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Managing Bacterial Pneumonia in Children Without Antimicrobials

13. februar 2020 opdateret af: 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.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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.

Undersøgelsestype

Observationel

Tilmelding (Faktiske)

350

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Tyskland
    • Baden-Württemberg
      • Filderstadt, Baden-Württemberg, Tyskland, 70794
        • Arcim Institute

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

Ikke ældre end 18 år (Barn, Voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Prøveudtagningsmetode

Sandsynlighedsprøve

Studiebefolkning

Children from infancy till adolecence admitted to hospital (Filderklinik, Germany) for pneumonia treatment

Beskrivelse

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

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Cure rate of non-antimicrobial management of bacterial pneumonia
Tidsramme: 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
Tidsramme: Between admission and 3 months after discharge
Medical complication rate among children with bacterial pneumonia, treated with or without antimicrobials
Between admission and 3 months after discharge
Length of hospital stay
Tidsramme: 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
Tidsramme: 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
Tidsramme: Between admission and 3 months after discharge
Days to temperature normalization (< 38°C) in children with bacterial pneumonia, managed with or without antimicrobials
Between admission and 3 months after discharge
Days of supplemental oxygen need
Tidsramme: Between admission and 3 months after discharge
Days of supplemental oxygen need in children with bacterial pneumonia, managed with or without antimicrobials
Between admission and 3 months after discharge

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Changes in respiratory rate
Tidsramme: Between admission and 3 months after discharge
Changes in respiratory rate as an indicator for pulmonary infection
Between admission and 3 months after discharge
Changes in Bacterial Pneumonia Score
Tidsramme: Between admission and 3 months after discharge
Changes in Bacterial Pneumonia Score as an indicator for pulmonary infection
Between admission and 3 months after discharge
Changes in oxygen saturation
Tidsramme: Between admission and 3 months after discharge
Changes in oxygen saturation as an indicator for pulmonary infection
Between admission and 3 months after discharge
Changes in CRP
Tidsramme: Between admission and 3 months after discharge
Changes in CRP as an indicator for infection
Between admission and 3 months after discharge
Changes in leukocyte count
Tidsramme: Between admission and 3 months after discharge
Changes in leukocyte count as an indicator for infection
Between admission and 3 months after discharge
Changes in pH
Tidsramme: Between admission and 3 months after discharge
Changes in pH as an indicator for respiratory distress
Between admission and 3 months after discharge
Changes in pCO2
Tidsramme: Between admission and 3 months after discharge
Changes in pCO2 as an indicator for respiratory distress
Between admission and 3 months after discharge
Rate of chronic and acute-infectious co-morbidities
Tidsramme: Day of admission
Rate of chronic and acute-infectious co-morbidities on admission in children with bacterial pneumonia, subsequently managed with or without antimicrobials
Day of admission
Utilization rate of a package of complementary treatment measures
Tidsramme: Between admission and 3 months after discharge
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
Between admission and 3 months after discharge
Antimicrobial treatment rate in children with viral pneumonia
Tidsramme: Between admission and 3 months after discharge
Antimicrobial treatment rate in children classified as viral pneumonia by Bacterial Pneumonia Score
Between admission and 3 months after discharge
Number of patients treated with antipyretics
Tidsramme: Between admission and 3 months after discharge
Number of patients treated with antipyretics
Between admission and 3 months after discharge

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

ARCIM Institute Academic Research in Complementary and Integrative Medicine

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

15. oktober 2017

Primær færdiggørelse (Faktiske)

30. november 2017

Studieafslutning (Faktiske)

25. februar 2018

Datoer for studieregistrering

Først indsendt

6. juli 2017

Først indsendt, der opfyldte QC-kriterier

17. august 2017

Først opslået (Faktiske)

22. august 2017

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

17. februar 2020

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

13. februar 2020

Sidst verificeret

1. februar 2020

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • PKA_01

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

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