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Mecillinam for Treatment of Genital Chlamydia Infection (MecillinamCT)

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified March 2014 by Oslo University Hospital
Sponsor:
Collaborator:
More and Romsdal Health Trust
Information provided by (Responsible Party):
Anne Olaug Olsen, Oslo University Hospital
ClinicalTrials.gov Identifier:
NCT02083276
First received: March 5, 2014
Last updated: March 7, 2014
Last verified: March 2014
  Purpose

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.


Condition Intervention Phase
Chlamydia Trachomatis Infection
Chlamydial Urethritis
Drug: Pivmecillinamhydrochlorid
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Mecillinam for Treatment of Genital Chlamydia Infection in Asymptomatic Men

Resource links provided by NLM:


Further study details as provided by Oslo University Hospital:

Primary Outcome Measures:
  • Negative control test for Chlamydia in urine (NAAT; Nucleic Acid AmplificationTest) [ Time Frame: 3 weeks after end of treatment ] [ Designated as safety issue: No ]

Estimated Enrollment: 50
Study Start Date: March 2014
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Pivmecillinamhydrochlorid
Selexid 400 mg x 3 , 7 days
Drug: Pivmecillinamhydrochlorid
PO 400 mg x3 for 7 days
Other Name: Selexid

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02083276

Contacts
Contact: Anne Olaug Olsen, MD, Phd 23075840 ext +47 anools@ous-hf.no
Contact: Einar Nilsen, MD 71122137 ext +47 einar.nilsen@helse-mr.no

Locations
Norway
Olafia Clinic,Oslo University Hosptial Not yet recruiting
Oslo, Norway
Principal Investigator: Anne Olaug Olsen, MD PhD         
Sponsors and Collaborators
Oslo University Hospital
More and Romsdal Health Trust
Investigators
Principal Investigator: Anne Olaug Olsen, MD, PhD Oslo UniversityHospital , Olafia Clinic
  More Information

No publications provided

Responsible Party: Anne Olaug Olsen, MD PhD, Oslo University Hospital
ClinicalTrials.gov Identifier: NCT02083276     History of Changes
Other Study ID Numbers: 2013/1917, 2013-002379-17
Study First Received: March 5, 2014
Last Updated: March 7, 2014
Health Authority: Norway:National Committee for Medical and Health Research Ethics
Norway: Norwegian Medicines Agency

Keywords provided by Oslo University Hospital:
Chlamydia trachomatis
Urethritis
Genital Diseases, Male

Additional relevant MeSH terms:
Chlamydia Infections
Communicable Diseases
Infection
Urethritis
Bacterial Infections
Chlamydiaceae Infections
Genital Diseases, Female
Genital Diseases, Male
Gram-Negative Bacterial Infections
Sexually Transmitted Diseases
Sexually Transmitted Diseases, Bacterial
Urethral Diseases
Urologic Diseases

ClinicalTrials.gov processed this record on November 25, 2014