Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01965340
Other study ID # Protocol 195/13
Secondary ID
Status Completed
Phase N/A
First received September 27, 2013
Last updated November 10, 2016
Start date October 2013
Est. completion date October 2016

Study information

Verified date November 2016
Source University of Lausanne Hospitals
Contact n/a
Is FDA regulated No
Health authority Switzerland: Ethikkommission
Study type Interventional

Clinical Trial Summary

Sepsis is the major cause of morbidity and mortality amongst burn patients. Burn shock and respiratory failure that used to be the major cause of mortality have progressively been replaced by sepsis and multiple organ failure. It is not rare that treatment failures occurs several weeks, or even months after injury as a consequence of sepsis usually caused by multi-drug resistant (MDR) microorganisms. Introduction of early surgery combined with topical and systemic antibiotherapy dramatically enhanced survival from sepsis after burn trauma, but further improvement is impaired by the rapid development of hard-to-treat MDR bacteria.

Correct prescription of anti-infective agents could be one way to curb the steadily increasing development of multidrug resistance. Administration of antibiotic to burn patient is complex: they frequently suffer from kidney dysfunction, they usually experience tremendous shifts of liquids between intra-vascular - inter-cellular and intra-cellular compartments, they often are hypo-albumin and protein-emic, and finally they present with a profoundly modified metabolism. All those aspects make this particular population of patients at high risk of both under or over prescription.

Monitoring of drug concentrations in the plasma of patients, so-called TDM for Therapeutic Drug Monitoring, has been introduced to clinical practice for several decades primarily to avoid toxicity of a small number of drugs with narrow therapeutic windows. However, with the increasing availability of detection techniques, the number of drugs that can be measured in the plasma of patients has grown tremendously over the last decade. As a consequence, it is currently possible to monitor drug concentrations not only to prevent toxicity, but also to improve efficacy. For instance, several studies demonstrated that TDM improved antibiotic prescription in different populations of hospitalized patients, including critically ill patients, with a direct impact on outcome.

Such studies amongst burn patients are however lacking, although this particular population is at high risk to suffer from mis-prescription. We thus hypothesize that systematic TDM could improve antibiotic prescription in this peculiar population. To this end, we propose to implement a 3-year prospective, randomized, mono-centric, clinical trial that will analyze the impact of systematic TDM on anti-infective agent prescription amongst burned patients.


Recruitment information / eligibility

Status Completed
Enrollment 39
Est. completion date October 2016
Est. primary completion date October 2016
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- All adult burn patients (= 18 years) admitted to the University Hospital of Lausanne during the study period receiving systemic anti-infectives agents for which TDM is available will be included.

Exclusion Criteria:

- Patients not receiving systemic anti-infective agents therapy

- Patients with length of hospital stay <72 hours

- Patients refusing to give their written consent (or for which the therapeutic representative refuses) or incapable of understanding and lack of legal representative

- Pregnant or breastfeeding women

- Children <18 years

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Other:
Systematic Therapeutic Drug Monitoring for the intervention group


Locations

Country Name City State
Switzerland Centre Hospitalier Universitaire Vaudois Lausanne Vaud

Sponsors (1)

Lead Sponsor Collaborator
University of Lausanne Hospitals

Country where clinical trial is conducted

Switzerland, 

Outcome

Type Measure Description Time frame Safety issue
Primary Time required to achieve anti-infective plasma concentrations in the target Up to 3 years Yes
Primary Numbers of concentrations within the target during an anti-infective agents course Up to 3 years Yes
Secondary Anti-infective agents consumption Up to 3 years No
Secondary Development of antibiotic resistance Up to 3 years Yes
Secondary Length of ICU stay based on TBSA Up to 3 years No
Secondary Characterization of the pharmacokinetic profile of most widely used antibiotics Up to 3 years No
Secondary Concentration - efficacy analysis Population pharmacokinetic (NONMEM software) Up to 3 years No
Secondary Failure / resolution rate of infectious episodes Up to 3 years Yes
Secondary Concentration - toxicity analysis Population pharmacokinetic (NONMEM software) Up to 3 years Yes
See also
  Status Clinical Trial Phase
Withdrawn NCT01302457 - Oral Care Study on Burn Patients N/A
Completed NCT02729259 - H2O VR for Burns 2015 N/A
Withdrawn NCT01225107 - Effect of Cranberry Extract on Infections in Burn Patients N/A
Completed NCT01983280 - The Effect of Healing Touch on Sleep Patterns of Pediatric Burn Patients N/A
Completed NCT00591448 - Study in the Use of Virtual Reality as an Adjunct to Pain Control in Burn Patients N/A
Active, not recruiting NCT02083900 - Use of Banana Leaf Dressing on Donor Site Wounds Phase 2
Completed NCT00242970 - Hypertrophic Scarring After Facial Burn Phase 2
Completed NCT00585325 - Instilled Lidocaine vs Placebo for Pain Management During Vacuum Assisted Closure (VAC) Dressing Changes N/A
Terminated NCT00591162 - Bone Disease in Severely Burned Children Phase 2/Phase 3
Terminated NCT02452255 - Fenofibrate and Propranolol in Burn Patients Phase 2/Phase 3
Completed NCT03183622 - A Follow-up Study to Evaluate the Safety of ALLO-ASC-DFU in ALLO-ASC-BI-101 Clinical Trial N/A
Completed NCT02427659 - VR High Tech Pain Control Burn Wound Care N/A
Not yet recruiting NCT00253279 - Alterations in Protein Synthesis Rates of Burn Patients Measured Over Time Using PET Scans Phase 1
Completed NCT04516148 - A Randomized, Controlled Trial of the Effectiveness of Perioperative Antibiotics for Reduction of Burn Wound Bacterial Concentration Following Grafting Phase 4
Withdrawn NCT02029261 - Observational Study of Insulin Resistance and Muscle Wasting After Burn Injury
Completed NCT00993889 - Virtual Reality Analgesia During Pediatric Physical Therapy N/A
Terminated NCT01062191 - Altrazeal Range of Motion Study Comparing With Typical Carboxymethyl N/A
Completed NCT02394873 - A Study to Evaluate the Safety of ALLO-ASC-DFU in the Subjects With Deep Second-degree Burn Wound Phase 1
Completed NCT00239668 - Multicenter Benchmarking of Functional and Psychosocial Outcomes of Pediatric Burn Survivors
Completed NCT04781348 - Efficacy of Platelet Rich Plasma Injection Plus Fat Grafting as Compared to Fat Grafting Alone on Burn Scar by Using Vancouver Scar Scale Phase 4