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

NCT02806141 | Terminated Phase 3 DMC

• 1 other identifier: HatYaiMec-Neonate
• Study Type: interventional
• Target: 204
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

Aerosolized colistin; Intravenous colistin

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (4)

• Number of Patients With Eradication

  Through study completion, an average of 2 weeks

• Number of Patients With Persistence

  Through study completion, an average of 2 weeks

• Number of Patients With Superinfection

  Through study completion, an average of 2 weeks

• Number of Patients With Adverse Events That Are Related to Study Drug

  Through study completion, an average of 4 weeks

Study Arms (2)

Aerosolized plus intravenous colistin

EXPERIMENTAL

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

Intravenous colistin

ACTIVE COMPARATOR

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

Drug: Intravenous colistin

Interventions

Aerosolized plus intravenous colistin DRUG

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)

Also known as: colistimethate sodium

Aerosolized plus intravenous colistin

Intravenous colistin DRUG

Intravenous colistin at a dose of 3.5 mg CBA/kg/dose twice daily (7 mg/kg/day)

Also known as: colistimethate sodium

Intravenous colistin

Eligibility Criteria

• Age: 1 Day - 30 Days
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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).

You may not qualify if:

• 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;

Sponsors & Collaborators

• Hat Yai Medical Education Center: lead

Study Sites (1)

Narongsak Nakwan

Hat Yai, Changwat Songkhla, 90110, Thailand

Location

Related Publications (3)

• 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.

  PMID: 20812247 BACKGROUND

• 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.

  PMID: 26065861 BACKGROUND

• 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.

  PMID: 27276179 BACKGROUND

MeSH Terms

Conditions

Pneumonia, Ventilator-Associated

Interventions

colistinmethanesulfonic acid

Condition Hierarchy (Ancestors)

Healthcare-Associated Pneumonia; Cross Infection; Infections; Pneumonia; Respiratory Tract Infections; Lung Diseases; Respiratory Tract Diseases; Iatrogenic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Narongsak Nakwan, MD

  Hat Yai Medical Education Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Division of Neonatalogy, Department of Pediatrics, Hat Yai Hospital

Study Record Dates

• First Submitted: June 8, 2016
• First Posted: June 20, 2016
• Study Start: September 1, 2016
• Primary Completion: October 1, 2017
• Study Completion: October 1, 2017
• Last Updated: August 2, 2018

Record last verified: 2018-07

Data Sharing

• IPD Sharing: Will not share

Locations

TH (1)