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

Hospital Infection Clinical Trial

— XDR  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02328183
• Other study ID #: 568/2557(EC4)
• Status: Recruiting
• Phase: Phase 4
• First received: December 15, 2014
• Last updated: August 31, 2015
• Start date: December 2014
• Est. completion date: November 2015

Study information

• Verified date: August 2015
• Source: Mahidol University
• Contact: Thundon Ngamprasertchai, MD.
• Phone: 66850887736
• Email: thundon_ngamprasertchai[@]hotmail.com
• Is FDA regulated: No
• Health authority: Thailand: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: November 2015
• Est. primary completion date: November 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hospital Infection
• Infection

Intervention

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

Locations

Country	Name	City	State
Thailand	Siriraj hospital	Bangkok

Sponsors (1)

Lead Sponsor	Collaborator
Mahidol University

Country where clinical trial is conducted

Thailand, 

References & Publications (2)

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, Thaila — View 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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	mortality rate	mortality rate of gram negative bacteria infected patients receiving Polymyxin B at day 28 after enrollment	participants will be followed for the duration of hospital stay, an expected average of 4 weeks	Yes
Secondary	adverse drug reactions	we assess adverse drug reactions in 2 aspects; nephrotoxicity and neurotoxicity	participants will be followed for the duration of hospital stay, an expected average of 4 weeks	Yes
Secondary	microbiological clearance	we perform culture and staining to assess bacterial clearance after apply the study drug every 3 days until culture is negative	participants will be followed for the duration of hospital stay, an expected average of 4 weeks	Yes
Secondary	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.	participants will be followed for the duration of hospital stay, an expected average of 4 weeks	Yes

External Links

•   Centers for Disease Control (CDC) drug resistance 2013