Several publicly funded clinical studies are conducted to characterise efficacy, toxicity and other aspects of this drug.
FP7 funded project MAGICBULLET: Optimisation of treatment with off-patent antimicrobial agents of ventilator-associated pneumonia
MagicBullet will carry out a randomized, open label, multicenter, non-inferiority phase IV clinical trial to compare safety and efficacy of colistin vs. meropenem, both combined with levofloxacin, for empirical treatment of VAP. A total of 496 patients will be included from 29 hospitals located in Spain, Italy, and Greece which are the most prevalent countries for infections caused by MDR-GNB.
NIAID (The National Institute of Allergy and Infectious Diseases, USA) funded a Randomized Controlled Clinical Trial for the Treatment of Extensively Drug-Resistant Gram-negative Bacilli comparing combination antimicrobial therapy with monotherapy for the treatment of Acinetobacter baumannii, a major cause of bloodstream infection and pneumonia in health care settings. This study has a similar study design as the AIDA clinical trial and will determine whether the treatment regimen of Colistimethate sodium combined with Imipenem-cilistatin is associated with a decreased risk for mortality compared to colistin alone for patients with bloodstream infection and/or pneumonia due to XDR-GNB. Secondary goal is to determine what treatment regimen (colistin monotherapy or colistin combined with imipenem) is more likely to reduce the emergence of colistin resistance among XDR-GNB isolates during therapy
Principal investigator is Keith Kaye, M.D., M.P.H., Wayne State University, Detroit
Observational Multinational Study (INCREMENT, Spanish Network for Research in Infectious Diseases): Impact of Specific Antimicrobials and MIC Values on the Outcome of Bloodstream Infections Due to Extended-spectrum Beta-lactamase (ESBL) or Carbapenemase-producing Enterobacteriaceae
Population Pharmacokinetic Study of Colistin in Patients Infected With Multiresistant Gram-negative Bacteria
Poitiers University Hospital: This study determines the pharmacokinetics of colistin in patients receiving this drug.