Working… Menu

Mecillinam for Treatment of Genital Chlamydia Infection (MecillinamCT)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02083276
Recruitment Status : Terminated (Treatment failure on study medication observed)
First Posted : March 11, 2014
Last Update Posted : June 19, 2015
Møre og Romsdal Hospital Trust
Information provided by (Responsible Party):
Anne Olaug Olsen, 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).

Condition or disease Intervention/treatment Phase
Chlamydia Trachomatis Infection Chlamydial Urethritis Drug: Pivmecillinamhydrochlorid Phase 2

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Mecillinam for Treatment of Genital Chlamydia Infection in Asymptomatic Men
Study Start Date : March 2014
Actual Primary Completion Date : April 2015
Actual Study Completion Date : May 2015

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Pivmecillinamhydrochlorid
Selexid 400 mg x 3 , 7 days
Drug: Pivmecillinamhydrochlorid
PO 400 mg x3 for 7 days
Other Name: Selexid

Primary Outcome Measures :
  1. Negative control test for Chlamydia in urine (NAAT; Nucleic Acid AmplificationTest) [ Time Frame: 3 weeks after end of treatment ]

Information from the National Library of Medicine

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, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02083276

Layout table for location information
Olafia Clinic,Oslo University Hosptial
Oslo, Norway
Sponsors and Collaborators
Oslo University Hospital
Møre og Romsdal Hospital Trust
Layout table for investigator information
Principal Investigator: Anne Olaug Olsen, MD, PhD Oslo UniversityHospital , Olafia Clinic
Publications automatically indexed to this study by Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Anne Olaug Olsen, MD PhD, Oslo University Hospital Identifier: NCT02083276    
Other Study ID Numbers: 2013/1917
2013-002379-17 ( EudraCT Number )
First Posted: March 11, 2014    Key Record Dates
Last Update Posted: June 19, 2015
Last Verified: June 2015
Keywords provided by Anne Olaug Olsen, Oslo University Hospital:
Chlamydia trachomatis
Genital Diseases, Male
Additional relevant MeSH terms:
Layout table for MeSH terms
Communicable Diseases
Chlamydia Infections
Disease Attributes
Pathologic Processes
Chlamydiaceae Infections
Gram-Negative Bacterial Infections
Bacterial Infections
Bacterial Infections and Mycoses
Sexually Transmitted Diseases, Bacterial
Sexually Transmitted Diseases
Urethral Diseases
Urologic Diseases
Amdinocillin Pivoxil
Anti-Infective Agents, Urinary
Anti-Infective Agents
Renal Agents
Anti-Bacterial Agents