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Mecillinam for Treatment of Genital Chlamydia Infection (MecillinamCT)

Primary Purpose

Chlamydia Trachomatis Infection, Chlamydial Urethritis

Status
Terminated
Phase
Phase 2
Locations
Norway
Study Type
Interventional
Intervention
Pivmecillinamhydrochlorid
Sponsored by
Oslo University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chlamydia Trachomatis Infection focused on measuring Chlamydia trachomatis, Urethritis, Genital Diseases, Male

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

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

Sites / Locations

  • Olafia Clinic,Oslo University Hosptial

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Pivmecillinamhydrochlorid

Arm Description

Selexid 400 mg x 3 , 7 days

Outcomes

Primary Outcome Measures

Negative control test for Chlamydia in urine (NAAT; Nucleic Acid AmplificationTest)

Secondary Outcome Measures

Full Information

First Posted
March 5, 2014
Last Updated
June 18, 2015
Sponsor
Oslo University Hospital
Collaborators
Møre og Romsdal Hospital Trust
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1. Study Identification

Unique Protocol Identification Number
NCT02083276
Brief Title
Mecillinam for Treatment of Genital Chlamydia Infection
Acronym
MecillinamCT
Official Title
Mecillinam for Treatment of Genital Chlamydia Infection in Asymptomatic Men
Study Type
Interventional

2. Study Status

Record Verification Date
June 2015
Overall Recruitment Status
Terminated
Why Stopped
Treatment failure on study medication observed
Study Start Date
March 2014 (undefined)
Primary Completion Date
April 2015 (Actual)
Study Completion Date
May 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Oslo University Hospital
Collaborators
Møre og Romsdal Hospital Trust

4. Oversight

Data Monitoring Committee
No

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chlamydia Trachomatis Infection, Chlamydial Urethritis
Keywords
Chlamydia trachomatis, Urethritis, Genital Diseases, Male

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Pivmecillinamhydrochlorid
Arm Type
Experimental
Arm Description
Selexid 400 mg x 3 , 7 days
Intervention Type
Drug
Intervention Name(s)
Pivmecillinamhydrochlorid
Other Intervention Name(s)
Selexid
Intervention Description
PO 400 mg x3 for 7 days
Primary Outcome Measure Information:
Title
Negative control test for Chlamydia in urine (NAAT; Nucleic Acid AmplificationTest)
Time Frame
3 weeks after end of treatment

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anne Olaug Olsen, MD, PhD
Organizational Affiliation
Oslo UniversityHospital , Olafia Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Olafia Clinic,Oslo University Hosptial
City
Oslo
Country
Norway

12. IPD Sharing Statement

Citations:
PubMed Identifier
27165786
Citation
Nilsen E, Aasterod M, Hustad PS, Olsen AO. Mecillinam against genital Chlamydia trachomatis infection: a small-scale proof-of-concept study shows a low cure rate. J Antimicrob Chemother. 2016 Aug;71(8):2270-2. doi: 10.1093/jac/dkw134. Epub 2016 May 10.
Results Reference
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Mecillinam for Treatment of Genital Chlamydia Infection

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