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

Information source: Mahidol University
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Hospital Infection

Intervention: Polymyxin B (Drug)

Phase: Phase 4

Status: Recruiting

Sponsored by: Mahidol University

Official(s) and/or principal investigator(s):
Visanu Thamlikitkul, MD, Principal Investigator, Affiliation: Infectious disease and tropical medicine, Siriraj hospital

Overall contact:
Thundon Ngamprasertchai, MD., Phone: 66850887736, Email: thundon_ngamprasertchai@hotmail.com

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.

Clinical Details

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

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

Primary outcome: mortality rate

Secondary outcome:

adverse drug reactions

microbiological clearance

Peak Plasma Concentration (Cmax) of polymyxin B

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

Minimum age: 18 Years. Maximum age: 75 Years. Gender(s): Both.

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

Locations and Contacts

Thundon Ngamprasertchai, MD., Phone: 66850887736, Email: thundon_ngamprasertchai@hotmail.com

Siriraj hospital, Bangkok 10700, Thailand; Recruiting
Thundon Ngamprasertchai, MD, Phone: 66850887736, Email: thundon_ngamprasertchai@hotmail.com
Visanu Thamlikitkul, MD, Phone: 66818206271, Email: visanu.tha@mahidol.ac.th
Adhiratha Boonyasiri, MD, Sub-Investigator
Additional Information

Centers for Disease Control (CDC) drug resistance 2013

Starting date: December 2014
Last updated: December 26, 2014

Page last updated: August 23, 2015

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