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Completed

NCT Number: NCT02688322

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

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

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

Hat Yai, Changwat Songkhla, 90110, Thailand

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Primary outcomes

  1. concentration of sulbactam in plasma

    Time frame: 12 h profile after 7th of sulbactam

Sponsors and collaborators

Lead sponsor

Sutep Jaruratanasirikul

Other

Collaborators

  • Prince of Songkla University

Registry information

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
Feb 23, 2016
Registry last updated
Sep 20, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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