Pentaglobin in CRE and PA Neutropenic Infections (PENTALLO)
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|ClinicalTrials.gov Identifier: NCT03494959|
Recruitment Status : Not yet recruiting
First Posted : April 11, 2018
Last Update Posted : November 14, 2019
|Condition or disease||Intervention/treatment||Phase|
|Septic Shock||Drug: Pentaglobin||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||120 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Pentaglobin as Early Adjuvant Treatment for Febrile Neutropenia in Acute Leukemia or Allogeneic Hematopoietic Stem Cell Transplant Patients Colonized by Carbapenem-resistant Enterobacteriaceae (CRE) or Pseudomonas Aeruginosa (PA)|
|Estimated Study Start Date :||December 1, 2019|
|Estimated Primary Completion Date :||December 1, 2020|
|Estimated Study Completion Date :||December 1, 2021|
Experimental: Treatment with Pentaglobin
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.
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.
- Sepsis-related mortality [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03494959
|Contact: MAssimo Martino||334 /firstname.lastname@example.org|
|Contact: Sonia Mammoliti||0039 010 email@example.com|
|Principal Investigator:||Fabio Ciceri||Ospedale San Rafafele|