Actively Recruiting

Phase 4
Age: 61Days - 18Years
All Genders
NCT06293677

Adjustment of Antibiotic Dosage in Pediatric Oncology Patients With Febrile Neutropenia and Augmented Renal Clearance

Led by Centre Hospitalier Universitaire Vaudois · Updated on 2024-07-11

30

Participants Needed

1

Research Sites

104 weeks

Total Duration

On this page

Sponsors

C

Centre Hospitalier Universitaire Vaudois

Lead Sponsor

U

Unisanté Centre universitaire de médecine générale et santé publique

Collaborating Sponsor

AI-Summary

What this Trial Is About

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). One significant concern is febrile neutropenia, where children experience a fever during a period of low white blood cell count. This condition often results from bacterial infections, necessitating prompt wide-spectrum antibiotic treatment. However, some children eliminate antibiotics in the urine too quickly during febrile neutropenia. Their kidneys function more than they normally do (renal hyperfiltration). This can lead to insufficient exposure to antibiotics to control the infection. The current standard antibiotic regimens do not account for this variable elimination rate. In this study we focus on two antibiotics used in this context: piperacillin-tazobactam and meropenem. The main questions this study aims to answer are, in these children: * Would higher doses of antibiotics result in better blood levels of antibiotics? * Would they have more sides effects with higher antibiotics dosages? * Would they recover more quickly with higher antibiotic doses? All patients will undergo a blood test upon hospital arrival, including an assessment of renal function. If renal function is normal or diminished, the patient will receive the standard antibiotic dose. Children with increased renal function will be randomly assigned to two groups during each episode of febrile neutropenia. One group will receive standard antibiotic dosages, while the other will receive higher doses to compensate for renal hyperfiltration. Throughout the study, antibiotic levels in the blood will be monitored for all patients. This monitoring will determine if target concentrations can be achieved more quickly with experimental dosages and will allow doctors to readjust the doses if needed.

CONDITIONS

Official Title

Adjustment of Antibiotic Dosage in Pediatric Oncology Patients With Febrile Neutropenia and Augmented Renal Clearance

Who Can Participate

Age: 61Days - 18Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Children with cancer aged between 2 months and 17 years
  • High likelihood of febrile neutropenia during the study period
  • Written informed consent from parents and adolescents over 14 years
Not Eligible

You will not qualify if you...

  • Neutropenia not caused by cancer or chemotherapy
  • Declined participation in the study
  • Non-French speaking parents or patients older than 11 years
  • No febrile neutropenia or agranulocytosis during the study period
  • Severe renal failure with GFR less than 15 mL/min/1.73 m²
  • Pregnancy
  • Inability to obtain first therapeutic drug monitoring result within 72 hours of sampling

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Trial Site Locations

Total: 1 location

1

Centre Hospitelier Universitaire Vaudois (CHUV)

Lausanne, Canton of Vaud, Switzerland, 1011

Actively Recruiting

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Research Team

M

Margherita Plebani

CONTACT

P

Pierre-Alex Crisinel

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

3

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Adjustment of Antibiotic Dosage in Pediatric Oncology Patients With Febrile Neutropenia and Augmented Renal Clearance | DecenTrialz