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

July 31, 2018 updated by: Dr. Narongsak Nakwan, Hat Yai Medical Education Center

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

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

204

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Thailand
    • Songkhla
      • Hat Yai, Songkhla, Thailand, 90110
        • Narongsak Nakwan

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 day to 1 month (CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: 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)
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)
Other Names:
  • colistimethate sodium
ACTIVE_COMPARATOR: Intravenous colistin
Neonates with VAP due to PDR-A. baumannii who receive only intravenous colistin (3.5 mg/kg/dose twice daily)
Drug: Intravenous colistin
Intravenous colistin at a dose of 3.5 mg CBA/kg/dose twice daily (7 mg/kg/day)
Other Names:
  • colistimethate sodium

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Patients With Cure
Time Frame: Through study completion, an average of 2 weeks
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
Time Frame: Through study completion, an average of 2 weeks
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
Time Frame: Through study completion, an average of 2 weeks
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
Time Frame: Through study completion, an average of 2 weeks
Clinical outcome is classified in 4 categories: Cure, Improved, Failure, and Death
Through study completion, an average of 2 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Patients With Eradication
Time Frame: Through study completion, an average of 2 weeks
Microbiological response is classified in 3 categories: Eradication Persistence, Superinfection
Through study completion, an average of 2 weeks
Number of Patients With Persistence
Time Frame: Through study completion, an average of 2 weeks
Microbiological response is classified in 3 categories: Eradication Persistence, Superinfection
Through study completion, an average of 2 weeks
Number of Patients With Superinfection
Time Frame: Through study completion, an average of 2 weeks
Microbiological response is classified in 3 categories: Eradication Persistence, Superinfection
Through study completion, an average of 2 weeks
Number of Patients With Adverse Events That Are Related to Study Drug
Time Frame: 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.
Through study completion, an average of 4 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hat Yai Medical Education Center

Investigators

  • Principal Investigator: Narongsak Nakwan, MD, Hat Yai Medical Education Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2016

Primary Completion (ACTUAL)

October 1, 2017

Study Completion (ACTUAL)

October 1, 2017

Study Registration Dates

First Submitted

June 8, 2016

First Submitted That Met QC Criteria

June 15, 2016

First Posted (ESTIMATE)

June 20, 2016

Study Record Updates

Last Update Posted (ACTUAL)

August 2, 2018

Last Update Submitted That Met QC Criteria

July 31, 2018

Last Verified

July 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HatYaiMec-Neonate

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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