Identifying risk factors for inadequate beta-lactam treatment in critically ill patients
Risk Factors for Beta-lactam Target Non Attainment in Critically Ill Patients
This study looks at what factors might cause critically ill patients with sepsis to not get enough of their beta-lactam antibiotics, to see how this affects their recovery.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 300 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Centre Hospitalier de Saint-Brieuc Academic / other |
| Locations | 1 site (Saint-Brieuc) |
| Trial ID | NCT06596096 on ClinicalTrials.gov |
What this trial studies
This observational study aims to investigate the risk factors associated with beta-lactam underexposure in critically ill patients suffering from sepsis. It focuses on how various physiological changes in ICU patients can affect the pharmacokinetics of beta-lactam antibiotics, potentially leading to treatment failures and the emergence of multi-resistant bacteria. Participants will be monitored from the time of inclusion until their discharge from the intensive care unit, with data collected over a maximum period of three months. The study seeks to clarify the relationship between beta-lactam exposure and patient outcomes in this vulnerable population.
Who should consider this trial
Good fit: Ideal candidates for this study are adults over 18 years old who are hospitalized in an intensive care unit with a documented bacterial infection and have been treated with beta-lactam antibiotics for less than 48 hours.
Not a fit: Patients who are allergic to beta-lactam antibiotics or have complex infectious sites may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved dosing strategies for beta-lactam antibiotics in critically ill patients, enhancing treatment efficacy and reducing the risk of antibiotic resistance.
How similar studies have performed: While there is limited clinical evidence supporting the optimization of beta-lactam dosing in septic ICU patients, this study addresses significant gaps in current knowledge, making it a novel approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Participant over 18 years of age. * Hospitalized in intensive care unit. * Bacterial infection documented by culture. * Treatment with beta-lactam for less than 48 hours. * Person not objecting to participation in the study. If the particpant is unable to receive the information, it will be given to a relative and his or her non-opposition will be collected; the patient's non opposition will be sought and collected as soon as his or her condition permits. Exclusion Criteria: * Measurement of MIC of the bacterium in question impossible. * Patients allergic to beta-lactam antibiotics. * Patients with an estimated hospital stay of less than 3 days. * Participants with "complex" infectious sites: central nervous system infection, osteoarticular infection, etc. * Patients already included in the present study on the occasion of a previous beta-lactam administration. * Adult patients under legal protection (safeguard of justice, curatorship, guardianship), persons deprived of liberty.
Where this trial is running
Saint-Brieuc
- Fillatre — Saint-Brieuc, France (Recruiting)
Study contacts
- Principal investigator: Pierre FILLATRE — Centre Hospitalier Saint-Brieuc Paimpol Treguier Reanimation
- Study coordinator: Nicolas Massart
- Email: nicolas.massart@armorsante.bzh
- Phone: +33296017057
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.