CIGMA (Concentrated IgM for Application) Study
Research type
Research Study
Full 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)
IRAS ID
136296
Contact name
Mervyn Singer
Contact email
Sponsor organisation
Biotest AG
Eudract number
2010-022380-35
ISRCTN Number
n/a
Clinicaltrials.gov Identifier
n/a
Research summary
Study design:
This is a randomized, double-blind, placebo-controlled, multicenter, parallel-group, adaptive group-sequential phase II studywith two interim analyses.
Number of patients: 160 randomized and evaluable patients with severe community aquired pneumonia (sCAP)
Countries / Number of centres: approx. 30 centres in Europe (Germany, Spain, UK, Belgium and other European countries)
BT086 is a human immunoglobulin (Ig) preparation enriched with IgM for intravenous administration.
BT086 contains: Immunoglobulins 95%, thereof IgM 18–28% (mean 23%), IgG 48–66%, IgA 15–27%;
Comparator: Placebo Human Albumin (1%)Justification and relevance:
IgM is the first antibody that is produced in the course of an immune response. 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 for sCAP patients.
The majority of clinical trials with IgM-enriched immunoglobulins have been performed in sepsis and not explicitly in sCAP. However, sCAP patients usually form the largest patient group within sepsis trials.
Two relevant systematic reviews of clinical trials concluded that immunoglobulins and in particular IgM-enriched immunoglobulins are of benefit in adult and older paediatric sepsis patients. These therapies resulted in a significant reduction in mortality (Alejandria et al., 2010, Kreymann et al., 2007).
sCAP is a serious and life-threatening condition with a poor prognosis despite intensive treatment. It is expected that BT086 will be effective in reducing disease duration/intensity/aggravation in sCAP patients.
Inclusion and exclusion criteria in this trial have been developed on the basis of the CAP/sCAP criteria of the IDSA/ATS guidelines, the Food and Drug Administration’s Guidance for Industry and the German S3 “Leitlinien”.REC name
East of England - Cambridge Central Research Ethics Committee
REC reference
13/EE/0293
Date of REC Opinion
20 Nov 2013
REC opinion
Further Information Favourable Opinion