Phase IV, randomized, open, parallel groups clinical trial for evaluating the early Stop of antibiotic Treatment in febrile neutropenic Oncohematological Paediatric patients.

Phase 1

• Conditions: MedDRA version: 20.0Level: PTClassification code 10016288Term: Febrile neutropeniaSystem Organ Class: 10005329 - Blood and lymphatic system disorders; Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]; Febrile neutrophenia in oncohematological pediatric patients.

• Registration Number: EUCTR2018-000775-32-ES
• Lead Sponsor: Vall d'Hebron Institut de Recerca

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2018-04-09
• Last Update Posted: 18 June 2018

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 250

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 <0.5 neutrophils/mm3, or expected to fall below 0.5 neutrophils/mm3 during the next 48 hours).
-Antibiotic treatment initiated in the current FN episode (prior standard antimicrobial prophylaxis will be accepted).
-Low risk of invasive bacterial infection at admission:
oNone of the following: serum level of CRP = 9 mg/dl, hypotension, relapse of leukemia as type of cancer, platelet count =50,000 platelets/mm3, initiation of fever less than 7 days from last chemotherapy). Platelet count =50,000 platelets/mm3 or initiation of fever less than 7 days from the last chemotherapy alone will be accepted.
-Absence of a demonstrated bacterial infection at 48h-72 hours after admission (positive culture from a sterile site, clinically diagnosed infection or radiologically confirmed pneumonia).
-Good clinical evolution at 48-72 hours after admission (afebrile >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 < 0.5 neutrophils/mm3 at 48-72 hours after admission.
-Patient/parent(s)/legal representative(s) must possess writing and reading abilities sufficient to comprehend the study.
-Patient/parent(s)/legal representative(s) is considered reliable and capable of adhering to the protocol.
Are the trial subjects under 18? yes
Number of subjects for this age range: 250
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

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).

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified