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

NCT ID: NCT02688322

Last Updated: 2017-09-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 18 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-09-30
• Study Completion Date: 2016-08-31

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.

Conditions

Acinetobacter Infections

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

2 g q12 of sulbactam, 1 h infusion

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.

Group Type: EXPERIMENTAL

Sulbactam

Intervention Type: DRUG

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

Interventions

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

Intervention Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Prince of Songkla University

OTHER

Sponsor Role: collaborator

Sutep Jaruratanasirikul

OTHER

Sponsor Role: lead

Responsible Party

Sutep Jaruratanasirikul

Prince of Songkla Univeersity

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

Division of Clinical Pharmacology, Department of Medicine, Faculty of Medicine, Prince of Songkla University

Hat Yai, Changwat Songkhla, Thailand

Countries

Thailand

Other Identifiers

SULBAC552011411

Identifier Type: -

Identifier Source: org_study_id