Therapeutic Drug Monitoring - Targeting IMproved Effectiveness

Sepsis Clinical Trial

— TDM-TIME  

Official title:

Therapeutic Drug Monitoring - Targeting Improved Effectiveness (TDM-TIME): An Observational Study of Turnaround Time for Therapeutic Drug Monitoring of Antimicrobial Agents in Critically Ill Patients With Respiratory Sepsis

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05971979
• Other study ID #: B01949
• Status: Recruiting
• Start date: December 14, 2023
• Est. completion date: July 31, 2024

Study information

• Verified date: April 2024
• Source: Manchester University NHS Foundation Trust
• Contact: Lynne Webster
• Phone: +441617015057
• Email: research.sponsor[@]mft.nhs.uk
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Severe infections can be caused by various organisms, such as bacteria or viruses, and lead to otherwise healthy people getting very unwell, sometimes needing treatment in hospital or even intensive care. For the treatment of bacterial infections to be successful, the correct antibiotics need to be given promptly. Early in the course of illness, clinicians often do not know exactly which bacteria are causing the infection. Furthermore, patients differ in terms of how their bodies process the antibiotics they are given; this means that some may get too much and others too little. This can in turn lead to some patients not being fully cured, and others coming to harm due to side effects of higher doses of these drugs. For certain types of antibiotics, clinicians are able to measure their levels in the bloodstream, which can help guide dosing. This is called therapeutic drug monitoring, and is commonly used in clinical practice. One of the problems with therapeutic drug monitoring is that it is often not available outside of regular working hours, is costly, and most importantly, provides clinicians with useful information only after a few days of treatment have already been completed. This may be too late to treat these severely ill patients with life-threatening infections, where early and appropriate treatments matter. The aim of our study, called TDM-TIME, is to look at how long it takes for blood samples to get from the patient to the laboratory to be measured, with the results then communicated back to clinicians. We are further looking to investigate whether steps can be taken to improve these timings, which would lead to shorter times until treatments can be improved. As our study is observational, we will not change anything about the treatment of our patients, but will only be measuring levels of antibiotics in their blood.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: July 31, 2024
• Est. primary completion date: July 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Age > 18 years;
• Admitted to intensive care;
• Treated for presumed or confirmed lower respiratory tract infection;
• Receiving OR about to receive the first dose of intravenous antimicrobials (either meropenem of piperacillin/tazobactam);
• Valid informed consent OR enrolment through deferred consent appropriate.

Exclusion Criteria:

• Severe anaemia (haemoglobin level < 70 g/L);
• Unlikely to survive 24 hours as judged by the treating physician;
• Study antimicrobial course started more than 24 hours ago.

Related Conditions & MeSH terms

• Bacterial Infections
• Infection, Bacterial
• Pneumonia
• Sepsis

Intervention

Other:
• No intervention
No intervention

Locations

Country	Name	City	State
United Kingdom	Wythenshawe Hospital, Manchester University NHS Foundation Trust	Manchester

Sponsors (1)

Lead Sponsor	Collaborator
Manchester University NHS Foundation Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Availability of LC-MS/MS results within two dose intervals of antimicrobial (dichotomous)	Proportion of participants within timeframe for antimicrobial	48 hours
Secondary	Time elapsed from peripheral blood collection to LC-MS/MS result availability	Mean time required for result availability	48 hours
Secondary	Time elapsed from first dose of antimicrobial to LC-MS/MS result availability	Mean time required for result availability from first antimicrobial dose administration	72 hours
Secondary	Duration of pre-analytical stage	Mean time required for pre-analytical stage	24 hours
Secondary	Duration of analytical stage	Mean time required for analytical stage	24 hours
Secondary	Duration of post-analytical stage	Mean time required for post-analytical stage	24 hours
Secondary	Therapeutic target attainment (100% fT>4xMIC)	Proportion of patients attaining target (100% fT>4xMIC)	72 hours
Secondary	28-day mortality	Proportion of patients alive at 28 days from enrolment	28 days
Secondary	ICU length of stay	Number of days from ICU admission to discharge	28 days
Secondary	Hospital length of stay	Number of days from hospital admission to discharge	28 days