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| Name | Class |
|---|---|
| Richmond Pharmacology Limited | INDUSTRY |
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A randomised, open labelled study design is selected in order to determine the emergence and persistence of antibiotic resistant bacteria in humans and on the composition of the indigenous microbiotas at various body sites. These will involve the administration to volunteers of minocycline and amoxicillin- a control group will receive a placebo. Microbiology of the skin, saliva, faecal, skin and nasal micro flora, safety and adverse events, vital signs, will be evaluated. The objectives of metagenomic analysis are:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 3 doses of amoxicillin daily for 7 days | Active Comparator | Cohort A: 3 doses of amoxicillin daily for 7 days (n=14). Follow up 12 months. |
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| 2 doses of minocycline daily for 5 days | Active Comparator | Cohort B: 2 doses of minocycline daily for five days (n=14). Follow up 12 months. |
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| 2 doses of placebo daily for 5 days | Placebo Comparator | Cohort C: 2 doses of placebo daily for five days (n=14). Follow up 12 months. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 3 doses of amoxicillin daily for 7 days | Drug |
| ||
| 2 doses of minocycline daily for five days |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of resistant bacteria collected from body sites in subjects receiving minocycline/ amoxicillin compared to the baseline. | 12 Months |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse events (AEs) will be monitored throughout the study | 12 Months |
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Inclusion Criteria:
Exclusion Criteria:
Regular use of medication, except contraceptive, vitamin tablets, treatment with antimicrobial agents within the 3 months preceding the study, Use of antibiotics for 4 weeks prior to the study drug application or use of concomitant systemic or topical antibiotics, Systemic treatment with immunosuppressive drugs e.g. cyclosporine, azathioprine or oral corticosteroids within 4 weeks prior to baseline visit (Visit 2) .
Participation in a trial with another investigational drug within the 3 months preceding the study
Present or residual gastrointestinal, renal insufficiency or hepatic disorder
Abnormal pathology of nasal passages
Any clinically significant allergy or drug intolerance
Active hay fever, on-going cold/flu symptoms, including rhinitis at baseline (visit 2)
Any medical history of renal insufficiency or hepatic disorder or other conditions known to interfere with the absorption, distribution, metabolism or excretion of drugs
history of hypersensitivity to beta-lactams or tetracycline
pregnant or breast-feeding women
Subjects known or suspected of not being able to comply with trial protocol (e.g. alcoholism, drug dependency, or psychological state). History of regular alcohol consumption exceeding an average weekly intake of alcohol greater than 21 units for female and 28 units for male.
One unit is equivalent to a half-pint of beer or one measure of spirits or one glass of wine.
Subjects with known or suspected immunodeficiency.
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| Name | Affiliation | Role |
|---|---|---|
| Jorg Taubel, MD | Richmond Pharmacology Limited | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Richmond Pharmacology Ltd | London | London | SW17 0RE, | United Kingdom |
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| Drug |
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| 2 doses of placebo daily for five days | Other |
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