Pneumonia in infants and children

Carey, Benjamin W.; Cooley, Thomas B.

doi:10.1016/s0022-3476(39)80130-5

Cited by 10 publications

(5 citation statements)

References 6 publications

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“…Society in general, the medical community, governmental regulatory agencies, and parents and guardians are highly unlikely to endorse a clinical trial that exposes children to potential adverse effects as a direct consequence of their participation. Furthermore, as discussed, placebo-controlled trials (albeit with a rudimentary randomization scheme) have already confirmed that antibacterials are superior to placebo for the treatment of pediatric CAP [7,8] and provide data sufficient for an effect size to be estimated. Thus, a noninferiority trial with an active comparator is an appropriate clinical trial design for testing the efficacy of new antibiotics for the treatment of pediatric CAP.…”

Section: Placebo-controlled and Dose-ranging Trialsmentioning

confidence: 90%

“…A parent may not be willing to allow a child to experience adverse consequences in a clinical trial, if the possibility exists that the child might receive an ineffective drug or placebo. Information on the risks of nontreatment for hospitalized infants and children with CAP exists; in placebo-controlled clinical trials of sulfapyridine, mortality rates decreased from 12.6% to 4.3% among infants aged !2 years, and the duration of pneumonia in those who survived decreased from 12 days to 6 days [8]. Similar placebo-controlled trials have never been performed with ambulatory pediatric populations.…”

Section: Children As Experimental Subjectsmentioning

confidence: 99%

“…The first randomized, controlled studies of sulfapyridine for the treatment of CAP in children occurred in 1939 [7,8]. Carey and Cooley [8] gave 630 children hospitalized with pneumonia in Detroit treatment with sulfapyridine ( ), antipneumon p 248 coccal serum ( ), or no specific treatment ( ). n p 106 n p 276 The diagnosis of pneumonia was based on compatible clinical symptoms, supported by chest radiograph findings for 90% of the children.…”

Section: Historical Data On Pediatric Capmentioning

confidence: 99%

“…It is important to know the benefits of treatments, to allow a comparison with the adverse events that may result from antibiotic exposure. However, in a placebo-controlled trial, the children with bacterial pneumonia who are randomized to receive placebo will derive no personal benefit from the trial and are placed at real risk for morbidity and mortality [7,8]. Society in general, the medical community, governmental regulatory agencies, and parents and guardians are highly unlikely to endorse a clinical trial that exposes children to potential adverse effects as a direct consequence of their participation.…”

Section: Placebo-controlled and Dose-ranging Trialsmentioning

confidence: 99%

“…The rate of resolution of signs and symptoms of infection, as reported by patients and/or parents, is an acceptable end point for clinical trials of upper respiratory tract infections [52] in young infants and has been used to describe outcomes for lower respiratory tract infections in studies dating back to 1939 [7,8,12]. Scoring systems that use time to resolution of clinical symptoms may accurately distinguish the clinical outcome between 2 antibiotic therapies.…”

Section: Clinical Outcomes In Pediatric Cap On the Basis Of Current Smentioning

confidence: 99%

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Unique Considerations in the Evaluation of Antibacterials in Clinical Trials for Pediatric Community‐Acquired Pneumonia

Bradley

McCracken

2008

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There are few placebo-controlled, randomized, prospective clinical trials of antibiotic therapy for community-acquired pneumonia (CAP) in children. The reduction in mortality seen in early trials of antibacterials for treatment of bacterial CAP in adults and children was dramatic and led to the adoption of antibacterial therapy as the standard of care for CAP in both adults and children. Because of the efficacy of antibacterials for treatment of CAP in adults and the reluctance of society to place children at risk of adverse outcomes in placebo-controlled clinical trials, pediatric investigations of this type were not performed after 1940. Instead, comparative trials were subsequently conducted and reported. More recently, comparative trials using a noninferiority trial design have been used by regulatory agencies to grant approval of antibiotic therapy for pediatric CAP. We cannot reliably distinguish between pneumonia cases caused by bacterial, viral, or atypical pathogens among the relatively homogeneous population of children with CAP who are enrolled into clinical trials. Patient- or parent-reported outcomes represent an option for appropriate, defined clinical trial outcomes for pediatric CAP, because the disease in children has a relatively short and potentially self-resolving clinical course. Clinical trials that require invasive techniques for diagnosis and placebo-controlled randomized trials are not acceptable for children, who are considered to be a vulnerable population.

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Section: Placebo-controlled and Dose-ranging Trialsmentioning

confidence: 90%

Section: Children As Experimental Subjectsmentioning

confidence: 99%

Section: Historical Data On Pediatric Capmentioning

confidence: 99%

Section: Placebo-controlled and Dose-ranging Trialsmentioning

confidence: 99%

Section: Clinical Outcomes In Pediatric Cap On the Basis Of Current Smentioning

confidence: 99%

See 3 more Smart Citations

Unique Considerations in the Evaluation of Antibacterials in Clinical Trials for Pediatric Community‐Acquired Pneumonia

Bradley

McCracken

2008

CLIN INFECT DIS

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Effect of Chemotherapy on Pneumonia in Infants Under One Year of Age

Greengard¹

1941

Arch Pediatr Adolesc Med

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The mortality from pneumonia in childhood has always been greatest in infancy. In the infant ward at Cook County Hospital many patients with pneumonia are treated, and the mortality has always been high. In 1937 and 1938, before chemotherapy was used, the mortality rates were 32 per cent and 31 per cent respectively. The infants, all under 1 year of age, were drawn from essentially the same group and were treated by the same medical personnel and with the same therapeutic measures other than specific chemotherapy as the 1940 series which is the subject of this paper. While it is true that the incidence and mortality of pneumonia vary somewhat from season to season, these figures at least serve as a base line from which some conclusions can be drawn with regard to a human experiment in which adequate control is practically impossible.With the advent of specific therapy, particularly specific chemotherapy, there was a distinct change in the outlook for babies with pneumonia. Serum therapy never was of outstanding value for this age group because of the difficulties encountered in obtaining and typing organisms. The administration of sulfapyridine (2-[paraaminobenzenesulfonamidoj-pyridine), however, could be initiated quickly, without the necessity of knowing the exact organism present in a given case. This report consists of an analysis of the results obtained for a series of 289 infants observed from March 1939 to July 1940, to whom sulfapyridine was given.In the past few years a considerable amount of literature has accumulated relating to the use of sulfapyridine or related compounds in the therapy of pneumonia. In general, the results have shown a Read at a meeting of the Chicago Pediatric Society, Jan. 21, 1941.

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Staphylococcic (Suppurative) Pneumonia in Infancy and in Childhood and Its Surgical Aspects

Blumenthal¹,

Neuhof²

1946

Arch Pediatr Adolesc Med

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Pneumonia in infants and children

Cited by 10 publications

References 6 publications

Unique Considerations in the Evaluation of Antibacterials in Clinical Trials for Pediatric Community‐Acquired Pneumonia

Unique Considerations in the Evaluation of Antibacterials in Clinical Trials for Pediatric Community‐Acquired Pneumonia

Effect of Chemotherapy on Pneumonia in Infants Under One Year of Age

Staphylococcic (Suppurative) Pneumonia in Infancy and in Childhood and Its Surgical Aspects

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