Compassionate Use of REGEN-COV ® in Patients with COVID-19 and Immunodeficiency-Associated Antibody Disorders

Abstract Background Patients with immunodeficiency-associated antibody disorders are at a higher risk of prolonged/persistent COVID-19 infection, having no viable treatment options. Methods A retrospective analysis of patients with primary and/or secondary immunodeficiency-associated antibody disorders who received casirivimab and imdevimab (REGEN-COV ®) under emergency compassionate use. Objectives describe safety and response to REGEN-COV, focusing on the subset of patients who had COVID-19 duration ≥21 days before treatment. Results Quantitative (change in oxygenation status and/or viral load) and/or qualitative (physician-reported clinical status) patient outcomes data are reported from 64 patients who received REGEN-COV. Improvement in ≥1 outcome was observed in 90.6% of the overall patient group. Thirty-seven of these had COVID-19 duration ≥21 days before treatment; median time from diagnosis to REGEN-COV was 60.5 days. Of the 29 patients with COVID-19 duration ≥21 days before treatment and available outcome data, 96.6% showed improvement in ≥1 outcome. In the 14 patients with post-treatment RT-PCR results available, 11 (78.6%) reported a negative RT-PCR following treatment, with 5 (45.5%) reporting a negative RT-PCR within 5 days and 8 (72.7%) within 21 days of treatment. Ten of 85 patients (11.8%) experienced serious adverse events, only one was an infusion-related reaction, possibly related to REGEN-COV. Two deaths were reported, neither were attributed to REGEN-COV. Conclusions In this retrospective analysis of immunodeficient patients granted REGEN-COV under the compassionate use program, REGEN-COV treatment was associated with rapid viral clearance and clinical improvement in patients with long-standing COVID-19. Adverse events were consistent with COVID-19 and its associated complications, and due to patients’ concurrent medical conditions.

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Reversal of SARS-CoV2 Induced Hypoxia by Nebulized Sodium-Ibuprofen in a Compassionate Use Program

10.21203/rs.3.rs-390980/v1 ◽

2021 ◽

Author(s):

Oscar Salva ◽

Pablo Alexis Doreski ◽

Celia Sara Giler ◽

Dario Conrado Quinodoz ◽

Lucia Guadalupe Guzman ◽

...

Keyword(s):

Adverse Events ◽

Average Length ◽

Vital Signs ◽

Standard Of Care ◽

Ambient Air ◽

Outcome Data ◽

Compassionate Use ◽

Rapid Improvement ◽

Serious Adverse Events ◽

Average Length Of Stay

Abstract BackgroundSodium-ibuprofenate in hypertonic saline (NaIHS) administered directly to the lungs by nebulization and inhalation has antibacterial and anti-inflammatory effects with the potential to deliver these benefits to hypoxic patients. We describe a compassionate use program that offered this therapy to hospitalized COVID-19 patients.MethodsNaIHS (50 mg ibuprofen, tid) was provided in addition to standard of care to hospitalized Covid-19 patients until oxygen saturation levels of >94% were achieved on ambient air. Patients wore a containment hood to diminish aerosolization. Outcome data from participating patients treated at multiple hospitals in Argentina between April 04, 2020, through October 31, 2020 are summarized.Results383 patients were treated, including 327 not on mechanical ventilation at baseline (MV) and 56 ICU patients receiving MV. For those not on baseline MV (59±0.8 years), 64% were male, most with at least one recognized risk factor for disease severity, and mean NEWS2 score prior to treatment initiation of 7.0±0.1. The average length of stay (ALOS) was 11.5±0.3 days and length of treatment (LOT) 9.0±0.2 days. In patients on baseline MV (60.6±2.2 years), 69.9% were male, baseline mean NEWS2 Score was 8.8±0.4, ALOS 15.5±1.4 days and LOT 10.5±0.7 days. Reversal of deterioration in oxygenation and NEWS2 scores was observed acutely following initiation of therapy. Overall in-hospital mortality was 10.7% among patients not on MV at baseline, and 19.6% among patients receiving MV at baseline. No serious adverse events were considered related to ibuprofen therapy.ConclusionsTreatment of COVID-19 pneumonitis with inhalational nebulized NaIHS was associated with rapid improvement in hypoxia and vital signs, with no serious adverse events attributed to therapy. Nebulized NaIHS is worthy of further study in randomized, placebo-controlled trials.(ClinicalTrials.gov:NCT04382768).

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Prevention, recognition, and management of adverse events associated with gemtuzumab ozogamicin use in acute myeloid leukemia

Journal of Hematology & Oncology ◽

10.1186/s13045-020-00975-2 ◽

2020 ◽

Vol 13 (1) ◽

Author(s):

Jorge E. Cortes ◽

Marcos de Lima ◽

Hervé Dombret ◽

Elihu H. Estey ◽

Sergio A. Giralt ◽

...

Keyword(s):

Adverse Events ◽

Myeloid Leukemia ◽

Tumor Lysis Syndrome ◽

Gemtuzumab Ozogamicin ◽

Sinusoidal Obstruction Syndrome ◽

Serious Adverse Events ◽

Hematopoietic Stem ◽

Increased Risk ◽

Adults And Children ◽

Related Reaction

Abstract Gemtuzumab ozogamicin (GO), a humanized anti-CD33 monoclonal antibody conjugated to the cytotoxic antibiotic agent calicheamicin, is approved for the treatment of newly-diagnosed CD33 + AML in adults and children ≥ 1 month old, and relapsed or refractory CD33 + AML in adults and children ≥ 2 years old. GO treatment has been associated with an increased risk of hepatotoxicity and hepatic veno-occlusive disease/sinusoidal obstruction syndrome (VOD/SOS), especially following hematopoietic stem cell transplantation. Other non-specific serious adverse events (SAEs) associated with GO treatment are myelosuppression, bleeding/thrombocytopenia, infusion-related reaction, and tumor lysis syndrome. This report summarizes an expert panel of physicians’ recommendations for the evaluation and management of SAEs following GO, emphasizing the prevention and management of VOD/SOS.

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Rate of Serious Adverse Events Associated with Diazoxide Treatment of Patients with Hyperinsulinism

Hormone Research in Paediatrics ◽

10.1159/000497458 ◽

2019 ◽

Vol 91 (1) ◽

pp. 25-32 ◽

Cited By ~ 4

Author(s):

Paul Thornton ◽

Lisa Truong ◽

Courtney Reynolds ◽

Tyler Hamby ◽

Jonathan Nedrelow

Keyword(s):

Pulmonary Hypertension ◽

Adverse Events ◽

Retrospective Analysis ◽

First Line ◽

Serious Adverse Events ◽

Infants Of Diabetic Mothers ◽

Drug Agency ◽

Different Types ◽

The Difference ◽

Diabetic Mothers

Introduction: Diazoxide is the first line and only Federal Drug Agency approved pharmacological agent for the treatment of hyperinsulinism. Its use has increased over the years to include patients with various genetic forms of hyperinsulinism, perinatal stress hyperinsulinism and infants of diabetic mothers with more babies than ever being exposed to this therapy. Methods: We performed a retrospective analysis of 194 patients with hyperinsulinism in our clinic and looked for those who had experienced serious adverse events (SAE) including pulmonary hypertension and neutropenia. We compared the rates of SAE in the different types of hyperinsulinism. Results: Out of 194 patients with hyperinsulinism, 165 (85.1%) were treated with diazoxide. There were 17 SAEs in 16 patients including 8 cases of pulmonary hypertension and 8 of neutropenia. These data show that overall the frequency of SAE associated with diazoxide use is 9.7%, but that those with perinatal stress hyperinsulinism have a much higher rate than those with genetic forms of hyperinsulinism (16.7 vs. 3.6%; p = 0.01). We also found diazoxide is associated with pulmonary hypertension (4.8% of patients treated). Although more patients with perinatal stress hyperinsulinism (7.6%) were affected than genetic hyperinsulinism (1.2%), the difference was not significant (p = 0.088). Conclusion: The rate of SAEs associated with (not necessarily caused by) diazoxide has been demonstrated. The rate of SAE in newborns with perinatal stress hyperinsulinism is significantly higher than that of otherwise healthy babies with genetic forms of hyperinsulinism, suggesting that caution should be used when prescribing diazoxide to this population. This information should help balance the risk benefit of treatment and provide guidance on screening for these complications in the population of treated patients.

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SARS-CoV-2 infection and adverse events in patients with cancer receiving immune checkpoint inhibitors: an observational prospective study

Journal for ImmunoTherapy of Cancer ◽

10.1136/jitc-2020-001694 ◽

2021 ◽

Vol 9 (2) ◽

pp. e001694

Author(s):

Mario Mandala ◽

Paul Lorigan ◽

Matilde De Luca ◽

Andrea Bianchetti ◽

Barbara Merelli ◽

...

Keyword(s):

Adverse Events ◽

Immune Checkpoint ◽

Immune Checkpoint Inhibitors ◽

Checkpoint Inhibitors ◽

Treatment Options ◽

Antigen Expression ◽

Serious Adverse Events ◽

Exact Test ◽

Cancer Subtypes ◽

Patients With Cancer

BackgroundIn ambulatory patients with cancer with asymptomatic or pauci-symptomatic SARS-CoV-2 infection, the safety of targeted therapies (TTs), chemotherapy (CT) or immune checkpoint inhibitors (ICIs) therapy is still unknown.Material and methodsFrom the start of the first epidemic wave of SARS-CoV-2 in Bergamo, Italy, we have prospectively screened all consecutive outpatients who presented for treatment to the Oncology Division of the Papa Giovanni XXIII Hospital, Bergamo for SARS-CoV-2 antigen expression. We identified patients treated with ICIs and compared these to patients with the same cancer subtypes treated with TTs or CT.ResultsBetween March 5 and May 18, 293 consecutive patients (49% melanoma, 34% non-small cell lung cancer, 9% renal cell carcinoma, 8% other) were included in this study: 159 (54%), 50 (17%) and 84 (29%) received ICIs, CT or TTs, respectively. Overall 89 patients (30.0%) were SARS-CoV-2 positive. Mortality of SARS-CoV-2-positive patients was statistically significantly higher compared with SARS-CoV-2 negative patients (8/89 vs 3/204, respectively, Fisher’s exact test p=0.004). All deaths were due to COVID-19. Serious adverse events (SAEs) were more frequent in SARS-CoV-2-positive patients compared with SARS-CoV-2-negative cases (Cochran-Mantel-Haenszel (CMH) test p=0.0008). The incidence of SAEs in SARS-CoV-2 positive compared with SARS-CoV-2 negative patients was similar in ICI and CT patients (17.3% and 3.7% for positive and negative patients in ICIs and 15.4% and 2.7% in CT, Breslow-Day test p=0.891). No COVID-19-related SAEs were observed in the TTs patients.ConclusionsThe incidence of SAEs was higher for SARS-CoV-2-positive patients treated with ICIs and CT, mostly in advanced disease. No SAEs were observed in patients treated with TTs. SAEs were COVID-19 related rather than treatment related. Treatment with ICIs does not appear to significantly increase risk of SAEs compared with CT. This information should be considered when determining treatment options for patients.

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Compassionate use of recombinant human IL-7-hyFc as a salvage treatment for restoring lymphopenia in patients with recurrent glioblastoma

10.1101/2022.01.09.22268651 ◽

2022 ◽

Author(s):

Stephen Ahn ◽

Jae-Sung Park ◽

Heewon Kim ◽

Minkyu Heo ◽

Young Chul Sung ◽

...

Keyword(s):

Adverse Events ◽

Lymphocyte Count ◽

Randomized Clinical Trials ◽

Case Series ◽

Recurrent Glioblastoma ◽

Total Lymphocyte Count ◽

Compassionate Use ◽

Serious Adverse Events ◽

Total Lymphocyte ◽

Recurrent Gbm

Purpose Lymphopenia is frequently observed and is associated with poor prognosis in glioblastoma (GBM) patients. Restoring lymphopenia in cancer patients has been suggested as a novel immunotherapeutic strategy. As interleukin-7 (IL-7) is necessary for proliferation of lymphocytes and to amplify the total lymphocyte count (TLC), IL-7 therapy has been tried for various cancers, although the results are inconclusive. Here, we describe the clinical results of recurrent GBM treated with long-acting engineered version of recombinant human IL-7 (rhIL-7-hyFc). Methods This prospective case series based on compassionate use was approved by the Ministry of Food and Drug Safety in South Korea. Patients with recurrent GBM were enrolled to Seoul St. Mary's Hospital. Primary outcomes were the safety profile and elevated total lymphocyte count (TLC). Secondary outcomes were overall survival (OS) and progressionbfree survival (PFS). The duration of median follow up was 372.6 days (range 98-864 days). Results Among 18 patients enrolled, 10 received rhIL-7-hyFc with temozolomide, 5 received rhIL-7-hyFc with bevacizumab, 1 received rhIL-7-hyFc with PCV chemotherapy, and 2 received rhIL-7-hyFc alone. The mean TLC of enrolled patients after the first treatment with rhIL-7-hyFc was significantly increased from 1,131 cells/mm^3 (range 330-2,989) at baseline to 4,356 cells/mm^3 (range 661-22,661). Similar increase was observed in 16 of 18 patients (88.8%), only after the first treatment of rhIL-7-hyFc. TLCs of these patients were maintained higher while rhIL-7-hyFc was repeatedly administered. Most common adverse events were injection sites reactions (64.7%) including urticaria and itching sensation, however, there were no serious adverse events more than grade III. Median OS and PFS were 378 days (range 107-864 days) and 231 days (55-726 days), respectively. Conclusion Our study first reports that IL-7 immunotherapy can restore lymphopenia and maintain TLC with various salvageable chemotherapies in recurrent GBM patients without serious adverse toxicities. This outcome warrants further larger and randomized clinical trials to validate the clinical benefits of rhIL-7-hyFc for GBM patients.

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Personalized DNA neoantigen vaccine in combination with plasmid IL-12 for the treatment of a patient with anaplastic astrocytoma.

Journal of Clinical Oncology ◽

10.1200/jco.2021.39.15_suppl.e14561 ◽

2021 ◽

Vol 39 (15_suppl) ◽

pp. e14561-e14561

Author(s):

Tanner Michael Johanns ◽

Alfredo Perales-Puchalt ◽

Roger Stupp ◽

Mitchel Berger ◽

William E. Gillanders ◽

...

Keyword(s):

T Cell ◽

Adverse Events ◽

Anaplastic Astrocytoma ◽

Ex Vivo ◽

T Cell Responses ◽

Compassionate Use ◽

Serious Adverse Events ◽

Tumor Bed ◽

Cell Responses ◽

Whole Exome

e14561 Background: Tumor neoantigens are epitopes derived from tumor-specific mutations that may be incorporated in personalized vaccines to prime T cell responses. DNA vaccines delivered with electroporation have recently shown strong CD8 and CD4 T cell responses in clinical trials. In preclinical studies, DNA-encoded neoantigen vaccines have shown induction of CD8 T cells against 50% of predicted high affinity epitopes with the ability to impact tumor growth. Methods: Two resection samples from a patient with IDH+ MGMT-methylated anaplastic astrocytoma were subject to whole exome and transcriptome sequencing. Epitopes derived from 27 neoantigens and 3 shared tumor-associated antigens were prioritized and included in a personalized vaccine. The patient was treated with surgery, radiotherapy and temozolomide starting June 2018 and received the first dose of the personalized vaccine in June 2019 under a compassionate use single patient IND application with the FDA. Results: As of February 10, 2021, the patient has received 10 doses of the DNA personalized vaccine. No serious adverse events have been reported. Related adverse events are limited to grade 1 injection site reactions. The patient remains progression-free 32 months after surgery and 20 months after starting vaccination. Three weeks following the third dose, a hyperintense image on the tumor bed was identified, which disappeared on the following MRI, 2 weeks following dose 5, being catalogued as pseudo progression. Ex vivo ELISpot have identified T cell responses to 21/30 epitopes (70%), including 18/27 (67%) neoantigens and 3/3 (100%) shared antigens. Flow cytometry analysis has determined that T cell responses are 92.3% CD8 and 69.2% CD4 (30.8% CD8 only; 61.5% both CD8 and CD4; and 7.7% CD4 only). Conclusions: This compassionate use treatment in an adjuvant setting demonstrates manufacturing feasibility, safety, tolerability, immunogenicity, and suggests potential for persistent clinical response of DNA encoded personalized vaccines. The data supports further investigation of DNA-encoded personalized vaccines into newly diagnosed high-grade gliomas.

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Compassionate Use of Tocilizumab for Treatment of SARS-CoV-2 Pneumonia

Clinical Infectious Diseases ◽

10.1093/cid/ciaa812 ◽

2020 ◽

Cited By ~ 15

Author(s):

Stanley C Jordan ◽

Phillip Zakowski ◽

Hai P Tran ◽

Ethan A Smith ◽

Cyril Gaultier ◽

...

Keyword(s):

Adverse Events ◽

Morbidity And Mortality ◽

Cytokine Storm ◽

Compassionate Use ◽

Serious Adverse Events ◽

T Cell Therapy ◽

Reactive Protein ◽

Single Center Study ◽

Oxygen Requirements

Abstract Background Preliminary data from severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) pneumonia patients indicate that a cytokine storm may increase morbidity and mortality. Tocilizumab (anti-IL-6R) is approved by the Food and Drug Administration for treatment of cytokine storm associated with chimeric antigen receptor T-cell therapy. Here we examined compassionate use of tocilizumab in patients with SARS-CoV-2 pneumonia. Methods We report on a single-center study of tocilizumab in hospitalized patients with SARS-CoV-2 pneumonia. All patients had confirmed SARS-CoV-2 pneumonia and oxygen saturations <90% on oxygen support with most intubated. We examined clinical and laboratory parameters including oxygen and vasopressor requirements, cytokine profiles, and C-reactive protein (CRP) levels pre- and post-tocilizumab treatment. Results Twenty-seven SARS-CoV-2 pneumonia patients received one 400 mg dose of tocilizumab. Interleukin (IL)-6 was the predominant cytokine detected at tocilizumab treatment. Significant reductions in temperature and CRP were seen post-tocilizumab. However, 4 patients did not show rapid CRP declines, of whom 3 had poorer outcomes. Oxygen and vasopressor requirements diminished over the first week post-tocilizumab. Twenty-two patients required mechanical ventilation; at last follow-up, 16 were extubated. Adverse events and serious adverse events were minimal, but 2 deaths (7.4%) occurred that were felt unrelated to tocilizumab. Conclusions Compared to published reports on the morbidity and mortality associated with SARS-CoV-2, tocilizumab appears to offer benefits in reducing inflammation, oxygen requirements, vasopressor support, and mortality. The rationale for tocilizumab treatment is supported by detection of IL-6 in pathogenic levels in all patients. Additional doses of tocilizumab may be needed for those showing slow declines in CRP. Proof of efficacy awaits randomized, placebo-controlled clinical trials.

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Pregnancy Outcomes of Patients Exposed to Adalimumab in Japan

Digestive Diseases ◽

10.1159/000493462 ◽

2018 ◽

Vol 37 (2) ◽

pp. 123-130 ◽

Cited By ~ 5

Author(s):

Yumi Kawai ◽

Tsuyoshi Tsuchiya ◽

Shigeru Aoki

Keyword(s):

Adverse Events ◽

Pregnancy Outcomes ◽

Outcome Data ◽

Full Term ◽

Third Trimester ◽

Serious Adverse Events ◽

Additional Risk ◽

Safety Database ◽

Induced Abortions ◽

Adalimumab Treatment

Background: This is the first retrospective report of pregnancy outcomes after exposure to adalimumab treatment in Japan. Methods: Using the AbbVie safety database, we analyzed pregnancy outcome data from patients who received adalimumab treatment from April 16, 2008, to May 15, 2017. Results: Data were extracted retrospectively for 74 pregnancies in 73 patients. More than half of the patients included in the study received adalimumab for the treatment of Crohn’s disease (37.8%) or ulcerative colitis (20.3%), while 9.5% received adalimumab for rheumatoid arthritis. Of the 53 pregnancies with available outcome data, 45 newborns (45/53 [84.9%]) were delivered. Of these births, 30 were full-term, 2 were preterm, and 13 were unknown. Apgar scores were available for 11 of the 16 newborns whose mothers were exposed to adalimumab in the third trimester; all scores were within the normal range. Low birth weight was observed in 5 infants out of the 30 full-term deliveries. There were also 5 miscarriages (5/53 [9.4%]), 2 induced abortions (2/53 [3.8%]), and 1 stillbirth (1/53 [1.9%]). Eight maternal adverse events were observed in 5 pregnancies; no serious adverse events occurred. Conclusion: Although safety concerns were inconclusive, these data do not report additional risk to pregnancy outcomes with adalimumab exposure.

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Crizanlizumab and comparators for adults with sickle cell disease: a systematic review and network meta-analysis

BMJ Open ◽

10.1136/bmjopen-2019-034147 ◽

2020 ◽

Vol 10 (9) ◽

pp. e034147

Author(s):

Howard Thom ◽

Jeroen Jansen ◽

Jason Shafrin ◽

Lauren Zhao ◽

George Joseph ◽

...

Keyword(s):

Sickle Cell Disease ◽

Adverse Events ◽

Sickle Cell ◽

Meta Analysis ◽

Treatment Options ◽

Credible Interval ◽

Bayesian Probability ◽

Cell Disease ◽

Serious Adverse Events ◽

Hydroxyurea Treatment

ObjectivesTreatment options for preventing vaso-occlusive crises (VOC) among patients with sickle cell disease (SCD) are limited, especially if hydroxyurea treatment has failed or is contraindicated. A systematic literature review (SLR) and network meta-analysis (NMA) were conducted to evaluate the efficacy and safety of crizanlizumab for older adolescent and adult (≥16 years old) SCD patients.MethodsThe SLR included randomised controlled trials (RCTs) and uncontrolled studies. Bayesian NMA of VOC, all-cause hospitalisation days and adverse events were conducted.ResultsThe SLR identified 51 studies and 9 RCTs on 14 treatments that met the NMA inclusion criteria. The NMA found that crizanlizumab 5.0 mg/kg was associated with a reduction in VOC (HR 0.55, 95% credible interval (0.43, 0.69); Bayesian probability of superiority >0.99), all-cause hospitalisation days (0.58 (0.50, 0.68); >0.99) and no evidence of difference on adverse events (0.91 (0.59, 1.43) 0.66) or serious adverse events (0.93 (0.47, 1.87); 0.59) compared with placebo. The HR for reduction in VOC for crizanlizumab relative to L-glutamine was (0.67 (0.50, 0.88); >0.99). These results were sensitive to assumptions regarding whether patient age is an effect modifier.ConclusionsThis NMA provides preliminary evidence comparing the efficacy of crizanlizumab with other treatments for VOC prevention.

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PP16 Prehospital recognition and antibiotics for 999 patients with sepsis: feasibility study results

Emergency Medicine Journal ◽

10.1136/emermed-2019-999abs.16 ◽

2019 ◽

Vol 36 (10) ◽

pp. e8.1-e8

Author(s):

Jenna Bulger ◽

Susan Allen ◽

Jan Davies ◽

Timothy Driscoll ◽

Gemma Ellis ◽

...

Keyword(s):

Adverse Events ◽

Early Recognition ◽

Randomised Trial ◽

Intervention Group ◽

Final Diagnosis ◽

Outcome Data ◽

Control Group ◽

Serious Adverse Events ◽

Study Results ◽

The Mean

BackgroundSepsis is a common condition which kills approximately 44,000 people annually in the UK. Early recognition and management of sepsis has been shown to reduce mortality and improve outcomes. Paramedics frequently attend patients with sepsis, and are well placed to provide early diagnosis and treatment. We aimed to assess whether a multi-centre randomised trial to evaluate pre-hospital antibiotics was feasible.MethodsVolunteer paramedics used scratchcards to allocate patients with ‘Red Flag’ Sepsis at random between experimental and control arms. The primary outcome was mortality at six months. We also measured: adverse events, costs, final diagnosis, length of stay in hospital, and quality of care; and collected qualitative data about acceptability to patients in interviews, and paramedics in focus groups. We pre-specified criteria for deciding whether to progress to a fully powered trial based on: recruitment of paramedics and patients; retrieval of outcome data; safety; acceptability; and diagnostic accuracy.ResultsFifty-four paramedics completed their training and were issued scratchcards to randomly allocate patients to trial arms. Patients were recruited from 1.12.17 to 31.5.18. In total, 118 patients were randomly allocated to trial arms; four patients dissented to be included in the trial, leaving 114 patients to follow-up. Sixty-two patients (54%) were allocated to the intervention arm. The mean age of the control arm was 71.2 years (range 28–97); 33 (65%) control participants were female. In the intervention arm the mean age was 75.6 years (range 30–99) and 38 patients (61%) were female. Nine patients in the control group (18%) and 17 in the intervention group (28%) were already taking antibiotics at the time of their 999 call. Twenty-three questionnaires were received. No serious adverse events were reported.ConclusionsComplete results will be presented at the time of the conference, when routine linked anonymised outcomes are available.

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