Safety and Efficacy Study of BT086 to Evaluate Adjunctive Therapy in sCAP
Information source: Biotest
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Community Acquired Pneumonia
Intervention: BT086 (Drug); 1% Human Albumin infusion (Drug)
Phase: Phase 2
Status: Completed
Sponsored by: Biotest Official(s) and/or principal investigator(s): Tobias Welte, MD, Principal Investigator, Affiliation: Hannover Medical School
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).
Clinical Details
Official title: A Randomized, Double-blind, Placebo-controlled, Multicenter, Parallel-group, Adaptive Group-sequential Phase II Study, to Determine the Efficacy and Safety of BT086 as an Adjunctive Treatment in Severe Community Acquired Pneumonia (sCAP)
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Primary outcome: Ventilator Free Days (VFDs)
Secondary outcome: 28-day all cause mortality28-day pneumonia-cause mortality Time (days) to discharge from ICU Time (days) to discharge from hospital SOFA: Score Sequential Organ Failure Assessment Vasopressor-free days Glasgow Coma Score
Detailed description:
Severe Community-Acquired Pneumonia (sCAP) is usually defined clinically as pneumonia
acquired from outside the hospital (CAP) that requires intensive medical care. Mortality of
(s)CAP patients admitted to ICU range from 35-58% depending on time and admission of the
patient and has not much improved in the last years.
BT086 contains a sufficient number of antibodies against the most frequent pathogens as well
as antibodies against lipopolysaccharides and lipid A. Therefore, it can be assumed that
administration of BT086 early in the clinical course of a severe infection such as sCAP may
provide an effective adjunctive treatment to standard antibiotic therapy for sCAP patients.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
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 diagnosed a maximum of 72 hours after admission. Patients from
nursing homes or similar institutions are eligible.
- Major sCAP criterion: need for endotracheal ventilation
- Treatment of patient with BT086 must start within 12 hours but not earlier than 1
hour after start of endotracheal ventilation
Exclusion Criteria:
- For incapacitated patients: any indication that the patient's presumed will would be
against inclusion in the trial
- Patients with suspected hospital-acquired pneumonia
- Severe lung diseases interfering with sCAP therapy e. g. patients with cystic
fibrosis,
- Patients receiving Xigris® (drotrecogin alfa, activated Protein C) or medications not
approved for sCAP (e. g. Dornase alpha) are excluded from inclusion in the study
- Patients on dialysis
- Presence of other severe diseases impairing life expectancy (e. g. patients are not
expected to survive 28 days given their pre-existing uncorrectable medical
condition).
- Patients unable to be treated due to obesity
- Selective, absolute IgA deficiency with known antibodies to IgA
- Patients with neutrophil count <1,000/mm³ or platelet count <50,000/mm³
- Pregnant or lactating women. A pregnancy test will be performed in all women aged <65
years and the result must be available at study inclusion.
- Known relevant intolerance to immunoglobulins, vaccines or other substances of human
origin
- Participation in another interventional clinical trial within 30 days before entering
the study or during the study, and/or previous participation in this study
(participation in non-interventional trials is allowed).
Locations and Contacts
401, Brussels, Belgium
108, Berlin, Germany
114, Chemnitz, Germany
110, Dresden, Germany
111, Erfurt, Germany
116, Frankfurt, Germany
117, Greifswald, Germany
103, Halle, Germany
115, Hamburg, Germany
101, Hannover, Germany
107, Homburg/Saar, Germany
118, Köln, Germany
119, Köln, Germany
109, Lübeck, Germany
106, Marburg, Germany
120, Stuttgart, Germany
105, Tübingen, Germany
113, Wuppertal, Germany
213, Badalona, Spain
201, Barcelona, Spain
206, Barcelona, Spain
204, Girona, Spain
207, Madrid, Spain
208, Mataro, Spain
210, Palma de Mallorca, Spain
212, Sabadell, Spain
209, Santiago de Compostela, Spain
205, Tarragona, Spain
211, Terrassa, Spain
203, Valencia, Spain
303, Cardiff, United Kingdom
304, Kings Lynn, Norfolk, United Kingdom
301, London, United Kingdom
306, London, United Kingdom
302, Poole, Dorset, United Kingdom
305, Reading, Berkshire, United Kingdom
Additional Information
Starting date: August 2011
Last updated: July 28, 2015
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