infection with bacteria
Conditions
Interventions
Trade Name: Meropenem
Product Name: Meropenem
Pharmaceutical Form: Powder for injection
CAS Number: 96036-03-2
Other descriptive name: MEROPENEM
Concentration unit: g gram(s)
Concentration type: equal
Sponsors
Cliniques universitaires Saint-Luc
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Adult > 18 years old (male or female) - non-pregnant woman / breastfeeding - Non-obese (BMI or = 60ml/min) - Requiring meropenem treatment for a bacterial infection requiring a treatment duration of at least 10 days. - The studied dosing regimen will be administered during the "non-acute" phase of the infection, i.e. 2 days before the planned discontinuation of treatment or discharge of the patient with HAD-OPA. 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 16 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 4
Exclusion criteria
Exclusion criteria: - pregnant woman - creatinine clearance below 60ml/min
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The objective of this study is to evaluate the overall exposure to meropenene when administered at a dose of 2g 3x/d compared to the traditional regimen (2g 3x/d over 24h) in order to assess the feasibility of administering it at home.;Secondary Objective: Not applicable;Primary end point(s): Treatement ok;Timepoint(s) of evaluation of this end point: 09/2020 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Not applicable;Timepoint(s) of evaluation of this end point: Not applicable | — |
Countries
Belgium
Contacts
Public ContactHospital pharmacist
Cliniques universitaires Saint-Luc
Outcome results
None listed