Community acquired pneumonia CURB-65 class >1 MedDRA version: 14.1 Level: LLT Classification code 10010120 Term: Community acquired pneumonia System Organ Class: 100000004862
Conditions
Interventions
Trade Name: rifampicine
rifadin
Product Name: rifampicine
Pharmaceutical Form: Concentrate and solvent for injection
INN or Proposed INN: RIFAMPICIN
CAS Number: 13292-46-1
Concentration unit: mg/ml mi
Sponsors
LUMC
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Patient aged 18 years or above 2. Community acquired pneumonia with CURB65 score = 2 Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 20 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 20
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary end point(s): LTA release- morbidity;Timepoint(s) of evaluation of this end point: 30-day;Main Objective: 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). ;Secondary Objective: • 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. | — |
Secondary
| Measure | Time frame |
|---|---|
| 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. ;Timepoint(s) of evaluation of this end point: 30-day | — |
Countries
Netherlands
Contacts
Public ContactG.H. Groeneveld
LUMC
Outcome results
None listed