Pentaglobin in CRE and PA Neutropenic Infections

NCT03494959 | Active Not Recruiting Phase 2 DMC

• 2 other identifiers: GITMO PENTALLO2018-001344-57
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 20

Brief 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.

Conditions

Septic Shock

Keywords

Pentaglobin; Carbapenem-resistant Klebsiella pneumoniae; Pseudomonas aeruginosa; febrile neutropenia; infection-related mortality

Outcome Measures

Primary Outcomes (3)

• Sepsis-related mortality

  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

  day +30 from the onset of neutropenic fever

• Overall Survival

  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.

  at 4 months from the start of intensive treatment

• Non-Relapse Mortality

  It is defined as the probability of dying without previous occurrence of a relapse, which is a competing event

  at 4 months from the start of intensive treatment.

Study Arms (1)

Treatment with Pentaglobin

EXPERIMENTAL

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.

Drug: Pentaglobin

Interventions

Pentaglobin DRUG

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.

Treatment with Pentaglobin

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age \> or = 18 years
• Performance status: ECOG \<3
• Diagnosis of acute myeloid leukemia or acute lymphoblastic leukemia candidate to intensive chemotherapy
• Indication to allogeneic Hematopoietic stem cell transplantation (HSCT) for hematological cancers, including severe aplastic anemia (second transplants allowed)
• Pre-treatment colonization by Carbapenem-resistant Enterobacteriaceae (CRE) or Pseudomonas aeruginosa (PA) documented by rectal and/or pharyngeal swab.
• Pre-treatment bloodstream infection sustained by CRE or PA.
• Written and signed informed consent

You may not qualify if:

• Uncontrolled systemic infection
• Anaphylaxis or severe prior reactions to immunoglobulins preparation
• Severe concomitant illness:
• patients with severe renal impairment, i.e. patients on dialysis or prior renal transplantation or S-creatinine \> 3.0 x ULN or calculated (CKD-EPI) creatinine-clearance \< 50 ml/min
• patients with severe pulmonary impairment (DLCOSB (Hb-adjusted)/or FEV1 \< 50 % or severe dyspnea at rest or requiring oxygen supply);
• patients with severe cardiac impairment (LVEF \< 40 %)
• patients with severe hepatic impairment (hyperbilirubinemia \> 3 x ULN or ALT / AST \> 5 x ULN).
• patients who on the basis of the investigator's consideration are not able to give the informed consent

Sponsors & Collaborators

• Gruppo Italiano Trapianto di Midollo Osseo: lead

Study Sites (20)

Ospedale Binaghi

Cagliari, Italy, Italy

Location

Ospedale Cardarelli

Napoli, napoli, Italy

Location

Azienda Ospedaliero-Universitaria Ospedali Riuniti

Ancona, Italy

Location

Policlinico di Bari-Ematologia con trapianti

Bari, Italy

Location

Ospedale San Orsola

Bologna, Italy

Location

AO Spedali Civili di Brescia- USD - TMO Adulti

Brescia, Italy

Location

S.C. Ematologia - Azienda Ospedaliera S. Croce e Carle

Cuneo, Italy

Location

Cattedra di Ematologia - Azienda Ospedaliera di Careggi

Florence, Italy

Location

Ematologia e Centro Trapianti Midollo Osseo - Ospedale IRCCS Casa Sollievo della Sofferenza

Foggia, Italy

Location

Trapianti Midollo Osseo - Policlinico S. Martino

Genova, Italy

Location

Policlinico VIto Fazzi

Lecce, Italy

Location

Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico

Milan, Italy

Location

Ospedale San Raffaele

Milan, Italy

Location

Ospedale G. Da Saliceto di Piacenza

Piacenza, Italy

Location

Cattedra di Ematologia - Policlinico

Roma, Italy

Location

Divisione di Ematologia - Istituto di Semeiotica Medica - Policlinico A. Gemelli

Roma, Italy

Location

Policlinico Universitario Tor Vergata

Roma, Italy

Location

Ospedale Moscati

Taranto, Italy

Location

AOU CIttà della Salute e della Scienza

Torino, Italy

Location

Clinica Ematologica - Policlinico Universitario

Udine, Italy

Location

MeSH Terms

Conditions

Shock, Septic; Pseudomonas Infections; Febrile Neutropenia

Interventions

pentaglobulin

Condition Hierarchy (Ancestors)

Sepsis; Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Shock; Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Neutropenia; Agranulocytosis; Leukopenia; Cytopenia; Hematologic Diseases; Hemic and Lymphatic Diseases; Leukocyte Disorders

Study Officials

• Fabio Ciceri

  Ospedale San Rafafele

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 5, 2018
• First Posted: April 11, 2018
• Study Start: December 6, 2019
• Primary Completion: May 31, 2024
• Study Completion: May 31, 2025
• Last Updated: January 6, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

IT (20)