Safety and Efficacy Study of BT086 to Evaluate Adjunctive Therapy in sCAP (NCT01420744) | Clinical Trial Compass
CompletedPhase 2
Safety and Efficacy Study of BT086 to Evaluate Adjunctive Therapy in sCAP
Belgium, Germany160 participantsStarted 2011-08
Plain-language summary
The purpose of this study is to determine whether the adjunctive therapy to standard antibiotic treatment of BT086 is safe and effective of decreasing the days patients require endotracheal ventilation due to Severe Community-Acquired Pneumonia (sCAP).
Who can participate
Age range18 Years
SexALL
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Inclusion Criteria:
* Written informed consent:
* given by the patient or
* a legal/authorised representative of the patient or
* a waiver for written informed consent due to emergency situation, in compliance with all local legal requirements.
* Male or female patients aged 18 years or older
* Patient receiving adequate antibiotic treatment for pneumonia
* Prior to endotracheal ventilation and therapy, the patient must have at least one of the following two signs of inflammation:
* Fever/Hypothermia Fever defined as an oral, tympanic, oesophageal or vesical temperature of \>38°C, tympanic temperature of \>38°C or rectal temperature of \>38.5°C, or hypothermia (rectal temperature \<35.5°C) (measurement with temperature probe or device) or
* White blood cell (WBC) count \>10,000/mm³ or WBC \<4,500/mm³
* Patient must have at least one of the following signs and symptoms of pneumonia:
* New or increased cough
* Production of purulent sputum or change in sputum characteristics
* Dyspnoea or tachypnoea (respiratory rate \>20 breaths/minute)
* Pleuritic chest pain
* Auscultatory findings on pulmonary examination of rales and/or crackles and/or evidence of pulmonary consolidation (e.g. dullness on percussion, bronchial breath sounds, or egophony)
* Radiological (or other imaging technique) evidence of (an) infiltrate(s) consistent with bacterial pneumonia
* Pneumonia has been acquired outside the hospital. In hospital-admitted patients, pneumonia has been dia…