Back to resultsPharmacodynamics Modeling to Optimize Dosage Regimens of Sulbactam in Patients With Acinetobacter Infections
Primary Purpose
Acinetobacter Infections
Status
Completed
Phase
Phase 4
Locations
Thailand
Study Type
Interventional
Intervention
Sulbactam
Sponsored by
About this trial
This is an interventional other trial for Acinetobacter Infections focused on measuring sulbactam, pharmacokinetics, pharmacodynamics, Acinetobacter infections
Eligibility Criteria
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
Sites / Locations
- Division of Clinical Pharmacology, Department of Medicine, Faculty of Medicine, Prince of Songkla University
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
2 g q12 of sulbactam, 1 h infusion
Arm Description
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.
Outcomes
Primary Outcome Measures
concentration of sulbactam in plasma
Secondary Outcome Measures
Full Information
NCT ID
NCT02688322
First Posted
February 17, 2016
Last Updated
September 19, 2017
Sponsor
Sutep Jaruratanasirikul
Collaborators
Prince of Songkla University
1. Study Identification
Unique Protocol Identification Number
NCT02688322
Brief Title
Pharmacodynamics Modeling to Optimize Dosage Regimens of Sulbactam in Patients With Acinetobacter Infections
Official Title
Pharmacodynamics Modeling to Optimize Dosage Regimens of Sulbactam in Patients With Acinetobacter Infections
Study Type
Interventional
2. Study Status
Record Verification Date
January 2015
Overall Recruitment Status
Completed
Study Start Date
September 2014 (undefined)
Primary Completion Date
August 2016 (Actual)
Study Completion Date
August 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Sutep Jaruratanasirikul
Collaborators
Prince of Songkla University
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acinetobacter Infections
Keywords
sulbactam, pharmacokinetics, pharmacodynamics, Acinetobacter infections
7. Study Design
Primary Purpose
Other
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
18 (Actual)
8. Arms, Groups, and Interventions
Arm Title
2 g q12 of sulbactam, 1 h infusion
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Sulbactam
Intervention Description
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
Primary Outcome Measure Information:
Title
concentration of sulbactam in plasma
Time Frame
12 h profile after 7th of sulbactam
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Division of Clinical Pharmacology, Department of Medicine, Faculty of Medicine, Prince of Songkla University
City
Hat Yai
State/Province
Songkla
ZIP/Postal Code
90110
Country
Thailand
12. IPD Sharing Statement
Learn more about this trial
Pharmacodynamics Modeling to Optimize Dosage Regimens of Sulbactam in Patients With Acinetobacter Infections
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