Distribution, metabolism and excretion of ampicillin, penicillin and gentamicin after intravenous administration to near-term or term neoantes

• Conditions: neonatal sepsis, pneumonia and meningitis; Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]

• Registration Number: EUCTR2012-002836-97-EE
• Lead Sponsor: Tartu University Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-09-12
• Last Update Posted: 7 September 2015

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 84

Inclusion Criteria

1.GA = 32 weeks
2.PNA < 28 days
3.Informed consent (IC) given by parents or guardian
4.Central venous or arterial catheter placed or will be placed on clinical indication
5.Treatment with intravenous ampicillin or penicillin G with or without gentamicin for suspected or proven neonatal sepsis, defined as at least two clinical and at least two laboratory criteria as listed below. In neonates with positive blood culture yielding a known pathogen (apart from CoNS for wich at least 2 positive blood cultures will be required) for the diagnosis of sepsis will be based on the presence of one clinical and one laboratory criterion.
Clinical criteria:
•hyper- or hypothermia or temperature instability,
•reduced urinary output or hypotension or mottled skin or impaired peripheral perfusion
•apnea or increased oxygen requirement or increased requirement for ventilator support,
•bradycardia spells or tachycardia or rhythm instability,
•feeding intolerance or abdominal distension,
•lethargy or hypotonia or irritability,
•skin and subcutaneous lesions such as petechial rash or sclerema
Laboratory criteria:
•white blood cells (WBC) count < 4 or > 21 x 109 cells/L,
•immature to total neutrophil ratio (I/T) > 0.2,
•platelet count < 100 x 109/L,
•C-reactive protein (CRP) > 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 (< 40 mg/dL) confirmed at least two times,
•acidosis as characterized by base excess (BE) < -10 mmol/L or lactate with value above 2 mmol/L.
6.No major malformations
7.Likely survival for more than 24 h from inclusion into the study

Are the trial subjects under 18? yes
Number of subjects for this age range: 84
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

1.GA < 32 weeks
2.PNA > 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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified