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Managing Bacterial Pneumonia in Children Without Antimicrobials

13 februari 2020 uppdaterad 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.

Studieöversikt

Status

Avslutad

Betingelser

Intervention / Behandling

Detaljerad beskrivning

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.

Studietyp

Observationell

Inskrivning (Faktisk)

350

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studieorter

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

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

Inte äldre än 18 år (Barn, Vuxen)

Tar emot friska volontärer

Nej

Kön som är behöriga för studier

Allt

Testmetod

Sannolikhetsprov

Studera befolkning

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

Beskrivning

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

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Cure rate of non-antimicrobial management of bacterial pneumonia
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Changes in respiratory rate
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: Between admission and 3 months after discharge
Number of patients treated with antipyretics
Between admission and 3 months after discharge

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

ARCIM Institute Academic Research in Complementary and Integrative Medicine

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Faktisk)

15 oktober 2017

Primärt slutförande (Faktisk)

30 november 2017

Avslutad studie (Faktisk)

25 februari 2018

Studieregistreringsdatum

Först inskickad

6 juli 2017

Först inskickad som uppfyllde QC-kriterierna

17 augusti 2017

Första postat (Faktisk)

22 augusti 2017

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

17 februari 2020

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

13 februari 2020

Senast verifierad

1 februari 2020

Mer information

Termer relaterade till denna studie

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

  • PKA_01

Läkemedels- och apparatinformation, studiedokument

Studerar en amerikansk FDA-reglerad läkemedelsprodukt

Nej

Studerar en amerikansk FDA-reglerad produktprodukt

Nej

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