Mecillinam for Treatment of Genital Chlamydia Infection (MecillinamCT)

June 18, 2015 updated by: Anne Olaug Olsen, Oslo University Hospital

Mecillinam for Treatment of Genital Chlamydia Infection in Asymptomatic Men

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).

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

20

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Norway
      • Oslo, Norway
        • Olafia Clinic,Oslo University Hosptial

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Pivmecillinamhydrochlorid
Selexid 400 mg x 3 , 7 days
Drug: Pivmecillinamhydrochlorid
PO 400 mg x3 for 7 days
Other Names:
  • Selexid

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Oslo University Hospital

Collaborators

Møre og Romsdal Hospital Trust

Investigators

  • Principal Investigator: Anne Olaug Olsen, MD, PhD, Oslo UniversityHospital , Olafia Clinic

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2014

Primary Completion (Actual)

April 1, 2015

Study Completion (Actual)

May 1, 2015

Study Registration Dates

First Submitted

March 5, 2014

First Submitted That Met QC Criteria

March 7, 2014

First Posted (Estimate)

March 11, 2014

Study Record Updates

Last Update Posted (Estimate)

June 19, 2015

Last Update Submitted That Met QC Criteria

June 18, 2015

Last Verified

June 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2013/1917
  • 2013-002379-17 (EudraCT Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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