This trial is !
Search for a recruiting clinical trial for your condition
You can access this
clinical trial
if you have
Pneumonia or Blood Stream Infection
and you are
between 18 and 95
years old
Phase
3
This is a trial in the final phase before the treatment is released on the market.
Show me locations

The purpose

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.

Provided treatments

  • Drug: colistin and meropenem
  • Drug: colistin and placebo
Wondering what is the locations section for?
We will connect you to the doctor responsible for this trial and help you get more information.

Locations near you

Unfortunately, there are no recruiting locations near you. Please check the list with all locations below.
Tris trial is registered with FDA with number: NCT01597973. The sponsor of the trial is University of Michigan and it is looking for 444 volunteers for the current phase.
Official trial title:
Randomized Controlled Trial for the Treatment of Extensively Drug-Resistant Gram-negative Bacilli