E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Unnecessary long-term exposure to antibiotics can cause adverse events such as renal and hepatic toxicity, health-care-related infections and antibiotic resistance. Staphylococcus aureus bacteremia is one of the most common serious bacterial infections worldwide. Complicated SAB is typically treated with 6 weeks of antibiotics, but there are no randomized studies to guide this duration. International guidelines are not conclusive and recommend 4 to 6 weeks of treatment. |
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E.1.1.1 | Medical condition in easily understood language |
Staphylococcus aureus bacteremia is one of the most common serious bacterial infections worldwide. It is unknown if the infection should be treated for 4 or for 6 weeks. |
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E.1.1.2 | Therapeutic area | Diseases [C] - Bacterial Infections and Mycoses [C01] |
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 |
This study aims to demonstrate that for patients who have responded well to the initial treatment, a total antibiotic duration of 4 weeks is non-inferior to 6 weeks. The primary endpoint is a composite of all-cause mortality or bacteriologically confirmed disease relapse. |
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E.2.2 | Secondary objectives of the trial |
Secondary outcomes will include antibiotic-related toxicity, length of hospital admission, perceived quality of life and societal costs. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Adults with methicillin-sensitive complicated SAB with satisfactory clinical response to initial treatment will be eligible for inclusion. |
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E.4 | Principal exclusion criteria |
Patients with infected prosthetic material or pregnant/lactating will be excluded. |
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E.5 End points |
E.5.1 | Primary end point(s) |
The primary endpoint is a composite of all-cause mortality or bacteriologically confirmed disease relapse. |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
Follow-up period is from 28 days after initiation of therapy to 6 months thereafter. |
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E.5.2 | Secondary end point(s) |
Secondary outcomes will include antibiotic-related toxicity, length of hospital admission, perceived quality of life and societal costs. |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
Follow-up period is from 28 days after initiation of therapy to 6 months thereafter. |
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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) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
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 | Yes |
E.8.2.3.1 | Comparator description |
Participants will be randomized to stop flucloxacillin after 4 weeks (28 days) or 6 weeks (42 days). |
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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 | 9 |
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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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 4 |
E.8.9.1 | In the Member State concerned months | |
E.8.9.1 | In the Member State concerned days | |