Back to resultsAerosolized Plus Intravenous vs. Intravenous Colistin for VAP Due to Pandrugs-resistant A. Baumannii in Neonates
Primary Purpose
Pneumonia, Ventilator-Associated, Colistin Adverse Reaction, Infection Due to Multidrug Resistant Acinetobacter
Status
Terminated
Phase
Phase 3
Locations
Thailand
Study Type
Interventional
Intervention
Aerosolized plus intravenous colistin
Intravenous colistin
Sponsored by
About this trial
This is an interventional treatment trial for Pneumonia, Ventilator-Associated focused on measuring Aerosolized colistin, Intravenous colistin
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;
Sites / Locations
- Narongsak Nakwan
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Aerosolized plus intravenous colistin
Intravenous colistin
Arm Description
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)
Neonates with VAP due to PDR-A. baumannii who receive only intravenous colistin (3.5 mg/kg/dose twice daily)
Outcomes
Primary Outcome Measures
Number of Patients With Cure
Clinical outcome is classified in 4 categories: Cure, Improved, Failure, and Death
Number of Patients With Improved
Clinical outcome is classified in 4 categories: Cure, Improved, Failure, and Death
Number of Patients With Failure
Clinical outcome is classified in 4 categories: Cure, Improved, Failure, and Death
Number of Patients With Death
Clinical outcome is classified in 4 categories: Cure, Improved, Failure, and Death
Secondary Outcome Measures
Number of Patients With Eradication
Microbiological response is classified in 3 categories: Eradication Persistence, Superinfection
Number of Patients With Persistence
Microbiological response is classified in 3 categories: Eradication Persistence, Superinfection
Number of Patients With Superinfection
Microbiological response is classified in 3 categories: Eradication Persistence, Superinfection
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.
Full Information
NCT ID
NCT02806141
First Posted
June 8, 2016
Last Updated
July 31, 2018
Sponsor
Hat Yai Medical Education Center
1. Study Identification
Unique Protocol Identification Number
NCT02806141
Brief Title
Aerosolized Plus Intravenous vs. Intravenous Colistin for VAP Due to Pandrugs-resistant A. Baumannii in Neonates
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
July 2018
Overall Recruitment Status
Terminated
Why Stopped
No patient included at target sample sizes
Study Start Date
September 2016 (undefined)
Primary Completion Date
October 2017 (Actual)
Study Completion Date
October 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hat Yai Medical Education Center
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pneumonia, Ventilator-Associated, Colistin Adverse Reaction, Infection Due to Multidrug Resistant Acinetobacter, Infection Resistant to Multiple Drugs
Keywords
Aerosolized colistin, Intravenous colistin
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
204 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Aerosolized plus intravenous colistin
Arm Type
Experimental
Arm Description
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)
Arm Title
Intravenous colistin
Arm Type
Active Comparator
Arm Description
Neonates with VAP due to PDR-A. baumannii who receive only intravenous colistin (3.5 mg/kg/dose twice daily)
Intervention Type
Drug
Intervention Name(s)
Aerosolized plus intravenous colistin
Other Intervention Name(s)
colistimethate sodium
Intervention Description
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)
Intervention Type
Drug
Intervention Name(s)
Intravenous colistin
Other Intervention Name(s)
colistimethate sodium
Intervention Description
Intravenous colistin at a dose of 3.5 mg CBA/kg/dose twice daily (7 mg/kg/day)
Primary Outcome Measure Information:
Title
Number of Patients With Cure
Description
Clinical outcome is classified in 4 categories: Cure, Improved, Failure, and Death
Time Frame
Through study completion, an average of 2 weeks
Title
Number of Patients With Improved
Description
Clinical outcome is classified in 4 categories: Cure, Improved, Failure, and Death
Time Frame
Through study completion, an average of 2 weeks
Title
Number of Patients With Failure
Description
Clinical outcome is classified in 4 categories: Cure, Improved, Failure, and Death
Time Frame
Through study completion, an average of 2 weeks
Title
Number of Patients With Death
Description
Clinical outcome is classified in 4 categories: Cure, Improved, Failure, and Death
Time Frame
Through study completion, an average of 2 weeks
Secondary Outcome Measure Information:
Title
Number of Patients With Eradication
Description
Microbiological response is classified in 3 categories: Eradication Persistence, Superinfection
Time Frame
Through study completion, an average of 2 weeks
Title
Number of Patients With Persistence
Description
Microbiological response is classified in 3 categories: Eradication Persistence, Superinfection
Time Frame
Through study completion, an average of 2 weeks
Title
Number of Patients With Superinfection
Description
Microbiological response is classified in 3 categories: Eradication Persistence, Superinfection
Time Frame
Through study completion, an average of 2 weeks
Title
Number of Patients With Adverse Events That Are Related to Study Drug
Description
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
1 Day
Maximum Age & Unit of Time
30 Days
Accepts Healthy Volunteers
No
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;
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Narongsak Nakwan, MD
Organizational Affiliation
Hat Yai Medical Education Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Narongsak Nakwan
City
Hat Yai
State/Province
Songkhla
ZIP/Postal Code
90110
Country
Thailand
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
20812247
Citation
Nakwan N, Wannaro J, Thongmak T, Pornladnum P, Saksawad R, Nakwan N, Chokephaibulkit K. Safety in treatment of ventilator-associated pneumonia due to extensive drug-resistant Acinetobacter baumannii with aerosolized colistin in neonates: a preliminary report. Pediatr Pulmonol. 2011 Jan;46(1):60-6. doi: 10.1002/ppul.21324. Epub 2010 Sep 1.
Results Reference
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PubMed Identifier
26065861
Citation
Nakwan N, Lertpichaluk P, Chokephaibulkit K, Villani P, Regazzi M, Imberti R. Pulmonary and Systemic Pharmacokinetics of Colistin Following a Single Dose of Nebulized Colistimethate in Mechanically Ventilated Neonates. Pediatr Infect Dis J. 2015 Sep;34(9):961-3. doi: 10.1097/INF.0000000000000775.
Results Reference
background
PubMed Identifier
27276179
Citation
Nakwan N, Usaha S, Chokephaibulkit K, Villani P, Regazzi M, Imberti R. Pharmacokinetics of Colistin Following a Single Dose of Intravenous Colistimethate Sodium in Critically Ill Neonates. Pediatr Infect Dis J. 2016 Nov;35(11):1211-1214. doi: 10.1097/INF.0000000000001263.
Results Reference
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Aerosolized Plus Intravenous vs. Intravenous Colistin for VAP Due to Pandrugs-resistant A. Baumannii in Neonates
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