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New treatment option for Febrile Neutropenia
Official title Adjustment of Antibiotic Dosage in Pediatric Oncology Patients With Febrile Neutropenia and Augmented Renal Clearance
ClinicalTrials.gov ID: NCT06293677
What this study is testing
What is Dosage Adjustment Rules for Augmented Renal Clearance (DAR-ARC) for piperacillin-tazobactam and meropenem?
Dosage Adjustment Rules for Augmented Renal Clearance (DAR-ARC) for piperacillin-tazobactam and meropenem is an investigational medicine, given as an once-daily infusion into a vein, being studied as a potential treatment for febrile neutropenia.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This clinical trial focuses on children with cancer who face infections after receiving chemotherapy. Chemotherapy affects the bone marrow, leading to a decrease in the production of certain white blood cells, particularly those that defend against bacterial infections (neutrophils).
- Phase 4: studies an already-approved treatment
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 61 to 18
You may be able to join if
- Patients' Oncologic patients aged 2 months to 17 years (older than 60 days and younger than 18 years),
- High probability of febrile neutropenia during the study period
- Written informed consent from parents and adolescents older than 14 years Patients'
You likely can't join if
- Neutropenia not related to cancer and/or chemotherapy
- Refusal to participate
- Non-French speaking parents/patients older than 11 years old
- Absence of febrile neutropenia or agranulocytosis during the study period (secondary exclusion) Febrile neutropenia episodes inclusion criteria
- Febrile neutropenia or agranulocytosis defined as:
- Neutropenia: absolute neutrophils \<500 cells/µL or agranulocytosis: absolute neutrophils \<100 cells/µL or patients expected to be neutropenic in...
See the full eligibility criteria
- Patients' Oncologic patients aged 2 months to 17 years (older than 60 days and younger than 18 years),
- High probability of febrile neutropenia during the study period
- Written informed consent from parents and adolescents older than 14 years Patients'
- Neutropenia not related to cancer and/or chemotherapy
- Refusal to participate
- Non-French speaking parents/patients older than 11 years old
- Absence of febrile neutropenia or agranulocytosis during the study period (secondary exclusion) Febrile neutropenia episodes inclusion criteria
- Febrile neutropenia or agranulocytosis defined as:
- Neutropenia: absolute neutrophils \<500 cells/µL or agranulocytosis: absolute neutrophils \<100 cells/µL or patients expected to be neutropenic in the next 24 hours due to ongoing chemotherapy
- body temperature (tympanic or axillary) ≥38°C during at least one hour or a single T ≥38.5°C
- At least 2 weeks after the end of the previous antibiotic treatment for another included episode of febrile neutropenia. Febrile neutropenia episodes exclusion criteria:
- Severe renal failure (GFR\<15 mL/min/1.73 m²)
- Pregnancy
- Inability to obtain the first therapeutic drug monitoring (TDM) result within 72 hours of sampling (e.g. admission before or during public holidays laboratory closure)
The study team makes the final eligibility decision.
Where it's taking place
- Lausanne, Canton of Vaud, Switzerland
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
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, 61 days to 18 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Lausanne, Canton of Vaud, Switzerland. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.