Pharmacodynamics Modeling to Optimize Dosage Regimens of Sulbactam in Patients With Acinetobacter Infections

Study Overview
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Brief Summary
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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.

Official Title
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Pharmacodynamics Modeling to Optimize Dosage Regimens of Sulbactam in Patients With Acinetobacter Infections

Conditions
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Acinetobacter Infections

Intervention / Treatment
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* Drug: Sulbactam


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient aged ≥ 18 years Patients who had diagnosed an Acinetobacter infections that sensitive to sulbactam and colistin Infected at sterile site Pneumonia was defined by a new and persistent infiltrate on chest radiography associated with at least one of the following: purulent sputum, temperature>38.3°C or <36°C, a leukocyte count>10,000 cell per mm3, heart rate of >90 beats per min and respiratory rate >20 breaths per min Urinary tract infection: Acinetobacter spp ≥ 100,000 cfu/mm3 Exclusion Criteria: Patients who are pregnant. Patients who have documented hypersensitivity to sulbactam and colistin Patients who are chronic renal disease Patients who are shock

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 2 g q12 of sulbactam, 1 h infusion<br>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<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| concentration of sulbactam in plasma |  | 12 h profile after 7th of sulbactam | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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sulbactam, pharmacokinetics, pharmacodynamics, Acinetobacter infections