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

Phase 3

Terminated

• Conditions: Pneumonia, Ventilator-Associated; Colistin Adverse Reaction; Infection Due to Multidrug Resistant Acinetobacter; Infection Resistant to Multiple Drugs
• Interventions: Drug: Intravenous colistin; Drug: Aerosolized plus intravenous colistin

• Registration Number: NCT02806141
• Lead Sponsor: Hat Yai Medical Education Center

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.

Study Timeline

• Study First Submitted: 2016-06-08
• Study First Submitted QC: 2016-06-15
• Study First Posted: 2016-06-20
• Study Start: 2016-09
• Primary Completion: 2017-10
• Study Completion: 2017-10
• Status Verified: 2018-07
• Last Update Submitted: 2018-07-31
• Last Update Posted: 2018-08-02

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 204

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;

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intravenous colistin	Intravenous colistin	Neonates with VAP due to PDR-A. baumannii who receive only intravenous colistin (3.5 mg/kg/dose twice daily)
Aerosolized plus intravenous colistin	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)

Primary Outcome Measures

Name	Time	Method
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 Failure	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

Secondary Outcome Measures

Name	Time	Method
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 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.
Number of Patients With Persistence	Through study completion, an average of 2 weeks	Microbiological response is classified in 3 categories: Eradication Persistence, Superinfection

Trial Locations

Locations (1)

Narongsak Nakwan; 🇹🇭 Hat Yai, Songkhla, Thailand