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NCT06596096
Risk Factors for Beta-lactam Target Non Attainment in Critically Ill Patients BETALACTACRIT
trial in Sepsis in 300 participants. Completed in 30 June 2025.
11 June 2025
Quick facts
| Lead sponsor | Centre Hospitalier de Saint-Brieuc |
|---|---|
| Status | Completed |
| Study type | OBSERVATIONAL |
| Enrollment | 300 |
| Start date | 12 June 2023 |
| Primary completion | 11 June 2025 |
| Estimated completion | 30 June 2025 |
| Sites | 1 location across France |
Conditions studied
- Sepsis — all drugs for Sepsis →
Sponsor
Centre Hospitalier de Saint-Brieuc
Who can join
18 and older, any sex, with Sepsis. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Beta-lactams agents are time-dependent antibiotics. Their bactericidal effects are associated with the time spent above the minimal inhibitory concentration (MIC) of the bacteria. In ICU patients, many pathophysiological changes may occur, which significantly alter beta-lactam pharmacokinetics (increasing in distribution volume, hypoalbuminemia or change in glomerular filtration rate…), leading to antibiotic underexposure, which may explain some treatment failures and risk of emergence of a multi-resistant bacteria. Many guidelines advocate to reach a fixed target for the steady-state free plasma concentration of beta-lactam between 4 and 8 times of the MIC. However, clinical evidences supporting that septic patients in ICU would benefit from such optimization remain low and contradictory, and use of surrogate MICs based on critical breakpoints instead of actual MICs are significant limitations in the description of beta-lactam exposure among ICU patients with sepsis. In this study, the investigators aim to indentify profiles of intensive care unit patients which are more likely to be associated with pharmacological failure (\< 4 time the MIC of the bacteria). The investigators also aim to identify association between failure and poor clinical outcome.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT06596096
- Europe PMC full search
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Other Centre Hospitalier de Saint-Brieuc trials
Trials by the same sponsor.
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT06596096 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Centre Hospitalier de Saint-Brieuc
- Last refreshed: 9 July 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06596096.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing