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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Polymyxin B | Experimental | Polymyxin B 1.5-2.5 mg/kg/day intravenous q 12 hrs duration 7-14 days |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Polymyxin B | 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 |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| microbiological clearance |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Thundon Ngamprasertchai, MD. | Contact | 66850887736 | thundon_ngamprasertchai@hotmail.com | |
| Adhiratha Boonyasiri, MD | Contact | 66850632181 | nonghor@yahoo.com |
| Name | Affiliation | Role |
|---|---|---|
| Visanu Thamlikitkul, MD | Infectious disease and tropical medicine, Siriraj hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Siriraj hospital | Recruiting | Bangkok | Bangkok | 10700 | Thailand |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 17291803 | Result | 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. | |
| 24700659 |
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| ID | Term |
|---|---|
| D003428 | Cross Infection |
| ID | Term |
|---|---|
| D007239 | Infections |
| D007049 | Iatrogenic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
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| ID | Term |
|---|---|
| D011112 | Polymyxin B |
| ID | Term |
|---|---|
| D011113 | Polymyxins |
| D010456 | Peptides, Cyclic |
| D047028 | Macrocyclic Compounds |
| D011083 | Polycyclic Compounds |
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|
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 |
| 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 |
| 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. |
| D013568 |
| Pathological Conditions, Signs and Symptoms |
| D055666 |
| Lipopeptides |
| D008055 | Lipids |
| D023181 | Antimicrobial Cationic Peptides |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D000089882 | Antimicrobial Peptides |
| D052899 | Pore Forming Cytotoxic Proteins |
| D008565 | Membrane Proteins |
| D011506 | Proteins |