Mecillinam for Treatment of Genital Chlamydia Infection

Mecillinam for Treatment of Genital Chlamydia Infection in Asymptomatic Men

Sponsors

Lead Sponsor: Oslo University Hospital

Collaborator: Møre og Romsdal Hospital Trust

Source Oslo University Hospital
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).

Overall Status Terminated
Start Date March 2014
Completion Date May 2015
Primary Completion Date April 2015
Phase Phase 2
Study Type Interventional
Primary Outcome
Measure Time Frame
Negative control test for Chlamydia in urine (NAAT; Nucleic Acid AmplificationTest) 3 weeks after end of treatment
Enrollment 20
Condition
Intervention

Intervention Type: Drug

Intervention Name: Pivmecillinamhydrochlorid

Description: PO 400 mg x3 for 7 days

Arm Group Label: Pivmecillinamhydrochlorid

Other Name: Selexid

Eligibility

Criteria:

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

Gender: Male

Minimum Age: 18 Years

Maximum Age: N/A

Healthy Volunteers: No

Overall Official
Last Name Role Affiliation
Anne Olaug Olsen, MD, PhD Principal Investigator Oslo UniversityHospital , Olafia Clinic
Location
Facility: Olafia Clinic,Oslo University Hosptial
Location Countries

Norway

Verification Date

June 2015

Responsible Party

Type: Principal Investigator

Investigator Affiliation: Oslo University Hospital

Investigator Full Name: Anne Olaug Olsen

Investigator Title: MD PhD

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 1
Arm Group

Label: Pivmecillinamhydrochlorid

Type: Experimental

Description: Selexid 400 mg x 3 , 7 days

Acronym MecillinamCT
Study Design Info

Allocation: N/A

Intervention Model: Single Group Assignment

Primary Purpose: Treatment

Masking: None (Open Label)

Source: ClinicalTrials.gov