E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Asymptomatic genital Chlamydia Trachomatis infection |
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E.1.1.1 | Medical condition in easily understood language |
Genital Chlamydia infection without sypmtoms. |
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E.1.1.2 | Therapeutic area | Diseases [C] - Bacterial Infections and Mycoses [C01] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 14.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10070169 |
E.1.2 | Term | Chlamydia trachomatis test positive |
E.1.2 | System Organ Class | 100000004848 |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 14.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10063313 |
E.1.2 | Term | Chlamydial DNA test positive |
E.1.2 | System Organ Class | 100000004848 |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 14.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10067198 |
E.1.2 | Term | Chlamydia trachomatis infection |
E.1.2 | System Organ Class | 100000004862 |
|
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 14.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10008540 |
E.1.2 | Term | Chlamydia trachomatis infection of lower genitourinary sites |
E.1.2 | System Organ Class | 100000004862 |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
The objective of the study is to prove the concept of treating genital Chlamydia trachomatis infection with mecillinam po.. |
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E.2.2 | Secondary objectives of the trial |
Form the basis for a larger randomised trials with the goal of documenting a new treatment for genital Chlamydia. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal 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.
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E.4 | Principal 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
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E.5 End points |
E.5.1 | Primary end point(s) |
Negative test of cure. (Nucleic Acid Amplification Test) |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
Three to six weeks after end of treatment |
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E.5.2 | Secondary end point(s) |
Tolerability of the treatment. |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
Continous during treatment up to the timepoit of delivering test of cure sample. |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | No |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | No |
E.8.1.1 | Randomised | No |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.7 | Trial has a data monitoring committee | Yes |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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When the last included participant has delivered test of cure sample and follow-up questionnaire, or when the last participant is deemed "lost from follow-up".(Not returned follow-up questionnaire within 6 weeks after treatment.) |
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | |
E.8.9.1 | In the Member State concerned months | 5 |
E.8.9.1 | In the Member State concerned days | |