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Pentaglobin in CRE and PA Neutropenic Infections
Sponsor: Gruppo Italiano Trapianto di Midollo Osseo
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
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