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
Overview
- Phase
- Phase 3
- Intervention
- Aerosolized plus intravenous colistin
- Conditions
- Pneumonia, Ventilator-Associated
- Sponsor
- Hat Yai Medical Education Center
- Enrollment
- 204
- Locations
- 1
- Primary Endpoint
- Number of Patients With Death
- Status
- Terminated
- Last Updated
- 7 years ago
Overview
Brief 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.
Investigators
Dr. Narongsak Nakwan
Head of Division of Neonatalogy, Department of Pediatrics, Hat Yai Hospital
Hat Yai Medical Education Center
Eligibility 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;
Arms & Interventions
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)
Intervention: Aerosolized plus intravenous colistin
Intravenous colistin
Neonates with VAP due to PDR-A. baumannii who receive only intravenous colistin (3.5 mg/kg/dose twice daily)
Intervention: Intravenous colistin
Outcomes
Primary Outcomes
Number of Patients With Death
Time Frame: Through study completion, an average of 2 weeks
Clinical outcome is classified in 4 categories: Cure, Improved, Failure, and Death
Number of Patients With Failure
Time Frame: Through study completion, an average of 2 weeks
Clinical outcome is classified in 4 categories: Cure, Improved, Failure, and Death
Number of Patients With Cure
Time Frame: Through study completion, an average of 2 weeks
Clinical outcome is classified in 4 categories: Cure, Improved, Failure, and Death
Number of Patients With Improved
Time Frame: Through study completion, an average of 2 weeks
Clinical outcome is classified in 4 categories: Cure, Improved, Failure, and Death
Secondary Outcomes
- Number of Patients With Eradication(Through study completion, an average of 2 weeks)
- Number of Patients With Superinfection(Through study completion, an average of 2 weeks)
- Number of Patients With Adverse Events That Are Related to Study Drug(Through study completion, an average of 4 weeks)
- Number of Patients With Persistence(Through study completion, an average of 2 weeks)