Neonatal Vancomycin Trial

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

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

242 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-02-27

Study Completion Date

2020-04-01

Brief Summary

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The study aims to compare the efficacy, safety and pharmacokinetics (PK) of an optimised dosing to a standard dosing regimen of vancomycin in neonates and infants aged ≤ 90 days with late onset bacterial sepsis known or suspected to be caused by Gram-positive microorganisms

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Detailed Description

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Detailed objectives of the study are:

* To compare the efficacy of an optimised vancomycin dosing regimen to a standard vancomycin dosing regimen in patients with late onset, bacterial sepsis, known or suspected to be caused by Gram-positive microorganisms.
* To compare the safety of vancomycin (including renal and hearing safety) by allocation group in the intention to treat (ITT) population
* To describe the PK parameters according to vancomycin dosing regimen and outcome using population PK modelling in the ITT population
* To describe PK/PD in terms of the probability of target attainment (PTA) with different vancomycin dosing regimens in the ITT and per protocol (PP) populations
* To describe outcomes and duration of therapy at the end of vancomycin treatment and at the short term follow-up visit by allocation group in the ITT and PP populations
* To compare the clinical outcome to the antibacterial susceptibility of infecting organisms
* To compare colonisation by resistant microorganisms (e.g. vancomycin-resistant enterococci (VRE)) and Candida spp. by allocation group at baseline, TOC and short-term follow-up
* To validate across multiple centres a host biomarker panel to allow improved diagnosis of bacterial sepsis and monitor response to antibacterial therapy

Conditions

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Late Onset Neonatal Sepsis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Vancomycin - Optimised Regimen

A single loading dose of 25 mg/kg followed by a maintenance dose of:

Postmenstrual age ≤ 35 weeks - 15 mg/kg 12 hourly; Postmenstrual age \> 35 weeks - 15 mg/kg 8 hourly

Group Type EXPERIMENTAL

Vancomycin

Intervention Type DRUG

Vancomycin is an antibiotic used to treat a number of bacterial infections.It is recommended intravenously as a treatment for complicated skin infections, bloodstream infections, endocarditis, bone and joint infections, and meningitis caused by methicillin-resistant S. aureus.

Vancomycin - Standard Regimen

Postmenstrual age \< 29 weeks - 15 mg/kg given 24 hourly; Postmenstrual age 29 - 35 weeks - 15 mg/kg 12 hourly; Postmenstrual age \> 35 weeks - 15 mg/kg 8 hourly

Group Type ACTIVE_COMPARATOR

Vancomycin

Intervention Type DRUG

Vancomycin is an antibiotic used to treat a number of bacterial infections.It is recommended intravenously as a treatment for complicated skin infections, bloodstream infections, endocarditis, bone and joint infections, and meningitis caused by methicillin-resistant S. aureus.

Interventions

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Vancomycin

Vancomycin is an antibiotic used to treat a number of bacterial infections.It is recommended intravenously as a treatment for complicated skin infections, bloodstream infections, endocarditis, bone and joint infections, and meningitis caused by methicillin-resistant S. aureus.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Postnatal age ≤ 90 days AND
* Postnatal age ≥ 72 hours at onset of sepsis AND
* Clinical sepsis as defined by presence of any three clinical or laboratory criteria from the list below OR
* Confirmed, significant bacterial sepsis as defined by positive culture with a Gram-positive bacterium from a normally sterile site and at least one clinical or one laboratory criterion from the list below, in the 24 hours before randomisation

Clinical criteria

* hyper- or hypothermia,
* hypotension or impaired peripheral perfusion or mottled skin,
* apnoea or increased oxygen requirement or increased requirement for ventilatory support,
* bradycardic episodes or tachycardia,
* worsening feeding intolerance or abdominal distension,
* lethargy or hypotonia or irritability

Laboratory criteria:

* white blood cell (WBC) count \< 4 or \> 20 x 109 cells/L
* immature to total neutrophil ratio (I/T) \> 0.2
* platelet count \< 100 x 109/L
* C-reactive protein (CRP) \> 10 mg/L
* glucose intolerance as defined by a blood glucose value \> 180 mg/dL (\> 10 mmol/L) when receiving normal glucose amounts (8 - 15 g/kg/day)
* metabolic acidosis as defined by a base excess (BE) \< -10 mmol/L (-10 mEq/L) or a blood lactate value \> 2 mmol/L

Exclusion Criteria

* Administration of any systemic antibiotic regimen for more than 24 hours prior to randomisation, unless the change is driven by the apparent lack of efficacy of the original regimen
* Treatment with vancomycin for ≥ 24 hours at any time within 7 days of enrolment
* Known toxicity, hypersensitivity or intolerance to vancomycin
* Known renal impairment with urinary output \< 0.7 ml/kg/hour for 24 hours or a creatinine value ≥ 100 µmol/L (1.13 mg/dL)
* Patient receiving (or planned to receive) haemofiltration, haemodialysis, peritoneal dialysis, extracorporeal membrane oxygenation (ECMO) or cardiopulmonary bypass
* Severe congenital malformations where the infant is not expected to survive for more than 3 months
* Patient known to have S. aureus (MSSA or MRSA) bacteraemia
* Patient with osteomyelitis, septic arthritis, urinary tract infection (UTI) or meningitis
* Patient with high suspicion of/confirmed sepsis caused by Gram-negative organisms or fungi
* Other situations where the treating physician considers a different empiric antibiotic regimen necessary
* Current participation in any other clinical study of an investigational medicinal product (IMP)

Post-randomisation exclusions

• Any participant found to have Gram-negative or fungal sepsis, osteomyelitis, septic arthritis, UTI, meningitis or S. aureus (MSSA or MRSA) bacteraemia after randomisation will be excluded from analysis. Participants who have received at least one dose of study vancomycin will be followed up for safety

Minimum Eligible Age

72 Hours

Maximum Eligible Age

90 Days

Eligible Sex

ALL

Accepts Healthy Volunteers

No