Febrile neutrophenia in oncohematological pediatric patients. MedDRA version: 20.0 Level: PT Classification code 10016288 Term: Febrile neutropenia System Organ Class: 10005329 - Blood and lymphatic system disorders
Conditions
Interventions
Product Name: piperacillin tazobactam
Pharmaceutical Form: Powder and solvent for solution for infusion
INN or Proposed INN: PIPERACILLIN
Other descriptive name: PIPERACILLIN
Concentration unit: mg mi
Sponsors
Vall d'Hebron Institut de Recerca
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Female and male outpatients =18 years with haematological or solid malignancies. - Admission due to FN (defined as an axillary temperature >38.3°C or two consecutive readings of >38.0°C for 1 hour and an absolute neutrophil count 24h (temperature =38ºC), haemodinamic stability, stable pediatric assessment triangle). - CRP = 5 mg/dl and PCT = 0.5 ng/dl at 48-72 hours after admission. - ANC =65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: - Patient that has undergone stem cell transplantation - Patient with acute myeloblastic leukemia or Philadelphia-positive acute lymphoblastic leukemia - Admission due to other cause different from FN. - Antibiotic treatment prior to admission other than the usual antimicrobial prophylaxis. - Empiric antibiotic therapy not in accordance with internal protocol. - Confirmed allergy to betalactams. - Bad clinical evolution in the first 12 hours after admission (haemodinamic instability, admission to PICU, death). - Actively participating in the study at the beginning of the current FN episode. - Concurrent participation in any other clinical trial. - Any condition for which, in opinion of the investigator, participation would not be in the best interest of the patient or that could prevent, limit or confound the protocol-specified assessments. - Female subjects who are pregnant or breast-feeding - Signed informed consent by patient/parent(s)/legal representative(s).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary end point(s): Adverse events attributed to infection (death, PICU admission, sepsis, microbiology and/or clinically defined infection, radiologically confirmed pneumonia).;Main Objective: To evaluate safety of antibiotic withholding in pediatric cancer patients with FN with negative bacterial cultures at 48-72 hours after the onset of fever, absence of demonstrated bacterial infection, good clinical evolution (fever resolution and clinical stability) and PCT < 0,5ng/ml (experimental group), compared to classical strategy (control group), with regards to adverse events attributed to infection (death, PICU admission, sepsis, microbiology defined infection, radiologically confirmed pneumonia).;Secondary Objective: 1. To evaluate efficacy of antibiotic withholding as described previously, with regards to days of fever and total days of antibiotics. 2. To evaluate days of antibiotic reduction in the experimental group. 3. To evaluate reduction of adverse effects of prolonged antibiotic therapy in the experimental group. 4. To retrospectively evaluate the utility of biomarkers to better predict invasive bacterial infection at the fever onset and 48-72 hours after. 5. To validate a risk stratification score in our population.;Timepoint(s) of evaluation of this end point: 28 days | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - Days of fever. - Days of and type of antimicrobials. - Days of neutropenia. - Patient characteristics: age, gender, origin, underlying disease, treatment phase, days from last chemotherapy, catheter type, clinical features, physical examination, hours of fever at admission, vital signs, PICU admission, risk score. - Analytical values (at admission, at 48-72 hours and at 28 days): hematology panel, serum chemistry panel (appendix), PCR, PCT. - IL-8 (at admission and at 48-72 hours). - Microbiological results: blood and urine cultures. Others if performed (nasopharyngeal swab, cerebrospinal fluid culture, etc). - Imaging results: X-ray, CT scan, MRI, US, others. - Incidence and severity of adverse effects. - Concomitant medication.;Timepoint(s) of evaluation of this end point: 48 and 72 hours 7 and 14 days | — |
Countries
Spain
Contacts
Public ContactPere Soler
Vall d'Hebron Institut de Recerca
Outcome results
None listed