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Reduction of Intravenous Antibiotics In Neonates

NCT03247920 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 510

Last updated 2021-08-24

No results posted yet for this study

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

Conditions

  • Neonatal Infection
  • Neonatal SEPSIS

Interventions

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

Sponsors & Collaborators

Principal Investigators

  • Gerdien Tramper · Franciscus Gasthuis & Vlietland

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
1 Day
Max Age
28 Days
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-11-04
Primary Completion
2021-06-15
Completion
2021-07-15

Countries

  • Netherlands

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03247920 on ClinicalTrials.gov