Trial for the Treatment of Extensively Drug-Resistant Gram-negative Bacilli
Status:
Completed
Trial end date:
2020-08-09
Target enrollment:
Participant gender:
Summary
Approximately 444 subjects who are greater than or equal to 18 to 95 years of age, are
non-pregnant, and are in the inpatient setting of one of the study sites will be evaluated to
treatment efficacy. Analysis will include subjects with bloodstream infection (BSI) or
pneumonia due to at least one of the following gram-negative bacilli organisms: Acinetobacter
baumannii, Klebsiella spp, Escherichia coli, Enterbactor spp. and/or Pseudomonas aeruginosa
that demonstrates in vitro non-susceptibility defined as extensively drug-resistant
Gram-negative bacilli (XDR-GNB) which includes XDR-AB, XDR-PA and CRE. If a subject has both
BSI and pneumonia at the time of study enrollment, they will be included as a subject with
pneumonia.
Objectives:
Primary:
•Determine whether the treatment regimen of Colistimethate sodium (colistin) combined with a
carbapenem (imipenem or meropenem) is associated with a decreased risk for mortality compared
to colistin alone for subjects with bloodstream infection (BSI) and/or pneumonia due to
XDR-GNB.
Secondary:
•Determine what treatment regimen (colistin monotherapy or colistin combined with a
carbapenem (imipenem or meropenem) is more likely to reduce the emergence of colistin
resistance among XDR-GNB isolates during therapy.