proven or suspected sepsis, lower respiratory tract infection, complicated intraabdominal infection
Conditions
Interventions
Trade Name: meronem
Product Name: meronem
Pharmaceutical Form: Powder and solvent for solution for injection
INN or Proposed INN: MEROPENEM
CAS Number: 96036-03-2
Concentration unit: mg/ml milligram(s
Sponsors
Tartu University Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Gestational age of = 32 weeks and birth weight below 1500 grams; 2. Postnatal age of = 56 days 3. Written consent signed by parents or legal representatives 4. Required hospitalisation into intensive care unit 5. Arterial or venous cannula settled for clinical reasons 6. Need for meropenem treatment on following clinical indications: a. Proven or suspected sepsis, lower respiratory tract infection, complicated intraabdominal infection b. Clinical deterioration with symptoms suggesting worsening of infection during antibacterial treatment used for empiric treatment of EOS c. Isolation of bacteria from normally sterile sites known to be or suspected to be resistant to presently used antibiotics but susceptible to meropenem d. Suspected infection with multi-resistant bacteria, that is in-ward at same time patient with multiresistant bacteria 7. Expected not to die within 24 hours 8. No major uncorrected congenital malformations Are the trial subjects under 18? yes Number of subjects for this age range: F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Patients with gestational age > 32 weeks and birth weight > 1500 grams; 2. Patients with postnatal age > 56 days 3. Written consent not signed by parents or legal representative 4. Arterial or venous cannula not settled for clinical reasons 5. Patients not needing meropenem treatment 6. Patients expected to die within 24 hours 7. Patients with major uncorrected congenital malformations 8. Patients participating in other studies of investigational agents
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To describe the pharmacokinetic profile of the first meropenem dose of the presently recommended intravenous dose of meropenem given as a continuous infusion over 4 hours or as a bolus injection over 30 minutes in very low birth weight infants To describe the safety of the presently recommended intravenous dose when given as a continuous infusion over 4 hours or as a bolus injection over 30 minutes in very low birth weight infants;Secondary Objective: to descibe safety of meropenem in very low birth weight neonates;Primary end point(s): 1.AUC- area under the plasma concentration-time curve during a dosing interval 2.T1/2- plasma concentration half-life 3.Clt- total body clearance 4.Clr-renal clearance 5.Vd- volume of distribution 6.Cmax-maximal concentration during a dosing interval | — |
Countries
Estonia
Outcome results
None listed