Meropenem pharmacokinetics in very low birth weight neonates

• Conditions: proven or suspected sepsis, lower respiratory tract infection, complicated intraabdominal infection

• Registration Number: EUCTR2009-017823-24-EE
• Lead Sponsor: Tartu University Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2009-12-30
• Last Update Posted: 24 July 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 20

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

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

Study & Design

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