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

Oslo University Hospital healt Trust0 个研究点目标入组 50 人开始时间: 2013年12月3日最近更新: 2021年5月10日

适应症

试验速览

暂无简介。

•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

•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

发起方

Oslo University Hospital healt Trust