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Efficacy of Polymyxin B Against Infections Caused by Extensively Drug-resistant (XDR) Gram-Negative Bacteria (XDR)

Primary Purpose

Hospital Infection

Status
Unknown status
Phase
Phase 4
Locations
Thailand
Study Type
Interventional
Intervention
Polymyxin B
Sponsored by
Mahidol University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hospital Infection focused on measuring polymyxin B, carbapenem resistant bacteria

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Age 18-75 year-old
  • The infection caused by carbapenem-resistant (CR) Enterobacteriaceae, CR P.aeruginosa or CR A. baumannii which susceptible to colistin
  • The duration of treatment approximately between 7-14 days
  • Kidney function, according to Kidney Disease Improving Global Outcomes (KDIGO) classification, should less than stage 4 and no replacement therapy in all modality.
  • The patients are anticipated to live more than 48 hrs after participation.
  • In case of Colistin administration beforehand, it should not exceed 24 hrs.
  • All of participants should be willing to join this project.

Exclusion Criteria:

  • Pregnancy and lactation
  • End stage renal disease who take renal replacement therapy
  • Any type of Neuromuscular disease
  • Body mass index exceed 30
  • Infection that require treatment more than 14 days

Sites / Locations

  • Siriraj hospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Polymyxin B

Arm Description

Polymyxin B 1.5-2.5 mg/kg/day intravenous q 12 hrs duration 7-14 days

Outcomes

Primary Outcome Measures

mortality rate
mortality rate of gram negative bacteria infected patients receiving Polymyxin B at day 28 after enrollment

Secondary Outcome Measures

adverse drug reactions
we assess adverse drug reactions in 2 aspects; nephrotoxicity and neurotoxicity
microbiological clearance
we perform culture and staining to assess bacterial clearance after apply the study drug every 3 days until culture is negative
Peak Plasma Concentration (Cmax) of polymyxin B
we do the blood test for drug level at before the third date dose then 1,2,4 hours after administration of the polymixin B and before the fourth dose.

Full Information

First Posted
December 15, 2014
Last Updated
August 31, 2015
Sponsor
Mahidol University
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1. Study Identification

Unique Protocol Identification Number
NCT02328183
Brief Title
Efficacy of Polymyxin B Against Infections Caused by Extensively Drug-resistant (XDR) Gram-Negative Bacteria
Acronym
XDR
Official Title
Efficacy of Polymyxin B Against Infections Caused by Extensively Drug-resistant (XDR) Gram-Negative Bacteria
Study Type
Interventional

2. Study Status

Record Verification Date
August 2015
Overall Recruitment Status
Unknown status
Study Start Date
December 2014 (undefined)
Primary Completion Date
November 2015 (Anticipated)
Study Completion Date
November 2015 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Mahidol University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The objective of the study is to evaluate the efficacy of Polymyxin B for treatment Gram negative bacterial infection. The hypothesis of study is Polymyxin B would be the new antibacterial agents for Thai Gram negative infected patients in case of desirable outcomes and minimal side effects.
Detailed Description
Investigator is notified by doctors who take care of gram negative infected patients. Investigator inform patient or their relatives about all topics in project, eligible criteria, method, material and monitoring treatment. After patient or their relatives are appreciated to join this project, investigator collect data in case record form;electronics form, then implement the drug. Duration of treatment is determined by site and severity of infection, approximately 7-14 days. Sample size calculation, by prevalence formula, we estimate the mortality rate about 50 %, deviation 10 %,and 2-sided 95% Confidence interval, therefore,97 persons We estimate gather data about 100 persons. Statistical descriptive analysis for descriptive data. During the study is performing, all unexpected adverse event definitely report to Siriraj institutional Review Board immediately, in addition to subjects or their relatives.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hospital Infection
Keywords
polymyxin B, carbapenem resistant bacteria

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Polymyxin B
Arm Type
Experimental
Arm Description
Polymyxin B 1.5-2.5 mg/kg/day intravenous q 12 hrs duration 7-14 days
Intervention Type
Drug
Intervention Name(s)
Polymyxin B
Other Intervention Name(s)
X-Gen Phamaceuticals, USA Polymyxin B
Intervention Description
administrate drug by 0.75-1.25 mg/kg/dose intravenously q 12 hrs both saline and dextrose solution can be dissolved duration 7-14 days
Primary Outcome Measure Information:
Title
mortality rate
Description
mortality rate of gram negative bacteria infected patients receiving Polymyxin B at day 28 after enrollment
Time Frame
participants will be followed for the duration of hospital stay, an expected average of 4 weeks
Secondary Outcome Measure Information:
Title
adverse drug reactions
Description
we assess adverse drug reactions in 2 aspects; nephrotoxicity and neurotoxicity
Time Frame
participants will be followed for the duration of hospital stay, an expected average of 4 weeks
Title
microbiological clearance
Description
we perform culture and staining to assess bacterial clearance after apply the study drug every 3 days until culture is negative
Time Frame
participants will be followed for the duration of hospital stay, an expected average of 4 weeks
Title
Peak Plasma Concentration (Cmax) of polymyxin B
Description
we do the blood test for drug level at before the third date dose then 1,2,4 hours after administration of the polymixin B and before the fourth dose.
Time Frame
participants will be followed for the duration of hospital stay, an expected average of 4 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age 18-75 year-old The infection caused by carbapenem-resistant (CR) Enterobacteriaceae, CR P.aeruginosa or CR A. baumannii which susceptible to colistin The duration of treatment approximately between 7-14 days Kidney function, according to Kidney Disease Improving Global Outcomes (KDIGO) classification, should less than stage 4 and no replacement therapy in all modality. The patients are anticipated to live more than 48 hrs after participation. In case of Colistin administration beforehand, it should not exceed 24 hrs. All of participants should be willing to join this project. Exclusion Criteria: Pregnancy and lactation End stage renal disease who take renal replacement therapy Any type of Neuromuscular disease Body mass index exceed 30 Infection that require treatment more than 14 days
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Thundon Ngamprasertchai, MD.
Phone
66850887736
Email
thundon_ngamprasertchai@hotmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Adhiratha Boonyasiri, MD
Phone
66850632181
Email
nonghor@yahoo.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Visanu Thamlikitkul, MD
Organizational Affiliation
Infectious disease and tropical medicine, Siriraj hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Siriraj hospital
City
Bangkok
ZIP/Postal Code
10700
Country
Thailand
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Thundon Ngamprasertchai, MD
Phone
66850887736
Email
thundon_ngamprasertchai@hotmail.com
First Name & Middle Initial & Last Name & Degree
Visanu Thamlikitkul, MD
Phone
66818206271
Email
visanu.tha@mahidol.ac.th
First Name & Middle Initial & Last Name & Degree
Adhiratha Boonyasiri, MD

12. IPD Sharing Statement

Citations:
PubMed Identifier
17291803
Citation
Koomanachai P, Tiengrim S, Kiratisin P, Thamlikitkul V. Efficacy and safety of colistin (colistimethate sodium) for therapy of infections caused by multidrug-resistant Pseudomonas aeruginosa and Acinetobacter baumannii in Siriraj Hospital, Bangkok, Thailand. Int J Infect Dis. 2007 Sep;11(5):402-6. doi: 10.1016/j.ijid.2006.09.011. Epub 2007 Feb 8.
Results Reference
result
PubMed Identifier
24700659
Citation
Nation RL, Velkov T, Li J. Colistin and polymyxin B: peas in a pod, or chalk and cheese? Clin Infect Dis. 2014 Jul 1;59(1):88-94. doi: 10.1093/cid/ciu213. Epub 2014 Apr 3.
Results Reference
result
Links:
URL
http://www.cdc.gov/drugresistance/threat-report-2013/pdf/ar-threats-2013-508.pdf
Description
Centers for Disease Control (CDC) drug resistance 2013

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Efficacy of Polymyxin B Against Infections Caused by Extensively Drug-resistant (XDR) Gram-Negative Bacteria

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