Mecillinam for Treatment of Genital Chlamydia Infection (MecillinamCT)
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|ClinicalTrials.gov Identifier: NCT02083276|
Recruitment Status : Terminated (Treatment failure on study medication observed)
First Posted : March 11, 2014
Last Update Posted : June 19, 2015
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).
|Condition or disease||Intervention/treatment||Phase|
|Chlamydia Trachomatis Infection Chlamydial Urethritis||Drug: Pivmecillinamhydrochlorid||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||20 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Mecillinam for Treatment of Genital Chlamydia Infection in Asymptomatic Men|
|Study Start Date :||March 2014|
|Actual Primary Completion Date :||April 2015|
|Actual Study Completion Date :||May 2015|
Selexid 400 mg x 3 , 7 days
PO 400 mg x3 for 7 days
Other Name: Selexid
- Negative control test for Chlamydia in urine (NAAT; Nucleic Acid AmplificationTest) [ Time Frame: 3 weeks after end of treatment ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02083276
|Olafia Clinic,Oslo University Hosptial|
|Principal Investigator:||Anne Olaug Olsen, MD, PhD||Oslo UniversityHospital , Olafia Clinic|