Clinical trial NCT03256474: Managing Bacterial Pneumonia in Children Without Antimicrobials
Official title: Can Community-acquired Bacterial Pneumonia in Children be Safely Managed Without Antibiotics in an Integrative Medicine Context? A Retrospective Cohort Analysis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pneumonia
Lead sponsor: ARCIM Institute Academic Research in Complementary and Integrative Medicine
Sponsor class: OTHER
First posted: 2017-08-22
Enrollment: 350
Sex: ALL
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Children from infancy till adolecence admitted to hospital (Filderklinik, Germany) for pneumonia treatment

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Cure rate of non-antimicrobial management of bacterial pneumonia
timeFrame: Between admission and 3 months after discharge
measure: Medical complication rate
timeFrame: Between admission and 3 months after discharge
measure: Length of hospital stay
timeFrame: Between admission and 3 months after discharge
measure: Readmission rate
timeFrame: 7 - 10 years after hospitalization
measure: Temperature normalization
timeFrame: Between admission and 3 months after discharge
measure: Days of supplemental oxygen need
timeFrame: Between admission and 3 months after discharge
Secondary outcomes:
measure: Changes in respiratory rate
timeFrame: Between admission and 3 months after discharge
measure: Changes in Bacterial Pneumonia Score
timeFrame: Between admission and 3 months after discharge
measure: Changes in oxygen saturation
timeFrame: Between admission and 3 months after discharge
measure: Changes in CRP
timeFrame: Between admission and 3 months after discharge
measure: Changes in leukocyte count
timeFrame: Between admission and 3 months after discharge
measure: Changes in pH
timeFrame: Between admission and 3 months after discharge
measure: Changes in pCO2
timeFrame: Between admission and 3 months after discharge
measure: Rate of chronic and acute-infectious co-morbidities
timeFrame: Day of admission
measure: Utilization rate of a package of complementary treatment measures
timeFrame: Between admission and 3 months after discharge
measure: Antimicrobial treatment rate in children with viral pneumonia
timeFrame: Between admission and 3 months after discharge
measure: Number of patients treated with antipyretics
timeFrame: Between admission and 3 months after discharge
Other outcomes:
Locations:
city: Filderstadt
country: Germany
facility: Arcim Institute
state: Baden-Württemberg
Study officials:
References: