A Phase 4 interventional study of Sulbactam in Acinetobacter Infections, sponsored by Sutep Jaruratanasirikul. Completed at 1 site in Thailand. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2017-09-20.
Sponsored by Sutep Jaruratanasirikul · Phase 4, Interventional, and Other
Acinetobacter species have emerged as agents of serious nosocomial infections in critically ill patients. Only a few effective antibiotics are currently available for the treatment of this pathogen and, therefore, sulbactam is being considered as an alternative treatment option. The aims of this study were to i) reveal the population pharmacokinetics and ii) assess the probability of target attainment (PTA) of sulbactam in septic critically ill patients caused by Acinetobacter spp. infections.
The study was conducted in septic critically ill patients caused by Acinetobacter spp. Each patient received 2 g every 12 h of sulbactam for 10 days, after which PK studies were carried out on day 4 of sulbactam therapy and a Monte Carlo simulation was performed to determine the probability of attaining a specific pharmacodynamic target.
6,687 studies on the registry are indexed under Infections; 807 are open to participants now.
This study's enrollment of 18 is below the median of 120 across 4,200 interventional studies indexed under Infections.
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2 g of sulbactam in 100 ml of normal saline solution was administered via an infusion pump at a constant flow rate 1 h every 12 h.
Drug: Sulbactam
2 g in 100 ml of normal saline solution and administered via an infusion pump at a constant flow rate 1 h every 12 h. Blood samples (approximately 5 ml) will be obtained by direct venepuncture at the following time: 0, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8 and 12 h after 7th dose of sulbactam
concentration of sulbactam in plasma
Time frame: 12 h profile after 7th of sulbactam
This study is completed, as verified in Jan 2015. You cannot join it, but the record below documents what was studied.
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Sutep Jaruratanasirikul