PneumoniaTDM-TIMENCT05971979
Therapeutic Drug Monitoring - Targeting IMproved Effectiveness
An observational study of Pneumonia and Sepsis, run by Manchester University NHS Foundation Trust at 1 site in United Kingdom.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pneumonia, Sepsis, Infection, Bacterial
- How many people
- 30 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 12 Dec 2023to 21 Jun 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All individuals will be considered for inclusion in this study regardless of age, disability, gender reassignment, marriage and civil partnership, pregnancy and maternity, race, religion and belief, sex, and sexual orientation except where the study inclusion and exclusion criteria explicitly state otherwise.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Wythenshawe Hospital, Manchester University NHS Foundation Trust
Manchester, M23 9LT
About this study
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
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.
- Conditions
- Pneumonia, Sepsis, Infection, Bacterial
- Being tested
- No intervention
- Keywords
- drug monitoring, sepsis, antibacterial agents, respiratory tract infections, antimicrobial stewardship
- Medical subject headings
- Pneumonia, Sepsis, Bacterial Infections, Respiratory Tract Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionOther
No intervention
| Study group | Role | What they receive |
|---|---|---|
| Critically ill patients with presumed or confirmed lower respiratory tract infection | Non-interventional. Admitted to intensive care unit. Presumed or confirmed lower respiratory tract infection. Receiving either piperacillin/tazobactam or meropenem. Participants will have samples collected during an antimicrobial dose cycle. Receives: Other: No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Availability of LC-MS/MS results within two dose intervals of antimicrobial (dichotomous)
Proportion of participants within timeframe for antimicrobial
Measured: 48 hours
Secondary outcomes (9)
Time elapsed from peripheral blood collection to LC-MS/MS result availability
Mean time required for result availability
Measured: 48 hours
Time elapsed from first dose of antimicrobial to LC-MS/MS result availability
Mean time required for result availability from first antimicrobial dose administration
Measured: 72 hours
Duration of pre-analytical stage
Mean time required for pre-analytical stage
Measured: 24 hours
Duration of analytical stage
Mean time required for analytical stage
Measured: 24 hours
Duration of post-analytical stage
Mean time required for post-analytical stage
Measured: 24 hours
Therapeutic target attainment (100% fT>4xMIC)
Proportion of patients attaining target (100% fT>4xMIC)
Measured: 72 hours
28-day mortality
Proportion of patients alive at 28 days from enrolment
Measured: 28 days
ICU length of stay
Number of days from ICU admission to discharge
Measured: 28 days
Hospital length of stay
Number of days from hospital admission to discharge
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2023
- Study start12 Dec 2023
- Primary completion21 Jun 2024
- Study completion21 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for PneumoniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Manchester University NHS Foundation Trust
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Jan Hansel, MD, Principal investigator, University of Manchester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05971979
- Sponsor's protocol ID
- B01949
- Acronym
- TDM-TIME
- Status last verified
- Nov 2024
- First submitted
- 25 Jul 2023
- Last updated
- 21 Nov 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Hansel J, Lain J, Erhieyovwe EO, Ismayilli A, Orr J, Keevil BG, Ogungbenro K, Dark PM, Felton TW. A prospective cohort feasibility study of real-time beta-lactam antimicrobial therapeutic drug monitoring in critically ill patients with lower respiratory infection: The TDM-TIME study. J Intensive Care Soc. 2025 Dec 24;27(1):22-29. doi: 10.1177/17511437251404324. eCollection 2026 Feb.
PubMed 41459019
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05971979
- Acronym / sponsor ID
- TDM-TIME / B01949
- Conditions
- Pneumonia, Sepsis, Infection, Bacterial
- Keywords
- drug monitoring, sepsis, antibacterial agents, respiratory tract infections, antimicrobial stewardship
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Manchester University NHS Foundation TrustOther government
- Study start
- 12 Dec 2023 (actual)
- Primary completion
- 21 Jun 2024 (actual)
- Study completion
- 21 Jun 2024 (actual)
- First posted
- 2 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Critically ill patients with presumed or confirmed lower respiratory tract infection | – | Other: No interventionNon-interventional. Admitted to intensive care unit. Presumed or confirmed lower respiratory tract infection. Receiving either piperacillin/tazobactam or meropenem. Participants will have samples collected during an antimicrobial dose cycle. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All individuals will be considered for inclusion in this study regardless of age, disability, gender reassignment, marriage and civil partnership, pregnancy and maternity, race, religion and belief, sex, and sexual orientation except where the study inclusion and exclusion criteria explicitly state otherwise.
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No interventionNo intervention | Other | Critically ill patients with presumed or confirmed lower respiratory tract infection |
Primary outcome
Availability of LC-MS/MS results within two dose intervals of antimicrobial (dichotomous)
Time frame: 48 hours
Proportion of participants within timeframe for antimicrobial
9 secondary outcomes
Time elapsed from peripheral blood collection to LC-MS/MS result availability
Time frame: 48 hours
Time elapsed from first dose of antimicrobial to LC-MS/MS result availability
Time frame: 72 hours
Duration of pre-analytical stage
Time frame: 24 hours
Duration of analytical stage
Time frame: 24 hours
Duration of post-analytical stage
Time frame: 24 hours
Therapeutic target attainment (100% fT>4xMIC)
Time frame: 72 hours
28-day mortality
Time frame: 28 days
ICU length of stay
Time frame: 28 days
Hospital length of stay
Time frame: 28 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Nov 2024.
- Derived from this study: PubMed 41459019Hansel J, Lain J, Erhieyovwe EO, Ismayilli A, Orr J, Keevil BG, Ogungbenro K, Dark PM, Felton TW. A prospective cohort feasibility study of real-time beta-lactam antimicrobial therapeutic drug monitoring in critically ill patients with lower respiratory infection: The TDM-TIME study. J Intensive Care Soc. 2025 Dec 24;27(1):22-29. doi: 10.1177/17511437251404324. eCollection 2026 Feb.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jan Hansel, MD principal investigator
University of Manchester
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pneumonia and Sepsis, run by Manchester University NHS Foundation Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Availability of LC-MS/MS results within two dose intervals of antimicrobial (dichotomous) (time frame: 48 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05971979, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Nov 2024.