Acinetobacter baumannii causes severe infections (pneumonia, bacteremia, organ space) with
high lethality in hospitalised critically ill patients. It can acquire resistance to all
classes of antibiotics (multidrug resistance, MDR) except an 'old' drug, colistin, which may
be the only therapeutic option. However, colistin is not registered for this indication. The
addition of rifampicin to colistin has been shown to be synergistic in vitro, and may be
promising in vivo, but this combination has not been studied in comparison with colistin
alone.
The purpose of this randomised, open-label, multicentre clinical trial is to assess whether
the association of colistin and rifampicin reduces significantly the mortality of patients
with severe MDR A. baumannii infections compared with colistin alone.
The trial will enroll 210 patients from intensive care units (ICU) of five tertiary care
hospitals where MDR A. baumannii infection is endemic with epidemic phases. Patients will be
randomly allocated to either colistin alone (control arm) or colistin plus rifampicin
(experimental arm).
Primary end point is overall mortality, defined as death occurring within 30 days from
randomisation.
Secondary end points will be disease-specific death, microbiological eradication,
hospitalization length, emergence of resistance to colistin during treatment.
Phase:
Phase 3
Details
Lead Sponsor:
Second University of Naples University of Campania "Luigi Vanvitelli"