Mecillinam for Treatment of Genital Chlamydia Infection

Study Overview
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Brief Summary
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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).

Official Title
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Mecillinam for Treatment of Genital Chlamydia Infection in Asymptomatic Men

Conditions
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Chlamydia Trachomatis Infection, Chlamydial Urethritis

Intervention / Treatment
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* Drug: Pivmecillinamhydrochlorid


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Pivmecillinamhydrochlorid<br>Selexid 400 mg x 3 , 7 days | Drug: Pivmecillinamhydrochlorid<br>* PO 400 mg x3 for 7 days<br>* Other names: Selexid;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Negative control test for Chlamydia in urine (NAAT; Nucleic Acid AmplificationTest) |  | 3 weeks after end of treatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Chlamydia trachomatis, Urethritis, Genital Diseases, Male