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

NCT02806141 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 204

Last updated 2018-08-02

No results posted yet for this study

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

Interventions

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)

DRUG

Intravenous colistin

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

Sponsors & Collaborators

  • Hat Yai Medical Education Center

    lead OTHER

Principal Investigators

  • Narongsak Nakwan, MD · Hat Yai Medical Education Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
1 Day
Max Age
30 Days
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-09-30
Primary Completion
2017-10-31
Completion
2017-10-31

Countries

  • Thailand

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02806141 on ClinicalTrials.gov