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

Pneumonia, Ventilator-Associated Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02806141
• Other study ID #: HatYaiMec-Neonate
• Status: Terminated
• Phase: Phase 3
• Start date: September 2016
• Est. completion date: October 2017

Study information

• Verified date: July 2018
• Source: Hat Yai Medical Education Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 204
• Est. completion date: October 2017
• Est. primary completion date: October 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 30 Days

Eligibility

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;

Related Conditions & MeSH terms

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

Intervention

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

Locations

Country	Name	City	State
Thailand	Narongsak Nakwan	Hat Yai	Songkhla

Sponsors (1)

Lead Sponsor	Collaborator
Hat Yai Medical Education Center

Country where clinical trial is conducted

Thailand, 

References & Publications (3)

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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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	Number of Patients With Eradication	Microbiological response is classified in 3 categories: Eradication Persistence, Superinfection	Through study completion, an average of 2 weeks
Secondary	Number of Patients With Persistence	Microbiological response is classified in 3 categories: Eradication Persistence, Superinfection	Through study completion, an average of 2 weeks
Secondary	Number of Patients With Superinfection	Microbiological response is classified in 3 categories: Eradication Persistence, Superinfection	Through study completion, an average of 2 weeks
Secondary	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.	Through study completion, an average of 4 weeks