Colistin Adverse Reaction, Infection Due to Multidrug Resistant Acinetobacter, Infection Resistant to Multiple Drugs, Pneumonia, Ventilator-Associated
Conditions
Keywords
Aerosolized colistin, Intravenous colistin
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.
Interventions
DRUGAerosolized 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)
DRUGIntravenous colistin
Intravenous colistin at a dose of 3.5 mg CBA/kg/dose twice daily (7 mg/kg/day)
Sponsors
Hat Yai Medical Education Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
1 Days to 30 Days
Healthy volunteers
No
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;
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Patients With Death | 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 | 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 | 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 | Through study completion, an average of 2 weeks | Clinical outcome is classified in 4 categories: Cure, Improved, Failure, and Death |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Patients With Eradication | Through study completion, an average of 2 weeks | Microbiological response is classified in 3 categories: Eradication Persistence, Superinfection |
| Number of Patients With Persistence | Through study completion, an average of 2 weeks | Microbiological response is classified in 3 categories: Eradication Persistence, Superinfection |
| Number of Patients With Superinfection | Through study completion, an average of 2 weeks | Microbiological response is classified in 3 categories: Eradication Persistence, Superinfection |
| Number of Patients With Adverse Events That Are Related to Study Drug | Through study completion, an average of 4 weeks | 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. |
Countries
Thailand
Outcome results
None listed