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ACTIVE NOT RECRUITING
NCT03494959
PHASE2

Pentaglobin in CRE and PA Neutropenic Infections

Sponsor: Gruppo Italiano Trapianto di Midollo Osseo

View on ClinicalTrials.gov

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.

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)

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

120

Start Date

2019-12-06

Completion Date

2025-05-31

Last Updated

2025-01-06

Healthy Volunteers

No

Conditions

Interventions

DRUG

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.

Locations (20)

Ospedale Binaghi

Cagliari, Italy, Italy

Ospedale Cardarelli

Naples, napoli, Italy

Azienda Ospedaliero-Universitaria Ospedali Riuniti

Ancona, Italy

Policlinico di Bari-Ematologia con trapianti

Bari, Italy

Ospedale San Orsola

Bologna, Italy

AO Spedali Civili di Brescia- USD - TMO Adulti

Brescia, Italy

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

Cuneo, Italy

Cattedra di Ematologia - Azienda Ospedaliera di Careggi

Florence, Italy

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

Foggia, Italy

Trapianti Midollo Osseo - Policlinico S. Martino

Genova, Italy

Policlinico VIto Fazzi

Lecce, Italy

Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico

Milan, Italy

Ospedale San Raffaele

Milan, Italy

Ospedale G. Da Saliceto di Piacenza

Piacenza, Italy

Cattedra di Ematologia - Policlinico

Roma, Italy

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

Roma, Italy

Policlinico Universitario Tor Vergata

Roma, Italy

Ospedale Moscati

Taranto, Italy

AOU CIttà della Salute e della Scienza

Torino, Italy

Clinica Ematologica - Policlinico Universitario

Udine, Italy