Mecillinam for Treatment of Genital Chlamydia Infection

Chlamydia Trachomatis Infection Clinical Trial

— MecillinamCT  

Official title:

Mecillinam for Treatment of Genital Chlamydia Infection in Asymptomatic Men

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02083276
• Other study ID #: 2013/1917
• Secondary ID: 2013-002379-17
• Status: Terminated
• Phase: Phase 2
• First received: March 5, 2014
• Last updated: June 18, 2015
• Start date: March 2014
• Est. completion date: May 2015

Study information

• Verified date: June 2015
• Source: Oslo University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Norway:National Committee for Medical and Health Research EthicsNorway: Norwegian Medicines Agency
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• 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

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chlamydia Infections
• Chlamydia Trachomatis Infection
• Chlamydial Urethritis
• Infection
• Urethritis

Intervention

Drug:
• Pivmecillinamhydrochlorid
PO 400 mg x3 for 7 days

Locations

Country	Name	City	State
Norway	Olafia Clinic,Oslo University Hosptial	Oslo

Sponsors (2)

Lead Sponsor	Collaborator
Oslo University Hospital	More and Romsdal Health Trust

Country where clinical trial is conducted

Norway, 

Outcome

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