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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


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 mortality

28-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.


Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.


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


- 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


- 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

Page last updated: August 23, 2015

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