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

NCT02688322 | Completed Phase 4

• 1 other identifier: SULBAC552011411
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

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

Keywords

sulbactam; pharmacokinetics; pharmacodynamics; Acinetobacter infections

Outcome Measures

Primary Outcomes (1)

• concentration of sulbactam in plasma

  12 h profile after 7th of sulbactam

Study Arms (1)

2 g q12 of sulbactam, 1 h infusion

EXPERIMENTAL

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

Interventions

Sulbactam 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

2 g q12 of sulbactam, 1 h infusion

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Patients who are pregnant.
• Patients who have documented hypersensitivity to sulbactam and colistin
• Patients who are chronic renal disease
• Patients who are shock

Sponsors & Collaborators

• Sutep Jaruratanasirikul: lead
• Prince of Songkla University: collaborator

Study Sites (1)

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

Hat Yai, Changwat Songkhla, 90110, Thailand

Location

MeSH Terms

Conditions

Acinetobacter Infections

Interventions

Sulbactam

Condition Hierarchy (Ancestors)

Moraxellaceae Infections; Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections

Intervention Hierarchy (Ancestors)

Penicillins; beta-Lactams; Lactams; Amides; Organic Chemicals; Sulfur Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Prince of Songkla Univeersity

Study Record Dates

• First Submitted: February 17, 2016
• First Posted: February 23, 2016
• Study Start: September 1, 2014
• Primary Completion: August 1, 2016
• Study Completion: August 1, 2016
• Last Updated: September 20, 2017

Record last verified: 2015-01

Locations

TH (1)