Overview

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

Status:
Terminated

Trial end date:
2017-10-01

Target enrollment:
0

Participant gender:
All

Summary

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.

Phase:

Phase 3

Accepts Healthy Volunteers?

Details

Lead Sponsor:

Hat Yai Medical Education Center

Treatments:

Colistin

Criteria

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;