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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
204
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)
Intravenous colistin at a dose of 3.5 mg CBA/kg/dose twice daily (7 mg/kg/day)
Narongsak Nakwan
Hat Yai, Changwat Songkhla, Thailand
Number of Patients With Cure
Clinical outcome is classified in 4 categories: Cure, Improved, Failure, and Death
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: Through study completion, an average of 2 weeks
Number of Patients With Eradication
Microbiological response is classified in 3 categories: Eradication Persistence, Superinfection
Time frame: Through study completion, an average of 2 weeks
Number of Patients With Persistence
Microbiological response is classified in 3 categories: Eradication Persistence, Superinfection
Time frame: Through study completion, an average of 2 weeks
Number of Patients With Superinfection
Microbiological response is classified in 3 categories: Eradication Persistence, Superinfection
Time frame: 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.
Time frame: Through study completion, an average of 4 weeks
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