E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
We are investigating the optimal treatment of MRSA carriage in throat |
|
E.1.1.1 | Medical condition in easily understood language |
Proven carrier of methicillin resistant Staphylococcus aureus (MRSA) |
|
E.1.1.2 | Therapeutic area | Diseases [C] - Skin and Connective Tissue Diseases [C17] |
MedDRA Classification |
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 |
Antibiotic resistance in bacteria is an increasing challenge worldwide. Methicillin resistant Staphylococcus aureus (MRSA) has been seen since 1961 . S. aureus is an opportunistic pathogen that can become invasive and cause a large spectrum of infections, but can also colonize the skin/mucosa. When colonization is confirmed, the person is called a carrier of MRSA and is at risk of a wide spectrum of infections, as well as giving it to others.
The Danish Health Authority has published a National guideline on how to prevent the spread of MRSA using a five day topical decolonization treatment. Unfortunately, many patients are still MRSA carriers after completing the treatment and especially throat carriers are difficult to clear.
We wish to investigate if a significantly higher number of MRSA throat carriers become MRSA free when treated with standard treatment plus the antibiotic clindamycin compared to the standard treatment alone. Primary endpoint: MRSA negative swabs at 1 months |
|
E.2.2 | Secondary objectives of the trial |
Secondary endpoint: MRSA negative swabs after 6 months |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
• Age ≥ 18 years
• MRSA carriage in the throat after first topical decolonization treatment (regardless of previous swabs)
• Has completed one standard topical decolonization treatment
|
|
E.4 | Principal exclusion criteria |
• Pregnant or lactating woman
• Sexually active women in the reproductive age that do not use approved contraceptives (appendix 4)
• Cannot read or speak Danish (the written participant information is in Danish)
• Skin infection or other active infections
• Activity in skin diseases such as eczema or psoriasis.
• MRSA isolate with clindamycin zone size < 22 or resistant to mupirocin
• Allergy to clindamycin, chlorhexidine or mupirocin
• Taking medications that interact with clindamycin according to the medicine information leaflet.
• MRSA active antibiotic treatment within 7 days before inclusion in the study or during study period
• Followed by specialist due to liver disease
• Severe overweight (BMI > 35) or weight < 50 kg
• Indwelling percutaneous permanent devices such as intravenous catheters or urinary tract catheters
• Daily contact with pigs or minks (decolonization therapy is generally not offered, according to The National Board of Health)
• Nursing home resident or health care worker (they have a more frequent control swab regime)
• Not being capable of completing another treatment successfully
• MRSA positive household members younger than 2 years (MRSA positive children below 2 years of age and their household members are generally not offered decolonization treatment according to The National Board of Health)
• MRSA positive household members, where it is judged that further decolonization attempts are not indicated
|
|
E.5 End points |
E.5.1 | Primary end point(s) |
Primary endpoint: MRSA negative swabs at 1 months
|
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
The study will take place Sep 1st 2019 – August 31st 2022. 24 months of including patients and collecting data, 12 months for analysis and publication of data.
Evaluation of primary endpoint will take place no later than 60 days after the 10 day active study period, by using MRSA control swabs. |
|
E.5.2 | Secondary end point(s) |
Secondary endpoint: MRSA negative swabs after 6 months
|
|
E.5.2.1 | Timepoint(s) of evaluation of this end point |
Evaluation of secndary endpoint will be evaluated 6 months after end of the 10 day active study period, with MRSA control swabs. Only those patients who were MRSA negative at 1 month, will have swabs taken at 6 months. Those who were MRSA positive at 1 month have left the trial. |
|
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 | No |
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) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
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 | Yes |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 2 |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 2 |
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
|
The end of the trial is when last MRSA control swab has been analyzed of the last included patient. |
|
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 | |
E.8.9.1 | In the Member State concerned days | |