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Biomedical subjects

J O Klein

Publications and source records attributed to J O Klein.

At least 19 recordsLinked to original sources
PubMed1992

Evaluation of new anti-infective drugs for the treatment of respiratory tract infections. Infectious Diseases Society of America and the Food and Drug Administration.

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.

Anti-Bacterial Agents↗
PubMed1992

Otitis media in children born to human immunodeficiency virus-infected mothers.

Acute otitis media (AOM) is thought to occur frequently in children infected with human immunodeficiency virus (HIV). We compared experience with AOM of 28 HIV-infected children with that of 33 children who seroreverted to HIV antibody negative status by age 18 months. The mean number of episodes/year of AOM for children who seroreverted decreased from 1.33 in the first year of life to 0.13 in the third year, whereas the mean number of episodes/year in HIV-infected children increased from 1.89 to 2.40. By age 3 years, all HIV-infected children had experienced 1 or more episodes of AOM, and 80% had experienced 6 or more, whereas 75% of children who seroreverted had experienced 1 or more episodes, and none had had 6 or more. HIV-infected children with normal T4 lymphocyte counts had a mean of 1.18 episodes of AOM in the first year of life compared with 2.35 episodes in HIV-infected children with decreased counts (P = 0.023). HIV-infected children with low counts had a nearly 3-fold increased risk of recurrent AOM (47% vs. 18%).

Acute Disease↗
PubMed1992

Therapy of bacterial sepsis, meningitis and otitis media in infants and children: 1992 poll of directors of programs in pediatric infectious diseases.

To determine current opinions among experts in pediatric infectious diseases for treatment of bacterial sepsis, meningitis and acute otitis media, we polled directors of training programs in January, 1992. Responses were received from 69 centers in the United States and Canada. For initial treatment of presumed bacterial meningitis, the third generation cephalosporins alone or combined with ampicillin have become drugs of choice in all age groups. Most infectious disease programs include dexamethasone in the management of presumed bacterial meningitis for children 2 months of age and older. Third generation cephalosporins are also drugs of choice for presumed sepsis: combined with ampicillin for infants 5 weeks of age; used alone for children 5 months and 12 years of age. Amoxicillin remains the preferred drug for initial treatment of acute otitis media. The combination of amoxicillin and clavulanic acid is favored in the setting of an increased proportion of beta-lactamase-producing bacterial pathogens. Comparison of these results with polls in 1987 and 1989 indicates a shift in recommendations of therapy of presumed bacterial sepsis and meningitis from ampicillin alone or combined with an aminoglycoside or chloramphenicol to use of a third generation cephalosporin alone or combined with ampicillin.

Age Factors↗
PubMed1991

Immunizations.

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Child↗
PubMed1990

Otitis media in infancy and intellectual ability, school achievement, speech, and language at age 7 years. Greater Boston Otitis Media Study Group.

To determine intellectual and linguistic sequelae of middle ear disease, 207 children were randomly selected from a cohort of 498 followed prospectively from birth until age 7 years. After controlling for confounding variables, estimated time spent with middle ear effusion (MEE) during the first 3 years of life was significantly associated with lower scores on tests of cognitive ability, speech and language, and school performance at age 7 years. The adjusted mean full-scale WISC-R were 113.1 for those with least time with MEE, 107.5 for those with moderate time, and 105.4 for those with most time. Similar significant differences were found for verbal and performance IQ scores. For the Metropolitan Achievement Test, we found that middle ear disease in the first 3 years of life was associated with significantly lower scores in mathematics and reading. Similar differences were found for articulation and use of morphologic markers. After considering time spent with MEE during the first 3 years of life, time spent after age 3 years was not a significant predictor of scores on any of the tests administered.

Child↗
PubMed1989

Epidemiology of otitis media during the first seven years of life in children in greater Boston: a prospective, cohort study.

To determine the epidemiology of acute otitis media (AOM) and duration of middle ear effusion (MEE), we followed consecutively enrolled children from shortly after birth until 7 y of age. Because some children dropped out of the study, data were analyzed for 877 children observed for at least 1 y; 698 were observed for at least 3 y, and 498 were observed until 7 y of age. By 1 y of age, 62% of the children had greater than or equal to 1 episode of AOM and 17% had greater than or equal to 3 episodes; by 3 y of age, 83% had greater than or equal to 1 episode of AOM and 46% had greater than or equal to 3 episodes. The peak incidence occurred during the second 6-mo period of life. Significantly increased risk (by multivariate analysis) for AOM was associated with male gender, sibling history of recurrent AOM, early occurrence of AOM, and not being breast fed. MEE persisted after onset of AOM for weeks to months; prolonged duration of MEE was associated with male gender, sibling history of ear infection, and not being breast fed.

Acute Disease↗