Mecillinam for Treatment of Genital Chlamydia Infection | NCT02083276

Studies
Mecillinam for Treatment of Genital Chlamydia Infection

NCT02083276

Sponsor

Oslo University Hospital

Status

Terminated

Last Update Posted

Jun 19, 2015Estimated

Enrollment

20Actual

Phase

Phase 2

Conditions

Chlamydia Trachomatis Infection
Chlamydial Urethritis

Interventions

Pivmecillinamhydrochlorid

Countries

Norway

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
2013-002379-17	EudraCT Number

Status Module

Record Verification Date

Jun 2015

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Treatment failure on study medication observed

Expanded Access Info

Start Date

Mar 2014

Primary Completion Date

Apr 2015Actual

Completion Date

May 2015Actual

First Submitted Date

Mar 5, 2014

First Submission Date that Met QC Criteria

Mar 7, 2014

First Posted Date

Mar 11, 2014Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 18, 2015

Last Update Posted Date

Jun 19, 2015Estimated

Name	Class
Møre og Romsdal Hospital Trust	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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).

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

20Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Pivmecillinamhydrochlorid	Experimental	Selexid 400 mg x 3 , 7 days	Drug: Pivmecillinamhydrochlorid

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Pivmecillinamhydrochlorid	Drug	PO 400 mg x3 for 7 days	Pivmecillinamhydrochlorid

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

Male

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Anne Olaug Olsen, MD, PhD	Oslo UniversityHospital , Olafia Clinic	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Olafia Clinic,Oslo University Hosptial		Oslo			Norway

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
27165786	Derived	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.

ID	Term
D014522	Urethral Diseases
D014570	Urologic Diseases
D052776	Female Urogenital Diseases
D005261	Female Urogenital Diseases and Pregnancy Complications

ID	Term
D000560	Amdinocillin
D010406	Penicillins
D047090	beta-Lactams
D007769	Lactams
D000577

ID	Term
D014526	Urethritis
D005832	Genital Diseases, Male