Hospital InfectionPhase 4XDRNCT02328183
Efficacy of Polymyxin B Against Infections Caused by Extensively Drug-resistant (XDR) Gram-Negative Bacteria
A Phase 4 study testing Polymyxin B in people with Hospital Infection, run by Mahidol University at 1 site in Thailand.
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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Hospital Infection
- What is being tested?
- Polymyxin B
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteThailand
- Study dates
- Dec 2014to Nov 2015
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Thailand1 site, 1 recruiting
- Recruiting
Siriraj hospital
Bangkok, Bangkok, 10700
Thundon Ngamprasertchai, MD, 66850887736, thundon_ngamprasertchai@hotmail.com
Visanu Thamlikitkul, MD, 66818206271, visanu.tha@mahidol.ac.th
About this study
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.
Read the 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.
- Conditions
- Hospital Infection
- Being tested
- Polymyxin B
- Keywords
- polymyxin B, carbapenem resistant bacteria
- Medical subject headings
- Cross Infection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Polymyxin BDrug
Also called X-Gen Phamaceuticals, USA 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
| Study group | Role | What they receive |
|---|---|---|
| Polymyxin B | Experimental | Polymyxin B 1.5-2.5 mg/kg/day intravenous q 12 hrs duration 7-14 days Receives: Drug: Polymyxin B |
What is being measured
The primary outcome is the main question the study is designed to answer.
mortality rate
mortality rate of gram negative bacteria infected patients receiving Polymyxin B at day 28 after enrollment
Measured: participants will be followed for the duration of hospital stay, an expected average of 4 weeks
Secondary outcomes (3)
adverse drug reactions
we assess adverse drug reactions in 2 aspects; nephrotoxicity and neurotoxicity
Measured: participants will be followed for the duration of hospital stay, an expected average of 4 weeks
microbiological clearance
we perform culture and staining to assess bacterial clearance after apply the study drug every 3 days until culture is negative
Measured: participants will be followed for the duration of hospital stay, an expected average of 4 weeks
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.
Measured: participants will be followed for the duration of hospital stay, an expected average of 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Dec 2014 (estimated)
- Study startDec 2014
- Primary completionNov 2015 (estimated)
- Study completionNov 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Hospital InfectionStudies of the same condition, open and under way.
- More trials run by Mahidol UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mahidol University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Visanu Thamlikitkul, MD, Principal investigator, Infectious disease and tropical medicine, Siriraj hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02328183
- Sponsor's protocol ID
- 568/2557(EC4)
- Acronym
- XDR
- Status last verified
- Aug 2015
- First submitted
- 15 Dec 2014
- Last updated
- 1 Sep 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 17291803Nation 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.
PubMed 24700659
Study at a glance
From the registry record, last updated by the sponsor on 1 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Polymyxin B Against Infections Caused by Extensively Drug-resistant (XDR) Gram-Negative Bacteria
- ClinicalTrials.gov ID
- NCT02328183
- Acronym / sponsor ID
- XDR / 568/2557(EC4)
- Conditions
- Hospital Infection
- Keywords
- polymyxin B, carbapenem resistant bacteria
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Mahidol UniversityUniversity, hospital or other
- Study start
- Dec 2014
- Primary completion
- Nov 2015 (estimated)
- Study completion
- Nov 2015 (estimated)
- First posted
- 31 Dec 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Polymyxin B | Experimental | Drug: Polymyxin BPolymyxin B 1.5-2.5 mg/kg/day intravenous q 12 hrs duration 7-14 days |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Polymyxin BAlso: X-Gen Phamaceuticals, USA Polymyxin Badministrate 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 | Drug | Polymyxin B |
Primary outcome
mortality rate
Time frame: participants will be followed for the duration of hospital stay, an expected average of 4 weeks
mortality rate of gram negative bacteria infected patients receiving Polymyxin B at day 28 after enrollment
3 secondary outcomes
adverse drug reactions
Time frame: participants will be followed for the duration of hospital stay, an expected average of 4 weeks
microbiological clearance
Time frame: participants will be followed for the duration of hospital stay, an expected average of 4 weeks
Peak Plasma Concentration (Cmax) of polymyxin B
Time frame: participants will be followed for the duration of hospital stay, an expected average of 4 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Sep 2015.
- Results publication: PubMed 17291803Koomanachai 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.
- Results publication: PubMed 24700659Nation 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Visanu Thamlikitkul, MD principal investigator
Infectious disease and tropical medicine, Siriraj hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Polymyxin B in people with Hospital Infection, run by Mahidol University at 1 site in Thailand.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 1 Sep 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Thailand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Thundon Ngamprasertchai, MD. (66850887736, thundon_ngamprasertchai@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
mortality rate (time frame: participants will be followed for the duration of hospital stay, an expected average of 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02328183, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Sep 2015.