Standard dosing of piperacillin and meropenem fail to achieve adequate plasma concentrations in ICU patients.
J Petersson, C G Giske, E Eliasson
https://pubmed.ncbi.nlm.nih.gov/27655029Actively Recruiting
Phase 4
Age: 61Days - 18Years
All Genders
ID06293677
Upward Adjustment of Wide-Spectrum Antibiotic Dosage in Children With Febrile Neutropenia and Suspected Increased Kidney Clearance: A Randomized Trial With Drug Monitoring
Led by Centre Hospitalier Universitaire Vaudois · Updated on 2024-07-11
30
Participants Needed
1
Research Sites
N/A
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 research aims to improve antibiotic treatment for children with cancer who develop febrile neutropenia, a condition where fever occurs alongside a low white blood cell count due to chemotherapy. This condition often requires broad-spectrum antibiotics to fight bacterial infections. However, some children experience faster kidney clearance of antibiotics (augmented renal clearance), which may reduce antibiotic levels and affect treatment effectiveness. The study focuses on two antibiotics, piperacillin-tazobactam and meropenem, to see if adjusting doses based on kidney function can improve outcomes. Participants will be divided into three groups based on kidney function and treatment: children with normal or low kidney function receiving standard antibiotic doses, children with increased kidney function randomly assigned to either standard doses or higher adjusted doses. Blood tests will be done to estimate kidney function and therapeutic drug monitoring will be performed regularly to measure antibiotic levels and adjust doses as needed. The study uses a randomized design and includes monitoring drug concentrations and adjusting doses to reach target levels safely. Children involved will undergo regular assessments including blood tests to monitor kidney function and antibiotic levels, clinical evaluations of fever duration, and tracking of any side effects related to antibiotics. Monitoring will continue throughout antibiotic treatment and up to two weeks after. The main outcome is the early achievement of target antibiotic levels, with secondary measures including fever duration, side effects, and the accuracy of different kidney function formulas. Participation involves close clinical and laboratory follow-up during febrile neutropenia episodes, with treatment adjustments guided by blood results.
CONDITIONS
Brief 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
You may qualify if you...
- Children aged 2 months to 17 years (older than 60 days and younger than 18 years)
- Diagnosed with cancer and at high risk of febrile neutropenia during the study
- Written informed consent from parents and adolescents older than 14 years
- Experiencing febrile neutropenia or agranulocytosis defined by specific low neutrophil counts and fever
- At least 2 weeks since previous antibiotic treatment for febrile neutropenia
You will not qualify if you...
- Neutropenia not related to cancer or chemotherapy
- Refusal to participate in the study
- Non-French speaking parents or patients older than 11 years
- No febrile neutropenia or agranulocytosis during study period
- Severe kidney failure (GFR less than 15 mL/min/1.73 m²)
- Pregnancy
- Inability to obtain first drug monitoring result within 72 hours of sampling
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Treatment
Duration - Duration of antibiotic treatment during febrile neutropenia episodes
Participants receive either standard or adjusted antibiotic dosages based on renal clearance, with therapeutic drug monitoring to adjust doses for effectiveness and safety.
At least twice weekly visits for therapeutic drug monitoring and dosage adjustments
Follow-up
Duration - Up to 2 weeks after treatment
Participants are monitored for side effects and fever duration up to 2 weeks after antibiotic treatment ends.
Follow-up visits as needed up to 2 weeks post-treatment
Trial Site Locations
Total: 1 location
1
Centre Hospitelier Universitaire Vaudois (CHUV)
Lausanne, Canton of Vaud, Switzerland, 1011
Actively Recruiting
Loading map...
Research Team
M
Margherita Plebani
P
Pierre-Alex Crisinel
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here
Published Research Related To This Trial
Therapeutic Drug Monitoring of Meropenem and Piperacillin in Critical Illness-Experience and Recommendations from One Year in Routine Clinical Practice.
Christina Scharf, Michael Paal, Ines Schroeder...
https://pubmed.ncbi.nlm.nih.gov/32245195Implications of augmented renal clearance in critically ill patients.
Andrew A Udy, Jason A Roberts, Jeffrey Lipman
https://pubmed.ncbi.nlm.nih.gov/21769107Augmented Renal Clearance in Pediatric Patients With Febrile Neutropenia Associated With Vancomycin Clearance.
Keita Hirai, Setsuko Ihara, Ayumi Kinae...
https://pubmed.ncbi.nlm.nih.gov/27172381Too much of a good thing: a retrospective study of β-lactam concentration-toxicity relationships.
Sahand Imani, Hergen Buscher, Debbie Marriott...
https://pubmed.ncbi.nlm.nih.gov/29091190Is high-dose β-lactam therapy associated with excessive drug toxicity in critically ill patients?
Craig McDonald, Menino O Cotta, Peter J Little...
https://pubmed.ncbi.nlm.nih.gov/27054905Strategies to enhance rational use of antibiotics in hospital: a guideline by the German Society for Infectious Diseases.
K de With, F Allerberger, S Amann...
https://pubmed.ncbi.nlm.nih.gov/27066980Ensuring Sufficient Trough Plasma Concentrations for Broad-Spectrum Beta-Lactam Antibiotics in Children With Malignancies: Beware of Augmented Renal Clearance!
Pascal André, Léonore Diezi, Kim Dao...
https://pubmed.ncbi.nlm.nih.gov/35083184