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

Hat Yai Medical Education Center

Status and phase: Terminated; Phase 3

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

Treatments: Drug: Intravenous colistin; Drug: Aerosolized plus intravenous colistin

Study type: Interventional

Funder types: Other

Identifiers

NCT02806141

HatYaiMec-Neonate

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 204 patients

Sex: All

Ages: 1 to 30 days old

Volunteers: No Healthy Volunteers

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;

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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204 participants in 2 patient groups

Aerosolized plus intravenous colistin

Experimental group

Description:

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)

Treatment:

Drug: Aerosolized plus intravenous colistin

Intravenous colistin

Active Comparator group

Description:

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

Treatment:

Drug: Intravenous colistin