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 pneumonia (sCAP) acquired outside the hospital

• Conditions: severe Community Acquired Pneumonia (sCAP); MedDRA version: 16.0Level: LLTClassification code 10010120Term: Community acquired pneumoniaSystem Organ Class: 100000004862; Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]

• Registration Number: EUCTR2010-022380-35-GB
• Lead Sponsor: Biotest AG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2013-08-12
• Last Update Posted: 4 August 2015

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 160

Inclusion Criteria

1. 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. 2. Male or female patients aged 18 years or older 3. Patient receiving adequate antibiotic treatment for pneumonia 4. 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, 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 5. 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) 6. Radiological (or other imaging technique) evidence of (an) infiltrate(s) consistent with bacterial pneumonia 7. 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. 8. Major sCAP criterion: need for endotracheal ventilation 9. Treatment of patient with BT086 must start within 12 hours but not earlier than 1 hour after start of endotracheal ventilation
Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 100
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 60

Exclusion Criteria

1. For incapacitated patients: any indication that the patient’s presumed will would be against inclusion in the trial 2. Patients with suspected hospital-acquired pneumonia 3. Severe lung diseases interfering with sCAP therapy e.g. patients with cystic fibrosis, 4. 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 5. Patients on dialysis 6. 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). 7. Patients unable to be treated due to obesity 8. Selective, absolute IgA deficiency with known antibodies to IgA 9. Patients with neutrophil count <1,000/mm³ or platelet count <50,000/mm³ 10. 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. 11. Known relevant intolerance to immunoglobulins, vaccines or other substances of human origin 12. 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).

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified