BACKGROUND: The spread of multidrug-resistant bacteria represents a well-known problem, which
must be face up by optimizing antibiotic therapy both in terms of choosing the most
appropriate drug and of an adequate treatment duration. The method of administration is also
a critical element. There are data relating to the maximization of the efficacy of
Carbapenems and Piperacillin/Tazobactam by continuous infusion, able to constantly maintain
adequate drug concentrations. Several studies, conducted comparing a standard administration
of Carbapenem or Piperacillin/Tazobactam to an extended administration or continuous
perfusion to evaluate safety and efficacy in terms of mortality reduction, have been
documented. The achievement of optimal serum concentrations during continuous infusion has
been documented both for Carbapenems and Piperacillin/Tazobactam, and for other types of
antibiotics such as Cefepime and Vancomycin. The duration of antibiotic treatment is a
critical factor for the prevention of relapses as well as the onset of resistance. The
recommended duration of antibiotic treatment varies according to the site of infection and
the type of pathogen and is generally between 7 and 14 days, however, in particular cases it
is possible that the administration of antibiotics must be longer than one month. In general,
the length of hospitalization is associated with a greater likelihood of complications for
patients, with a substantial increase in the risk of developing multiple types of
complications, such nosocomial infections, bed rest, bedsores, falls, malnutrition and
disorientation. It should also be noted that prolonged hospitalization leads to a substantial
increase in care costs. The advantage in terms of greater therapeutic success linked to the
continuous infusion of some types of antibiotics has been used for the development of home
infusion protocols for antibiotic therapy. There are numerous studies that show the
feasibility and effectiveness of home infusion antibiotic therapy using elastomeric devices,
documenting its substantial equivalence with respect to hospital treatment. The antibiotics
for which there is evidence of feasibility are various, including Cefepime, Vancomycin and
Piperacillin/Tazobactam.
STUDY DESIGN: The study is aimed to patients with severe bacterial infections who have
started an antibiotic treatment and are benefiting from such therapy. The purpose of the
study is to move the continuation of antibiotic therapy to the home setting once its efficacy
and tolerability during hospitalization have been documented, in order to allow the patient a
potentially eradicating treatment, of adequate duration without the need of hospitalization.
Patients are enrolled when the efficacy and tolerability of the ongoing antibiotic treatment
based on Cefepime, Meropenem, Piperacillin/Tazobactam or Vancomycin has been documented. The
protocol requires that the patient go to the hospital every morning to replace the elastomer
and to carry out a medical examination. Blood chemistry tests, which include at least blood
counts, electrolytes, renal function, liver function and inflammation indices are scheduled
to be performed at least once a week. Exams can also be done more frequently based on
clinical needs. Antibiotic therapy should be carried out until the infection is cured, as per
current clinical practice. For the purposes of the study, the patient remains under
observation for 30 days after enrollment. Blood samples for the assessment of antibiotic
concentrations will be performed in correspondence with the blood chemistry tests performed
routinely for patient assessment. In any case, for each patient, a sample is taken for the
dosage of the antibiotic used, which will be a single sample in the event of a continuous
infusion, or a downstream sample (within one hour of the new antibiotic administration) and
peak (30 minutes after the end of the infusion). The pharmacokinetic sampling relating to the
outpatient phase will be carried out on the third or fourth day of continuous infusion
therapy at the time of the elastomer change.
Phase:
Phase 1
Details
Lead Sponsor:
Ospedale San Carlo Borromeo
Collaborator:
Associazione Oncologica Milanese AmoLaVita ONLUS
Treatments:
Cefepime Meropenem Piperacillin Piperacillin, Tazobactam Drug Combination Tazobactam Vancomycin