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No patient included at target sample sizes
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This study is planned to compare the clinical efficacy and safety of aerosolized plus intravenous colistin vs. intravenous colistin as adjunctive therapy for the treatment of ventilator-associated pneumonia (VAP) due to pandrugs-resistant (PDR) Acinetobacter baumannii in the neonates.
This study will evaluate the neonates with VAP due to PDR-Acinetobacter baumannii who receive aerosolized plus intravenous colistin compare with intravenous colistin as adjunctive therapy. The efficacy and safety after study will be evaluated.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Aerosolized plus intravenous colistin | Experimental | Neonates with VAP due to PDR-A. baumannii who receive aerosolized colistin (4 mg/kg/dose twice daily) plus intravenous colistin (3.5 mg/kg/dose twice daily) |
|
| Intravenous colistin | Active Comparator | Neonates with VAP due to PDR-A. baumannii who receive only intravenous colistin (3.5 mg/kg/dose twice daily) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Aerosolized plus intravenous colistin | Drug | Aerosolized colistin at the dose of 4 mg colistin base activity (CBA)/kg twice daily (8 mg/kg/day) plus intravenous colistin at a dose of 3.5 mg CBA/kg/dose twice daily (7 mg/kg/day) |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Patients With Cure | Clinical outcome is classified in 4 categories: Cure, Improved, Failure, and Death | Through study completion, an average of 2 weeks |
| Number of Patients With Improved | Clinical outcome is classified in 4 categories: Cure, Improved, Failure, and Death | Through study completion, an average of 2 weeks |
| Number of Patients With Failure | Clinical outcome is classified in 4 categories: Cure, Improved, Failure, and Death | Through study completion, an average of 2 weeks |
| Number of Patients With Death | Clinical outcome is classified in 4 categories: Cure, Improved, Failure, and Death | Through study completion, an average of 2 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Patients With Eradication | Microbiological response is classified in 3 categories: Eradication Persistence, Superinfection | Through study completion, an average of 2 weeks |
| Number of Patients With Persistence |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Narongsak Nakwan, MD | Hat Yai Medical Education Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Narongsak Nakwan | Hat Yai | Changwat Songkhla | 90110 | Thailand |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20812247 | Background | Nakwan N, Wannaro J, Thongmak T, Pornladnum P, Saksawad R, Nakwan N, Chokephaibulkit K. Safety in treatment of ventilator-associated pneumonia due to extensive drug-resistant Acinetobacter baumannii with aerosolized colistin in neonates: a preliminary report. Pediatr Pulmonol. 2011 Jan;46(1):60-6. doi: 10.1002/ppul.21324. Epub 2010 Sep 1. | |
| 26065861 |
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|
| Intravenous colistin | Drug | Intravenous colistin at a dose of 3.5 mg CBA/kg/dose twice daily (7 mg/kg/day) |
|
|
Microbiological response is classified in 3 categories: Eradication Persistence, Superinfection
| Through study completion, an average of 2 weeks |
| Number of Patients With Superinfection | Microbiological response is classified in 3 categories: Eradication Persistence, Superinfection | Through study completion, an average of 2 weeks |
| Number of Patients With Adverse Events That Are Related to Study Drug | Number of Patients With Adverse Events That Are Related to Study Drug, Graded According to NCI CTCAE Version 3.0 focus on neurology, pulmonology, nephrology and metabolic/laboratory. | Through study completion, an average of 4 weeks |
| Nakwan N, Lertpichaluk P, Chokephaibulkit K, Villani P, Regazzi M, Imberti R. Pulmonary and Systemic Pharmacokinetics of Colistin Following a Single Dose of Nebulized Colistimethate in Mechanically Ventilated Neonates. Pediatr Infect Dis J. 2015 Sep;34(9):961-3. doi: 10.1097/INF.0000000000000775. |
| 27276179 | Background | Nakwan N, Usaha S, Chokephaibulkit K, Villani P, Regazzi M, Imberti R. Pharmacokinetics of Colistin Following a Single Dose of Intravenous Colistimethate Sodium in Critically Ill Neonates. Pediatr Infect Dis J. 2016 Nov;35(11):1211-1214. doi: 10.1097/INF.0000000000001263. |
| ID | Term |
|---|---|
| D053717 | Pneumonia, Ventilator-Associated |
| ID | Term |
|---|---|
| D000077299 | Healthcare-Associated Pneumonia |
| D003428 | Cross Infection |
| D007239 | Infections |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D007049 | Iatrogenic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| C004691 | colistinmethanesulfonic acid |
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