Clinical Trials Logo

Clinical Trial Summary

We will compare the percentage of patients having therapeutic vancomycin serum concentrations after current standard dosing, after dosing with our software. We will also include therapeutic outcomes and costs in the analysis.


Clinical Trial Description

Recent guidelines to use the antibiotic vancomycin for serious, resistant gram-positive bacterial infections advocate higher plasma concentrations than are routinely achieved with conventional dosing. Moreover, there is wide interpatient variability in vancomycin plasma concentrations, even with standardized dosing. The hypothesis for this study is that dosing vancomycin assisted by computer software and Bayesian algorithms will lead to more rapid and accurate attainment of therapeutic blood vancomycin concentrations in children and adults. This study will enroll 90 patients per year for three years, totaling 270 patients. Eligible patients will be of any age and who are to be prescribed vancomycin by their clinicians for medical indications. Patients with vancomycin-resistant organisms, severe vancomycin allergies or who need dialysis will not be eligible. Participants in the first group of 90 will be treated according to standard care. The second and third groups of patients will be dosed with vancomycin according to the recommendations made by the study team using the BestDose software developed by the USC Laboratory of Applied Pharmacokinetics. The second group will be dosed with the software in its current form, and the third group with funded updates. For all groups, no additional blood samples will be drawn for research purposes; only routinely obtained clinical data will be used. The primary outcome in all groups will be the percentage of participants with appropriate vancomycin concentrations. Secondary outcomes in those who receive vancomycin for at least 72 hours will include effectiveness, toxicity rates, and costs of therapy. Participation in the study will cease at the time of hospital discharge or 72 hours after termination of vancomycin therapy. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT01932034
Study type Observational
Source Children's Hospital Los Angeles
Contact
Status Completed
Phase N/A
Start date September 2012
Completion date July 4, 2016

See also
  Status Clinical Trial Phase
Completed NCT03726216 - Xydalba Utilization Registry in France
Completed NCT03605498 - OR PathTrac (Tracking Intra-operative Bacterial Transmission)
Withdrawn NCT05269121 - Bacteriophage Therapy in First Time Chronic Prosthetic Joint Infections Phase 1/Phase 2
Completed NCT02541695 - Characterization of Resistance Against Live-attenuated Diarrhoeagenic E. Coli N/A
Recruiting NCT02074865 - Children's Antibiotic Resistant Infections in Low Income Countries N/A
Completed NCT01689207 - To Investigate the Safety and Tolerability of Aztreonam-Avibactam (ATM-AVI) Phase 1
Completed NCT01412801 - Magnitude of the Antibody Response to and Safety of a GBS Trivalent Vaccine in HIV Positive and HIV Negative Pregnant Women and Their Offsprings Phase 2
Not yet recruiting NCT01159470 - The Rate of C-reactive Protein (CRP) Increase as a Marker for Bacterial Infections in Children N/A
Completed NCT00983255 - Ascending Dose Pharmacokinetic (PK) and Absolute Bioavailability (BA) Phase 1
Completed NCT00678106 - Study Of Dalbavancin Drug Levels Achieved In Hospitalized Adolescents Who Are Receiving Antibiotic Therapy For Bacterial Infections Phase 1
Completed NCT00799591 - French Study In ICU Patients Treated With Tigecycline N/A
Completed NCT00478855 - Tazocin Intervention Study Phase 4
Completed NCT01074775 - Human Innate Immune Responses To Mycobacterial Aerodigestive Tract Infection N/A
Terminated NCT00431028 - Sub-Tenon's Injection of Triamcinolone and Ciprofloxacin in a Controlled-Release System for Cataract Surgery Phase 1/Phase 2
Not yet recruiting NCT03634904 - Serum Ceftazidime Concentrations in Hemodialysis Patients N/A
Recruiting NCT05684705 - Study to Investigate the Penetration of Rifabutin Into the Lung After Multiple Intravenous Administrations of BV100 Phase 1
Recruiting NCT03858387 - PK/PD and Clinial Outcomes of Beta-lactams in ICU Patients
Enrolling by invitation NCT04764058 - Efficacy and Safety of Colistin Based Antibiotic Therapy Phase 1/Phase 2
Recruiting NCT06319235 - Clinical Trial to Demonstrate the Safety and Efficacy of DUOFAG® Phase 1/Phase 2
Completed NCT03332732 - VNRX-5133 Drug-Drug Interaction in Healthy Adult Volunteers Phase 1