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
|Condition or disease||Intervention/treatment||Phase|
|Hospital Infection||Drug: Polymyxin B||Phase 4|
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||100 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
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
- 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
- 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
- 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
- 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.
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
|Contact: Thundon Ngamprasertchai, MD.||firstname.lastname@example.org|
|Contact: Adhiratha Boonyasiri, MDemail@example.com|
|Principal Investigator:||Visanu Thamlikitkul, MD||Infectious disease and tropical medicine, Siriraj hospital|