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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-12-31

Study Completion Date

2015-11-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Polymyxin B Monotherapy vs Combination Therapy in Critically Ill Patients With Multi-drug Resistant Pathogens

NCT03159078

Trauma Resistant Infection Critical Illness

UNKNOWN PHASE3

Colistin Versus Colistin Plus Fosfomycin for Infections Caused by MDR Acinetobacter Baumannii

NCT01297894

Drug Safety

UNKNOWN PHASE3

A Post-Marketing Study to Assess the Efficacy and Safety of Intravenous Polymyxin B and Colistin Methanesulfonate in Patients With Carbapenem-Resistant Gram-Negative Bacterial Infection

NCT06966284

Bacteremia Caused by Gram-Negative Bacteria Bacterial Pneumonia

NOT_YET_RECRUITING

Trial for the Treatment of Extensively Drug-Resistant Gram-negative Bacilli (OVERCOME)

NCT01597973

Pneumonia Blood Stream Infection

COMPLETED PHASE3

Loading Regimen，Serum Trough Concentrations，Efficacy and Safety in Pneumonia Patients With Gram-positive Infections

NCT03229135

Pneumonia Gram-Positive Bacterial

COMPLETED

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

* 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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Hospital Infection

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Polymyxin B

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

Group Type EXPERIMENTAL

Polymyxin B

Intervention Type DRUG

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

X-Gen Phamaceuticals, USA Polymyxin B

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No