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Mecillinam for Treatment of Genital Chlamydia Infection

Mecillinam for Treatment of Genital Chlamydia Infection in Asymptomatic Men

Status
Terminated
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02083276
Acronym
MecillinamCT
Enrollment
20
Registered
2014-03-11
Start date
2014-03-31
Completion date
2015-05-31
Last updated
2015-06-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chlamydial Urethritis, Chlamydia Trachomatis Infection

Keywords

Chlamydia trachomatis, Urethritis, Genital Diseases, Male

Brief summary

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).

Interventions

DRUGPivmecillinamhydrochlorid

PO 400 mg x3 for 7 days

Sponsors

Møre og Romsdal Hospital Trust
CollaboratorOTHER
Oslo University Hospital
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Negative control test for Chlamydia in urine (NAAT; Nucleic Acid AmplificationTest)3 weeks after end of treatment

Countries

Norway

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 13, 2026