Prospective Study on Febrile Batteries in Pediatric Oncohaematological Patients (SuBiTo)
SuBiTo
Studio Prospettico Sulle Batteriemie Febbrili Nei Pazienti Oncoematologici Pediatrici
1 other identifier
observational
2,000
1 country
25
Brief Summary
The aim of this study is to define prospectively the incidence of multi-resistant germ batteries in paediatric oncoematological patients, to assess associated mortality, antibiotic resistance profile and the type of implemented therapy.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Apr 2020
Longer than P75 for all trials
25 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 22, 2020
CompletedFirst Submitted
Initial submission to the registry
March 8, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2023
CompletedFirst Posted
Study publicly available on registry
May 17, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2024
CompletedMay 17, 2024
May 1, 2024
3.7 years
March 8, 2021
May 16, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
Incidence of febrile bacteremia due to Gram-negative germs multi-resistant to antibiotics (MDR)
The evaluation of the incidence of febrile bacteremia due to MDR Gram-negative germs, i.e. bacteria that present resistance to at least 3 of the 5 classes of main antibiotics (3rd and 4th generation cephalosporins, beta-lactams, aminoglycosides, carbapenems and quinolones).
2020-2023
Secondary Outcomes (6)
Incidence of various types of febrile episodes
2020-2023
Bacteremia
2020-2023
Fungaemia
2020-2023
Risk factors for bacteremia and microbiologically documented infection (MDI)
2020-2023
Mortality at 30 days
30 days
- +1 more secondary outcomes
Interventions
Incidence of batteries from negative Gram germs; Incidence of batteries from gram positive germs; Incidence of fungemie; Incidence of septic shock; Incidence of batteries from colonising germs; Incidence of resistance to the main classes of antibiotics
Eligibility Criteria
Patients with febrile episodes managed during day-care (Day-Hospital) or with home oral or endovenous antibiotic therapy will be excluded.
You may qualify if:
- written informed consent,- onset of fever after chemotherapy or after hemopoietic stem cell transplantation (TCSE),
- endovenous antibiotic therapy for at least 72 hours for the treatment of the febrile episode.
- ordinary hospitalization scheme
- age \< 18
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (25)
Azienda Ospedaliera Universitaria Integrata
Verona, Italia, 37126, Italy
Azienda Ospedali Riuniti Presidio "G. Salesi"
Ancona, Italy
AOU Policlinico
Bari, Italy
Policlinico Sant'Orsola Malpighi Clinica
Bologna, Italy
Ospedale Regionale
Bolzano, Italy
Spedali Civili, Presidio Ospedale Dei Bambini
Brescia, Italy
Ospedale Pediatrico Microcitemico "Antonio Cao", Azienda Ospedaliera Brotzu
Cagliari, Italy
AOU Policlinico Vittorio Emanuele
Catania, Italy
Azienda Ospedaliero Universitaria Sant'Anna
Ferrara, Italy
Azienda Ospedaliero-Universitaria "Anna Meyer"
Florence, Italy
Istituto G.Gaslini
Genova, Italy
Fondazione IRCCS Istituto Nazionale Tumori
Milan, Italy
Azienda Policlinico Di Modena
Modena, Italy
Fondazione MBBM / AO San Gerardo Clinica
Monza, Italy
A.O.R.N. Santobono - Pausilipon
Napoli, Italy
Oncoematologia Pediatrica AOU di Padova
Padua, Italy
ARNAS Civico Di Cristina E Benfratelli
Palermo, Italy
Azienda Ospedaliero Universitaria Di Parma
Parma, Italy
Fondazione IRCCS, Policlinico San Matteo
Pavia, Italy
A.O.U. "S.M. Della Misericordia"
Perugia, Italy
Ospedale Civile Dello Spirito Santo Dipartimento Di Ematologia, Medicina Trasfusionale E Biotecnologie
Pescara, Italy
IRCCS Ospedale Pediatrico Bambino Gesù Dip.to di Oncoematologia e Terapia cellulare e Genica
Roma, Italy
IRCCS Ospedale "Casa Sollievo Della Sofferenza"
San Giovanni Rotondo, Italy
AOU Citta' Della Salute E Della Scienza Di Torino
Torino, Italy
IRCCS Materno Infantile "Burlo Garofolo"
Trieste, Italy
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- OTHER
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 8, 2021
First Posted
May 17, 2024
Study Start
April 22, 2020
Primary Completion
December 31, 2023
Study Completion
December 31, 2024
Last Updated
May 17, 2024
Record last verified: 2024-05
Data Sharing
- IPD Sharing
- Will not share