NCT03247920

Reduction of Intravenous Antibiotics In Neonates

Intravenous to Oral Antibiotic Switch Therapy for Probable Neonatal Bacterial Infections: Clinical Efficacy, Safety and Cost-effectiveness

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 510 (actual)
• Sponsor: Franciscus Gasthuis · Academic / Other
• Sex: All
• Age: 1 Day – 28 Days
• Healthy volunteers: Not accepted

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

Detailed description

Neonates have a high antibiotic consumption because of their susceptibility for bacterial infections. Since the early diagnosis of bacterial infection in neonates is difficult, intravenous broad-spectrum antimicrobial therapy is usually started promptly after subtle symptoms. The majority of neonates become asymptomatic shortly after initiation; when infection is probable or proven by elevated inflammatory markers and/or a positive blood culture, intravenous antibiotics are administered for at least 7 days. However, for neonates blood culture has a limited sensitivity. Therefore, the majority of neonates with probable infection are treated for a prolonged time with intravenous broad-spectrum antimicrobial therapy. In older children, intravenous antibiotics are often changed to oral antibiotics after cessation of symptoms and decreasing inflammatory parameters. This is not yet widely practised in neonates because of uncertainties in pharmacokinetics. Two explorative small studies from France and Italy into neonatal antibiotic switch therapy suggest that follow-up treatment with an oral antibiotic is promising; but the non-inferiority and safety was not yet properly addressed. Neonatal switch therapy, if proven to be safe and efficacious, would have a major impact on neonatal well-being, mother-to-child bonding and moreover costs.

Conditions

• Neonatal Infection
• Neonatal SEPSIS

Interventions

Type	Name	Description
DRUG	Amoxicillin Clavulanate	Dose 75 mg/kg/day, (3dd 25 mg/kg). Concentration amoxicillin/clavulanic acid: 4:1
DRUG	Antibiotics	Intravenous antibiotic therapy following local protocol

Timeline

• Start date: 2017-11-04
• Primary completion: 2021-06-15
• Completion: 2021-07-15
• First posted: 2017-08-14
• Last updated: 2021-08-24

Locations

18 sites across 1 country: Netherlands