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?
No
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;