Community Acquired Pneumonia in ChildrenNCT04681339
Antibiotic Prescription in Children Hospitalized for Community-acquired Pneumonia
An observational study of Community Acquired Pneumonia in Children and Antibiotic Stewardship, run by ARCIM Institute Academic Research in Complementary and Integrative Medicine at 2 sites in Germany.
Trial summary
A study to observe how often antibiotics are prescribed in children hospitalized for pneumonia and how doctors decide if a child needs antibiotics or not. Parent satisfaction will also be recorded. Read more about this study
- Who is it for?
- Ages 3 months to 18 years
- Conditions the study is for
- Community Acquired Pneumonia in Children, Antibiotic Stewardship
- What is being tested?
- Antibiotic treatment and No antibiotic treatment
- How many people
- 200 participants
- Where
- 2 sitesGermany
- Study dates
- 16 Sep 2022to Dec 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 3 months to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Children (aged 3 months to 18 years) who are hospitalized for pneumonia.
Who may be able to join
- Hospital admission at the pediatric department of the Filderklinik or at the pediatric department of the Herdecke Community Hospital
- Admission diagnosis pneumonia or pneumonia diagnosis within 48 hours of admission
- Written informed consent by care giver
- All inclusion criteria have to be fulfilled
Who cannot join
- Insufficient knowledge of German to understand the written patient information and questionnaire
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Germany2 sites, 2 recruiting
- Recruiting
Die Filderklinik
Filderstadt, Baden-Wurttemberg, 70794
Jan Vagedes, MD, Dr, +49 711 7703 ext. 1688, j.vagedes@arcim-institute.de
- Recruiting
Herdecke Community Hospital
Herdecke, North Rhine-Westphalia, 58313
Alfred Längler, Professor, +49 2330 622229, a.laengler@gemeinschaftskrankenhaus.de
About this study
Official title: Antibiotic Prescription in Children Hospitalized for Community-acquired Pneumonia: a Prospective, Observational Study
A study to observe how often antibiotics are prescribed in children hospitalized for pneumonia and how doctors decide if a child needs antibiotics or not. Parent satisfaction will also be recorded.
Read the detailed description
An observational study to document the antibiotic treatment rate of children hospitalized for community acquired pneumonia at a pediatric department with longstanding practice of restrictive antibiotic prescribing. Patients will be enrolled consecutively and treated according to in-house standard operating procedure. Antibiotic treatment rate, severity of disease and medical complication rate in antibiotic and non-antibiotic managed children, frequency of predefined factors in physician decision making on antibiotic use, and parental satisfaction will be recorded. Parents will be contacted at least 4 weeks after discharge to inquire about recurrence or readmission.
- Being tested
- Antibiotic treatment, No antibiotic treatment
- Keywords
- Community acquired pneumonia, Antibiotic use, Pediatrics, Hospitalised children, Integrative medicine
- Medical subject headings
- Community-Acquired Pneumonia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Antibiotic treatmentOther
Antibiotic treatment
No antibiotic treatmentOther
No antibiotic treatment
| Study group | Role | What they receive |
|---|---|---|
| Pneumonia with antibiotics | Children with non-severe community acquired pneumonia and fever: managed with antibiotics Receives: Other: Antibiotic treatment | |
| Pneumonia without antibiotics | Children with non-severe community acquired pneumonia and fever: managed without antibiotics Receives: Other: No antibiotic treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Antibiotic treatment rates in hospitalized children with non-severe community-acquired pneumonia and fever
Rates of treatment with and without antibiotics during hospitalization
Measured: During hospitalization, an average of 7 days
Secondary outcomes (9)
Number of medical complications
Medical complications defined as a) admission to intensive care, mechanical ventilation, transfer to tertiary car center OR b) pleural effusion or empyema, pneumothorax, lung abscess, bronchopleural fistula, necrotizing pneumonia, acute respiratory failure, infectious complication (meningitis, septic shock).
Measured: During hospitalization, an average of 7 days
Factors in physician decision making on antibiotic prescription
Physician questionnaire (closed-ended questions)
Measured: During hospitalization, an average of 7 days
Parental satisfaction
Parental satisfaction questionnaire (closed-ended questions)
Measured: At discharge, assessing the entire duration of the hospital stay, an average of 7 days
Hospitalization duration
Number of hospitalization days
Measured: At discharge, assessing the entire duration of the hospital stay, an average of 7 days
Number of children with relevant comorbidity
Co-morbidities that may affect decision on antimicrobial use: a) chronic conditions (e.g. neurological conditions such as cerebral palsy, Down syndrome; or chronic respiratory conditions such as asthma, cystic fibrosis; or heart conditions). b) acute infectious comorbidities: bronchiolitis, otitis media, urinary tract infection, confirmed influenza virus or Respiratory Syncytial Virus or SARS-CoV2.
Measured: During hospitalization, an average of 7 days
Days of supplemental oxygen use
Oxygen therapy for O2 saturation <92%
Measured: During hospitalization, an average of 7 days
Use of antipyretic medications
Number of doses of paracetamol or ibuprofen during hospitalization
Measured: During hospitalization, an average of 7 days
Number of complementary medicine medications used per child
Number of complementary medication during hospitalization
Measured: During hospitalization, an average of 7 days
Number of readmissions for pneumonia or new pneumonia recurrences within 4 weeks of hospital discharge
New hospital admission for pneumonia; treatment requiring recurrence of pneumonia
Measured: 4 weeks after end of hospitalization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Dec 2020
- Study start16 Sep 2022
- Primary completionDec 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Community Acquired Pneumonia in ChildrenStudies 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
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- ARCIM Institute Academic Research in Complementary and Integrative Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- Gemeinschaftskrankenhaus Herdecke, Germany
- Responsible party
- Sponsor
- Investigators
- Jan Vagedes, Dr, Principal investigator, Arcim Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04681339
- Sponsor's protocol ID
- PKA-03
- Status last verified
- Sep 2026
- First submitted
- 14 Dec 2020
- Last updated
- 17 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: IPD that underlie results in a publication
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Antibiotic Prescription in Children Hospitalized for Community-acquired Pneumonia: a Prospective, Observational Study
- ClinicalTrials.gov ID
- NCT04681339
- Acronym / sponsor ID
- PKA-03
- Keywords
- Community acquired pneumonia, Antibiotic use, Pediatrics, Hospitalised children, Integrative medicine
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- ARCIM Institute Academic Research in Complementary and Integrative MedicineUniversity, hospital or other
- Collaborators
- Gemeinschaftskrankenhaus Herdecke, Germany
- Study start
- 16 Sep 2022 (actual)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 23 Dec 2020 (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.
A study to observe how often antibiotics are prescribed in children hospitalized for pneumonia and how doctors decide if a child needs antibiotics or not. Parent satisfaction will also be recorded.
Detailed description
An observational study to document the antibiotic treatment rate of children hospitalized for community acquired pneumonia at a pediatric department with longstanding practice of restrictive antibiotic prescribing. Patients will be enrolled consecutively and treated according to in-house standard operating procedure. Antibiotic treatment rate, severity of disease and medical complication rate in antibiotic and non-antibiotic managed children, frequency of predefined factors in physician decision making on antibiotic use, and parental satisfaction will be recorded. Parents will be contacted at least 4 weeks after discharge to inquire about recurrence or readmission.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pneumonia with antibiotics | – | Other: Antibiotic treatmentChildren with non-severe community acquired pneumonia and fever: managed with antibiotics |
| Pneumonia without antibiotics | – | Other: No antibiotic treatmentChildren with non-severe community acquired pneumonia and fever: managed without antibiotics |
Who may qualify
- Ages
- 3 months to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Children (aged 3 months to 18 years) who are hospitalized for pneumonia.
Key inclusion criteria (4 listed)
- Hospital admission at the pediatric department of the Filderklinik or at the pediatric department of the Herdecke Community Hospital
- Admission diagnosis pneumonia or pneumonia diagnosis within 48 hours of admission
- Written informed consent by care giver
- All inclusion criteria have to be fulfilled
Key exclusion criteria (1 listed)
- Insufficient knowledge of German to understand the written patient information and questionnaire
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 |
|---|---|---|
| Antibiotic treatmentAntibiotic treatment | Other | Pneumonia with antibiotics |
| No antibiotic treatmentNo antibiotic treatment | Other | Pneumonia without antibiotics |
Primary outcome
Antibiotic treatment rates in hospitalized children with non-severe community-acquired pneumonia and fever
Time frame: During hospitalization, an average of 7 days
Rates of treatment with and without antibiotics during hospitalization
9 secondary outcomes
Number of medical complications
Time frame: During hospitalization, an average of 7 days
Factors in physician decision making on antibiotic prescription
Time frame: During hospitalization, an average of 7 days
Parental satisfaction
Time frame: At discharge, assessing the entire duration of the hospital stay, an average of 7 days
Hospitalization duration
Time frame: At discharge, assessing the entire duration of the hospital stay, an average of 7 days
Number of children with relevant comorbidity
Time frame: During hospitalization, an average of 7 days
Days of supplemental oxygen use
Time frame: During hospitalization, an average of 7 days
Use of antipyretic medications
Time frame: During hospitalization, an average of 7 days
Number of complementary medicine medications used per child
Time frame: During hospitalization, an average of 7 days
Number of readmissions for pneumonia or new pneumonia recurrences within 4 weeks of hospital discharge
Time frame: 4 weeks after end of hospitalization
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Sep 2026.
- Individual participant dataSharing planned: Yes. IPD that underlie results in a publication
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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.
Jan Vagedes, Dr principal investigator
Arcim Institute
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Community Acquired Pneumonia in Children and Antibiotic Stewardship, run by ARCIM Institute Academic Research in Complementary and Integrative Medicine at 2 sites 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 4 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: looking for participants now, as of the sponsor's last update on 17 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jan Vagedes, Dr (+49 711 7703 ext. 1688, j.vagedes@arcim-institute.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Antibiotic treatment rates in hospitalized children with non-severe community-acquired pneumonia and fever (time frame: During hospitalization, an average of 7 days). 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 Sep 2026.