mg)) it takes to be cured i.e to get a negative test result. The specimens are analyzed on first-catch-urine (men) or patient's self-obtained vaginal sample with quantitive nucleic acid amplification test(NAAT). A secondary aim is to detect macrolide resistant Mg-strains and study whether there are any emerging macrolide resistant Mg-strains after treatment with azithromycin. A third aim is to study whether the participating subjects are adherent to the study protocol meaning 12 samples taken during a period of four weeks.
Status | Recruiting |
Enrollment | 160 |
Est. completion date | September 2016 |
Est. primary completion date | August 2015 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Individuals attending the STD-clinic and being a sexual partner who has received an antibiotic treatment due to a non-specific urethritis/cervicitis or a confirmed Mycoplasma genitalium/Chlamydia trachomatis infection OR Having a confirmed infection described above or a symptomatic urethritis or cervicitis (non-gonorrhoic) Exclusion Criteria: - Allergy against any of the drugs, woman being pregnant or breast feeding, Not speaking or understanding Swedish fluently. Other medication with possible interaction to given treatment |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Sweden | R&D dept of Local Health Care, Östergötland county council | Linköping |
Lead Sponsor | Collaborator |
---|---|
Ostergotland County Council, Sweden | Statens Serum Institut |
Sweden,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Number or rate of patients adherent regarding sampling according to the protocol | To describe whether the subjects are adherent to the study protocol according to doing the sampling and sending the samples correctly. | One month after starting sampling | No |
Primary | Time from treatment starts to date of first negative test result is achieved up to 30 days. | Three arms. A randomisation (concealed envelopes) to either treatment with azithromycin 1g as a single dose or doxycycline for nine days (200 mg first day and 100 mg following nine (during summer time lymecycline 300mg twice daily for ten days). One un-randomized arm: Treatment with azithromycin 500 mg the first day and 250mg following four days or when indicated moxifloxacin 400 mg once daily for seven days. | From first day of treatment to date of first negative test up to 30 days per subject | No |
Secondary | Number of patients with emerging or existing macrolide resistance against Mycoplasma genitalium during or after treatment with azithromycin | Quantitive pcr of chlamydia and Mg is used. All Mg strains are tested for mutant genes. | One month after treatment has started | No |
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