pneumonia respiratory tract infection
Conditions
Interventions
All subjects will receive standard antibiotic treatment defined by the 2011
SWAB guidelines. Patients with moderately severe CAP (CURB-65 score = 2) will
be treated with monotherapy benzylpenicillin
-lactam
antibiotic), ciprofloxacin, 2 times a day 400 mg intravenously, will be added.
All patients with severe CAP will be treated with benzylpenicillin, 4 times a
day 0,5 million IU intravenously
Sponsors
Leids Universitair Medisch Centrum
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 1. Patient aged 18 years or above 2. Community acquired pneumonia with CURB65 score >= 2;OR 1. Patient aged 18 years or above • hospitalized for community acquired pneumonia, and • clinical suspicion of pneumococcal pneumonia because of one or more of these features: o pleuritic chest pain, or o acute onset of symptoms, or o cardiovascular disease in medical history, or o leukocyte count > 15 x10e9/l (4), or o on chest X-ray: an alveolar pattern (lobar, segmental or sub-segmental infiltrate) (5)
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;• Use of voriconazol or protease inhibitors ;• Female patients who are pregnant
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To primary objective is to demonstrate a reduction in lipoteichoic acid release in patients with pneumococcal pneumonia treated with rifampicin. This will be done by measuring lipoteichoic acid in serum and urine. Since lipoteichoic is released in excess shortly after administration of antibiotics, repetitive samples will be drawn in the hours after the first antibiotic gift. Qualitative and quantitative measurements will be done and compared. Evaluable patients for Intention-to-Treat analysis are those who met the following criteria: (1) enrollment criteria of pneumonia, with 2 or more points in the CURB65 score, for which a patient is admitted to the hospital, (2) Streptococcus pneumonia is identified as the cause of pneumonia, (3) received at least one dose of study drugs and (4) outcome is measured at 30 days. Evaluable patients for Per-Protocol analysis are those who meet the following criteria: (1) enrollment criteria of pneumonia, with 2 or more points in the CURB65 score, for which a patient is admitted to the hospital, (2) Streptococcus pneumonia is identified as the cause of pneumonia, (3) received the study drug for 48 hours and (4) outcome is measured at 30 days. | — |
Secondary
| Measure | Time frame |
|---|---|
| The secondary objectives of this study are to determine: • Duration of symptoms • Length of hospital stay • 30 Day all cause mortality • Length of ICU stay • (Multiple) organ failure on ICU • Adverse events • Serum 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, • 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. | — |
Countries
Netherlands
Outcome results
None listed