Pneumonia treated with rifampicine attenuates inflammation

Authors
Category Primary study
Registry of TrialsEU Clinical Trials Register
Year 2012
INTERVENTION: 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 milligram(s)/millilitre Concentration type: equal Concentration number: 5‐ CONDITION: Community acquired pneumonia CURB‐65 class >1 ; MedDRA version: 14.1 Level: LLT Classification code 10010120 Term: Community acquired pneumonia System Organ Class: 100000004862 Therapeutic area: Diseases [C] ‐ Respiratory Tract Diseases [C08] PRIMARY OUTCOME: 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). Primary end point(s): LTA release‐ 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.; Timepoint(s) of evaluation of this end point: 30‐day SECONDARY OUTCOME: 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 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
Epistemonikos ID: a2bd2f3bfbc6be9c67317ab36f4249e3e6de7416
First added on: Aug 22, 2024