Carotid atherosclerosis (CAS) is a disease of the aorta caused by lipid metabolism disorders and local inflammation. Acupuncture combined with traditional western medicine (such as aspirin or atorvastatin) for the treatment of CAS has been widely applied in clinical practice, but there is still a lack of supporting evidence for its efficacy and safety on CAS. Therefore, this systematic review and network meta-analysis (NMA) will summarise the effects of different types of acupuncture treatments on CAS, and a ranking of the therapeutic classes will also be presented, aiming to provide evidence-based medicine for its extensive clinical application.

Systematic and NMA searches will be conducted in seven electronic databases: PubMed, EMBASE, Medline, Cochrane Library, Chinese National Knowledge Infrastructure, Wanfang Database and Chongqing VIP databases. The search time is from their inception to December 2020, regardless of language and publication type. Randomised controlled trials and controlled clinical trials that include patients with CAS receiving acupuncture therapy compared with a control group will be considered eligible. The primary outcomes include the carotid intima-media thickness and vessel plaque quantification; the secondary outcomes include the carotid plaque Crouse score, greyscale median, lipid levels, the incidence of cardiovascular events, safety and adverse events. The selection of studies, data extraction, quality assessment and risk of bias assessment will be conducted by two independent reviewers. The NMA will be analysed with Stata V.15.0, RevMan V.5.3 software and WinBUGS V.1.4.3.

Ethical approval will not be required for this study as it will be based on de-identified, aggregated published data. We will publish the findings in a peer-reviewed journal.

CRD42020207260.

Recently, a randomised controlled trial (DIRECT-MT) demonstrated that mechanical thrombectomy (MT) was non-inferior to MT with intravenous alteplase as to the functional outcomes. This study aims to investigate whether MT alone is cost-effective compared with MT with alteplase in China.

A Markov decision analytic model was built from the Chinese healthcare perspective using a lifetime horizon. Probabilities, costs and outcomes data were obtained from the DIRECT-MT trial and other most recent/comprehensive literature. Base case calculation was conducted to compare the costs and effectiveness between MT alone and MT with alteplase. One-way and probabilistic sensitivity analyses were performed to evaluate the robustness of the results.

MT alone had a lower cost and higher effectiveness compared with MT with alteplase. The probabilistic sensitivity analysis demonstrated that, over a lifetime horizon, MT alone had a 99.5% probability of being cost-effective under the willingness-to-pay threshold of 1x gross domestic product per capita in China based on data obtained from the DIRECT-MT trial. These results remained robust under one-way sensitivity analysis.

MT alone was cost-effective compared with MT with alteplase in China. However, cautions are needed to extend this conclusion to regions outside of China.

Group A β-haemolytic Streptococcus (GAS), a Gram-positive bacterium, causes skin, mucosal and systemic infections. Repeated GAS infections can lead to autoimmune diseases acute rheumatic fever (ARF) and rheumatic heart disease (RHD). Aboriginal and Torres Strait Islander peoples in Australia have the highest rates of ARF and RHD in the world. Despite this, the contemporaneous prevalence and incidence of GAS pharyngitis and impetigo in remote Australia remains unknown. To address this, we have designed a prospective surveillance study of GAS pharyngitis and impetigo to collect coincident contemporary evidence to inform and enhance primary prevention strategies for ARF.

The Missing Piece Study aims to document the epidemiology of GAS pharyngitis and impetigo through collection of clinical, serological, microbiological and bacterial genomic data among remote-living Australian children. The study comprises two components: (1) screening of all children at school for GAS pharyngitis and impetigo up to three times a year and (2) weekly active surveillance visits to detect new cases of pharyngitis and impetigo. Environmental swabbing in remote schools will be included, to inform environmental health interventions. In addition, the application of new diagnostic technologies, microbiome analysis and bacterial genomic evaluations will enhance primary prevention strategies, having direct bearing on clinical care, vaccine development and surveillance for vaccine clinical trials.

Ethical approval has been obtained from the Western Australian Aboriginal Health Ethics Committee (Ref: 892) and Human Research Ethics Committee of the University of Western Australia (Ref: RA/4/20/5101). Study findings will be shared with community members, teachers and children at participating schools, together with academic and medical services. Sharing findings in an appropriate manner is important and will be done in a suitable way which includes plain language summaries and presentations. Finally, findings and updates will also be disseminated to collaborators, researchers and health planners through peer-reviewed journal publications.

To investigate whether the Charlson Comorbidity Index (CCI) predicted short-term and long-term mortality in patients with a bloodstream infection visiting the emergency department (ED) and compare it to the often-validated National Early Warning Score (NEWS).

A retrospective cohort study.

A tertiary hospital in the Netherlands.

Adult patients attending the ED with a blood culture-proven infection between 2012 and 2017 were included. We collected the comorbidities from the CCI and the vital signs from the NEWS.

Short-term mortality (30-day) and long-term mortality (1 year). We assessed the predictive performance by discrimination, expressed as the area under the curve (AUC).

We included 1039 patients with a blood culture-proven infection. Mortality was 10.4% within 30 days and 27.8% within 1 year. On average patients had two comorbidities (ranging from 0 to 6). Highly prevalent comorbidities were malignancy (30.2%) and diabetes mellitus (20.5%). The predictive performance of the CCI was highest for 1-year mortality (AUC 0.696 (95%CI) (0.660 to 0.732)) and better compared with the NEWS (AUC (95% CI) 0.594 (0.555 to 0.632)). For prediction of 30-day mortality, the NEWS was superior (AUC (95% CI) 0.706 (0.656 to 0.756)) to the comorbidities of the CCI (AUC (95% CI) 0.568 (0.507 to 0.628)).

We found that presenting comorbidity (ie, the CCI) is most useful to prognosticate long-term outcome in patients with bloodstream infection in the ED. Short-term mortality is more accurately predicted by deviating vital signs (ie, the NEWS).

Osteoarthritis (OA) is one of the leading chronic conditions in the older population. People with OA are more likely to have one or more other chronic conditions than those without. However, the temporal associations, clusters of the comorbidities, role of analgesics and the causality and variation between populations are yet to be investigated. This paper describes the protocol of a multinational study in four European countries (UK, Netherlands, Sweden and Spain) exploring comorbidities in people with OA.

This multinational study will investigate (1) the temporal associations of 61 identified comorbidities with OA, (2) the clusters and trajectories of comorbidities in people with OA, (3) the role of analgesics on incidence of comorbidities in people with OA, (4) the potential biomarkers and causality between OA and the comorbidities, and (5) variations between countries.

A combined case–control and cohort study will be conducted to find the temporal association of OA with the comorbidities using the national or regional health databases. Latent class analysis will be performed to identify the clusters at baseline and joint latent class analysis will be used to examine trajectories during the follow-up. A cohort study will be undertaken to evaluate the role of non-steroidal anti-inflammatory drugs (NSAIDs), opioids and paracetamol on the incidence of comorbidities. Mendelian randomisation will be performed to investigate the potential biomarkers for causality between OA and the comorbidities using the UK Biobank and the Rotterdam Study databases. Finally, a meta-analyses will be used to examine the variations and pool the results from different countries.

Research ethics was obtained according to each database requirement. Results will be disseminated through the FOREUM website, scientific meetings, publications and in partnership with patient organisations.

The objective of this study is to identify barriers for the timely delivery of endovascular thrombectomy (EVT) and to investigate the effects of potential workflow improvements in the acute stroke pathway.

Hospital data prospectively collected in the MR CLEAN Registry were linked to emergency medical services data for each EVT patient and used to build two Monte Carlo simulation models. The ‘mothership (MS) model’, reflecting patients who arrived directly at the comprehensive stroke centre (CSC); and the ‘drip and ship’ (DS) model, reflecting patients who were transferred to the CSC from primary stroke centres (PSCs).

Northern region of the Netherlands. One CSC provides EVT, and its catchment area includes eight PSCs.

248 patients who were treated with EVT between July 2014 and November 2017.

The main outcome measures were total delay from stroke onset until groin puncture, functional independence at 90 days (modified Rankin Scale 0–2) and mortality.

Barriers identified included fast-track emergency department routing, prealert for transfer to the CSC, reduced handover time between PSC and ambulance, direct transfer from CSC arrival to angiography suite entry, and reducing time to groin puncture. Taken together, all workflow improvements could potentially reduce the time from onset to groin puncture by 59 min for the MS model and 61 min for the DS model. These improvements could thus result in more patients—3.7% MS and 7.4% DS—regaining functional independence after 90 days, in addition to decreasing mortality by 3.0% and 5.0%, respectively.

In our region, the proposed workflow improvements might reduce time to treatment by about 1 hour and increase the number of patients regaining functional independence by 6%. Simulation modelling is useful for assessing the potential effects of interventions aimed at reducing time from onset to EVT.

To explore perceived sociocultural factors that may influence suicidality from key informants residing in coastal Kenya.

We used an exploratory qualitative study design.

Mombasa and Kilifi Counties of Coastal Kenya.

25 key informants including community leaders, professionals and community members directly and indirectly affected by suicidality.

We conducted in-depth interviews with purposively selected key informants to collect data on sociocultural perspectives of suicide. Thematic analysis was used to identify key themes using both inductive and deductive processes.

Four key themes were identified from the inductive content analysis of 25 in-depth interviews as being important for understanding cultural perspectives related to suicidality: (1) the stigma of suicidal behaviour, with suicidal victims perceived as weak or crazy, and suicidal act as evil and illegal; (2) the attribution of supernatural causality to suicide, for example, due to sorcery or inherited curses; (3) the convoluted pathway to care, specifically, delayed access to biomedical care and preference for informal healers; and (4) gender and age differences influencing suicide motivation, method of suicide and care seeking behaviour for suicidality.

This study provides an in depth understanding of cultural factors attributed to suicide in this rural community that may engender stigma, discrimination and poor access to mental healthcare in this community. We recommend multipronged and multilevel suicide prevention interventions targeted at changing stigmatising attitudes, beliefs and behaviours, and improving access to mental healthcare in the community.

Carpal tunnel syndrome (CTS) is the most common peripheral neuropathy. The optimal treatment strategy is still unknown. The objective of the Dutch Injection versus Surgery TRIal in patients with CTS (DISTRICTS) is to investigate if initial surgery of CTS results in a better clinical outcome and is more cost-effective when compared with initial treatment with corticosteroid injection.

The DISTRICTS is an ongoing multicenter, open-label randomised controlled trial. Participants with CTS are randomised to treatment with surgery or with a corticosteroid injection. If needed, any additional treatments after this first treatment are allowed and these are not dictated by the study protocol. The primary outcome is the difference between the groups in the proportion of participants recovered at 18 months. Recovery is defined as having no or mild symptoms as measured with the 6-item carpal tunnel symptoms scale. Secondary outcome measurements are among others: time to recovery, hand function, patient satisfaction, quality of life, additional treatments, adverse events, and use of care and health-related costs.

The study was approved by the Medical Ethical Committee of the Amsterdam University Medical Centers (study number 2017-171). Study results will be disseminated in peer-reviewed journals and conferences.

ISRCTN Registry: 13164336.

Older patients with multimorbidity, polypharmacy and related complex care needs represent a growing proportion of the population and a challenge for healthcare systems. Particularly in transitional care (hospital admission and hospital discharge), medical errors, inappropriate treatment, patient concerns and lack of confidence in healthcare are major problems that may arise from a lack of information continuity. The aim of this study is to develop an intervention to improve informational continuity of care at the interface between general practice and hospital care.

A qualitative approach will be used to develop our participatory intervention. Overall, 32 semistructured interviews with relevant stakeholders will be conducted and analysed. The stakeholders will include healthcare professionals from the outpatient setting (general practitioners, healthcare assistants, ambulatory care nurses) and the inpatient setting (clinical doctors, nurses, pharmacists, clinical information scientists) as well as patients and informal caregivers. At a series of workshops based on the results of the stakeholder analyses, we aim to develop a participatory intervention that will then be implemented in a subsequent pilot study. The same stakeholder groups will be invited for participation in the workshops.

Ethical approval for this study was waived by the Ethics Committee of Goethe University Frankfurt because of the nature of the proposed study. Written informed consent will be obtained from all study participants prior to participation. Results will be tested in a pilot study and disseminated at (inter)national conferences and via publication in peer-reviewed journals.

Clinical Trials Register: registration number DRKS00027649.

No proven treatment is available for severely ill COVID-19. Therapeutic use of COVID-19 convalescent plasma (COPLA) is under investigation.

To compare the efficacy of COPLA with standard medical therapy (SMT) alone in severe COVID-19 patients.

A multicentric, open-labelled, phase-III randomised controlled trial conducted at two treatment centres with COPLA collected at the third dedicated centre in North-India, the coordinating centre during trial from June 2020 to December 2020. The study population comprised 400 participants in the ratio of 1:1 in each treatment group.

One group received COPLA with SMT (n=200), and another group received SMT only (n=200).

Primary outcome was time to clinical improvement measured by a two-point reduction in the ordinal scale. Secondary outcomes included duration of O₂ therapy, the proportion of patients on mechanical ventilation at day-7, mortality, SARS-CoV-2 antibody levels, cytokine levels and incidence of adverse events.

The median time to a two-point reduction in the ordinal scale in both groups was 9 days (IQR=7–13) (p=0.328). The median duration of O₂ therapy was 8 days (IQR=6–12) in COPLA and 10 days (IQR=6–12) in SMT group (p=0.64). The PaO₂/FiO₂ ratio showed significant improvement at 7 days in COPLA group(p=0.036). There was no difference in mortality till 28 days in both groups (p=0.62). However, if COPLA was given within 3 days of hospital admission, a significant reduction in ordinal scale was observed (p=0.04). Neutralising antibody titres in COPLA group (80 (IQR 80–80)) were higher than SMT group (0 (IQR 0–80)) at 48 hours (p=0.001). COPLA therapy led to a significant reduction in TNF-α levels at 48 hours (p=0.048) and D-dimer at 7 days (p=0.02). Mild allergic reactions were observed in 3 (1.5%) patients in COPLA group.

Convalescent plasma with adequate antibody titres should be transfused in COVID-19 patients along with SMT in the initial 3 days of hospitalisation for better clinical outcomes.

NCT04425915.

Persistent infection with HPV can result in cancers affecting men and, especially, women. Lower uptake exists by area and different population groups. Increasing parental confidence about, and adolescent access to, the universal HPV vaccination programme may help reduce inequalities in uptake. However, the evidence-base for interventions to address uptake for schools-based HPV vaccination programmes is currently lacking. This study protocol outlines how a multicomponent intervention to address this evidence gap will be codesigned with parents.

The proposed research will be undertaken in localities covered by two immunisation teams in London and the south-west of England. The ‘person-based approach’ to intervention development will be followed. In the first phase, an exploratory qualitative study will be undertaken with key stakeholders (n=8) and parents (n=40) who did not provide consent for their adolescent child to be vaccinated. During the interviews, parents’ views on ways to improve parental confidence about, and adolescents’ access to, HPV vaccination will be sought. The findings will be used to inform the co-design of a preliminary plan for a targeted, multicomponent intervention. In the second phase, at least two parent working groups (n=8) will be convened and will work with creative designers to co-design communication materials aimed at increasing parents’ confidence in vaccination. At least two workshops with each parent group will be organised to obtain feedback on the intervention plan and communication materials to ensure they are fit for purpose. These findings will inform a protocol for a future study to test the effectiveness of the intervention at increasing HPV vaccination uptake.

The National Health Services Research Ethics Service and London School of Hygiene & Tropical Medicine Observational / Interventions Research Ethics Committee provided approvals for the study (reference 22/SW/0003 & 26902, respectively). We will work with parent advisory groups to inform our dissemination strategy and co-present our findings (eg, at community events or through social media). We will disseminate our findings with academics and healthcare professionals through webinars and academic conferences, as well as peer-reviewed publications.

To assess the difficulties faced by the pregnant women in seeking appropriate antenatal care due to the restrictions imposed during the COVID-19 pandemic; assess the difficulties encountered during delivery and postpartum period; the suitability of the teleconsultation services offered; effect of COVID-19 infection on pregnancy outcomes and the effect of restrictions on the nutrition profile of the pregnant women.

Prospective observational study.

We included 1374 pregnant women from the rural areas of three districts of Punjab, India registered at government health centres before the implementation of lockdown due to the COVID-19 pandemic on 24 March 2020.

The primary outcome was the difficulties faced by the women during their pregnancies due to restrictions imposed during the lockdown. The secondary outcomes included the effect of COVID-19 infections on pregnancy outcomes, satisfaction from the telemedicine services and restrictions on the nutrition profile of the pregnant women.

One-third of the women (38.4%) considered their last pregnancy unplanned. Women faced difficulties due to the restrictions in getting adequate nutrition (76.5%), accessing transportation facilities (35.4%), consultations from doctors (22.4%) or getting an ultrasonography scan (48.7%). One-fifth (21.9%) of women could not access safe abortion services. Only 3.6% of respondents ever took any teleconsultation services offered by the government. Most of them felt unsatisfied compared with routine visits (77.5%). COVID-19-infected women were primarily asymptomatic (76.1%), but there was a high incidence of preterm birth (42.8%). Frontline workers could visit 64.3% of the women in the postpartum period despite restrictions.

Lockdown compromised the antenatal care in our study area while the frontline workers attempted to minimise the inconvenience. Telemedicine services did not prove to be of many benefits to pregnant women and should only work as a supplement to the existing protocols of antenatal care.

The arrival of anti-vascular endothelial growth factor (anti-VEGF) therapies represented a treatment shift for several ophthalmological disorders and led to an increasing number of patients undergoing intravitreal injections. The aims of this observational study were to assess the expansion of anti-VEGF intravitreal injections in the Portuguese National Health System (NHS) and to identify factors correlated with geographical variations in episode rates.

Administrative database on discharge from Portuguese NHS hospitals was analysed for annual values and rates of intravitreal anti-VEGF injections at a national and regional level, between 2013 and 2018.

The number of episodes of anti-VEGF treatment and patients treated increased 16% and 9% per year, respectively, between 2013 and 2018. During the study period around 72% of patients were treated in the Metropolitan areas of Lisbon and Porto and in the Central region. Intravitreal anti-VEGF treatment rates in 2018 were 560 per 100 000 population and presented high variability between municipalities. Higher anti-VEGF treatment rates at the municipality level were associated with shorter distances between their residence and the hospital. At the hospital level, higher ratio of ophthalmologists and higher organisational level were associated with higher anti-VEGF treatment rates.

The number of episodes and patients treated with anti-VEGF injections has been growing in recent years. Proximity to healthcare, more access to ophthalmologists and hospitals with higher organisational levels are associated with higher anti-VEGF treatment rates. Improving access is crucial to reduce regional discrepancies and ensure optimal treatment frequency, which may improve health outcomes.

In locally advanced cervical cancer, nodal, local and distant relapse continue to be significant patterns of relapse. Therefore, strategies to improve the efficacy of chemoradiation are desirable such as biological pathway modifiers and immunomodulating agents. This trial will investigate the impact of nelfinavir, a protease inhibitor that targets the protein kinase B (AKT) pathway on disease-free survival (DFS).

Radiosensitising effect of nelfinavir in locally advanced carcinoma of cervix is a single-centre, open-label, parallel-group, 1:1 randomised phase-III study. Patients aged over 18 years with a diagnosis of carcinoma cervix stage III are eligible for the study. After consenting, patients will undergo randomisation to chemoradiation and brachytherapy arm or nelfinavir with chemoradiation and brachytherapy arm. The primary aim of the study is to compare the difference in 3-year DFS between the two arms. Secondary aims are locoregional control, overall survival, toxicity and quality of life between the two arms. Pharmacokinetics of nelfinavir and its impact on tumour AKT, programmed cell death ligand 1, cluster of differentiation 4, cluster of differentiation 8 and natural killer 1.1 expression will be investigated. The overall sample size of 348 with 1 planned interim analysis achieves 80% power at a 0.05 significance level to detect a HR of 0.66 when the proportion surviving in the control arm is 0.65. The planned study duration is 8 years.

The trial is approved by the Institutional Ethics Committee-I of Tata Memorial Hospital, Mumbai (reference number: IEC/0317/1543/001) and will be monitored by the data safety monitoring committee. The study results will be disseminated via peer-reviewed scientific journals, and conference presentations. Study participants will be accrued after obtaining written informed consent from them. The confidentiality and privacy of study participants will be maintained.

The trial is registered with Clinical Trials Registry-India (CTRI/2017/08/009265) and ClinicalTrials.gov (NCT03256916).

Chemotherapy-induced peripheral neuropathy (CIPN) is a poorly understood side effect of many antineoplastic agents. Patients may experience sensory, motor and autonomic symptoms, negatively impacting quality of life. A gold-standard assessment methodology has yet to be determined, limiting efforts to identify effective agents to prevent or treat CIPN.

This is a protocol of a systematic review of psychometric analyses of CIPN Clinician Reported Outcome Measures (ClinROM) and Patient-Reported Outcome Measures (PROM) among adults receiving, or who had previously received chemotherapy for cancer. The COnsensus-based Standards for the selection of health Measurement INstruments (COSMIN) quality ratings will be compared across studies and across ClinROMs and PROMs. Studies reporting psychometric proprieties of CIPN ClinROMs and/or PROMs among adults aged ≥18 years will be eligible for inclusion, with no restriction on language or year of publication. MEDLINE, Embase, CINAHL and APA PsycINFO databases will be searched from inception to 31 December 2021. Study characteristics, measurement properties of the ClinROMs and/or PROMs and the CIPN definitions will be extracted. The Synthesis Without Meta-analysis guideline will be used to guide data synthesis. The COSMIN Risk of Bias checklist will be used by two independent raters to assess methodological quality. Subgroup analyses by age, chemotherapy type, and study timing in relation to the delivery of chemotherapy will be carried out where data are available. An adapted version of Outcome Measures in Rheumatology filter 2.1 will be used to provide a best-evidence synthesis of CIPN ClinROMs and PROMs and to recommend a CIPN assessment tool for clinical and research settings.

Ethical approval is not necessary to be obtained for this systematic review protocol. Results will be disseminated to clinicians and policy-makers by publication in a peer-reviewed journal and by presenting at relevant conferences.

CRD42021278168.

The Protective Behavioural Strategies for Marijuana (PBSM-17) scale serves to identify and measure strategies employed by young adults before, during or after cannabis use. After the adaptation and translation of the PBSM-17 into French, a methodological study was conducted to evaluate the psychometric properties of this French version (FV) and of the original English version (EV) in a sample of bilingual Canadian university students.

A total of 211 cannabis users (mean age=22.1 years) completed a sociodemographic questionnaire, a question on frequency of cannabis use (four categories: 1–3 times a month, once a week, more than once a week, everyday) and both versions (FV and EV) of the PBSM-17.

Both versions had similar internal reliability (α=0.91; α=0.88). The one-factor solution explained 36.46% of the variance for the FV and 42.26% for the EV. As hypothesised, greater use of protective behavioural strategies was related to lower frequency of cannabis use. One-way ANOVA test results revealed a statistically significant difference in use of strategies by frequency of cannabis use for both the FV (F(3, 207)=27.38, p

The FV and EV of the PBSM-17 demonstrated satisfactory psychometric properties. The proposed FV of the PBSM-17 is a reliable instrument that could be used for research and clinical purposes. Protective behavioural strategies can serve as indicator of lower-risk cannabis use and could be targeted in prevention interventions.

This study aimed to estimate the prevalence of childhood diarrhoeal diseases (CDDs) and acute respiratory infections (ARIs) and also to determine the factors associated with these conditions at the population level in Bangladesh.

The study entailed an analysis of nationally representative cross-sectional secondary data from the most recent Bangladesh Demographic and Health Survey conducted in 2017–2018.

A total of 7222 children aged below 5 years for CDDs and 7215 children aged below 5 years for ARIs during the survey from mothers aged between 15 and 49 years were the participants of this study. In the bivariate and multivariable analyses, we used Pearson ² test and binary logistic regression, respectively, for both outcomes.

The overall prevalence of CDD and ARI among children aged below 5 years was found to be 4.91% and 3.03%, respectively. Younger children were more likely to develop both CDDs and ARIs compared with their older counterparts. Children belonging to households classified as poorest and with unimproved floor materials had a higher prevalence of diarrhoea than those from households identified as richest and with improved floor material, respectively. Stunted children had 40.8% higher odds of diarrhoea than normal children. Being male and having mothers aged below 20 years were 48.9% and two times more likely to develop ARI than female counterparts and children of mothers aged 20–34 years, respectively. Children whose mothers had no formal education or had primary and secondary education had higher odds of ARI compared with children of mothers having higher education.

This study found that children aged below 24 months were at higher risk of having CDDs and ARIs. Thus, programmes targeting these groups should be designed and emphasis should be given to those from poorest wealth quintile to reduce CDDs and ARIs.

Infections caused by carbapenemase-producing Enterobacterales are frequent and associated with high rates of mortality. Intestinal carriers are at increased risk of infection by these microorganisms. Decolonisation strategies with antibiotics have not obtained conclusive results. Faecal microbiota transplantation (FMT) could be an effective and safe strategy to decolonise intestinal carriers of KPC-producing Klebsiella pneumoniae (KPC-Kp) but this hypothesis needs evaluation in appropriate clinical trials.

The KAPEDIS trial is a single-centre, randomised, double-blind, placebo-controlled, phase 2, superiority clinical trial of FMT for eradication of intestinal colonisation by KPC-Kp. One hundred and twenty patients with rectal colonisation by KPC-Kp will be randomised 1:1 to receive encapsulated lyophilised FMT or placebo. The primary outcome is KPC-Kp eradication at 30 days. Secondary outcomes are: (1) frequency of adverse events; (2) changes in KPC-Kp relative load within the intestinal microbiota at 7, 30 and 90 days, estimated by real-time quantitative PCR analysis of rectal swab samples and (3) rates of persistent eradication, KPC-Kp infection and crude mortality at 90 days. Participants will be monitored for adverse effects throughout the intervention.

Ethical approval was obtained from Reina Sofía University Hospital Institutional Review Board (approval reference number: 2019-003808-13). Trial results will be published in peer-reviewed journals and disseminated at national and international conferences.

NCT04760665.