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Phase IV, randomized, open label, parallel groups clinical trial for evaluating the early Stop of antibiotic Treatment in high-risk febrile neutropenic Oncohaematological Paediatric patients (e-STOP 2)
EU CTIS ID: 2025-524264-38-00
What this study is testing
To evaluate the safety of discontinuing antibiotic therapy in paediatric patients with cancer and FN without proven invasive bacterial infection (IBI), who show good clinical evolution (resolution of fever and clinical stability), low biomarker levels (CRP <5 mg/dL or CRP <9 mg/dL and PCT <0.5 ng/mL), and an ANC <500/mm³ at 48–72 hours after the FN episode. The proportion of episodes of febrile neutropenia with uncomplicated resolution at 28 days from the onset of the episode will be compared. Uncomplicated resolution will be 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)
- Therapeutic use (Phase IV)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Male and female patients ≤18 years of age expected to develop prolonged neutropenia (>7 days), with: • Acute myeloblastic leukaemia at any phase of chemotherapy • Acute lymphoblastic leukaemia in induction, consolidation, or intensification phases • Biphenotypic leukaemia at any phase of chemotherapy • Lymphoblastic lymphoma in induction and consolidation phases • B-cell receiving high-intensity chemotherapy • Anaplastic lymphoma receiving high-intensity chemotherapy • Solid tumours receiving high-intensity chemotherapy • Relapsed leukaemia at any phase of treatment
- 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
- Patient and/or parent(s)/legal representative(s) must be considered reliable and capable of adhering to the protocol.
- 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
- 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).
- Low risk of invasive bacterial infection (IBI) at the start of the FN episode. Patients must meet all of the following: • CRP <9 mg/dL • PCT <0.5 ng/mL • Absence of hypotension
You likely can't join if
- Antibiotic treatment at the time of the FN episode different from that used prophylactically.
- Empirical antibiotic treatment different from that recommended in international guidelines
- Patient with poor clinical evolution during the first 12 hours (hemodynamic instability, PICU admission, death).
- Active participation in the same study at the onset of the current FN episode.
- Active participation in another clinical trial that, in the investigators’ opinion, may interfere with the assessment of the results.
- 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.
See the full eligibility criteria
- Male and female patients ≤18 years of age expected to develop prolonged neutropenia (>7 days), with: • Acute myeloblastic leukaemia at any phase of chemotherapy • Acute lymphoblastic leukaemia in induction, consolidation, or intensification phases • Biphenotypic leukaemia at any phase of chemotherapy • Lymphoblastic lymphoma in induction and consolidation phases • B-cell receiving high-intensity chemotherapy • Anaplastic lymphoma receiving high-intensity chemotherapy • Solid tumours receiving high-intensity chemotherapy • Relapsed leukaemia at any phase of treatment
- 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
- Patient and/or parent(s)/legal representative(s) must be considered reliable and capable of adhering to the protocol.
- 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
- 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).
- Low risk of invasive bacterial infection (IBI) at the start of the FN episode. Patients must meet all of the following: • CRP <9 mg/dL • PCT <0.5 ng/mL • Absence of hypotension
- Absence of proven or clinically suspected bacterial infection 48–72 hours after the FN episode. This includes: • No bacterial microbiological isolation from relevant clinical samples. • No 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: • The isolated microorganism is consistent with contamination according to standard microbiological criteria. • There are no clinical, laboratory, or radiological signs suggestive of bacterial infection
- Good clinical evolution 48–72 hours after the FN episode, defined as: • Afebrile for >48 hours (axillary temperature <38°C) • Haemodynamically stable • Stable paediatric early warning score (PEWS)
- 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).
- ANC <500 neutrophils/mm³ at the time of randomisation.
- Signed informed consent from the patient and/or parent(s)/legal representative(s).
- Antibiotic treatment at the time of the FN episode different from that used prophylactically.
- Empirical antibiotic treatment different from that recommended in international guidelines
- Patient with poor clinical evolution during the first 12 hours (hemodynamic instability, PICU admission, death).
- Active participation in the same study at the onset of the current FN episode.
- Active participation in another clinical trial that, in the investigators’ opinion, may interfere with the assessment of the results.
- 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.
- Female patients who are pregnant or breastfeeding
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 0-17 years, 18-64 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.