Overview

This trial is active, not recruiting.

Condition acinetobacter infections
Treatment sulbactam
Phase phase 4
Sponsor Sutep Jaruratanasirikul
Collaborator Prince of Songkla University
Start date September 2014
End date August 2016
Trial size 18 participants
Trial identifier NCT02688322, SULBAC552011411

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification pharmacokinetics/dynamics study
Intervention model single group assignment
Masking open label
Arm
(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.
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

Primary Outcomes

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

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

Official title Pharmacodynamics Modeling to Optimize Dosage Regimens of Sulbactam in Patients With Acinetobacter Infections
Trial information was received from ClinicalTrials.gov and was last updated in March 2016.
Information provided to ClinicalTrials.gov by Prince of Songkla University.