CEFEPIME for Febrile neutropenia | Acute myeloid leukaemia | Acute lymphoblastic leukaemia | Biphenotypic leukaemia | Lymphoblastic lymphoma | B-cell lymphoma | Anaplastic large cell lymphoma | Solid tumours

Inclusion criteria

• {"criterion_text":"- Male and female patients ≤18 years of age expected to develop prolonged neutropenia (>7 days), with: •\tAcute myeloblastic leukaemia at any phase of chemotherapy •\tAcute lymphoblastic leukaemia in induction, consolidation, or intensification phases •\tBiphenotypic leukaemia at any phase of chemotherapy •\tLymphoblastic lymphoma in induction and consolidation phases •\tB-cell receiving high-intensity chemotherapy • Anaplastic lymphoma receiving high-intensity chemotherapy •\tSolid tumours receiving high-intensity chemotherapy •\tRelapsed leukaemia at any phase of treatment\n- Patient and/or parent(s)/legal representative(s) must have sufficient reading and writing skills to understand and provide consent to participate in the study\n- Patient and/or parent(s)/legal representative(s) must be considered reliable and capable of adhering to the protocol.\n- Episode of febrile neutropenia (FN), defined as a single axillary temperature ≥38.0°C in a patient with an absolute neutrophil count (ANC) <500 neutrophils/mm³, or expected to fall below this value within the next 48–72 hours\n- Antibiotic treatment initiated for the current FN episode (routine antimicrobial prophylaxis is allowed, as well as teicoplanin 3 days/week for patients with AML included in the CHIP-AML-2022 protocol and therefore in the Pro-teico study).\n- Low risk of invasive bacterial infection (IBI) at the start of the FN episode. Patients must meet all of the following: •\tCRP <9 mg/dL •\tPCT <0.5 ng/mL •\tAbsence of hypotension\n- Absence of proven or clinically suspected bacterial infection 48–72 hours after the FN episode. This includes: •\tNo bacterial microbiological isolation from relevant clinical samples. •\tNo signs, symptoms, or clinical or radiological findings suggestive of a localised or invasive infection. In cases where a microbiological isolate is considered a contaminant, the patient may still be considered for inclusion provided that: •\tThe isolated microorganism is consistent with contamination according to standard microbiological criteria. •\tThere are no clinical, laboratory, or radiological signs suggestive of bacterial infection\n- Good clinical evolution 48–72 hours after the FN episode, defined as: •\tAfebrile for >48 hours (axillary temperature <38°C) •\tHaemodynamically stable •\tStable paediatric early warning score (PEWS)\n- CRP <5 mg/dL, or CRP <9 mg/dL and PCT <0.5 ng/mL, with decreasing trend at the time of randomisation (values will be assessed on day 3 and day 5 after the FN episode).\n- ANC <500 neutrophils/mm³ at the time of randomisation.\n- Signed informed consent from the patient and/or parent(s)/legal representative(s)."}

Exclusion criteria

• {"criterion_text":"- Antibiotic treatment at the time of the FN episode different from that used prophylactically.\n- Empirical antibiotic treatment different from that recommended in international guidelines\n- Patient with poor clinical evolution during the first 12 hours (hemodynamic instability, PICU admission, death).\n- Active participation in the same study at the onset of the current FN episode.\n- Active participation in another clinical trial that, in the investigators’ opinion, may interfere with the assessment of the results.\n- Any condition which, in the investigator’s opinion, makes study participation unsuitable for the patient or could limit, prevent, or confound the assessments planned in the protocol.\n- Female patients who are pregnant or breastfeeding"}

Primary endpoints

• {"endpoint_text":"- To evaluate the safety of discontinuing antibiotics by comparing the proportion of febrile neutropenia episodes with uncomplicated resolution at 28 days between the experimental group and the control group.","definition_or_measurement_approach":"Uncomplicated resolution defined as the absence of: - death from any cause - admission to the ICU - sepsis - microbiologically documented bacterial infection - clinically documented bacterial infection (including radiologically confirmed pneumonia). Proportion compared between experimental and control groups at 28 days from onset of episode."}

Secondary endpoints

• {"endpoint_text":"- Days with fever.","definition_or_measurement_approach":"Count of days with fever during the episode."}
• {"endpoint_text":"- Days and type of antimicrobials administered.","definition_or_measurement_approach":"Number of antibiotic days and classification by antimicrobial agent; compared between groups to assess reduction in days of antibiotic therapy."}
• {"endpoint_text":"- Days of neutropenia.","definition_or_measurement_approach":"Count of days with neutropenia."}
• {"endpoint_text":"- Patient characteristics: age, sex, underlying disease, treatment phase, days since last chemotherapy cycle, type of catheter, clinical characteristics, physical examination, hours of fever on admission, vital signs, admission to paediatric ICU, risk stratification","definition_or_measurement_approach":"Baseline and clinical characteristic collection and comparison between groups."}
• {"endpoint_text":"- Laboratory values (at the start of the FN episode, at 48-72 hours, at 5 days - if applicable - and at 28 days): complete blood count, serum biochemistry (see Appendix II), CRP, PCT.","definition_or_measurement_approach":"Specified lab parameters measured at defined timepoints (start, 48-72h, day 5 if applicable, day 28)."}
• {"endpoint_text":"- IL-8 (at the onset of NF and at 48-72 hours)","definition_or_measurement_approach":"IL-8 measured at NF onset and at 48-72 hours."}
• {"endpoint_text":"- Microbiological results: blood cultures and urine cultures and others if performed (nasopharyngeal swab, cerebrospinal fluid culture, etc.).","definition_or_measurement_approach":"Microbiological sampling and results reporting as performed clinically."}
• {"endpoint_text":"- Results of B-HCG in urine.","definition_or_measurement_approach":"Urine B-HCG results recorded."}
• {"endpoint_text":"- Imaging test results: X-ray, CT, MRI, ultrasound, among others.","definition_or_measurement_approach":"Imaging findings recorded if performed."}
• {"endpoint_text":"- Incidence and severity of adverse events","definition_or_measurement_approach":"AE collection and grading per protocol."}
• {"endpoint_text":"- Concomitant medication","definition_or_measurement_approach":"Concomitant medications recorded."}

Spain

Earliest CTIS Part Ii Submission Date

01-04-2026

Latest Decision Or Authorization Date

05-05-2026

Processing Time Days

34

Number Of Sites

4

Number Of Participants

136

Primary sponsor

Full Name

Fundacio Hospital Universitari Vall D’Hebron Institut De Recerca

Organisation Type

Laboratory/Research/Testing facility

Country Of Registered Address

Spain