Mecillinam for Treatment of Genital Chlamydia Infection

NCT ID: NCT02083276

Last Updated: 2015-06-19

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-03-31
• Study Completion Date: 2015-05-31

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).

Conditions

Chlamydia Trachomatis Infection; Chlamydial Urethritis

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Pivmecillinamhydrochlorid

Selexid 400 mg x 3 , 7 days

Group Type: EXPERIMENTAL

Pivmecillinamhydrochlorid

Intervention Type: DRUG

PO 400 mg x3 for 7 days

Interventions

Pivmecillinamhydrochlorid

PO 400 mg x3 for 7 days

Intervention Type: DRUG

Other Intervention Names

Selexid

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Møre og Romsdal Hospital Trust

OTHER

Sponsor Role: collaborator

Oslo University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Anne Olaug Olsen

MD PhD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Anne Olaug Olsen, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Oslo UniversityHospital , Olafia Clinic

Locations

Olafia Clinic,Oslo University Hosptial

Oslo, , Norway

Countries

Norway

References

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.

Reference Type: DERIVED

PMID: 27165786 (View on PubMed)

Other Identifiers

2013-002379-17

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

2013/1917

Identifier Type: -

Identifier Source: org_study_id