Managing Bacterial Pneumonia in Children Without Antimicrobials
2020년 2월 13일 업데이트: ARCIM Institute Academic Research in Complementary and Integrative Medicine
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.
연구 개요
상세 설명
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.
연구 유형
관찰
등록 (실제)
350
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 장소
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Baden-Württemberg
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Filderstadt, Baden-Württemberg, 독일, 70794
- Arcim Institute
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참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
18년 이하 (어린이, 성인)
건강한 자원 봉사자를 받아들입니다
아니
연구 대상 성별
모두
샘플링 방법
확률 샘플
연구 인구
Children from infancy till adolecence admitted to hospital (Filderklinik, Germany) for pneumonia treatment
설명
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
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Cure rate of non-antimicrobial management of bacterial pneumonia
기간: Between admission and 3 months after discharge
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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
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Medical complication rate
기간: Between admission and 3 months after discharge
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Medical complication rate among children with bacterial pneumonia, treated with or without antimicrobials
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Between admission and 3 months after discharge
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Length of hospital stay
기간: Between admission and 3 months after discharge
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Length of hospital stay for children with bacterial pneumonia, managed with or without antimicrobials
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Between admission and 3 months after discharge
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Readmission rate
기간: 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
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Temperature normalization
기간: 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
기간: Between admission and 3 months after discharge
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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
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Changes in respiratory rate
기간: 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
기간: 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
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Changes in oxygen saturation
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
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Number of patients treated with antipyretics
기간: 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
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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작 (실제)
2017년 10월 15일
기본 완료 (실제)
2017년 11월 30일
연구 완료 (실제)
2018년 2월 25일
연구 등록 날짜
최초 제출
2017년 7월 6일
QC 기준을 충족하는 최초 제출
2017년 8월 17일
처음 게시됨 (실제)
2017년 8월 22일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2020년 2월 17일
QC 기준을 충족하는 마지막 업데이트 제출
2020년 2월 13일
마지막으로 확인됨
2020년 2월 1일
추가 정보
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .
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