neonatal sepsis, pneumonia and meningitis
Conditions
Interventions
Trade Name: Standacillin 1 g
Product Name: ampicillin
Pharmaceutical Form: Powder for solution for injection/infusion
INN or Proposed INN: Ampicillinum
CAS Number: 69-53-4
Other descriptive name: AMPI
Sponsors
Tartu University Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. GA = 32 weeks 2. PNA 21 x 109 cells/L, • immature to total neutrophil ratio (I/T) > 0.2, • platelet count 15 mg/L, • glucose intolerance when receiving normal glucose amounts (8-15 g/kg/day) as expressed by blood glucose values > 180 mg/dL or hypoglycemia (=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. GA 28 days 3. Informed consent not given by parents or guardian 4. No central venous or arterial catheter in place 5. Known hypersensitivity to study drug 6. Likely to be infected with organisms resistant to study antibiotics 7. Participation in any other study, apart from observational studies involving only data registration on clinical treatment
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To describe the PK of ampicillin, penicillin G and gentamicin in neonates with suspected or proven neonatal sepsis or pneumonia and GA of = 32 week in order to define optimal dosing regimen of the studied antibiotics. ;Secondary Objective: 1) To describe the safety of ampicillin, penicillin G and gentamicin in neonates with GA =32 weeks 2) To describe the PK of ampicillin, penicillin G and gentamicin in CSF of neonates with suspected or proven bacterial meningitis and of GA =32 weeks 3)To describe the bronchoalveolar lavage fluid (BALF) concentrations of ampicillin, penicillin G and gentamicin achieved with the dosing regimen used in the study in neonates with GA =32 weeks requiring invasive ventilator support ;Primary end point(s): The PK endpoints are Cmax, Cmin, Tmax, , CLssdrug, T1/2, Vd The secondary PK endpoints are drug concentration in BALF (ELF + AM) and CSF with AUCELF, AUCCSF calculated if feasible; and renal drug clearance (ClRdrug) PD endpoints: T>MIC for penicillin and ampicillin and Cmax/MIC for gentamicin in plasma ;Timepoint(s) of evaluation of this end point: pharmacokinetic sampling visit | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Safety endpoints, what include the description of all adverse events (AE) experienced by infants receiving study drugs: Clinical and laboratory AE will be recorded until end of therapy (EOT) visit and graded according to the need for a specific medical intervention. Renal function parameters (creatinine, urea) will be recorded at least once before and once during treatment with the study regimen (EOT visit inclusive). Clinical evaluation for seizures will be performed throughout the treatment with the study drug with EEG performed at the discretion of the treating physician. Neurological evaluation by cerebral ultrasound undertaken as clinically indicated at any time during treatment with the study regimen (EOT visit inclusive). ;Timepoint(s) of evaluation of this end point: All study patients will be monitored continuously plus additional evaluation at pharmacokinetic sampling visit and end of therapy visit | — |
Countries
Estonia
Contacts
Public ContactChildren`s Clinic
Tartu University Hospital
Outcome results
None listed