Safety and Efficacy Study of BT086 to Evaluate Adjunctive Therapy in sCAP

PHASE2CompletedINTERVENTIONAL
Enrollment

160

Participants

Timeline

Start Date

August 31, 2011

Primary Completion Date

February 28, 2015

Study Completion Date

April 30, 2015

Conditions
Community Acquired Pneumonia
Interventions
DRUG

BT086

"BT086 will be administered per intravenous infusion (IV). The dose to be administered is 3.65 mL /kg bw/day and is calculated by the mean Immunoglobulin M (IgM) content of BT086 which is 23%.~Infusion rate:~Starting rate is 0.1 mL/min. Maximum infusion rate is 0.5 mL/min (target infusion rate) Treatment will be administered over a 5-day period."

DRUG

1% Human Albumin infusion

"1% Albumin will be administered per intravenous infusion (IV). The dose to be administered is 3.65 mL /kg bw/day.~Infusion rate:Starting rate is 0.1 mL/min. Maximum infusion rate is 0.5 mL/min (target infusion rate). Rate is to be raised in steps of 0.1 mL every 10 min until the target infusion rate is reached.~Treatment will be administered over a 5-day period.~Starting rate is 0.1 mL/min. Maximum infusion rate is 0.5 mL/min (target infusion rate)"

Trial Locations (36)

Unknown

401, Brussels

108, Berlin

114, Chemnitz

118, Cologne

119, Cologne

110, Dresden

111, Erfurt

116, Frankfurt

117, Greifswald

103, Halle

115, Hamburg

101, Hanover

107, Homburg/Saar

109, Lübeck

106, Marburg

120, Stuttgart

105, Tübingen

113, Wuppertal

213, Badalona

201, Barcelona

206, Barcelona

204, Girona

207, Madrid

208, Mataró

210, Palma de Mallorca

212, Sabadell

209, Santiago de Compostela

205, Tarragona

211, Terrassa

203, Valencia

303, Cardiff

304, Kings Lynn, Norfolk

301, London

306, London

302, Poole, Dorset

305, Reading, Berkshire

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Biotest

INDUSTRY

NCT01420744 - Safety and Efficacy Study of BT086 to Evaluate Adjunctive Therapy in sCAP | Biotech Hunter | Biotech Hunter