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

Phase 4

Completed

• Conditions: Acinetobacter Infections
• Interventions: Drug: Sulbactam

• Registration Number: NCT02688322
• Lead Sponsor: Sutep Jaruratanasirikul

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-09
• Status Verified: 2015-01
• Study First Submitted: 2016-02-17
• Study First Submitted QC: 2016-02-17
• Study First Posted: 2016-02-23
• Primary Completion: 2016-08
• Study Completion: 2016-08
• Last Update Submitted: 2017-09-19
• Last Update Posted: 2017-09-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 18

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
2 g q12 of sulbactam, 1 h infusion	Sulbactam	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.

Primary Outcome Measures

Name	Time	Method
concentration of sulbactam in plasma	12 h profile after 7th of sulbactam

Trial Locations

Locations (1)

Division of Clinical Pharmacology, Department of Medicine, Faculty of Medicine, Prince of Songkla University; 🇹🇭 Hat Yai, Songkla, Thailand