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

NCT01420744 | Completed Phase 2 DMC

• 1 other identifier: CIGMA Study 982
• Study Type: interventional
• Target: 160
• Locations: 4 countries
• Sites: 36

Brief 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).

Conditions

Community Acquired Pneumonia

Keywords

Endotracheal ventilation; Bacterial pneumonia

Outcome Measures

Primary Outcomes (1)

• Ventilator Free Days (VFDs)

  VFDs are defined as the number of days between successful weaning from endotracheal ventilation and day 28 after study enrolment.

  28 days

Secondary Outcomes (7)

• 28-day all cause mortality

  28 days (672 hours from randomization)

• 28-day pneumonia-cause mortality

  28 days (672 hours from randomization)

• Time (days) to discharge from ICU

  28 days

• Time (days) to discharge from hospital

  28 days

• SOFA: Score Sequential Organ Failure Assessment

  28 days

Study Arms (2)

BT086 infusion

EXPERIMENTAL

Drug: BT086

1% Human Albumin infusion

PLACEBO COMPARATOR

Drug: 1% Human Albumin infusion

Interventions

BT086 DRUG

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.

BT086 infusion

1% Human Albumin infusion DRUG

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)

1% Human Albumin infusion

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• Patients with suspected hospital-acquired pneumonia
• Severe lung diseases interfering with sCAP therapy e.g. patients with cystic fibrosis,
• 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
• 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).

Sponsors & Collaborators

• Biotest: lead

Study Sites (36)

401

Brussels, Belgium

Location

108

Berlin, Germany

Location

114

Chemnitz, Germany

Location

118

Cologne, Germany

Location

119

Cologne, Germany

Location

110

Dresden, Germany

Location

111

Erfurt, Germany

Location

116

Frankfurt, Germany

Location

117

Greifswald, Germany

Location

103

Halle, Germany

Location

115

Hamburg, Germany

Location

101

Hanover, Germany

Location

107

Homburg/Saar, Germany

Location

109

Lübeck, Germany

Location

106

Marburg, Germany

Location

120

Stuttgart, Germany

Location

105

Tübingen, Germany

Location

113

Wuppertal, Germany

Location

213

Badalona, Spain

Location

201

Barcelona, Spain

Location

206

Barcelona, Spain

Location

204

Girona, Spain

Location

207

Madrid, Spain

Location

208

Mataró, Spain

Location

210

Palma de Mallorca, Spain

Location

212

Sabadell, Spain

Location

209

Santiago de Compostela, Spain

Location

205

Tarragona, Spain

Location

211

Terrassa, Spain

Location

203

Valencia, Spain

Location

303

Cardiff, United Kingdom

Location

304

Kings Lynn, Norfolk, United Kingdom

Location

301

London, United Kingdom

Location

306

London, United Kingdom

Location

302

Poole, Dorset, United Kingdom

Location

305

Reading, Berkshire, United Kingdom

Location

Related Publications (2)

• Jahn K, Handtke S, Palankar R, Weissmuller S, Nouailles G, Kohler TP, Wesche J, Rohde M, Heinz C, Aschenbrenner AF, Wolff M, Schuttrumpf J, Witzenrath M, Hammerschmidt S, Greinacher A. Pneumolysin induces platelet destruction, not platelet activation, which can be prevented by immunoglobulin preparations in vitro. Blood Adv. 2020 Dec 22;4(24):6315-6326. doi: 10.1182/bloodadvances.2020002372.

  PMID: 33351126 DERIVED

• Welte T, Dellinger RP, Ebelt H, Ferrer M, Opal SM, Singer M, Vincent JL, Werdan K, Martin-Loeches I, Almirall J, Artigas A, Ignacio Ayestaran J, Nuding S, Ferrer R, Sirgo Rodriguez G, Shankar-Hari M, Alvarez-Lerma F, Riessen R, Sirvent JM, Kluge S, Zacharowski K, Bonastre Mora J, Lapp H, Wobker G, Achtzehn U, Brealey D, Kempa A, Sanchez Garcia M, Brederlau J, Kochanek M, Reschreiter HP, Wise MP, Belohradsky BH, Bobenhausen I, Dalken B, Dubovy P, Langohr P, Mayer M, Schuttrumpf J, Wartenberg-Demand A, Wippermann U, Wolf D, Torres A. Efficacy and safety of trimodulin, a novel polyclonal antibody preparation, in patients with severe community-acquired pneumonia: a randomized, placebo-controlled, double-blind, multicenter, phase II trial (CIGMA study). Intensive Care Med. 2018 Apr;44(4):438-448. doi: 10.1007/s00134-018-5143-7. Epub 2018 Apr 9.

  PMID: 29632995 DERIVED

MeSH Terms

Conditions

Community-Acquired Pneumonia; Pneumonia, Bacterial

Condition Hierarchy (Ancestors)

Community-Acquired Infections; Infections; Pneumonia; Respiratory Tract Infections; Respiratory Tract Diseases; Bacterial Infections; Bacterial Infections and Mycoses; Lung Diseases

Study Officials

• Tobias Welte, MD

  Hannover Medical School

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 19, 2011
• First Posted: August 22, 2011
• Study Start: August 1, 2011
• Primary Completion: February 1, 2015
• Study Completion: April 1, 2015
• Last Updated: July 29, 2015

Record last verified: 2015-07

Locations

GB (6); BE (1); DE (17); ES (12)