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Managing Bacterial Pneumonia in Children Without Antimicrobials

13. februar 2020 oppdatert av: 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.

Studieoversikt

Status

Fullført

Forhold

Intervensjon / Behandling

Detaljert 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.

Studietype

Observasjonsmessig

Registrering (Faktiske)

350

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

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

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

Ikke eldre enn 18 år (Barn, Voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Prøvetakingsmetode

Sannsynlighetsprøve

Studiepopulasjon

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

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
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
Tiltaksbeskrivelse
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

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

ARCIM Institute Academic Research in Complementary and Integrative Medicine

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

15. oktober 2017

Primær fullføring (Faktiske)

30. november 2017

Studiet fullført (Faktiske)

25. februar 2018

Datoer for studieregistrering

Først innsendt

6. juli 2017

Først innsendt som oppfylte QC-kriteriene

17. august 2017

Først lagt ut (Faktiske)

22. august 2017

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

17. februar 2020

Siste oppdatering sendt inn som oppfylte QC-kriteriene

13. februar 2020

Sist bekreftet

1. februar 2020

Mer informasjon

Begreper knyttet til denne studien

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • PKA_01

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

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