PneumoniaNCT03256474
Managing Bacterial Pneumonia in Children Without Antimicrobials
An observational study of Pneumonia, run by ARCIM Institute Academic Research in Complementary and Integrative Medicine at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages Up to 18 years
- Conditions the study is for
- Pneumonia
- What is being tested?
- Multimodal Therapy
- How many people
- 350 participants
- Where
- 1 siteGermany
- Study dates
- 15 Oct 2017to 25 Feb 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Children from infancy till adolecence admitted to hospital (Filderklinik, Germany) for pneumonia treatment
Who may be able to join
- 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)
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Pneumonia
- Being tested
- Multimodal Therapy
- Medical subject headings
- Pneumonia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multimodal TherapyOther
Drugs, external applications like chest wraps, inhalations
What is being measured
The primary outcome is the main question the study is designed to answer.
Cure rate of non-antimicrobial management of bacterial pneumonia
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.
Measured: Between admission and 3 months after discharge
Medical complication rate
Medical complication rate among children with bacterial pneumonia, treated with or without antimicrobials
Measured: Between admission and 3 months after discharge
Length of hospital stay
Length of hospital stay for children with bacterial pneumonia, managed with or without antimicrobials
Measured: Between admission and 3 months after discharge
Readmission rate
Readmission rate for pneumonia among children with bacterial pneumonia, managed with or without antimicrobials
Measured: 7 - 10 years after hospitalization
Temperature normalization
Days to temperature normalization (< 38°C) in children with bacterial pneumonia, managed with or without antimicrobials
Measured: Between admission and 3 months after discharge
Days of supplemental oxygen need
Days of supplemental oxygen need in children with bacterial pneumonia, managed with or without antimicrobials
Measured: Between admission and 3 months after discharge
Secondary outcomes (11)
Changes in respiratory rate
Changes in respiratory rate as an indicator for pulmonary infection
Measured: Between admission and 3 months after discharge
Changes in Bacterial Pneumonia Score
Changes in Bacterial Pneumonia Score as an indicator for pulmonary infection
Measured: Between admission and 3 months after discharge
Changes in oxygen saturation
Changes in oxygen saturation as an indicator for pulmonary infection
Measured: Between admission and 3 months after discharge
Changes in CRP
Changes in CRP as an indicator for infection
Measured: Between admission and 3 months after discharge
Changes in leukocyte count
Changes in leukocyte count as an indicator for infection
Measured: Between admission and 3 months after discharge
Changes in pH
Changes in pH as an indicator for respiratory distress
Measured: Between admission and 3 months after discharge
Changes in pCO2
Changes in pCO2 as an indicator for respiratory distress
Measured: Between admission and 3 months after discharge
Rate of chronic and acute-infectious co-morbidities
Rate of chronic and acute-infectious co-morbidities on admission in children with bacterial pneumonia, subsequently managed with or without antimicrobials
Measured: Day of admission
Utilization rate of a package of complementary treatment measures
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
Measured: Between admission and 3 months after discharge
Antimicrobial treatment rate in children with viral pneumonia
Antimicrobial treatment rate in children classified as viral pneumonia by Bacterial Pneumonia Score
Measured: Between admission and 3 months after discharge
Number of patients treated with antipyretics
Number of patients treated with antipyretics
Measured: Between admission and 3 months after discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2017
- Study start15 Oct 2017
- Primary completion30 Nov 2017
- Study completion25 Feb 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PneumoniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 350 participants (actual)
Sponsor and investigators
- Lead sponsor
- ARCIM Institute Academic Research in Complementary and Integrative Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03256474
- Sponsor's protocol ID
- PKA_01
- Status last verified
- Feb 2020
- First submitted
- 6 Jul 2017
- Last updated
- 17 Feb 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Can Community-acquired Bacterial Pneumonia in Children be Safely Managed Without Antibiotics in an Integrative Medicine Context? A Retrospective Cohort Analysis
- ClinicalTrials.gov ID
- NCT03256474
- Acronym / sponsor ID
- PKA_01
- Conditions
- Pneumonia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 350 participants (actual)
- Lead sponsor
- ARCIM Institute Academic Research in Complementary and Integrative MedicineUniversity, hospital or other
- Study start
- 15 Oct 2017 (actual)
- Primary completion
- 30 Nov 2017 (actual)
- Study completion
- 25 Feb 2018 (actual)
- First posted
- 22 Aug 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- Up to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Children from infancy till adolecence admitted to hospital (Filderklinik, Germany) for pneumonia treatment
Key inclusion criteria (2 listed)
- 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)
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Multimodal TherapyDrugs, external applications like chest wraps, inhalations | Other | – |
Primary outcome
Cure rate of non-antimicrobial management of bacterial pneumonia
Time frame: 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.
Medical complication rate
Time frame: Between admission and 3 months after discharge
Medical complication rate among children with bacterial pneumonia, treated with or without antimicrobials
Length of hospital stay
Time frame: Between admission and 3 months after discharge
Length of hospital stay for children with bacterial pneumonia, managed with or without antimicrobials
Readmission rate
Time frame: 7 - 10 years after hospitalization
Readmission rate for pneumonia among children with bacterial pneumonia, managed with or without antimicrobials
Temperature normalization
Time frame: Between admission and 3 months after discharge
Days to temperature normalization (< 38°C) in children with bacterial pneumonia, managed with or without antimicrobials
Days of supplemental oxygen need
Time frame: Between admission and 3 months after discharge
Days of supplemental oxygen need in children with bacterial pneumonia, managed with or without antimicrobials
11 secondary outcomes
Changes in respiratory rate
Time frame: Between admission and 3 months after discharge
Changes in Bacterial Pneumonia Score
Time frame: Between admission and 3 months after discharge
Changes in oxygen saturation
Time frame: Between admission and 3 months after discharge
Changes in CRP
Time frame: Between admission and 3 months after discharge
Changes in leukocyte count
Time frame: Between admission and 3 months after discharge
Changes in pH
Time frame: Between admission and 3 months after discharge
Changes in pCO2
Time frame: Between admission and 3 months after discharge
Rate of chronic and acute-infectious co-morbidities
Time frame: Day of admission
Utilization rate of a package of complementary treatment measures
Time frame: Between admission and 3 months after discharge
Antimicrobial treatment rate in children with viral pneumonia
Time frame: Between admission and 3 months after discharge
Number of patients treated with antipyretics
Time frame: Between admission and 3 months after discharge
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pneumonia, run by ARCIM Institute Academic Research in Complementary and Integrative Medicine at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cure rate of non-antimicrobial management of bacterial pneumonia (time frame: Between admission and 3 months after discharge). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Feb 2020.