Ignite Creation Date:
2024-05-19 @ 5:34 PM
Last Modification Date:
2024-10-26 @ 3:30 PM
Study NCT ID:
NCT06419426
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-05-17
First Post:
2021-03-08
Brief Title:
Prospective Study on Febrile Batteries in Pediatric Oncohaematological Patients SuBiTo
Sponsor:
Associazione Italiana Ematologia Oncologia Pediatrica
Organization:
Associazione Italiana Ematologia Oncologia Pediatrica
Study Overview
Official Title:
Studio Prospettico Sulle Batteriemie Febbrili Nei Pazienti Oncoematologici Pediatrici
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
SuBiTo
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
Detailed Description:
Bacterial infections are the most frequent cause of infectious morbidity and mortality in the patient undergoing chemotherapy or hemopoietic stem cell transplantation TCSE The main predisposing factor is the impairment of innate immunity as a result of the alteration of mucous barriers mucositisenteritis from chemotherapy or radiotherapy skin CVC and neutropenia non-specific haematological toxicity due to chemotherapy or radiotherapy on bones with hemopoietic marrow The most frequent form of infection is represented by fever whose cause remains indeterminate in 60-80 of cases In about 10-15 of cases fever is accompanied by the positivization of hemoculture and is configured as a microbiologically determined infection IMD In the remaining cases infectious episodes may be clinically documented such as pneumonia or bronchitis confirmed for radiological examination or CT scans without the identification of the causative agent these are defined as clinically determined infections ICDs
The knowledge through hemoculture of the germs responsible for febrile batteries over a given period of time allows the definition of the predominant typology of germs responsible for systemic infection On this basis it is used to define the empirical antibiotic treatment that is given to the patient within a few hours of the onset of fever Empirical antibiotic therapy must be effective with regard to the germs most represented in the department or in the area in question Once the result of hemoculture has been received usually within 48-72 hours empirical antibiotic therapy can be maintained or modified in relation to the type of isolated germ and its susceptibility to antibiotics included in the empirical scheme In fact there is ample evidence that ready-to-treat with broad-spectrum antibiotics reduces mortality from bacterial infection in the immunocompromised patient so this procedure is now a recommended approach by the guidelines In addition to the knowledge of prevalent bacterial epidemiology for a certain type of immunocompromised patients in a given geographical area a second tool capable of allowing appropriate empirical antibiotic therapy is the choice of therapy based on the presence or not of asymptomatic bacterial colonization of the patient In fact it is estimated that in 20-30 of cases the colonizing germ can become the cause of a batteriemia facilitated by favoring factors such as the rupture of skin-mucous reefs or the appearance of neutropenia The need to start empirical antibiotic therapy with effective molecules against causal germ appropriate empirical therapy has been shown to reduce bacterial infectious mortality at a time when antibiotic resistance is gradually increasing It has been shown that inappropriate empirical antibiotic therapy based on antibiotics to which the germ is not sensitive is associated with increased infectious mortality from sepsis and septic shock Among the adjuvant therapies used in immunosuppressed patients in addition to antibiotic therapy especially in patients with septic shock there is the administration of opsonizing immunoglobulins and able to activate the complement such as for example immunoglobulins enriched in IgM This practice is generally more established in immunocompetent patients while there are no prospective data in immunocompromised patients
Primary objective Incidence of febrile batteries from antibiotic-resistant gram negative germs MDR
Secondary objectives 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 used empirically cephalosporins of 3 and 4 generation ceftazidime cefipime semisitical penicillins piperacillintazobactam carbapenemas meropenem imipenem aminoglycosides aminoglycosides aikacin second generation fluorquinolones Response to empirical antibiotic therapy within 72 hours without modification of empirical antibiotic therapy and without the use of Pentablobin Response to empirical antibiotic therapy within 72 hours with the use of Pentaglobin within 72 hours of the onset of fever Response to empirical antibiotic therapy with modification of the antibiotic without the addition of antifungal without the use of Pentaglobin Response to empirical antibiotic therapy with modification of the antibiotic without the addition of antifungal with the use of Pentaglobin Response of antibiotic therapy with empirical addition of antifungal with or without the use of Pentaglobin Mortality at 30 days Mortality at 90 days
Design of the study Prospective observational non-interventional study to determine the incidence of febrile batteries from MDR germs in febrile oncohaematological patients
The study is aimed at the centers belonging to the Italian Society of Pediatric Oncology Hematology IAEOP Patients will be enrolled prospectively from the date of activation of the center
Eligible patients will include patients who develop fever after chemotherapy either after first diagnosis or relapse or after hemopoietic stem cell transplantation TCSE autologhe or allogenic managed in ordinary hospitalization subjected to endovenous antibiotic therapy for at least 72 hours for the treatment of the febrile episode These patients will be the denominator of the study population Patients who turn out to have positive hemoculture will represent the cases of the study population A patient may be enrolled several times in the study both as denominatorcontrol hospitalization and example for several febrile episodes and as a case second episode of febrile batteriemia In the latter case the interval between the conclusion of a febrile episode stable slibration negative hemoculture and the subsequent febrile episode must be at least 7 days The febrile episodes considered will be only those in ordinary hospitalization minimum 2 nights of hospitalization while febrile episodes managed exclusively in day-care Day-Hospital or with home oral or endovenous antibiotic therapy are excluded
Each participating centre must declare at the opening the standard procedure relating to
1 Study of colonization yes no method of investigation
2 Standard antibiotic prophylaxis in acute myeloid leukemia LLA acute myeloid leukemia LMA non-Hodgkin lymphoma LNH allogenic TCSE autologous TCSE
3 Standard empirical therapy in non-colonized patient first 48-72 hours
4 Use of Pentaglobin yesno criteria for use dose
In the study patients hospitalized by febrile episode in endovenous antibiotic therapy the following information will be collected sex age at the time of the febrile episode age at diagnosis of the basic disease type of tumor stage of treatment in hospitalization type of transplant presence or not of transplant disease against the host only for allogenic transplantation colonization or not CVC or not type of CVC presence or not of urinary catheter clinical characteristics of the febrile episode date onset fever-date end fever date start-date end of antibiotic therapy date start-date end antifungal therapy date start-date end therapy with Pentaglobin result of haemoculture and antibiogram number of neutrophils number of lymphocytes hypotension in relation to normal values for age saturation O2 need or not of hospitalization in intensive care whether or not fluids are used ventilatory support renal replacement therapy maximum PCR-value in the first 72 hours PCT-value maximum in the first 72 hours Galactomanane maximum value during the episode β-D glucan maximum value during the episode survival at 30 and 90 days final definition of the infectious episode FUO ICD IMD and possible toxicity related to antibiotic therapy
The knowledge through hemoculture of the germs responsible for febrile batteries over a given period of time allows the definition of the predominant typology of germs responsible for systemic infection On this basis it is used to define the empirical antibiotic treatment that is given to the patient within a few hours of the onset of fever Empirical antibiotic therapy must be effective with regard to the germs most represented in the department or in the area in question Once the result of hemoculture has been received usually within 48-72 hours empirical antibiotic therapy can be maintained or modified in relation to the type of isolated germ and its susceptibility to antibiotics included in the empirical scheme In fact there is ample evidence that ready-to-treat with broad-spectrum antibiotics reduces mortality from bacterial infection in the immunocompromised patient so this procedure is now a recommended approach by the guidelines In addition to the knowledge of prevalent bacterial epidemiology for a certain type of immunocompromised patients in a given geographical area a second tool capable of allowing appropriate empirical antibiotic therapy is the choice of therapy based on the presence or not of asymptomatic bacterial colonization of the patient In fact it is estimated that in 20-30 of cases the colonizing germ can become the cause of a batteriemia facilitated by favoring factors such as the rupture of skin-mucous reefs or the appearance of neutropenia The need to start empirical antibiotic therapy with effective molecules against causal germ appropriate empirical therapy has been shown to reduce bacterial infectious mortality at a time when antibiotic resistance is gradually increasing It has been shown that inappropriate empirical antibiotic therapy based on antibiotics to which the germ is not sensitive is associated with increased infectious mortality from sepsis and septic shock Among the adjuvant therapies used in immunosuppressed patients in addition to antibiotic therapy especially in patients with septic shock there is the administration of opsonizing immunoglobulins and able to activate the complement such as for example immunoglobulins enriched in IgM This practice is generally more established in immunocompetent patients while there are no prospective data in immunocompromised patients
Primary objective Incidence of febrile batteries from antibiotic-resistant gram negative germs MDR
Secondary objectives 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 used empirically cephalosporins of 3 and 4 generation ceftazidime cefipime semisitical penicillins piperacillintazobactam carbapenemas meropenem imipenem aminoglycosides aminoglycosides aikacin second generation fluorquinolones Response to empirical antibiotic therapy within 72 hours without modification of empirical antibiotic therapy and without the use of Pentablobin Response to empirical antibiotic therapy within 72 hours with the use of Pentaglobin within 72 hours of the onset of fever Response to empirical antibiotic therapy with modification of the antibiotic without the addition of antifungal without the use of Pentaglobin Response to empirical antibiotic therapy with modification of the antibiotic without the addition of antifungal with the use of Pentaglobin Response of antibiotic therapy with empirical addition of antifungal with or without the use of Pentaglobin Mortality at 30 days Mortality at 90 days
Design of the study Prospective observational non-interventional study to determine the incidence of febrile batteries from MDR germs in febrile oncohaematological patients
The study is aimed at the centers belonging to the Italian Society of Pediatric Oncology Hematology IAEOP Patients will be enrolled prospectively from the date of activation of the center
Eligible patients will include patients who develop fever after chemotherapy either after first diagnosis or relapse or after hemopoietic stem cell transplantation TCSE autologhe or allogenic managed in ordinary hospitalization subjected to endovenous antibiotic therapy for at least 72 hours for the treatment of the febrile episode These patients will be the denominator of the study population Patients who turn out to have positive hemoculture will represent the cases of the study population A patient may be enrolled several times in the study both as denominatorcontrol hospitalization and example for several febrile episodes and as a case second episode of febrile batteriemia In the latter case the interval between the conclusion of a febrile episode stable slibration negative hemoculture and the subsequent febrile episode must be at least 7 days The febrile episodes considered will be only those in ordinary hospitalization minimum 2 nights of hospitalization while febrile episodes managed exclusively in day-care Day-Hospital or with home oral or endovenous antibiotic therapy are excluded
Each participating centre must declare at the opening the standard procedure relating to
1 Study of colonization yes no method of investigation
2 Standard antibiotic prophylaxis in acute myeloid leukemia LLA acute myeloid leukemia LMA non-Hodgkin lymphoma LNH allogenic TCSE autologous TCSE
3 Standard empirical therapy in non-colonized patient first 48-72 hours
4 Use of Pentaglobin yesno criteria for use dose
In the study patients hospitalized by febrile episode in endovenous antibiotic therapy the following information will be collected sex age at the time of the febrile episode age at diagnosis of the basic disease type of tumor stage of treatment in hospitalization type of transplant presence or not of transplant disease against the host only for allogenic transplantation colonization or not CVC or not type of CVC presence or not of urinary catheter clinical characteristics of the febrile episode date onset fever-date end fever date start-date end of antibiotic therapy date start-date end antifungal therapy date start-date end therapy with Pentaglobin result of haemoculture and antibiogram number of neutrophils number of lymphocytes hypotension in relation to normal values for age saturation O2 need or not of hospitalization in intensive care whether or not fluids are used ventilatory support renal replacement therapy maximum PCR-value in the first 72 hours PCT-value maximum in the first 72 hours Galactomanane maximum value during the episode β-D glucan maximum value during the episode survival at 30 and 90 days final definition of the infectious episode FUO ICD IMD and possible toxicity related to antibiotic therapy
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None