To determine whether a novel urine collection device (the ‘Pee-in-Pot (PiP)’) produces the same rates of reportable urine culture results as standard of care (SOC) urine collection. To determine whether the PiP produces comparable microscopy results to SOC urine collection. To estimate the carbon footprint of the PiP compared to SOC urine collection.

A prospectively designed, single-centre, paired comparison study.

A district general hospital in Southwest England, including antenatal clinical, accident and emergency, medical and surgical ward environments.

Adults aged 18 or over.

Urine passed through the PiP device before being decanted into a 10 mL boric acid tube for microscopy and culture, compared with the same urine contained only in a sterile plastic vessel before being decanted into a boric acid tube for microscopy and culture.

The proportion of positive urine culture results.

The proportion of heavy mixed growth culture results. Comparison of particle counts: all small particles, bacteria, red blood cells and white blood cells.

Microscopy was performed for 1353 paired samples, of which 808 paired samples both underwent culture. Overall, urine cultures were positive in 9.3% (75/808) and 10.0% (81/808) of PiP and control cases, respectively. Overall matching between PiP and control arms for reportable positive culture results was 98.5% (796/808), with a Cohen’s Kappa test coefficient () of 0.9149 (almost perfect agreement). There was no significant difference in the rate of positive urine culture results between testing arms for any organisms (margin of non-inferiority prospectively defined as ±2.5% for Escherichia coli positive cultures). For microscopy, there was agreement in meeting culture thresholds for 1308 of 1353 paired samples with a difference in culturing rates of 0.00517 (95% CI –0.0045 to 0.015, ie, high level of agreement). The estimated base case carbon footprint of PiP testing was 95g CO2e compared to 270g CO2e for SOC testing.

This study found the PiP to be non-inferior for routine urine microscopy and culture testing and to have a lower carbon footprint compared with SOC urine testing.

A significant proportion of infants born at ≤29+6 weeks’ gestation develop lung disease during the neonatal period, thus putting them at risk of developing prematurity-associated lung disease in childhood and adulthood. After discharge from the neonatal unit, pre-existing lung disease in preterm-born infants is exacerbated by (often frequent) respiratory viral infections requiring greater health utilisation, including hospital admissions, than their term-born equivalents. Opportunities to prevent viral infections in infancy are largely limited to anti-respiratory syncytial virus (RSV) antibody prophylaxis and recently maternal RSV immunisation, but in term-born infants, trained immunity-based vaccines such as Bactek (MV130, Inmunotek, Spain) are increasingly used. Bactek provides a promising therapeutic avenue for preterm-born infants to target postdischarge respiratory viral infection in this vulnerable group of infants. The BALLOON study aims to assess this treatment in a very/extremely preterm-born population and determine if treatment with the trained immunity-based vaccine Bactek decreases the risk of unscheduled visits to healthcare professionals for lower respiratory tract infections, when compared with placebo. Included infants are born at ≤29+6 weeks’ gestation and treated daily from term-equivalent (37–43 weeks’ postmenstrual age, PMA) or from discharge, if earlier, up to 1 year of corrected age.

542 infants are being recruited prior to discharge by neonatal units in the UK. They are being randomised to receive Bactek or placebo, once daily dose of 2 sprays (each 0.1 mL) of IMP (300 Formazin Turbidity Units), from 37 to 43 weeks’ PMA or discharge if earlier up to 1 year of corrected age. The primary objective is to assess if sublingual Bactek spray decreases the risk of health professional diagnosed lower respiratory tract infections (LRTIs) (unscheduled visits to general practitioners, accident and emergency departments and hospital admissions) between enrolment and 1 year of corrected age. Secondary outcomes include the number of parent-reported, health professional-confirmed unscheduled visits for LRTIs, the time to first parent-reported, health professional-confirmed unscheduled visit for LRTI, parent-reported wheeze episodes (identification aided by WheezeScan (Omron, Japan)), parent-reported use of respiratory medications, growth (weight, length and head circumference), parent(s)/guardian(s) reported time missed from work and/or nursery time missed for the infant and volume of adverse reactions. Viruses associated with LRTIs will also be identified.

Ethics permission has been granted by the Wales Research Ethics Committee 3 (Ref 24/WA/0181), and regulatory permission by the Medicines and Healthcare Products Regulatory Agency (CTA reference 21323/0063/001-0004). The study is registered on ISRCTN (ISRCTN14019493). Findings will be disseminated via national and international peer-reviewed journals, and conferences. Oversight of the study is being provided by an Independent Data Monitoring Committee and an independent Trial Steering Committee (TSC). The Trial Management Group (TMG) meets every month.

ISRCTN14019493.

Community-acquired pneumonia is the leading global cause of infection-related death. A subset of patients with pneumonia develops aberrant immune responses, resulting in harmful inflammation, tissue damage and significant mortality. Immunomodulatory therapies aim to blunt this dysregulated immune response and reduce resultant injury. No consensus exists on the use or impacts of immunomodulatory therapies in the management of community-acquired pneumonia. This protocol describes the methods we will use to undertake a systematic review and network meta-analysis of the effects of immunomodulatory therapies on the mortality of patients with community-acquired pneumonia.

We will undertake a systematic review and network meta-analysis investigating the use of immunomodulatory therapies in community-acquired pneumonia. Our protocol has been developed and reported following the Preferred Reporting Items for Systematic Reviews and Meta-Analyses Protocols guidelines and prospectively registered with PROSPERO (CRD42024565301). The primary objectives of this work are to compare the impact of immunomodulatory therapies on 28-day and 90-day mortality in adult patients admitted to hospital with a primary diagnosis of community-acquired pneumonia. The secondary objectives of this work are to identify any differences in the effectiveness of these immunomodulatory therapies in managing community-acquired pneumonia of differing aetiology and severity.

We will conduct a literature search of Medline, Embase, Scopus, Web of Science and Global Health for all relevant articles until 30 June 2024. All observational, interventional and epidemiological studies published in English will be included, and each type of study design will be examined separately. All studies will have their titles and abstracts independently screened by two reviewers, followed by a full article eligibility review and data extraction. A third reviewer will adjudicate any disagreements. Data extracted will include, but not be limited to, the study design, country in which it was undertaken, patient characteristics (eg, age, sex, cause of CAP, severity of CAP), details regarding the immunomodulatory therapy and dosing used and the 28-day and 90-day mortality of each study arm.

The risk of bias will be assessed using the Risk of Bias in Non-randomised Studies - of Exposure tool for non-randomised studies and the Cochrane Risk of Bias 2 tool for randomised control trials. The quality of evidence will be evaluated using the Grading of Recommendations, Assessment, Development, and Evaluations for network meta-analysis framework. A quantitative synthesis of data is planned for 28-day and 90-day mortality rates.

We will fit a random-effects network meta-analysis model that includes random effects for between-study heterogeneity and for inconsistency. This will be done using the metafor package for R. We will use a contrast-based approach, modelling estimated treatment effects using reference treatments. In the case of the primary objective, this will be the log odds ratio (OR) of mortality in one treatment compared with another.

Each type of study design will be examined separately. Treatments using the same immunotherapy at different doses may be grouped if appropriate.

This will be a systematic review of published literature; therefore, ethical approval is not required. To ensure communication of our findings, we will publish our results in a peer-reviewed journal and present our findings at appropriate local, national and international meetings.

CRD42024565301.