What are the optimal doses of cephalosporins of first and second generation to manage obese patients?

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2011-004070-29-BE

Enrollment

160

Registered

2011-09-12

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

Antibiotic prophylaxis in digestive surgery or any other surgery with antibiotic prophylaxis MedDRA version: 14.1 Level: PT Classification code 10036898 Term: Prophylaxis System Organ Class: 10042613 - Surgical and medical procedures

Interventions

Trade Name: ZINACEF Product Name: ZINACEF Pharmaceutical Form: Powder for solution for injection CAS Number: 55268-75-2 Other descriptive name: CEFUROXIME Concentration unit: mg milligram(s) Concentra

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: -patient age >= 18y with BMI >= 15 kg/m² -who has a bariatric (gastric BYPASS) or a digestive surgery or any other surgery 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 120 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 40

Exclusion criteria

Exclusion criteria: -Patient treated with different dose of cefuroxim or cefazolin -pregnant woman -unscheduled surgery -patient unable to give consent

Design outcomes

Primary

Measure	Time frame
Main Objective: To determine the optimal doses of first and second generation cephalosporins in obese patients by comparing the results from the obese patient group to the results from the non-obese patient group (case-control) ;Secondary Objective: To best evaluate the renal function, a dosage of Cystatin C will be performed;Primary end point(s): NA;Timepoint(s) of evaluation of this end point: NA	—

Measure

Time frame

Main Objective: To determine the optimal doses of first and second generation cephalosporins in obese patients by comparing the results from the obese patient group to the results from the non-obese patient group (case-control) ;Secondary Objective: To best evaluate the renal function, a dosage of Cystatin C will be performed;Primary end point(s): NA;Timepoint(s) of evaluation of this end point: NA

—

Secondary

Measure	Time frame
Secondary end point(s): NA;Timepoint(s) of evaluation of this end point: NA	—

Countries

Belgium

Contacts

Public ContactFrederique Jacobs

Hopital Erasme

frederique.jacobs@erasme.ulb.ac.be003225556476

Outcome results

None listed

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