About: Evaluation of New Anti-Infective Drugs for the Treatment of Respiratory Tract Infections

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Attributes	Values
type	Academic Article research paper schema:ScholarlyArticle
isDefinedBy	Covid-on-the-Web dataset
has title	Evaluation of New Anti-Infective Drugs for the Treatment of Respiratory Tract Infections
Creator	Meyer, Richard Hall, Caroline Chow, Anthony Kammer, Robert Klein, Jerome Remington, Jack
Source	PMC
abstract	These guidelines deal with the evaluation of anti-infective drugs for the treatment of respiratory tract infections. Five clinical entities are described: streptococcal pharyngitis and tonsillitis, otitis media, sinusitis, bronchitis, and pneumonia. A wide variety of microorganisms are potentially pathogenetic in these diseases; these guidelines focus on the bacterial infections. Inclusion of a patient in a trial of a new drug is based on the clinical entity, with the requirement that a reasonable attempt will be made to establish a specific microbial etiology. Microbiologic evaluation of efficacy requires isolation of the pathogen and testing for in vitro susceptibility. Alternatively, surrogate markers may be used to identify the etiologic agent. The efficacy of new drugs is evaluated with reference to anticipated response rates. Establishment of the microbial etiology of respiratory tract infections is hampered by the presence of “normal flora” of the nose, mouth, and pharynx, which may include asymptomatic carriage of potential pathogens. This issue is addressed for each category of infection described. For example, it is suggested that for initial phase 2 trials of acute otitis media and acute sinusitis tympanocentesis or direct sinus puncture be used to collect exudate for culture. Acute exacerbations of chronic bronchitis also present difficulties in the establishment of microbial etiology. These guidelines suggest that clinical trials employ an active control drug but leave open the possibility of a placebo-controlled trial. For pneumonia, the guidelines suggest the identification and enrollment of patients by the clinical type of pneumonia, e.g., atypical pneumonia or acute bacterial pneumonia, rather than by etiologic organism or according to whether it was community or hospital acquired. For each respiratory infection, the clinical response is judged as cure, failure, or indeterminate. Clinical improvement is not acceptable unless quantitative response measures can be applied.
has issue date	1992-11-01(xsd:dateTime)
bibo:doi	10.1093/clind/15.supplement_1.s62
bibo:pmid	1477253
has license	no-cc
sha1sum (hex)	4631b967f3e9b5a09000edb1513237b698d468c8
schema:url	https://doi.org/10.1093/clind/15.supplement_1.s62
resource representing a document's title	Evaluation of New Anti-Infective Drugs for the Treatment of Respiratory Tract Infections
has PubMed Central identifier	PMC7110372
has PubMed identifier	1477253
schema:publication	Clin Infect Dis
resource representing a document's body	covid:4631b967f3e9b5a09000edb1513237b698d468c8#body_text
is schema:about of	named entity 'chronic bronchitis' named entity 'pharynx' named entity 'phase 2' named entity 'suggested' named entity 'acute' named entity 'presence' named entity 'focus' named entity 'initial' named entity 'PRESENT' named entity 'HOSPITAL ACQUIRED' named entity 'CLINICAL RESPONSE' named entity 'NEW' named entity 'DRUGS' named entity 'THESE' named entity 'SURROGATE MARKERS' named entity 'STREPTOCOCCAL PHARYNGITIS' named entity 'TESTING' named entity 'DIRECT' named entity 'CHRONIC BRONCHITIS ' named entity 'TYMPANOCENTESIS' named entity 'INCLUSION' named entity 'etiologic agent' named entity 'microorganisms' named entity 'possibility' named entity 'reasonable' named entity 'otitis media' named entity 'entities' named entity 'trials' named entity 'anti-infective' named entity 'response' named entity 'type' named entity 'microbial' named entity 'pathogen' named entity 'pneumonia' named entity 'anti-infective' named entity 'microorganisms' named entity 'pathogenetic' named entity 'tonsillitis' named entity 'respiratory tract infections' named entity 'pharynx' named entity 'pathogen' named entity 'chronic bronchitis' named entity 'bacterial pneumonia' named entity 'pneumonia' named entity 'microbial' named entity 'respiratory infection' named entity 'otitis media' named entity 'biopsy' named entity 'immune status' named entity 'endoscopic' named entity 'oropharyngeal' named entity 'phase 2 trial' named entity 'signs and symptoms' named entity 'Coxiella' named entity 'South Africa' named entity 'sensitive and specific' named entity 'penicillin' named entity 'rapid diagnostic test' named entity 'lymphoma' named entity 'parenteral therapy' named entity 'C. pneumoniae' named entity 'gram-negative' named entity 'respiratory failure' named entity 'pleural' named entity 'sputum' named entity 'tympanometry' named entity 'leukocytosis' named entity 'neutropenic' named entity 'Canadian' named entity 'MBCs' named entity 'blood agar' named entity 'streptococci' named entity 'sterilize' named entity 'auscultatory' named entity 'tracheal' named entity 'chronic diseases'

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