E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Community acquired pneumonia CURB-65 class >1 |
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E.1.1.1 | Medical condition in easily understood language |
patients with pneumonia who need admittance in the hospital |
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E.1.1.2 | Therapeutic area | Diseases [C] - Respiratory Tract Diseases [C08] |
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 | 10010120 |
E.1.2 | Term | Community acquired pneumonia |
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 |
To demonstrate reduced release of inflammatory components from the bacterial cell wall by adding a short course of rifampicin to standard medical treatment of community acquired pneumonia. In this way less inflammatory biomarkers will be released and less inflammation may lead to shorter duration of hospitalization en more rapid improvement of symptoms (morbidity). |
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E.2.2 | Secondary objectives of the trial |
• 30 Day all cause mortality
• length of ICU stay
• (multiple) organ failure on ICU
• adverse events
• biomarkers (C-reactive protein (CRP), Procalcitonin (PCT), Plasma secretory leukocyte protease inhibitor (SLPI), Soluble triggering receptor expressed on myeloid cells (sTREM)-1 (doet prof. Hiemstra niet), IP-10, vitamin D and antimicrobial peptides like Cathelicidin and Beta-defensin-2.; lipopolysaccharide and lipoteichoid acid
• microbiological diagnosis
• evaluation of empirical coverage of the microbiological diagnosis (with this, we can determine whether the empirical treatment was appropriate or not)
• Emerging of resistant microorganism carriage.
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1. Patient aged 18 years or above
2. Community acquired pneumonia with CURB65 score ≥ 2
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E.4 | Principal exclusion criteria |
• Known allergy to rifampicin or anaemia or thrombopenia as side effect of rifampicin in medical history
• Medication induced hepatitis or acute liver failure
• Porphyria
• ????Renal failure with creatinin clearance < 25 ml/min
• Use of voriconazol or protease inhibitors
health care associated pneumonia
• Female patients who are pregnant
• Lung transplant recipients
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E.5 End points |
E.5.1 | Primary end point(s) |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
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E.5.2 | Secondary end point(s) |
30 Day all cause mortality
• length of ICU stay
• (multiple) organ failure on ICU
• adverse events
• biomarkers (C-reactive protein (CRP), Procalcitonin (PCT), Plasma secretory leukocyte protease inhibitor (SLPI), Soluble triggering receptor expressed on myeloid cells (sTREM)-1, IP-10, vitamin D and antimicrobial peptides like Cathelicidin and Beta-defensin-2.; lipopolysaccharide and lipoteichoid acid
• microbiological diagnosis
• evaluation of empirical coverage of the microbiological diagnosis (with this, we can determine whether the empirical treatment was appropriate or not)
• Emerging of resistant microorganism carriage.
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
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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 | 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) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
E.8 Design of the trial |
E.8.1 | Controlled | No |
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 | No |
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 | 5 |
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 | 2 |
E.8.9.1 | In the Member State concerned months | 6 |
E.8.9.1 | In the Member State concerned days | 0 |