Reduction of Intravenous Antibiotics In Neonates

• Status: Completed
• Trial end date: 2021-07-15
• Target enrollment: 0
• Participant gender: All

Summary

Randomized controlled open-label non-inferiority trial comparing complete intravenous antibiotic treatment with a short iv. course followed by oral antibiotics in neonates (0-28 days) with probable bacterial infection.

Primary outcome:

• Bacterial re-infection within 28 days after finishing of antibacterial therapy.

Secondary outcome(s):

• Pharmacokinetic profile of oral amoxicillin/clavulanic acid

• Quality of life

• Cost-effectiveness

• Alterations in gut microbiome

• Use of molecular techniques for better detection of bacterial pathogens

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Franciscus Gasthuis
• Collaborator: Erasmus Medical Center
• Treatments: Amoxicillin; Amoxicillin-Potassium Clavulanate Combination; Anti-Bacterial Agents; Antibiotics, Antitubercular; Clavulanic Acid; Clavulanic Acids

Criteria

Inclusion Criteria:

• Neonates (≥ 35+0 weeks, 0-28 days old, ≥ 2 kg)

• Probable bacterial infection defined as clinical symptoms and/or maternal risk factors and elevated inflammatory markers for which empiric broad-spectrum antibiotic treatment was initiated and needs to be continued for > 48 hours

• Clinically well

• Toleration of oral feeding without overt vomiting

• Signed informed consent

Exclusion Criteria:

• Proven bloodstream infection

• Absence of blood culture

• Severe localized infection (meningitis, osteomyelitis, necrotizing enterocolitis)

• Severe clinical sepsis (compromised circulation, need for mechanical ventilation)

• Continuous need for a central venous line

• Severe hyperbilirubinemia exceeding the exchange level

• Parents inability to administer medication

• Major congenital or syndromic anomalies