Daily Respiratory Research Analysis

Low- and middle-income countries face substantial challenges in immunizing against severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), including high costs, limited access, and insufficient local manufacturing. To address these issues, we developed and locally manufactured the AVX/COVID-12 vaccine using a cost-effective Newcastle disease virus LaSota platform to express a stabilized SARS-CoV-2 spike protein (HexaPro-S). We evaluated the AVX/COVID-12 vaccine in a phase 2/3 parallel-group, double-blind, active-controlled, noninferiority trial with 4056 volunteers, demonstrating its safety, good tolerability, and ability to induce neutralizing antibodies against ancestral SARS-CoV-2 and the Omicron BA.2 and BA.5 variants. It also stimulated interferon-γ-producing CD8

BACKGROUND: WHO recommends Xpert MTB/RIF Ultra (Ultra) for stool testing for tuberculosis diagnosis in children. Stool processing requires removal of debris and PCR inhibitors, frequently by using centrifugation, which can be an implementation barrier for low-income and middle-income countries (LMICs). We evaluated the diagnostic accuracy of Ultra on stool using three centrifuge-free processing methods, the simple one-step (SOS), stool processing kit (SPK), and the optimised sucrose flotation (OSF) methods against a microbiological reference standard (MRS). METHODS: In this observational, prospective, multicountry, diagnostic accuracy study, we collected two respiratory samples and two stool samples in children younger than 15 years with presumptive tuberculosis in one hospital in Uganda and two hospitals in Zambia for Ultra testing and culture (on respiratory samples only). We defined positive MRS as positive culture or Ultra on respiratory sample and negative MRS as two negative respiratory samples by either culture or Ultra. We assessed the perception of the laboratory operators of test ease-of-use using a self-administered questionnaire at all sites. This study is registered with ClinicalTrials.gov (NCT04203628) and the Pan African Clinical Trial Registry (PACTR202006814433059). FINDINGS: Of the 216 children enrolled between Jan 13, 2020, and Dec 31, 2021, 215 were included in the study and of these 104 (48·4%) were female and 211 (51·6%) were male, the median age was 1·8 years (IQR 1·1-4·8), 68 (31·6%) were HIV positive, and 38 (17·7%) were MRS positive. For one or both stool samples, depending on availability, the sensitivity of stool Ultra against MRS was 69·7% (95% CI 51·3-84·4) for SOS, 69·7% (51·3-84·4) for SPK, and 73·5% (55·6-87·1) for OSF (McNemar test p>0·6 for all), with a specificity above 96% for all methods. The SOS stool method was considered the easiest by six of seven operators because it required least manipulation and no additional reagents. INTERPRETATION: Centrifuge-free stool processing methods could improve access to microbiological diagnosis of tuberculosis in LMICs. These results contributed to the WHO endorsement of the SOS and OSF methods. FUNDING: UNITAID.

BACKGROUND: With the increasing prevalence of patients on home mechanical ventilation (HMV), changing indications, shortage of hospital resources and rapidly evolving technology, there is an urgent need for evaluating the added value of telemedicine in initiation and follow-up of HMV. This European Respiratory Society (ERS) clinical practice guideline provides evidence-based recommendations on the use of telemedicine in HMV. METHODS: The ERS Task Force consisted of 20 members, including a patient representative and her caregiver. The Task Force addressed five PICO (Population, Intervention, Comparison, Outcome) questions and three narrative questions. Systematic searches were performed in MEDLINE, Embase, Cochrane and CINAHL. Evidence was synthesised by conducting meta-analyses, when possible, or when not, narratively. Certainty of evidence was rated with GRADE (Grading of Recommendations Assessment, Development and Evaluation) guidance. The Evidence-to-Decision framework was used to decide on the direction and formulate strengths of recommendations. RESULTS: The panel makes a conditional recommendation for the initiation of HMV with telemedicine in patients with neuromuscular diseases or restrictive thoracic diseases and in patients with COPD. No recommendation could be made for obesity hypoventilation syndrome. The panel conditionally recommends the use of telemedicine for the follow-up of patients on HMV, although could not make recommendations on parameters to be monitored. Suggestions were mainly based on theoretical benefits and patient preferences, as our confidence in the evidence was low. CONCLUSIONS: With these guidelines, clinical practice recommendations are provided for the use of telemedicine in HMV. Technological advances and the use of advanced data processing algorithms and artificial intelligence were identified as drivers for future research and telemedicine use.