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

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ClinicalTrials.gov Identifier: NCT02328183
Recruitment Status : Unknown
Verified August 2015 by Mahidol University.
Recruitment status was:  Recruiting
First Posted : December 31, 2014
Last Update Posted : September 1, 2015
Sponsor:
Information provided by (Responsible Party):
Mahidol University

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.

Condition or disease Intervention/treatment Phase
Hospital Infection Drug: Polymyxin B Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Efficacy of Polymyxin B Against Infections Caused by Extensively Drug-resistant (XDR) Gram-Negative Bacteria
Study Start Date : December 2014
Estimated Primary Completion Date : November 2015
Estimated Study Completion Date : November 2015

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Polymyxin B
Polymyxin B 1.5-2.5 mg/kg/day intravenous q 12 hrs duration 7-14 days
Drug: Polymyxin B
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
Other Name: X-Gen Phamaceuticals, USA Polymyxin B




Primary Outcome Measures :
  1. mortality rate [ Time Frame: participants will be followed for the duration of hospital stay, an expected average of 4 weeks ]
    mortality rate of gram negative bacteria infected patients receiving Polymyxin B at day 28 after enrollment


Secondary Outcome Measures :
  1. adverse drug reactions [ Time Frame: participants will be followed for the duration of hospital stay, an expected average of 4 weeks ]
    we assess adverse drug reactions in 2 aspects; nephrotoxicity and neurotoxicity

  2. microbiological clearance [ Time Frame: participants will be followed for the duration of hospital stay, an expected average of 4 weeks ]
    we perform culture and staining to assess bacterial clearance after apply the study drug every 3 days until culture is negative

  3. Peak Plasma Concentration (Cmax) of polymyxin B [ Time Frame: participants will be followed for the duration of hospital stay, an expected average of 4 weeks ]
    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.



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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02328183


Contacts
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Contact: Thundon Ngamprasertchai, MD. 66850887736 thundon_ngamprasertchai@hotmail.com
Contact: Adhiratha Boonyasiri, MD 66850632181 nonghor@yahoo.com

Locations
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Thailand
Siriraj hospital Recruiting
Bangkok, Thailand, 10700
Contact: Thundon Ngamprasertchai, MD    66850887736    thundon_ngamprasertchai@hotmail.com   
Contact: Visanu Thamlikitkul, MD    66818206271    visanu.tha@mahidol.ac.th   
Sub-Investigator: Adhiratha Boonyasiri, MD         
Sponsors and Collaborators
Mahidol University
Investigators
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Principal Investigator: Visanu Thamlikitkul, MD Infectious disease and tropical medicine, Siriraj hospital

Additional Information:
Publications of Results:
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Responsible Party: Mahidol University
ClinicalTrials.gov Identifier: NCT02328183     History of Changes
Other Study ID Numbers: 568/2557(EC4)
First Posted: December 31, 2014    Key Record Dates
Last Update Posted: September 1, 2015
Last Verified: August 2015
Keywords provided by Mahidol University:
polymyxin B
carbapenem resistant bacteria
Additional relevant MeSH terms:
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Infection
Communicable Diseases
Cross Infection
Iatrogenic Disease
Disease Attributes
Pathologic Processes
Polymyxins
Polymyxin B
Anti-Bacterial Agents
Anti-Infective Agents