NCT02806141

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

Aerosolized Plus Intravenous Colistin Compared With Intravenous Colistin for Adjunctive Treatment of Ventilator-associated Pneumonia Due to Pandrugs-resistant Acinetobacter Baumannii in the Neonates: Randomized Controlled Trial

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 204 (actual)
• Sponsor: Hat Yai Medical Education Center · Academic / Other
• Sex: All
• Age: 1 Day – 30 Days
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

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

Interventions

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

Timeline

• Start date: 2016-09-01
• Primary completion: 2017-10-01
• Completion: 2017-10-01
• First posted: 2016-06-20
• Last updated: 2018-08-02

Locations

1 site across 1 country: Thailand