Aerosolized Plus Intravenous vs. Intravenous Colistin for VAP Due to Pandrugs-resistant A. Baumannii 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

TERMINATED

Clinical Phase

PHASE3

Total Enrollment

204 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-09-30

Study Completion Date

2017-10-31

Brief Summary

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This study is planned to compare the clinical efficacy and safety of aerosolized plus intravenous colistin vs. intravenous colistin as adjunctive therapy for the treatment of ventilator-associated pneumonia (VAP) due to pandrugs-resistant (PDR) Acinetobacter baumannii in the neonates.

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Detailed Description

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This study will evaluate the neonates with VAP due to PDR-Acinetobacter baumannii who receive aerosolized plus intravenous colistin compare with intravenous colistin as adjunctive therapy. The efficacy and safety after study will be evaluated.

Conditions

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Pneumonia, Ventilator-Associated Colistin Adverse Reaction Infection Due to Multidrug Resistant Acinetobacter Infection Resistant to Multiple Drugs

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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Aerosolized plus intravenous colistin

Neonates with VAP due to PDR-A. baumannii who receive aerosolized colistin (4 mg/kg/dose twice daily) plus intravenous colistin (3.5 mg/kg/dose twice daily)

Group Type EXPERIMENTAL

Aerosolized plus intravenous colistin

Intervention Type DRUG

Aerosolized colistin at the dose of 4 mg colistin base activity (CBA)/kg twice daily (8 mg/kg/day) plus intravenous colistin at a dose of 3.5 mg CBA/kg/dose twice daily (7 mg/kg/day)

Intravenous colistin

Neonates with VAP due to PDR-A. baumannii who receive only intravenous colistin (3.5 mg/kg/dose twice daily)

Group Type ACTIVE_COMPARATOR

Intravenous colistin

Intervention Type DRUG

Intravenous colistin at a dose of 3.5 mg CBA/kg/dose twice daily (7 mg/kg/day)

Interventions

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Aerosolized plus intravenous colistin

Aerosolized colistin at the dose of 4 mg colistin base activity (CBA)/kg twice daily (8 mg/kg/day) plus intravenous colistin at a dose of 3.5 mg CBA/kg/dose twice daily (7 mg/kg/day)

Intervention Type DRUG

Intravenous colistin

Intravenous colistin at a dose of 3.5 mg CBA/kg/dose twice daily (7 mg/kg/day)

Intervention Type DRUG

Other Intervention Names

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colistimethate sodium colistimethate sodium

Eligibility Criteria

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Inclusion Criteria

* Neonates who are admitted to the neonatal intensive care unit, Hat Yai Hospital during the study period.
* Neonates who were complicated with VAP due to PDR-Acinetobacter baumannii susceptible to colistin (by minimal inhibitory concentration (MIC) \< 2 mcg/dL).

Exclusion Criteria

* Neonates who have a major anomaly or chromosomal abnormality.
* Neonates who receive colistin prior 7 days prior to study.
* Neonates who have a significant renal dysfunction defined as a serum creatinine (SCr) \>1.5 mg/dL or a decrease in urine output to \< 1 mL/kg/h;

Minimum Eligible Age

1 Day

Maximum Eligible Age

30 Days

Eligible Sex

ALL

Accepts Healthy Volunteers

No