Early Azithromycin Treatment to Prevent Respiratory Illness in Children . Although viral infections are often present, bacteria may also contribute to illness pathogenesis. Strategies that effectively attenuate such episodes are needed.

Objective. To evaluate if early administration of azithromycin, started prior to the onset of severe LRTI symptoms, in preschool children with recurrent severe LRTIs can prevent the progression of these episodes. Design, Setting, and Participants. A randomized, double- blind, placebo- controlled, parallel- group trial conducted across 9 academic US medical centers in the National Heart, Lung, and Blood Institute’s Asthma.

Net network, with enrollment starting in April 2. December 2. 01. 4.

Participants were 6. Download Whole Undercover Grandpa (2017) Movie more. LRTIs and minimal day- to- day impairment.

Intervention. Participants were randomly assigned to receive azithromycin (1. RTI (child’s signs or symptoms prior to development of LRTI), based on individualized action plans, over a 1. Main Outcomes and Measures. The primary outcome measure was the number of RTIs not progressing to a severe LRTI, measured at the level of the RTI, that would in clinical practice trigger the prescription of oral corticosteroids. Presence of azithromycin- resistant organisms in oropharyngeal samples, along with adverse events, were among the secondary outcome measures.

Technical Document for the decision limits for the confirmatory quantification of threshold substances.

Results. A total of 9. RTIs (azithromycin group, 4. LRTIs (azithromycin group, 3.

Azithromycin significantly reduced the risk of progressing to severe LRTI relative to placebo (hazard ratio, 0. Induction of azithromycin- resistant organisms and adverse events were infrequently observed. Conclusions and Relevance. Among young children with histories of recurrent severe LRTIs, the use of azithromycin early during an apparent RTI compared with placebo reduced the likelihood of severe LRTI. More information is needed on the development of antibiotic- resistant pathogens with this strategy. Trial Registration. Identifier: NCT0.

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Introduction. Acute episodes of severe lower respiratory tract illness (LRTI) are common among preschoolers, and up to 1. These severe episodes are often associated with substantial morbidity, resulting in unscheduled visits to physician offices, urgent care, and emergency departments. Many of these young children are diagnosed with asthma, and among them, 2. Thus, identification of novel treatment approaches that attenuate the severity of these recurrent episodes would provide substantial benefit to preschool children with recurrent severe LRTI. The etiology of these acute episodes has not been completely elucidated. Although initial reports showed frequent detection of respiratory viruses in nasopharyngeal secretions obtained during episodes of wheezing in preschoolers,4,5 bacteria are also often present during such episodes.

In children with asthma aged 4 through 1. Streptococcus pneumoniae or Moraxella catarrhalis from nasal samples also containing rhinovirus was associated with increased likelihood of having an asthma exacerbation. The ketolide antibiotic telithromycin, when started within the first 2. These findings are compatible with the decrease in neutrophilic inflammation observed in patients with severe asthma treated with the macrolide clarithromycin. The primary chemoattractant for neutrophils is interleukin 8 (IL- 8), and it has been shown that a polymorphism in the IL- 8 gene, rs. IL- 8 production.

1. Although in textbooks asthma and chronic obstructive pulmonary disease (COPD) are viewed as distinct disorders, there is increasing awareness that many patients have.
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Based upon these findings, we conducted a randomized clinical trial of early administration of the macrolide azithromycin, started early in the course of an RTI and prior to the onset of severe LRTI symptoms, in preschool children with recurrent severe LRTIs to determine if this intervention can safely prevent the progression of such episodes. The institutional review board at each center approved and monitored the study. Parents or guardians provided written informed consent. Participants received compensation for time and travel expenses. Details about inclusion and exclusion criteria are provided in Supplement 2. Briefly, eligible participants were children aged 1.

LRTIs that required systemic corticosteroids, an unscheduled physician office visit, an urgent or emergency department visit, or hospitalization. Exclusion criteria included more than 4 courses of systemic corticosteroids or more than 1 hospitalization in the past 1. These criteria excluded children with more severe disease who require daily controller medication. Children receiving monotherapy with asthma controllers (either low- dose inhaled corticosteroids or montelukast) at enrollment were eligible but had their controller discontinued upon study entry, consistent with recommendations for step- down therapy.

Children with significant symptomatic asthma and those with inadequate adherence to diary card completion (< 8. Supplement 2) were also excluded. Race was assessed by parent/guardian report, using National Institutes of Health race/ethnicity reporting standards and categories.

A participant was classified as having a positive modified asthma predictive index (API) if the participant had experienced at least 4 wheezing episodes in the past year and had 1 major criterion (physician- diagnosed atopic dermatitis, parental history of asthma, or allergic sensitization to . Parents or guardians were provided with an individualized care plan, developed with the study team, that instructed starting study therapy as soon as participants developed the symptoms or signs that parents or guardians defined as the child’s usual starting point before the development of a severe LRTI. During RTIs, all participants received albuterol inhalation treatments 4 times daily while awake for the first 4. RTI. 1. 3- 1. 5Computer- generated randomization was implemented via a secure web- based randomization module at the Data Coordinating Center and stratified by clinical center and age (1.

The trial began in April 2. RTIs not progressing to severe LRTI. In June 2. 01. 2, based upon a prespecified interval assessment that demonstrated a lower than expected RTI rate, the follow- up period was extended to 7. RTIs. Samples were inoculated onto sheep's blood agar containing 2 .

The absence or presence of normal upper respiratory tract flora was assessed, and pathogenic organisms were isolated and identified. Susceptibility testing was performed on pathogenic bacteria using disk diffusion for azithromycin, erythromycin, clindamycin, clarithromycin, and cefoxitin (to assess for Staphylococcus aureus). Nasal secretions were collected by direct “nasal blow technique” or nasal swab at scheduled visits at randomization and during each treated RTI at home by a trained parent or guardian.

Samples were frozen for later analysis for respiratory virus detection by polymerase chain reaction–based diagnostic assays. This assay detects the following viruses: rhinovirus or enteroviruses (not distinguishable by this assay); coronaviruses; adenoviruses B, C, and E; influenza A and B; parainfluenza viruses I- IV; respiratory syncytial virus A and B; metapneumovirus; and bocavirus. Participants were genotyped for the IL- 8 rs. Hd Video 720P Mad Max: Fury Road (2015). Further details are provided in Supplement 2.

Parents or guardians were instructed to call the clinical center if any of the following levels of symptoms that represented a severe LRTI occurred: (1) having symptoms that were more than mild after 3 albuterol administrations over 1 hour, (2) requiring albuterol administrations more often than once every 4 hours, (3) requiring more than 6 albuterol treatments over a 2. If the study physician concurred that the patient was experiencing this degree of symptomatology, the primary end point was reached.