Fosfomycin Versus Meropenem or Ceftriaxone in Bacteriemic Infections Caused by Multidrug Resistance in E.Coli
Status:
Completed
Trial end date:
2019-03-01
Target enrollment:
Participant gender:
Summary
Enterobacterieaceae (and specially Escherichia coli) showing resistance due to
multidrug-resistant Escherichia coli, plasmid mediated AmpC or quinolone resistance caused by
chromosomal mechanisms have spread worldwide during the last decades. This is important
because many of these isolates are also resistant to other first-line agents such as
fluoroquinolones or aminoglycosides, leaving few available options for therapy, and this
condition is associated with increased morbidity- mortality and length of hospital stay.
While carbapenems are considered the drugs of choice for multidrug-resistant Escherichia coli
and AmpC producers, recent data suggests that certain alternatives may be suitable for some
types of infections.
At the present time, finding therapeutic alternatives to carbapenems and cephalosporins for
the treatment of invasive infections due to multidrug-resistant Escherichia coli is critical.
Fosfomycin was discovered more than 40 years ago but was not investigated according to
present standards, and thus is not used in clinical practice except in desperate situations.
It is one of the so-considered neglected antibiotics with high potential interest for the
future.
With the aim of demonstrate the clinical non-inferiority of intravenous fosfomycin compared
to meropenem or ceftriaxone in the treatment of bacteraemic urinary tract infections caused
by multidrug-resistant Escherichia coli . The investigators propose a "real practise"
randomised, controlled, multicentre phase III clinical trial to compare the clinical and
microbiological efficacy and safety of intravenous fosfomycin (4 grammes every 6 hours) with
meropenem (1 gramme every 8 hours) or ceftriaxone (1 gramme every 24 hours) as targeted
therapy of the previously specified infection; change to oral therapy according to predefined
options is allowed in both arms after 5 days. Follow-up for the study is planned up to 60
days.
Phase:
Phase 3
Details
Lead Sponsor:
Fundación Pública Andaluza para la gestión de la Investigación en Sevilla
Collaborator:
Spanish Network for Research in Infectious Diseases