Assessing beta-lactam dosing for pneumonia in ICU patients on dialysis
Beta-Lactams Dosing In Pneumonia in ICU in Patients Treated by Continuous Renal Replacement Therapy
This study is trying to find the right dose of beta-lactam antibiotics for ICU patients with pneumonia who are on dialysis to make sure they get the right amount of medicine.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 65 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Centre Hospitalier de Valenciennes Research network |
| Locations | 1 site (Valenciennes, Nord) |
| Trial ID | NCT03897582 on ClinicalTrials.gov |
What this trial studies
This observational study aims to determine the appropriate dosing of beta-lactam antibiotics for patients with pneumonia who are undergoing continuous renal replacement therapy in the ICU. It will involve blood sampling to measure drug levels at specific intervals to ensure therapeutic plasma levels are achieved. The study will include multiple ICUs and will utilize local antibiogram data to assess bacterial susceptibility. The goal is to address the pharmacokinetic variability that can lead to underdosing or overdosing of antibiotics in this vulnerable patient population.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with pneumonia who are receiving intravenous beta-lactam antibiotics and are being treated for acute kidney injury with continuous renal replacement therapy.
Not a fit: Patients who do not have pneumonia or are not undergoing continuous renal replacement therapy may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could optimize antibiotic dosing for ICU patients with pneumonia, improving treatment outcomes and reducing the risk of toxicity.
How similar studies have performed: While there is limited data on this specific approach, similar studies have explored antibiotic dosing in renal impairment, indicating potential for success in optimizing treatment.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Aged ≥ 18 years * Receiving intraveinous beta-lactam : amoxicillin, amoxicillin-clavulanic acid, piperacillin-tazobactam, cefotaxime, ceftazidime, cefepime, meropenem, imipenem * With AKI defined as any of the following, and treated with Multifiltrate Ci-Ca CVVHD 1000® kit with a dialysis dose of 25 ml/kg/h : * Increase in creatininemia ≥ 0.3 mg/dl (≥ 26.5 µmol/l) within 48 hours * Increase in creatininemia ≥ 1.5 times baseline, which is known or presumed to have occurred within the prior 7 days * Urine volume \< 0.5 ml/kg/h for 6 hours * Hospitalized in ICU * Presence of a catheter to facilitate sample collection * With pneumonia defined as any of the following : * Chest X-ray pneumonia : opacities, new or progressive infiltrates * AND at least one of the following : hyperthermia \> 38°C or hypothermia \< 36°C with no other explanation ; leukopenia \< 4 G/L ou leukocytosis \> 12G/L * AND at least one of the following : new onset purulent sputum or change in sputum character, new onset or worsening cough or dyspnea or tachypnea, rales or bronchial breathing, lower oxygen saturation/hypoxemia or increase of oxygen needs or respiratory assistance * Treated within 24 hours by citrate hemodialysis AND beta-lactam respecting dose and administration conditions of the study : * Amoxicillin : loading dose followed immediately by 2g by extended infusion for 4 hours every 8 hours * Amoxicillin-clavulanic acid : 2g every 8 hours by intermittent bolus * Piperacillin-tazobactam: loading dose followed immediately by 4g/0.5g by continuous infusion every 8 hours (\< 80 kg) ou 6 hours (\> 80 kg) * Cefotaxime: loading dose followed immediately by 2g by continuous infusion every 8 hours Ceftazidime : loading dose followed immediately by 2g by continuous infusion every 8 hours * Cefepime: loading dose followed immediately by 2g by continuous infusion every 8 hours * Meropenem : loading dose followed immediately by 2g (\> 60 kg) ou 1,33g (\< 60 kg) by extended infusion for 4 hours every 8 hours * Imipenem : loading dose followed immediately by 750 mg (\< 80 kg) ou 1g (\> 80 kg) by extended infusion for 4 hours every 6 hours In case of extrem weight, dose will be on investigator's discretion but administration conditions have be to respected. * No objection has been obtained from the patient or their legally authorised representative Exclusion Criteria: * Aged \< 18 years * ECMO * Cystic fibrosis * Burn victim * Pregnant woman * Any rapidly-progressing disease or immediately life-threatening illness * Objection from the patients or their legally authorised representative * No social security scheme * Interruption of antibiotic before samples * Patient in prison
Where this trial is running
Valenciennes, Nord
- Centre Hospitalier de Valenciennes — Valenciennes, Nord, France (Recruiting)
Study contacts
- Study coordinator: Fabien Lambiotte, MD
- Email: lambiotte-f@ch-valenciennes.fr
- Phone: + 33 3 27 14 33 33
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.