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what are the optimal doses of broad spectrum B-lactams to administer to obese patients if infected?

what are the optimal doses of broad spectrum B-lactams to administer to obese patients if infected?

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2011-004239-29-BE
Enrollment
120
Registered
2011-09-19
Start date
2011-10-04
Completion date
Unknown
Last updated
2022-03-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

any patient with a BMI >= 30kg/m² and has a simple or severe infection. MedDRA version: 14.0 Level: PT Classification code 10060945 Term: Bacterial infection System Organ Class: 10021881 - Infections and infestations

Interventions

Trade Name: tazocin Product Name: tazocin Pharmaceutical Form: Powder for solution for infusion INN or Proposed INN: TAZOBACTAM CAS Number: 89786-04-9 Concentration unit: g gram(s) Concentration type:

Sponsors

Hopital Erasme
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: -patient >= 18y -any hospitalised obese patient (BMI >= 30kg/m²), receiving an intravenous broad spectrum B-lactam , for an infection (suspected or confirmed). Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 90 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 30

Exclusion criteria

Exclusion criteria: -hemodialysis or renal replacement therapy -pregnant woman

Design outcomes

Primary

MeasureTime frame
Main Objective: to determine the pharmacocinetic parameters of broad spectrum B-lactams administred at usual doses in obese patients in order to propose dosing regimens of antibiotics based on patient weight. ;Secondary Objective: ;Primary end point(s):

Countries

Belgium

Contacts

Public Contactmaladies infectieuses

Hopital Erasme

elise.brisart@erasme.ulb.ac.be003225555680

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026