Pentaglobin in CRE and PA Neutropenic Infections

Condition(s) studied

Investigational drug(s) / intervention(s)

Pentaglobin: Antimicrobial treatment active against the multidrug-resistant strain should be started in case of neutropenic fever (oral temperature ≥38.3°C or temperature ≥38.0°C sustained over a one-hour period). Patients should receive the best available first-line therapy, usually a combination therapy, based on the in vitro susceptibility results of the pre-treatment screening swab in combination to Pentaglobin 5ml/kg over a 12h i.v. infusion for 3 consecutive days. Empirical treatment should be subsequently streamlined according to microbiological results (both positive and negative). Pentaglobin should be started within 12h from the onset of fever, regardless of the presence of hemodynamic stability.

Study summary

To demonstrate that the early addition of Pentaglobin to the best available antimicrobial therapy is able to reduce mortality and improve survival in neutropenic febrile acute leukemia or allo- Hematopoietic stem cell transplantation (HSCT) patients colonized by carbapenem-resistant Enterobacteriaceae or by any Pseudomonas aeruginosa.

Eligibility

Primary outcome measure(s)

• Sepsis-related mortality — day +30 from the onset of neutropenic fever
  Sepsis-related mortality is considered as the time from the onset of neutropenic fever to death caused by uncontrolled documented infection, in the absence of any other interfering cause of death
• Overall Survival — at 4 months from the start of intensive treatment
  is defined as the probability of survival irrespective of disease state at any point in time. Patients alive at their last follow-up are censored. It is analyzed by the Kaplan-Meier method, Log-Rank Test and parametric or semiparametric survival models.
• Non-Relapse Mortality — at 4 months from the start of intensive treatment.
  It is defined as the probability of dying without previous occurrence of a relapse, which is a competing event

Trial sites (20)

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