Clinical trial NCT02328183: Efficacy of Polymyxin B Against Infections Caused by Extensively Drug-resistant (XDR) Gram-Negative Bacteria
Official title: Efficacy of Polymyxin B Against Infections Caused by Extensively Drug-resistant (XDR) Gram-Negative Bacteria
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Hospital Infection
Keywords: polymyxin B
carbapenem resistant bacteria
Lead sponsor: Mahidol University
Sponsor class: OTHER
First posted: 2014-12-31
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: mortality rate
timeFrame: participants will be followed for the duration of hospital stay, an expected average of 4 weeks
Secondary outcomes:
measure: adverse drug reactions
timeFrame: participants will be followed for the duration of hospital stay, an expected average of 4 weeks
measure: microbiological clearance
timeFrame: participants will be followed for the duration of hospital stay, an expected average of 4 weeks
measure: Peak Plasma Concentration (Cmax) of polymyxin B
timeFrame: participants will be followed for the duration of hospital stay, an expected average of 4 weeks
Other outcomes:
Locations:
city: Bangkok
country: Thailand
facility: Siriraj hospital
Study officials:
affiliation: Infectious disease and tropical medicine, Siriraj hospital
name: Visanu Thamlikitkul, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.