NCT02328183

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Dec 2014

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2014

Completed
14 days until next milestone

First Submitted

Initial submission to the registry

December 15, 2014

Completed
16 days until next milestone

First Posted

Study publicly available on registry

December 31, 2014

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2015

Completed
Last Updated

September 1, 2015

Status Verified

August 1, 2015

Enrollment Period

11 months

First QC Date

December 15, 2014

Last Update Submit

August 31, 2015

Conditions

Hospital Infection

Keywords

polymyxin Bcarbapenem resistant bacteria

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (3)

  • adverse drug reactions

    participants will be followed for the duration of hospital stay, an expected average of 4 weeks

  • microbiological clearance

    participants will be followed for the duration of hospital stay, an expected average of 4 weeks

  • Peak Plasma Concentration (Cmax) of polymyxin B

    participants will be followed for the duration of hospital stay, an expected average of 4 weeks

Study Arms (1)

Polymyxin B

EXPERIMENTAL

Polymyxin B 1.5-2.5 mg/kg/day intravenous q 12 hrs duration 7-14 days

Drug: Polymyxin B

Interventions

Polymyxin BDRUG

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

Also known as: X-Gen Phamaceuticals, USA Polymyxin B
Polymyxin B

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Siriraj hospital

Bangkok, Bangkok, 10700, Thailand

RECRUITING

Related 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, Thailand. Int J Infect Dis. 2007 Sep;11(5):402-6. doi: 10.1016/j.ijid.2006.09.011. Epub 2007 Feb 8.

    PMID: 17291803RESULT

  • 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.

    PMID: 24700659RESULT

MeSH Terms

Conditions

Cross Infection

Interventions

Polymyxin B

Condition Hierarchy (Ancestors)

InfectionsIatrogenic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

PolymyxinsPeptides, CyclicMacrocyclic CompoundsPolycyclic CompoundsLipopeptidesLipidsAntimicrobial Cationic PeptidesPeptidesAmino Acids, Peptides, and ProteinsAntimicrobial PeptidesPore Forming Cytotoxic ProteinsMembrane ProteinsProteins

Study Officials

  • Visanu Thamlikitkul, MD

    Infectious disease and tropical medicine, Siriraj hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Thundon Ngamprasertchai, MD.

CONTACT

66850887736thundon_ngamprasertchai@hotmail.com

Adhiratha Boonyasiri, MD

CONTACT

66850632181nonghor@yahoo.com

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 15, 2014

First Posted

December 31, 2014

Study Start

December 1, 2014

Primary Completion

November 1, 2015

Study Completion

November 1, 2015

Last Updated

September 1, 2015

Record last verified: 2015-08

Locations

TH(1)