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1.
Effect of nutritional support in patients with lower respiratory tract infection: Secondary analysis of a randomized clinical trial.
Baumgartner, A, Hasenboehler, F, Cantone, J, Hersberger, L, Bargetzi, A, Bargetzi, L, Kaegi-Braun, N, Tribolet, P, Gomes, F, Hoess, C, et al
Clinical nutrition (Edinburgh, Scotland). 2021;(4):1843-1850
Abstract
BACKGROUND In polymorbid patients with bronchopulmonary infection, malnutrition is an independent risk factor for mortality. There is a lack of interventional data investigating whether providing nutritional support during the hospital stay in patients at risk for malnutrition presenting with lower respiratory tract infection lowers mortality. METHODS For this secondary analysis of a randomized clinical trial (EFFORT), we analyzed data of a subgroup of patients with confirmed lower respiratory tract infection from an initial cohort of 2028 patients. Patients at nutritional risk (Nutritional Risk Screening [NRS] score ≥3 points) were randomized to receive protocol-guided individualized nutritional support to reach protein and energy goals (intervention group) or standard hospital food (control group). The primary endpoint of this analysis was all-cause 30-day mortality. RESULTS We included 378 of 2028 EFFORT patients (mean age 74.4 years, 24% with COPD) into this analysis. Compared to usual care hospital nutrition, individualized nutritional support to reach caloric and protein goals showed a similar beneficial effect of on the risk of mortality in the subgroup of respiratory tract infection patients as compared to the main EFFORT trial (odds ratio 0.47 [95%CI 0.17 to 1.27, p = 0.136] vs 0.65 [95%CI 0.47 to 0.91, p = 0.011]) with no evidence of a subgroup effect (p for interaction 0.859). Effects were also similar among different subgroups based on etiology and type of respiratory tract infection and for other secondary endpoints. CONCLUSION This subgroup analysis from a large nutrition support trial suggests that patients at nutritional risk as assessed by NRS 2002 presenting with bronchopulmonary infection to the hospital likely have a mortality benefit from individualized inhospital nutritional support. The small sample size and limited statistical power calls for larger nutritional studies focusing on this highly vulnerable patient population. CLINICAL TRIAL REGISTRATION Registered under ClinicalTrials.gov Identifier no. NCT02517476.
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2.
Influence of Dietary Advice Including Green Vegetables, Beef, and Whole Dairy Products on Recurrent Upper Respiratory Tract Infections in Children: A Randomized Controlled Trial.
van der Gaag, E, Brandsema, R, Nobbenhuis, R, van der Palen, J, Hummel, T
Nutrients. 2020;(1)
Abstract
BACKGROUND Since no treatment exists for children suffering from upper respiratory tract infections (URTIs) without immunological disorders, we searched for a possible tool to improve the health of these children. AIM: We evaluated whether dietary advice (based on food matrix and food synergy), including standard supportive care, can decrease the number and duration of URTIs in children with recurrent URTIs. DESIGN AND SETTING This study was a multicenter randomized controlled trial in two pediatric outpatient clinics in the Netherlands, with 118 children aged one to four years with recurrent URTIs. The dietary advice group received dietary advice plus standard supportive care, while the control group received standard supportive care alone for six months. The dietary advice consisted of green vegetables five times per week, beef three times per week, 300 mL whole milk per day, and whole dairy butter on bread every day. Portion sizes were age-appropriate. RESULTS AND CONCLUSION Children in the dietary advice group had 4.8 (1.6-9.5) days per month with symptoms of an URTI in the last three months of the study, compared to 7.7 (4.0-12.3) in the control group (p = 0.028). The total number of URTIs during the six-month study period was 5.7 (0.55) versus 6.8 (0.49), respectively (p = 0.068). The use of antibiotics was significantly reduced in the dietary advice group, as well as visits to a general practitioner, thereby possibly reducing healthcare costs. The results show a reduced number of days with symptoms of a URTI following dietary advice. The number of infections was not significantly reduced.
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3.
Bacteriotherapy with Streptococcus salivarius 24SMB and Streptococcus oralis 89a nasal spray for treatment of upper respiratory tract infections in children: a pilot study on short-term efficacy.
Manti, S, Parisi, GF, Papale, M, Licari, A, Salpietro, C, Miraglia Del Giudice, M, Marseglia, GL, Leonardi, S
Italian journal of pediatrics. 2020;(1):42
Abstract
BACKGROUND Recurrent respiratory infections (RRIs) are defined by the presence of at least one of the following criteria: (i) > 6 annual respiratory infections (RIs); (ii) > 1 monthly RIs involving the upper airways from September to April; (iii) > 3 annual RIs involving the lower airways represent a very common health problem in the first years of life. We conducted a multi-centre, prospective, single-open study to assess the efficacy and the safety of Streptococcus salivarius 24SMBc and Streptococcus oralis 89a in the prevention of upper respiratory tract infections (URTIs) in children. METHODS Ninety-one children (M:F = 47:44, mean age 7.4 ± 2.3 years) with RRIs were enrolled in the study between September and November 2018. At baseline, children received Streptococcus salivarius 24SMBc and Streptococcus oralis 89a as 2 puffs for nostril twice/day for 7 days/months. The treatment lasted for 3 consecutive months. Efficacy was expressed in terms of absence or presence of fever, cough, bronchospasm, rhinorrhea and otalgia, at 1 month (T1), and 3 (T3) months. Safety and tolerability of the probiotic were evaluated on the basis of the number and type of adverse events (AEs) recorded during the treatment. RESULTS Children treated with Streptococcus salivarius 24SMBc and Streptococcus oralis 89a showed a significant decrease of symptoms including episodes of fever, cough, bronchospasm, rhinorrhea, and otalgia (p < 0.001) compared to baseline. The treatment significantly reduced the number of episodes of fever, cough, bronchospasm, rhinorrhea, otalgia, and cough also in patients with positive familial history for atopy and in atopic children (p < 0.05). No significant differences in symptoms among children with negative familial history for atopy and children with positive familial history for atopy subgroups, not atopic and atopic children subgroups, and smoke-exposed and not smoke-exposed subgroups were observed (p > 0.05). Conducting a subgroup analysis according to the age, it has been reported that children aged 1-3 years old showed an improvement in all symptoms, however, they become statistically significant only at the end of the 3 months of treatment (p < 0.05). Conversely, in children aged 3-6 and 6-12 years old, the therapeutic efficacy was progressive and significant already from the first month of therapy (p < 0.05). None of the children were withdrawn from the study because of AEs, although 9 children experienced burning nose leading to interruption of therapy. CONCLUSIONS Our findings suggest that Streptococcus salivarius 24SMBc and Streptococcus oralis 89a treatment is safe and seems to be effective on short-term in the treatment of RRIs. Studies involving a longer observation period are necessary to establish the real efficacy of the product for the treatment of pediatric patients affected by RRIs.
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4.
The antipyretic efficacy and safety of propacetamol compared with dexibuprofen in febrile children: a multicenter, randomized, double-blind, comparative, phase 3 clinical trial.
Choi, SJ, Moon, S, Choi, UY, Chun, YH, Lee, JH, Rhim, JW, Lee, J, Kim, HM, Jeong, DC
BMC pediatrics. 2018;(1):201
Abstract
BACKGROUND We aimed to compare the antipyretic efficacy, safety, and tolerability between oral dexibuprofen and intravenous propacetamol in children with upper respiratory tract infection (URTI) presenting with fever. METHODS Patients aging from 6 months to 14 years admitted for URTI with axillary body temperature ≥ 38.0 °C were enrolled and randomized into the study or control group. Patients in the study group were intravenously infused with propacetamol and subsequently oral placebo medication was administered. Patients in the control group were intravenously infused with 100 mL of 0.9% sodium chloride solution without propacetamol and then oral dexibuprofen was administered. We checked the body temperature of all patients at 0.5 h (hr), 1 h, 1.5 h, 2 h, 3 h, 4 h, and 6 h after oral placebo or dexibuprofen had been applied. RESULTS A total of 263 patients (125 in the study group) were finally enrolled. The body temperatures of patients in the study group were significantly lower until 2 h after administration (37.73 ± 0.58 vs 38.36 ± 0.69 °C (p < 0.001), 37.37 ± 0.53 vs 37.88 ± 0.69 °C (p < 0.001), 37.27 ± 0.60 vs 37.62 ± 0.66 °C (p < 0.001), 37.25 ± 0.62 vs 37.40 ± 0.60 °C (p = 0.0452), at 0.5 h, 1 h, 1.5 h, and 2 h, respectively). The two groups showed no significant differences in terms of the range of body temperature decrease, the Area Under the Curve of body temperature change for antipyretic administration-and-time relationship, the maximum value of body temperature decrease during the 6 h test period, the number of patients whose body temperature normalized (< 37.0 °C), the mean time when first normalization of body temperature, and the development of adverse events including gastrointestinal problem, elevated liver enzyme, and thrombocytopenia. CONCLUSIONS Intravenous propacetamol may be a safe and effective choice for pediatric URTI patients presenting with fever who are not able to take oral medications or need faster fever control. TRIAL REGISTRATION CRIS KCT0002888 . Date of registration: July 31st, 2013.
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5.
Montelukast for postinfectious cough in adults: a double-blind randomised placebo-controlled trial.
Wang, K, Birring, SS, Taylor, K, Fry, NK, Hay, AD, Moore, M, Jin, J, Perera, R, Farmer, A, Little, P, et al
The Lancet. Respiratory medicine. 2014;(1):35-43
Abstract
BACKGROUND Postinfectious cough is common in primary care, but has no proven effective treatments. Cysteinyl leukotrienes are involved in the pathogenesis of postinfectious cough and whooping cough (pertussis). We investigated the effectiveness of montelukast, a cysteinyl leukotriene receptor antagonist, in the treatment of postinfectious cough. METHODS In this randomised, placebo-controlled trial, non-smoking adults aged 16-49 years with postinfectious cough of 2-8 weeks' duration were recruited from 25 general practices in England. Patients were tested for pertussis (oral fluid anti-pertussis toxin IgG) and randomly assigned (1:1) to montelukast 10 mg daily or image-matched placebo for 2 weeks. Patients chose whether to continue study drug for another 2 weeks. The randomisation sequence was computer-generated and stratified by general practice. Patients, health-care professionals, and researchers were masked to treatment allocation. Effectiveness was assessed with the Leicester Cough Questionnaire to measure changes in cough-specific quality of life; the primary outcomes were changes in total score between baseline and two follow-up stages (2 weeks and 4 weeks). The primary analysis was by intention to treat with imputation by last observation carried forward. Recruitment closed on Sept 21, 2012, and follow-up has been completed. This trial is registered with EudraCT (2010-019647-19), UKCRN Portfolio (ID 8360), and ClinicalTrials.gov (NCT01279668). FINDINGS From April 13, 2011, to Sept 21, 2012, we randomly assigned 276 patients to montelukast (n=137) or placebo (n=139). 70 (25%) patients had laboratory-confirmed pertussis. Improvements in cough-specific quality of life occurred in both groups after 2 weeks (montelukast: mean 2·7, 95% CI 2·2-3·3; placebo: 3·6, 2·9-4·3), but the difference between groups did not meet the minimum clinically important difference of 1·3 (mean difference -0·9, -1·7 to -0·04, p=0·04). This difference was not statistically significant in any sensitivity analyses. After 2 weeks, 192 of 259 participants from whom data were available elected to continue study drug (99 [77%] of 129 participants on montelukast; 93 [72%] of 130 on placebo). After 4 weeks, there were no significant between-group differences in cough-specific quality of life improvement (montelukast: 5·2, 4·5-5·9; placebo: 5·9, 5·1-6·7; mean difference -0·5, -1·5 to 0·6, p=0·38) or adverse event rates (21 (15%) of 137 patients on montelukast reported one or more adverse events; 31 (22%) of 139 on placebo; p=0·14). The most common adverse events reported were increased mucus production (montelukast, n=6; placebo, n=2), gastrointestinal disturbance (montelukast, n=3; placebo, n=5), and headache (montelukast, n=2; placebo, n=6). One serious adverse event was reported (placebo, n=1), which was unrelated to study drug (shortness of breath and throat tightness after severe coughing bouts). INTERPRETATION Montelukast is not an effective treatment for postinfectious cough. However, the burden of postinfectious cough in primary care is high, making it an ideal setting for future antitussive treatment trials. FUNDING National Institute for Health Research School for Primary Care Research, UK.
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6.
[Treatment of upper respiratory infection by fangfeng tongsheng granule: a randomized controlled study].
Wang, S, Zhao, T, Qi, WS, Liu, YJ, Yang, XJ, Mo, TT, Wang, J, Liu, GY, Gao, F, Liu, RK, et al
Zhongguo Zhong xi yi jie he za zhi Zhongguo Zhongxiyi jiehe zazhi = Chinese journal of integrated traditional and Western medicine. 2013;(10):1328-31
Abstract
OBJECTIVE To evaluate the clinical effectiveness and safety of Fangfeng Tongsheng Granule (FTG) in the treatment of upper respiratory infection (superficial cold and interior heat syndrome, exterior and interior excess syndrome). METHODS A randomized, double-blinded, multi-centered, placebo-parallel-controlled clinical trial was adopted. Totally 324 patients were enrolled and assigned to two groups, 216 patients in the treatment group and 108 patients in the control group. Those in the treatment group took FTG at the daily dose of 3 g, twice per day, the therapeutic course being 3 days. Those with axillary temperature more than 37 degrees C took one more time before medication. Those in the control group took simulated agent granules the same dose and dosage as the treatment group. The effect of Chinese medical syndrome (ECMS), the rate of temperature-dropping-to-normal (RT), the time of temperature-dropping-to-normal (TT), the curative effect of single symptom (CESS) and adverse reactions were observed. RESULTS Totally 203 completed the trial in the treatment group and 101 in the control group. In the treatment group, the cured-effective rate was 55.67% (113/ 101), the total effective rate was 93.10% (189/101), the ECMS score decreased by 9.24 +/- 4.46, while they were 5.94% (6/101), 36.63% (37/101), and 3.27 +/- 3.29, respectively in the control group (P < 0.01). The RT was 87.50% (98/112) in the treatment group and 58.49% (31/53) in the control group (P < 0.01). The TT in the treatment group was superior to that of the control group (P < 0.01). As for CESS, all of the three primary symptoms and nine secondary symptoms were improved more obviously in the treatment group than in the control group. The integral decreased obviously, showing statistical difference (P < 0.01). The decrease was more obvious in the treatment group than in the control group (P < 0.01). There was no adverse event related to FTG. CONCLUSION FTG was effective and safe in treating upper respiratory infection (superficial cold and interior heat syndrome, exterior and interior excess syndrome).
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7.
[The clinical evaluation of piperacillin and sulbactam sodium in treatment of respiratory, urinary tracts and other infections in 579 patients].
Zhou, J, Zhao, Y, Guo, W, Cao, QM, Zhao, SM, Li, GP, Ma, XJ
Zhonghua nei ke za zhi. 2011;(7):601-3
Abstract
OBJECTIVE To evaluate the clinical efficacy and safety of piperacillin and sulbactam sodium combinations in the treatment of common infections. METHODS This was a multi-centre, prospective and open study. All subjects from 57 wards caught common infection like respiratory (RTI) or urinary diseases (UTI). The dosages of piperacillin and sulbactam sodium combinations 2.5 g injection were determined according to indications: for adult, 2.5 g or 5 g per time, 2 time/day; for severe or obstinate infection, 2.5 g or 5 g per time, 3 time/day. General information, clinical response pre- and post-treatment, infected locus, drug recipe and protocol, prognosis and adverse reaction were recorded. RESULTS Data of 579 cases were collected with 388 males and 191 females. The average age was (66.8 ± 17.0) years. There were 500 patients who were suffering with RTI, with 362 cases of pneumonia, 102 of acute exacerbation of chronic bronchitis, and 36 of other infections. There were 50 cases with UTI, with 31 of simple urinary tract infection, and 19 of complex urinary tract infection. In addition, there were 9 cases of combined RTI and UTI, and 20 of other infections including peritonitis. The average duration of anti-microbial for RTI and UTI was (8.65 ± 3.78) days and (7.45 ± 3.46) days respectively with the total efficacy rate was 92.6% and 98.0% respectively for RTI and UTI. The incidence of adverse events was only 0.86% (5 cases), including nausea, rash, itching, ALT elevation and suspected drug induced fever in each one. CONCLUSION Piperacillin and sulbactam sodium compound had high clinical efficacy and safety in the treatment of common infections including RTI and UTI.
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8.
Guidance of antibiotic therapy with procalcitonin in lower respiratory tract infections: insights into the ProHOSP study.
Schuetz, P, Christ-Crain, M, Albrich, W, Zimmerli, W, Mueller, B, ,
Virulence. 2010;(2):88-92
Abstract
In the recently published ProHOSP trial, we investigated the safety and external validity of procalcitonin (PCT) guidance for antibiotic therapy in patients with different severities of lower respiratory tract infections, mainly pneumonia. In this addendum, we aim to extend the initial report by reinforcing the rational of the PCT algorithm and by presenting more detailed data on antibiotic therapy in different severities of infection. In milder, mostly viral respiratory infections (i.e. acute or chronic bronchitis) initial prescription of antibiotics was markedly reduced by PCT guidance because PCT remained low in most patients. In pneumonia, PCT showed a severity-dependent increase and highest levels in patients with positive blood cultures. Thus, the main effect in pneumonia was a severity- and bacteremia-adapted reduction of the duration of antibiotic courses. In lower respiratory tract infections, PCT guidance had a differential effect on antibiotic exposure depending on the underlying type and severity of respiratory tract infection.
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9.
Efficacy of a synbiotic supplementation in the prevention of common winter diseases in children: a randomized, double-blind, placebo-controlled pilot study.
Cazzola, M, Pham-Thi, N, Kerihuel, JC, Durand, H, Bohbot, S
Therapeutic advances in respiratory disease. 2010;(5):271-8
Abstract
BACKGROUND AND AIMS The purpose of this study was to investigate the efficacy of a synbiotic supplementation in reducing common winter diseases in children. METHODS A randomized, double-blind, placebo-controlled, multicentre study was conducted in young school-age children (3-7 years old) during a winter period. Participants were otherwise healthy children who suffered from at least three episodes of ear, nose and throat (ENT), respiratory tract or gastrointestinal illness during the previous winter. They were supplemented daily with either a synbiotic preparation (Lactobacillus helveticus R0052, Bifidobacterium infantis R0033, Bifidobacterium bifidum R0071, and fructooligosaccharide) or a matched placebo for 3 months. Over this period, all emergent health episodes of any type were recorded by parents in a diary. They were checked by investigators at regular monthly visits. The main study outcome was the percentage of children free of any episode during the study course. RESULTS We randomized 135 children (mean age: 4.1±1.0 years) to the synbiotic group (n = 62) or placebo (n = 73) group. At least one illness episode was reported in 32 children in the synbiotic group and 50 in the placebo group (51.6% versus 68.5%). This corresponded to a significant 25% relative risk reduction (95% CI 0.6-44.3%; p = 0.045). This difference was due to a decrease in the number of children who suffered from at least one ENT, respiratory tract or gastrointestinal disorder (50.0% with synbiotic versus 67.1% with placebo; p = 0.044). At least one sickness school day loss was noted in 25.8% of children with the synbiotic as compared with 42.5% with placebo (p = 0.043). No treatment related side effects were detected in either group. CONCLUSIONS This study suggests that a 3-month supplementation with this synbiotic preparation can decrease the risk of occurrence of common infectious diseases in children and limits the risk of school day loss.
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10.
Consumption of a fermented dairy product containing the probiotic Lactobacillus casei DN-114001 reduces the duration of respiratory infections in the elderly in a randomised controlled trial.
Guillemard, E, Tondu, F, Lacoin, F, Schrezenmeir, J
The British journal of nutrition. 2010;(1):58-68
Abstract
Common infectious diseases (CID) of the airways and the gastrointestinal tract are still a considerable cause of morbidity and mortality in elderly. The present study examined the beneficial effect of a dairy product containing the probiotic strain Lactobacillus casei DN-114 001 (fermented product) on the resistance of free-living elderly to CID. The study was multicentric, double blind and controlled, involving 1072 volunteers (median age = 76.0 years) randomised for consumption of either 200 g/d of fermented (n 537) or control (non-fermented) dairy product (n 535) for 3 months, followed by an additional 1 month's follow-up. The results showed that, when considering all CID, the fermented product significantly reduced the average duration per episode of CID (6.5 v. 8 d in control group; P = 0.008) and the cumulative duration of CID (7 v. 8 d in control group; P = 0.009). Reduction in both episode and cumulative durations was also significant for all upper respiratory tract infections (URTI; P < 0.001) and for rhinopharyngitis (P < 0.001). This was accompanied with an increase of L. casei species in stools throughout the fermented product consumption (2-3.8 x 107 equivalents of colony-forming unit/g of stools, P < 0.001). The cumulative number of CID (primary outcome) was not different between groups nor was the CID severity, fever, pathogens' occurrence, medication, immune blood parameters and quality of life. The fermented product was safe and well tolerated. In conclusion, consumption of a fermented dairy product containing the probiotic strain L. casei DN-114 001 in elderly was associated with a decreased duration of CID in comparison with the control group, especially for URTI such as rhinopharyngitis.