Clinical trial NCT02806141: 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
Overall status: TERMINATED
Phase: PHASE3
Conditions: Pneumonia, Ventilator-Associated
Colistin Adverse Reaction
Infection Due to Multidrug Resistant Acinetobacter
Infection Resistant to Multiple Drugs
Keywords: Aerosolized colistin
Intravenous colistin
Lead sponsor: Hat Yai Medical Education Center
Sponsor class: OTHER
First posted: 2016-06-20
Enrollment: 204
Sex: ALL
Minimum age (years): 1
Maximum age (years): 30
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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;

Primary outcomes:
measure: Number of Patients With Cure
timeFrame: Through study completion, an average of 2 weeks
measure: Number of Patients With Improved
timeFrame: Through study completion, an average of 2 weeks
measure: Number of Patients With Failure
timeFrame: Through study completion, an average of 2 weeks
measure: Number of Patients With Death
timeFrame: Through study completion, an average of 2 weeks
Secondary outcomes:
measure: Number of Patients With Eradication
timeFrame: Through study completion, an average of 2 weeks
measure: Number of Patients With Persistence
timeFrame: Through study completion, an average of 2 weeks
measure: Number of Patients With Superinfection
timeFrame: Through study completion, an average of 2 weeks
measure: Number of Patients With Adverse Events That Are Related to Study Drug
timeFrame: Through study completion, an average of 4 weeks
Other outcomes:
Locations:
city: Hat Yai
country: Thailand
facility: Narongsak Nakwan
state: Songkhla
Study officials:
affiliation: Hat Yai Medical Education Center
name: Narongsak Nakwan, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.