Managing Bacterial Pneumonia in Children Without Antimicrobials
Can Community-acquired Bacterial Pneumonia in Children be Safely Managed Without Antibiotics in an Integrative Medicine Context? A Retrospective Cohort Analysis
Retrospective cohort analysis of children hospitalized for pneumonia comparing disease severity on admission, clinical course, treatment and outcomes and prospective telephone based Follow-Up assessement.
調査の概要
詳細な説明
The investigators will conduct a retrospective cohort analysis of children hospitalized for pneumonia at the Filderklinik between December 2006 and November 2010.
The Bacterial Pneumonia Score, a validated composite laboratory, clinical and radiologic score developed by Moreno et al, will be retrospectively applied to define cases as either viral or bacterial pneumonia.
The investigators will compare disease severity on admission, clinical course, and outcomes (in terms of complications, length of stay and readmission rates) between antimicrobial and non-antimicrobial managed bacterial pneumonia cases.
Long-term Follow-Up will be assessed by telephone interviews with the parents.
研究の種類
観察的
入学 (実際)
350
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究場所
-
-
Baden-Württemberg
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Filderstadt、Baden-Württemberg、ドイツ、70794
- Arcim Institute
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-
参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
18年歳未満 (子、大人)
健康ボランティアの受け入れ
いいえ
受講資格のある性別
全て
サンプリング方法
確率サンプル
調査対象母集団
Children from infancy till adolecence admitted to hospital (Filderklinik, Germany) for pneumonia treatment
説明
Inclusion Criteria:
- Hospital admission at the pediatric department of the Filderklinik.
- Admission diagnosis pneumonia (ICD J12.0, J12.1, J12.8, J12.9, J14, J15.1, J15.6, J15.7, J15.8, J15.9, J16.8, J18.0, J18.1, J18.8, J18.9 - all 12s, 15s, 16s, 18s)
Exclusion Criteria:
- None
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Cure rate of non-antimicrobial management of bacterial pneumonia
時間枠：Between admission and 3 months after discharge
|
Cure rate of non-antimicrobial management of bacterial pneumonia (in the following and in the final publication, the term "bacterial pneumonia" will be used for children who fulfill the Moreno criteria for pneumonia): % of children managed without antimicrobials since admission, without subsequent need for antimicrobials or readmission.
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Between admission and 3 months after discharge
|
|
Medical complication rate
時間枠：Between admission and 3 months after discharge
|
Medical complication rate among children with bacterial pneumonia, treated with or without antimicrobials
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Between admission and 3 months after discharge
|
|
Length of hospital stay
時間枠：Between admission and 3 months after discharge
|
Length of hospital stay for children with bacterial pneumonia, managed with or without antimicrobials
|
Between admission and 3 months after discharge
|
|
Readmission rate
時間枠：7 - 10 years after hospitalization
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Readmission rate for pneumonia among children with bacterial pneumonia, managed with or without antimicrobials
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7 - 10 years after hospitalization
|
|
Temperature normalization
時間枠：Between admission and 3 months after discharge
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Days to temperature normalization (< 38°C) in children with bacterial pneumonia, managed with or without antimicrobials
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Between admission and 3 months after discharge
|
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Days of supplemental oxygen need
時間枠：Between admission and 3 months after discharge
|
Days of supplemental oxygen need in children with bacterial pneumonia, managed with or without antimicrobials
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Between admission and 3 months after discharge
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Changes in respiratory rate
時間枠：Between admission and 3 months after discharge
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Changes in respiratory rate as an indicator for pulmonary infection
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Between admission and 3 months after discharge
|
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Changes in Bacterial Pneumonia Score
時間枠：Between admission and 3 months after discharge
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Changes in Bacterial Pneumonia Score as an indicator for pulmonary infection
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Between admission and 3 months after discharge
|
|
Changes in oxygen saturation
時間枠：Between admission and 3 months after discharge
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Changes in oxygen saturation as an indicator for pulmonary infection
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Between admission and 3 months after discharge
|
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Changes in CRP
時間枠：Between admission and 3 months after discharge
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Changes in CRP as an indicator for infection
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Between admission and 3 months after discharge
|
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Changes in leukocyte count
時間枠：Between admission and 3 months after discharge
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Changes in leukocyte count as an indicator for infection
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Between admission and 3 months after discharge
|
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Changes in pH
時間枠：Between admission and 3 months after discharge
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Changes in pH as an indicator for respiratory distress
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Between admission and 3 months after discharge
|
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Changes in pCO2
時間枠：Between admission and 3 months after discharge
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Changes in pCO2 as an indicator for respiratory distress
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Between admission and 3 months after discharge
|
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Rate of chronic and acute-infectious co-morbidities
時間枠：Day of admission
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Rate of chronic and acute-infectious co-morbidities on admission in children with bacterial pneumonia, subsequently managed with or without antimicrobials
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Day of admission
|
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Utilization rate of a package of complementary treatment measures
時間枠：Between admission and 3 months after discharge
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Utilization rate of a package of complementary treatment measures from anthroposophic medicine (including oral medications, inhalation and external nursing applications) in children managed with or without antimicrobials
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Between admission and 3 months after discharge
|
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Antimicrobial treatment rate in children with viral pneumonia
時間枠：Between admission and 3 months after discharge
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Antimicrobial treatment rate in children classified as viral pneumonia by Bacterial Pneumonia Score
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Between admission and 3 months after discharge
|
|
Number of patients treated with antipyretics
時間枠：Between admission and 3 months after discharge
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Number of patients treated with antipyretics
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Between admission and 3 months after discharge
|
協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始 (実際)
2017年10月15日
一次修了 (実際)
2017年11月30日
研究の完了 (実際)
2018年2月25日
試験登録日
最初に提出
2017年7月6日
QC基準を満たした最初の提出物
2017年8月17日
最初の投稿 (実際)
2017年8月22日
学習記録の更新
投稿された最後の更新 (実際)
2020年2月17日
QC基準を満たした最後の更新が送信されました
2020年2月13日
最終確認日
2020年2月1日
詳しくは
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。
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