An observational study in Respiration Disorders, Respiratory Failure and Sepsis, sponsored by University of Manchester. Not yet recruiting at 1 site in United Kingdom. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-05-18.
Sponsored by University of Manchester · Observational
Among 55 studies in Respiration Disorders with a site in United Kingdom — 8 open to participants now, 11 under way, 1 of them phase 3. Respiration Disorders · United Kingdom.
Among the 55 studies in Respiration Disorders with a site in United Kingdom, this one is the 20th largest by planned enrollment of the 25 observational ones, is one of 4 that started in 2025, is one of 25 observational ones, reaches primary completion later than 9 of the 10 other live ones, and was the 54th registered.
359 studies on the registry are indexed under Respiration Disorders; 64 are open to participants now.
This study's planned enrollment of 119 is below the median of 250 across 134 observational studies indexed under Respiration Disorders.
Browse Respiration Disorders studies →8 of the 55 studies in Respiration Disorders with a site in United Kingdom are open now, in 1 country. Each count lists the studies.
Of the 45 Respiration Disorders studies recruiting now, 27 (60%) set no upper age limit and 13 (29%) stop at 75 or younger; 15 take children under 18; 21 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
The full table on the hub →55 studies; the count open now beside each. This study's row is marked.
First in 2010; this study’s year is marked. 4 started in 2025.
Median enrollment 76 across the 30 interventional studies, 313 across the 25 observational. Of the 41 that completed or were terminated, 8 (20%) have results posted.
28 of 55 have an industry lead sponsor. The 10 most frequent:
University of Manchester is the lead sponsor of 201 studies on the registry; 44 are open to participants now.
University of Manchester has 1 study filed under Respiration Disorders — fewer than ten, so there is no comparison to draw.
4 of the studies in Respiration Disorders with a site in United Kingdom that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07168408University of EdinburghProcedural Skills Transfer in Bronchoscopy | 2026-12 |
| NCT07398365University of EdinburghMedical Phenotyping of NHS General Adult Psychiatry (GAP) Inpatients | 2026-12-31 |
| NCT06977165University of ManchesterInvestigating the Impact of Sepsis Phenotypes on Antibiotic Treatment in Patients With Severe Pneumonia and Sepsis | 2027-06-30 |
| NCT06271213NHS Greater Glasgow and ClydeThe Gut-Lung Axis and Respiratory Illness in Children | 2027-11-01 |
Among the 55 studies in Respiration Disorders with a site in United Kingdom, from their registry updates:
Nothing recorded among them since 2026-09-25.
Aim of the research: To find out why antibiotics work differently in certain patients with severe pneumonia and sepsis.
Background: Individuals can become very unwell from pneumonia, sometimes requiring admission to hospital or even the intensive care unit (ICU). In some cases, pneumonia can lead to a condition called sepsis, which can be deadly if not treated quickly. In the UK, approximately 30,000 patients die from pneumonia every year. Clinicians use antibiotic injections to treat life-threatening infections such as severe pneumonia. After being injected into the bloodstream, antibiotics quickly spread throughout the body, attacking the infection. Antibiotics are eventually broken down and removed from the body by the kidneys and other organs. However, antibiotics fail to achieve the same consistent result for every patient. This may be to do with the way the antibiotics travel through and are removed from the body, leading to different antibiotic levels in the blood at any one time. Low antibiotic levels can result in worse outcomes and antibiotic resistance. Patients can be grouped based on how their immune system reacts to infections. The SIPRES Study aims to explore if these previously described groups explain the difference in antibiotic levels in patients with severe pneumonia and sepsis.
Procedures: We will study how adult patients with severe pneumonia respond when treated with the most commonly used antibiotic in the ICU called piperacillin/tazobactam. Alongside information on how quickly patients get better and how long they need to stay in hospital or in ICU, we will collect blood samples to measure antibiotic levels and assess each patient's immune system at two time points during their treatment. This will allow us to measure antibiotic levels in blood at different times and group patients based on their immune system reaction to infection. We will describe the range of antibiotic levels seen in the different immune system reaction groups using mathematical and statistical models.
Patient involvement: We are working closely with people who have experienced severe pneumonia and will work with two patient partners and a patient advisory group to help shape this research. Patient contributors have already shaped the development of the funding application and identified important study outcomes. Patients we have spoken to are concerned over the appropriate dosing of antibiotics and appreciate the need for improved and precise approaches to treating severe infections. Moving forward, patient partners will help finalise the protocol, develop patient and public facing materials, provide their perspective on the study results and shape plans to share the outcomes of the study more broadly.
Potential impact: The SIPRES Study will help identify a group of patients at risk of low antibiotic levels in blood, who are less likely to improve with treatment and more likely to develop antibiotic resistance. Mathematical models that can help clinicians personalise antibiotic dosing for each critically ill patient with severe pneumonia will be developed. Findings have the potential to limit the development of antibiotic resistance and help patients survive and get better faster so that they can return to their normal daily lives. Individualised dosing for patients with low antibiotic levels, as opposed to 'one size fits all' prescribing, also has the potential to more efficiently allocate scarce resources to those who will benefit the most.
Hospitalised critically ill patients admitted to the intensive care unit
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Piperacillin/tazobactam quantification using liquid chromatography-tandem mass spectrometry
Serum concentrations of antimicrobial
The primary outcome of serum concentrations of antimicrobials was chosen to assess the profile of medication processing in the body between the groups of interest. Multiple blood samples are taken over the space of one dosing interval (most often 6-8 hours for piperacillin/tazobactam), which allows the calculation of an area under the concentration curve over time. For participants who remain in ICU at Visit 2 (Day 3-5) and are still receiving antimicrobials, a second sampling episode will occur. Those discharged from ICU prior will undergo only a single sampling period.
Time frame: Day 0 ± Day 3-5
Baseline Sequential Organ Failure Assessment score (SOFA)
SOFA score at baseline
Time frame: Day 0
Change in SOFA score
Difference between aggregate SOFA scores
Time frame: From Day 0 to Day 3-5
All-cause mortality
Death censored at Day 28
Time frame: At Day 28
Days alive and out of hospital
Defined as the number of days not in hospital at Day 28
Time frame: At Day 28
Hospital and ICU length of stay
Number of days in hospital/ICU
Time frame: At Day 28
Clinical cure
Defined as the completion of antibiotic treatment course (on or prior to Day 28) without recommencement of antibiotic therapy within 48 hours of cessation
Time frame: At Day 28
Microbiological cure
Defined as at least two negative cultures following proven bacterial infection and no new positive cultures at Day 28
Time frame: At Day 28
Duration of primary course of antimicrobial treatment
Number of days of treatment with antimicrobial from baseline
Time frame: At Day 28
Isolated pathogens
Proportion of participants with isolated pathogens
Time frame: At Day 28
Emergence of resistant organisms
Any organism resistant to antimicrobials identified through culture from any source (blood, urine, sputum, stool)
Time frame: At Day 28
Therapeutic target attainment
100% fraction of the time (fT) above the minimal inhibitory concentration \[MIC\] 100% fraction of the time (fT) above four times the minimal inhibitory concentration \[4xMIC\] Assessed for Pseudomonas aeruginosa according to latest EUCAST ECOFF breakpoints at time of analysis
Time frame: At Day 0 ± Day 3-5
Immune signature
Phenotype category according to Davenport and Sinha classification
Time frame: At Day 0 ± Day 3-5
Safety and toxicity outcomes
Any serious adverse events reported during the study period
Time frame: At Day 28
Plan to share: Yes — The following anonymised data will be shared on an online accessible repository in line with Findability, Accessibility, Interoperability, and Reuse (FAIR) principles: Baseline clinical characteristics without identifiable data Outcome data Pharmacokinetic data Transcriptomic data Immune cytokine data
Supporting information: Study protocol, Statistical analysis plan, Informed consent form, Clinical study report, Analytic code
Time frame: Beginning one year after publication and indefinitely
Access criteria: A limited anonymised dataset will be shared openly, allowing secondary analyses; more detailed IPD may be shared with researchers upon reasonable request.
No publications or documents are linked to this record.
Start is estimated for Sep 2025; primary completion for Jun 2027, 21 months later.
Of 60 non-industry observational studies under Respiration Disorders, half reached primary completion within 32 months of starting (the median), counting those still running; a quarter within 14 and three quarters within 60. This study's planned 21 months is below that.
Counting every sponsor, half of 75 studies reached it within 26 months; a quarter within 10 and three quarters within 55.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in May 2025. You cannot join it, but the record below documents what was studied.
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