scholarly journals Oral clarithromycin in COVID-19 of moderate severity: the ACHIEVE open-label trial using concurrent matched comparators

2020 ◽  
Author(s):  
Konstantinos Tsiakos ◽  
Antonios Tsakiris ◽  
Georgios Tsibris ◽  
Pantazis Voutsinas ◽  
Periklis Panagopoulos ◽  
...  
Keyword(s):  
Viral Load ◽  
Tract Infection ◽  
Respiratory Tract ◽  
Respiratory Tract Infection ◽  
Lower Respiratory Tract Infection ◽  
Primary Endpoint ◽  
Odds Ratio ◽  
Lower Respiratory Tract ◽  
Open Label ◽  
Moderate Severity

AbstractBackgroundClarithromycin clinical efficacy has not been described in COVID-19.Research questionIs oral clarithromycin beneficial for treating patients diagnosed with COVID-19?Study and methodsAn open-label non-randomized trial in 90 patients with COVID-19 of moderate severity was conducted at four study sites in Greece between May and October 2020. Ninety participants with respiratory tract infections received clarithromycin 500 mg every 12 hours for 7 days; another 90 standard-of-care (SOC) propensity score-matched concurrent controls received azithromycin plus hydroxychloroquine. The composite primary endpoint was defined for patients with upper respiratory tract infection as: (a) no need for hospital re-admission or (b) lack of progression into lower respiratory tract infection and, for patients with lower respiratory tract infection, as at least 50% decrease of the score of respiratory symptoms at the end-of-treatment (EOT) without progression into severe respiratory failure (SRF). The incidence SRF at the test-of-cure (TOC) on day 14 was a secondary endpoint. For clarithromycin-treated patients, viral load of SARS-CoV-2, biomarkers, the function of mononuclear cells, and safety were assessed; biomarkers were also measured in SOC comparators.ResultsThe primary endpoint was attained in 86.7% of patients treated with clarithromycin (95% CIs 78.1-92.2%) and 73.3% of concurrent SOC comparators (95%CIs; 63.4-81.4%). The odds ratio for the primary endpoint with clarithromycin treatment in univariate analysis was 2.36 (95%CIs 1.09-5.08; P: 0.039). Results were confirmed after multivariate stepwise logistic regression analysis (odds ratio 3.30; 95% CI 1.10-9.87; P: 0.033). At the TOC visit, the incidence of SRF was 12.2% (n = 11 ; 95%CIs 6.9-20.6%) among patients treated with clarithromycin (odds ratio for SRF 0.38; 95%CIs 0.17-0.84) versus 26.7% (n= 24; 95%CIs 18.6-36.6%) among concurrent SOC comparators (P: 0.023). Clarithromycin use was associated with decreases in circulating levels of C-reactive protein, of tumour necrosis factor-alpha and of interleukin (IL)-6; by an increase of the ratio of Th1 to Th2 mononuclear responses; and by suppression of SARS-CoV-2 relative viral load. No safety concerns were reported. Patients starting clarithromycin with the first five days from symptoms onset achieved better responses.InterpretationClarithromycin treatment is associated with early clinical improvement in patients with moderate COVID-19. Modulation of the Th1/Th2 responses is proposed as the mechanism of action.Trial RegistrationClinicalTrials.gov, NCT04398004

scholarly journals COPD-Lower Respiratory Tract Infection Visual Analogue Score (c-LRTI-VAS) validation in stable and exacerbated patients with COPD

2021 ◽  
Vol 8 (1) ◽  
pp. e000761
Author(s):  
Hendrik Johannes Prins ◽  
Ruud Duijkers ◽  
Johannes M A Daniels ◽  
Thys van der Molen ◽  
Tjip S van der Werf ◽  
...  
Keyword(s):  
Tract Infection ◽  
Respiratory Tract ◽  
Respiratory Tract Infection ◽  
Lower Respiratory Tract Infection ◽  
Lower Respiratory Tract ◽  
Visual Analogue Score ◽  
Chronic Obstructive ◽  
Obstructive Pulmonary Disease ◽  
Significant Difference ◽  
Related Quality

BackgroundWe developed the chronic obstructive pulmonary disease (COPD)-Lower Respiratory Tract Infection-Visual Analogue Score (c-LRTI-VAS) in order to easily quantify symptoms during exacerbations in patients with COPD. This study aimed to validate this score.MethodsIn our study, patients with stable COPD as well as those with an acute exacerbations of COPD (AECOPD) were included. The results of c-LRTI-VAS were compared with other markers of disease activity (lung function parameters, oxygen saturation and two health related quality of life questionnaires (St Georges Respiratory Questionnaire (SGRQ) and Clinical COPD Questionnaire (CCQ)) and validity, reliability and responsiveness were assessed.ResultsEighty-eight patients with clinically stable COPD and 102 patients who had an AECOPD completed the c-LRTI-VAS questionnaire. When testing on two separate occasions for repeatability, no statistically significant difference between total scores was found 0.143 (SD 5.42) (p=0.826). Internal consistency was high across items (Cronbach’s apha 0.755). Correlation with SGRQ and CCQ total scores was moderate to high. After treatment for hospitalised AECOPD, the mean c-LRTI-VAS total score improved 8.14 points (SD 9.13; p≤0.001).Conclusionsc-LRTI-VAS showed proper validity, responsiveness to change and moderate to high correlation with other questionnaires. It, therefore, appears a reliable tool for symptom measurement during AECOPD.Trial registration numberNCT01232140.

Effect of acute lower respiratory tract infection on pulmonary artery pressure in children with post-tricuspid left-to-right shunt

2021 ◽  
pp. 1-5
Author(s):  
Sakshi Sachdeva ◽  
Shyam S. Kothari ◽  
Saurabh K. Gupta ◽  
Sivasubramanian Ramakrishnan ◽  
Anita Saxena
Keyword(s):  
Tract Infection ◽  
Pulmonary Artery ◽  
Respiratory Tract ◽  
Respiratory Tract Infection ◽  
Lower Respiratory Tract Infection ◽  
Pulmonary Artery Pressure ◽  
Lower Respiratory Tract ◽  
Systolic Pressure ◽  
Pulmonary Artery Systolic Pressure ◽  
Artery Pressure

Abstract We sought to examine the influence of clinically severe lower respiratory tract infection on pulmonary artery pressure in children having CHD with post-tricuspid left-to-right shunt, as it may have physiological and clinical implications. In a prospective single-centre observational study, 45 children with post-tricuspid left-to-right shunt and clinically severe lower respiratory tract infection were evaluated during the illness and 2 weeks after its resolution. Pulmonary artery systolic pressure was estimated non-invasively using shunt gradient by echocardiography and systolic blood pressure measured non-invasively. Median pulmonary artery systolic pressure during lower respiratory tract infection was only mildly (although statistically significantly) elevated during lower respiratory tract infection [60 (42–74) versus 53 (40–73) mmHg, (p < 0.0001)]. However, clinically significant change in pulmonary artery systolic pressure defined as the increase of >10 mmHg was present in only 9 (20%) patients. In the absence of hypoxia or acidosis, only a small minority (9%, n = 4) showed significant pulmonary artery systolic pressure rise >10 mmHg. In the absence of hypoxia or acidosis, severe lower respiratory tract infection in patients with acyanotic CHD results in only mild elevation of pulmonary artery systolic pressure in most of the patients.

scholarly journals 1502. Psychological Stress and Anxiety among Parents of Children Younger than 5 Years Hospitalized with RSV

2020 ◽  
Vol 7 (Supplement_1) ◽  
pp. S753-S754
Author(s):  
Krow Ampofo ◽  
Yoonyoung Choi ◽  
Evan G Heller ◽  
Alexander G Platt-Koch ◽  
Per H Gesteland ◽  
...  
Keyword(s):  
Tract Infection ◽  
Respiratory Tract ◽  
Respiratory Tract Infection ◽  
Lower Respiratory Tract Infection ◽  
Psychological Stress ◽  
Lower Respiratory Tract ◽  
Salt Lake ◽  
Post Discharge ◽  
Psychological Burden ◽  
Stressor Scale

Abstract Background Respiratory Syncytial Virus (RSV) is one of the most common causes of childhood lower respiratory tract infection (LRTI) worldwide. While financial burdens have been documented, there are few data on parental psychological stress associated with RSV hospitalizations. We evaluated the psychological stress and anxiety of parents whose children were hospitalized with RSV. Methods During the 2019-2020 RSV season, parents with children &lt; 5 years of age hospitalized with laboratory-confirmed RSV LRTI at Primary Children’s and Riverton Hospitals in Salt Lake City, Utah, were surveyed in person, and online after discharge. As part of the survey, parents completed the State-Trait Anxiety Inventory for Adults (STAIAD) instrument (short form) and the parental stressor scale (PSS). We evaluated the difference in parental stress and anxiety reported during hospitalization and at 2-weeks post-discharge using a paired t-test. Results Among 284 Salt Lake County resident children &lt; 5 years, and hospitalized with RSV LRTI, 75 (26%) and 57 (20%) parents completed both surveys on admission and at 2-weeks post-discharge respectively. In 11 of 20 STAIAD items gauging stress and anxiety, parents reported higher levels of stress and anxiety whilst their children were admitted compared to post-discharge (Table 1). Parents’ average score on several items associated with a “positive outlook,” e.g. I feel calm, significantly improved (p &lt; 0.05) at 2-weeks post-discharge. Similarly, several items associated with a “negative outlook,” e.g. I am worried, significantly decreased (p &lt; 0.05) at 2-weeks post-discharge (Table 1). For the PSS items, ≥ 50% of parents rated 15 out of 25 as being “very or extremely stressful”, including: feeling helpless about how to help my baby; my baby’s unusual or abnormal breathing; and when my baby seemed to be in pain (Table 2). Estimates of Psychological Burden of RSV lower respiratory tract infection (LRTI) Hospitalization of Children &lt;5 Years of Age on Parents: State-Trait Anxiety Inventory for Adults (STAIAD) Estimates of Psychological Burden of RSV lower respiratory tract infection (LRTI) Hospitalization of Children &lt;5 Years of Age on Parents: Parental Stressor Scale (PSS) Conclusion RSV LRTI hospitalization among children &lt; 5 years of age, imposed a significant psychological stress and anxiety on parents, which generally persisted up to 2-weeks post-discharge. Prevention of RSV infection through vaccines and immunoprophylaxis will help ease parental psychological burden associated with RSV hospitalization. Disclosures Krow Ampofo, MBChB, Merck (Grant/Research Support) Yoonyoung Choi, PhD, MS, RPh, Merck (Employee) Lyn Finelli, DrPH, MS, Merck & Co Inc, (Employee)

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