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

Acinetobacter Infections Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02688322
• Other study ID #: SULBAC552011411
• Status: Completed
• Phase: Phase 4
• First received: February 17, 2016
• Last updated: September 19, 2017
• Start date: September 2014
• Est. completion date: August 2016

Study information

• Verified date: January 2015
• Source: Prince of Songkla University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: August 2016
• Est. primary completion date: August 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acinetobacter Infections
• Communicable Diseases
• Infection

Intervention

Drug:
• 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

Locations

Country	Name	City	State
Thailand	Division of Clinical Pharmacology, Department of Medicine, Faculty of Medicine, Prince of Songkla University	Hat Yai	Songkla

Sponsors (2)

Lead Sponsor	Collaborator
Sutep Jaruratanasirikul	Prince of Songkla University

Country where clinical trial is conducted

Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	concentration of sulbactam in plasma		12 h profile after 7th of sulbactam