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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

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

Intervention / Treatment
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* Drug: Aerosolized plus intravenous colistin
* Drug: Intravenous colistin


Participation Criteria
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Eligibility Criteria
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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;

Ages Eligible for Study
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Minimum Age: 1 Day
Maximum Age: 30 Days

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Aerosolized plus intravenous colistin<br>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) | Drug: Aerosolized plus intravenous colistin<br>* 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)<br>* Other names: colistimethate sodium;|
| Active Comparator: Intravenous colistin<br>Neonates with VAP due to PDR-A. baumannii who receive only intravenous colistin (3.5 mg/kg/dose twice daily) | Drug: Intravenous colistin<br>* Intravenous colistin at a dose of 3.5 mg CBA/kg/dose twice daily (7 mg/kg/day)<br>* Other names: colistimethate sodium;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Patients With Cure | Clinical outcome is classified in 4 categories: Cure, Improved, Failure, and Death | Through study completion, an average of 2 weeks | 
| Number of Patients With Improved | Clinical outcome is classified in 4 categories: Cure, Improved, Failure, and Death | Through study completion, an average of 2 weeks | 
| Number of Patients With Failure | Clinical outcome is classified in 4 categories: Cure, Improved, Failure, and Death | Through study completion, an average of 2 weeks | 
| Number of Patients With Death | Clinical outcome is classified in 4 categories: Cure, Improved, Failure, and Death | Through study completion, an average of 2 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Patients With Eradication | Microbiological response is classified in 3 categories: Eradication Persistence, Superinfection | Through study completion, an average of 2 weeks | 
| Number of Patients With Persistence | Microbiological response is classified in 3 categories: Eradication Persistence, Superinfection | Through study completion, an average of 2 weeks | 
| Number of Patients With Superinfection | Microbiological response is classified in 3 categories: Eradication Persistence, Superinfection | Through study completion, an average of 2 weeks | 
| Number of Patients With Adverse Events That Are Related to Study Drug | Number of Patients With Adverse Events That Are Related to Study Drug, Graded According to NCI CTCAE Version 3.0 focus on neurology, pulmonology, nephrology and metabolic/laboratory. | Through study completion, an average of 4 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Aerosolized colistin, Intravenous colistin