Managing Bacterial Pneumonia in Children Without Antimicrobials
13 februari 2020 bijgewerkt door: 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.
Studie Overzicht
Gedetailleerde beschrijving
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.
Studietype
Observationeel
Inschrijving (Werkelijk)
350
Contacten en locaties
In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.
Studie Locaties
-
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Baden-Württemberg
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Filderstadt, Baden-Württemberg, Duitsland, 70794
- Arcim Institute
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Deelname Criteria
Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Niet ouder dan 18 jaar (Kind, Volwassen)
Accepteert gezonde vrijwilligers
Nee
Geslachten die in aanmerking komen voor studie
Allemaal
Bemonsteringsmethode
Kanssteekproef
Studie Bevolking
Children from infancy till adolecence admitted to hospital (Filderklinik, Germany) for pneumonia treatment
Beschrijving
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
Studie plan
Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.
Hoe is de studie opgezet?
Ontwerpdetails
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Cure rate of non-antimicrobial management of bacterial pneumonia
Tijdsspanne: 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.
|
Between admission and 3 months after discharge
|
|
Medical complication rate
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 7 - 10 years after hospitalization
|
Readmission rate for pneumonia among children with bacterial pneumonia, managed with or without antimicrobials
|
7 - 10 years after hospitalization
|
|
Temperature normalization
Tijdsspanne: Between admission and 3 months after discharge
|
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
Tijdsspanne: 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
|
Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Changes in respiratory rate
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: Between admission and 3 months after discharge
|
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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
|
|
Rate of chronic and acute-infectious co-morbidities
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: Between admission and 3 months after discharge
|
Number of patients treated with antipyretics
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Between admission and 3 months after discharge
|
Medewerkers en onderzoekers
Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.
Studie record data
Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.
Bestudeer belangrijke data
Studie start (Werkelijk)
15 oktober 2017
Primaire voltooiing (Werkelijk)
30 november 2017
Studie voltooiing (Werkelijk)
25 februari 2018
Studieregistratiedata
Eerst ingediend
6 juli 2017
Eerst ingediend dat voldeed aan de QC-criteria
17 augustus 2017
Eerst geplaatst (Werkelijk)
22 augustus 2017
Updates van studierecords
Laatste update geplaatst (Werkelijk)
17 februari 2020
Laatste update ingediend die voldeed aan QC-criteria
13 februari 2020
Laatst geverifieerd
1 februari 2020
Meer informatie
Termen gerelateerd aan deze studie
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- PKA_01
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Nee
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
Nee
Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .
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