New treatment for Klamydia infection.

MECILLINAM FOR TREATMENT OF GENITAL CHLAMYDIA INFECTION IN ASYMPTOMATIC MEN. - Chlamydia - mecillinam

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2013-002379-17-NO

Enrollment

Registered

2013-12-03

Start date

2013-12-06

Completion date

Unknown

Last updated

2021-05-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Asymptomatic genital Chlamydia Trachomatis infection MedDRA version: 14.1 Level: LLT Classification code 10070169 Term: Chlamydia trachomatis test positive System Organ Class: 100000004848 MedDRA version: 14.1 Level: LLT Classification code 10063313 Term: Chlamydial DNA test positive System Organ Class: 100000004848 MedDRA version: 14.1 Level: LLT Classification code 10067198 Term: Chlamydia trachomatis infection System Organ Class: 100000004862 MedDRA version: 14.1 Level: LLT Classification

Interventions

Trade Name: Selexid Product Name: SELEXID Product Code: SUB03884MIG Pharmaceutical Form: Tablet Other descriptive name: PIVMECILLINAM HYDROCHLORIDE Concentration unit: mg milligram(s) Concentration ty

Eligibility

Sex/Gender

Male

Inclusion 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. • Male gender. • 18 years old or older. • Hetero sexual. • Asymptomatic. • Signed informed consent and expected cooperation of the patients for the treatment and follow up must be obtained and documented according to ICH GCP, and national/local regulations. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 50 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: Patients will be excluded from the study if they meet any of the following criteria: • Known allergies for mecillinam, penicillin or cephalosporines. • Metabolic anomalies of aciduretic type. • Apparent underweight. • Use of valporate. • Use of mecillinam within the last two months. • Under treatment with other anti-infective drugs. • Use of immuno-modulative medication i.e. metotrexate, Interferone gamma, tumor necrosis factor inhibitors or monoclonal antibodies. • If there are, in the opinion of the investigator, obvious reasons why the patient will fail to adhere to the treatment and follow-up protocol. I.e. Psychiatric or mental disorders, alcohol abuse or other substance abuse, language barriers or other factors which makes adherence to the study protocol impossible

Design outcomes

Primary

Measure	Time frame
Main Objective: The objective of the study is to prove the concept of treating genital Chlamydia trachomatis infection with mecillinam po.. ;Secondary Objective: Form the basis for a larger randomised trials with the goal of documenting a new treatment for genital Chlamydia. ;Primary end point(s): Negative test of cure. (Nucleic Acid Amplification Test);Timepoint(s) of evaluation of this end point: Three to six weeks after end of treatment	—

Measure

Time frame

Main Objective: The objective of the study is to prove the concept of treating genital Chlamydia trachomatis infection with mecillinam po.. ;Secondary Objective: Form the basis for a larger randomised trials with the goal of documenting a new treatment for genital Chlamydia. ;Primary end point(s): Negative test of cure. (Nucleic Acid Amplification Test);Timepoint(s) of evaluation of this end point: Three to six weeks after end of treatment

—

Secondary

Measure	Time frame
Secondary end point(s): Tolerability of the treatment. ;Timepoint(s) of evaluation of this end point: Continous during treatment up to the timepoit of delivering test of cure sample.	—

Countries

Norway

Contacts

Public ContactStudiesykepleier, mecillinamstudien

Olafiaklinikken, Oslo universitetssykehus

UXAAMD@ous-hf.no004723075840

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026