Reduction of Intravenous Antibiotics In Neonates

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

510 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-11-04

Study Completion Date

2021-07-15

Brief Summary

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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

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Detailed Description

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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

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Neonatal Infection Neonatal SEPSIS

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Multicenter prospective randomized controlled non-inferiority trial

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Oral group

After 48 hours of intravenous antibiotics eligible neonates will switch to amoxicillin/clavulanic acid suspension for the remaining 5 days. When the oral suspension is well tolerated neonates can be discharged from hospital.

In order to investigate the pharmacokinetic profile of oral amoxicillin/clavulanic acid serum levels will be measured.

Group Type ACTIVE_COMPARATOR

Amoxicillin Clavulanate

Intervention Type DRUG

Dose 75 mg/kg/day, (3dd 25 mg/kg). Concentration amoxicillin/clavulanic acid: 4:1

Intravenous group

Neonates will complete the full course of antibiotics of 7 days intravenously in hospital following local protocol.

Group Type ACTIVE_COMPARATOR

Antibiotics

* 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

Minimum Eligible Age

1 Day

Maximum Eligible Age

28 Days

Eligible Sex

ALL

Accepts Healthy Volunteers

No