Chlamydia Trachomatis Infection Clinical Trial
— MecillinamCTOfficial title:
Mecillinam for Treatment of Genital Chlamydia Infection in Asymptomatic Men
The mainstay of treating both symptomatic and asymptomatic genital Chlamydia trachomatis
infection has been macrolide antibiotics in the form of azithromycin, and alternatively
tetracycline antibiotics in the form of doxycycline. Studies from the late nineties found a
single dose of 1 g azithromycin to be equally effective as a 7 day course of 200 mg
doxycycline a day. However, recent studies have reported increasing treatment failure that
may indicate that resistance to macrolide antibiotics among Chlamydia trachomatis is
evolving. Research regarding other bacterial species indicates a high frequency of mutation
based resistance in conjunction with azithromycin use, i.e. when treating Mycoplasma
genitalium infections. There has only been case reports of tetracycline resistance among
human Chlamydia isolates, but a recent study suggest that there might be decreasing
effectiveness also for doxycycline. Veterinaries has for several years observed increasing
prevalence of tetracycline resistance among Chlamydia suis. Within the Chlamydia population
there is promiscuous horizontal gene transfer.
If the current trend of declining cure rates continues, the investigators might face a
situation where there are no documented and effective treatments for Chlamydia trachomatis
infections. This underline an urgent need to expand the number of documented treatment
options and mecillinam seems to be one of the options that warrant further investigation.
The objectives of this study is to prove the concept of treating genital Chlamydia
trachomatis with mecillinam (Pivmecillinamhydrochlorid).
Status | Terminated |
Enrollment | 20 |
Est. completion date | May 2015 |
Est. primary completion date | April 2015 |
Accepts healthy volunteers | No |
Gender | Male |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Proficient in oral and written Norwegian - Positive NAAT in first void urine for Chlamydia trachomatis - Negative NAAT in first void urine for Mycoplasma genitalium - Heterosexual male - Asymptomatic Exclusion Criteria: - Known allergies for mecillinam, penicillin or cephalosporines - Metabolic anomalies of aciduric type - Apparent underweight - Use of mecillinam within the last two months - Under treatment with Valproat, other anti-infective drugs, immuno-modulating medication - In the opinion of investigator,obvious reasons why patient will fails to adhere to treatment and follow-up protocol |
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Norway | Olafia Clinic,Oslo University Hosptial | Oslo |
Lead Sponsor | Collaborator |
---|---|
Oslo University Hospital | More and Romsdal Health Trust |
Norway,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Negative control test for Chlamydia in urine (NAAT; Nucleic Acid AmplificationTest) | 3 weeks after end of treatment | No |
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