Early optimization of ceftazidine dosing regimen in critical care : FORTOPTIM_1

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Centre Hospitalier Universitaire De Saint Etienne

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Therapeutics [E02], Diseases [C] - Bacterial Infections and Mycoses [C01]

Decision date (initial)

2025-07-24

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

Funding sources

French Ministry of Health

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Pharmacokinetic, Therapy

to evaluate a ceftazidime regimen optimized for rapid attainment and maintenance of target concentration in the critical care patient versus the standard regimen.

Secondary objectives 6

1. evaluate the optimized dosing regimen versus the standard dosing regimen in terms of changes in patient severity between D0 and D7
2. evaluate the optimized dosing regimen versus the standard dosing regimen in terms of mortality at D28
3. evaluate the optimized dosing regimen versus the standard dosing regimen in terms of occurrence of adverse events
4. evaluate the optimized dosing regimen versus the standard dosing regimen in terms of occurrence of overdose
5. evaluate the optimized dosing regimen versus the standard dosing regimen in terms of estimation of renal function
6. evaluate the optimized dosing regimen versus the standard dosing regimen in terms of delay in effective antibiotic therapy

Conditions and MedDRA coding

sepsis

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 4

1. Patient at least 18 years old
2. Patient hospitalized in critical care for an expected duration of at least 72 hours, with an infection for which initiation of ceftazidime therapy is being considered
3. Patient with arterial catheter for blood sampling
4. Patient affiliated to or entitled under a social security scheme

Exclusion criteria 6

1. Pregnant, parturient and nursing women
2. Person deprived of liberty, hospitalized without consent
3. Adult subject to a legal protection measure (guardianship-curatorship)
4. History of severe hypersensitivity to ceftazidime, other cephalosporins or any other type of beta-lactam
5. Patients who have received ceftazidime within the last 72 hours
6. Patients undergoing renal replacement therapy or whose CKD-EPI at the start of treatment is less than 15 ml/min

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Percentage of subjects with a ceftazidime concentration equal to or above the target concentration threshold (35 mg/L) at both 3h and 24h after the first administration and below the toxicity threshold of 100 mg/L

Secondary endpoints 6

1. Patient severity assessed using the SOFA (Sepsis related Organ Failure Assessment) score at D0 and D7. The SOFA score is a tool used in intensive care to assess the severity of organ failure in critical patients. The score assesses the function of six systems: respiratory, cardiovascular, hepatic, hemostatic, renal and neurological. Each system is scored from 0 to 4, meaning that the total SOFA score can vary from 0 to 24. There is no specific threshold for determining disease severity, as the S
2. Death up to D28
3. Occurrence of neurological adverse events defined as: seizure, myoclonus, encephalopathy or delirium, altered consciousness (Glasgow score)
4. Occurrence of an overdose defined as a concentration greater than 100 mg/L
5. Renal function assessed using the following estimators: creatinemia cystatin CKD-EPI, creatinuria/creatininemia ratio (U×V/P) and eGFR creat-cystatin
6. Time to reach PK/PD targets (in hours post treatment introduction)

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Comparator 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Centre Hospitalier Universitaire De Saint Etienne

Sponsor organisation

Centre Hospitalier Universitaire De Saint Etienne

Address

Avenue Albert Raimond

City

Saint Priest En Jarez

Postcode

42270

Country

France

Scientific contact point

Organisation

Centre Hospitalier Universitaire De Saint Etienne

Contact name

Project manager

Public contact point

Organisation

Centre Hospitalier Universitaire De Saint Etienne

Contact name

Project manager

Locations

1 EU/EEA country · 8 investigational sites

By country

Investigational sites

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 15 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

2 submissions — initial application plus substantial / non-substantial modifications