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

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02688322

Enrollment

Registered

2016-02-23

Start date

2014-09-30

Completion date

2016-08-31

Last updated

2017-09-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acinetobacter Infections

Keywords

sulbactam, pharmacokinetics, pharmacodynamics, Acinetobacter infections

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.

Interventions

DRUGSulbactam

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

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

OTHER

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
concentration of sulbactam in plasma	12 h profile after 7th of sulbactam

Countries

Thailand

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026