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Completed

NCT Number: NCT05114161

Promoting Optimal Treatment for Community-acquired Pneumonia in the Emergency Room (PIONEER)

Pneumonia in children can be caused by different types of germs such as bacteria and viruses. Giving antibiotics to children with bacterial bugs is helpful while giving antibiotics to children with viruses will not help them. Unfortunately, it is difficult for doctors to tell when a child's pneumonia is caused by bacteria or viruses. Most young children are given antibiotics even though it doesn't help them.

Our study wants to test a new way to care for children with pneumonia so that only children who will benefit from antibiotics will receive them. The study will use a combination of the child's symptoms, x-rays results, and lab testing to better determine if a child needs antibiotics. The study team will then review the testing results and follow up with the patient and their family in the following days to ensure that the child is improving. PIONEER will test a novel care pathway for treating non-severe pediatric pneumonia with the goal of decreasing antibiotic prescription while maintaining equal clinical outcomes to standard care.

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Key information

Conditions

Community-Acquired Pneumonia Bacterial Infections Bacterial Infections and Mycoses Community-Acquired Infections Gram-Negative Bacterial Infections Infections Mycoplasma Infections Mycoplasmatales Infections Pneumonia Respiratory Tract Diseases Respiratory Tract Infections

Age range

6 month–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

McMaster Children's Hospital

Hamilton, Ontario, L8S 4K1, Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Diagnosed primarily with community-acquired pneumonia as per the ED MD and are well enough to be discharged home.
  • They also must have any one of:
  • tachypnoea;
  • cough;
  • increased work of breathing; or
  • auscultatory findings consistent with pneumonia;

Exclusion criteria

Children will be excluded if they have any of the following: cystic fibrosis, anatomic lung disease, bronchiectasis, congenital heart disease (requiring treatment or with exercise restrictions), history of repeated aspiration/velopharyngeal incompetence, malignancy (current or past), immunodeficiency (primary, acquired, or iatrogenic), pneumonia previously (clinically) diagnosed within the past month, or lung abscess diagnosed within the past six months. Children who present with ongoing fever after 4 or more days of beta-lactam therapy active against S. pneumoniae (ie. amoxicillin, amoxicillin-clavulanate, cefprozil, cephalexin, cefadroxil), levofloxacin/moxifloxacin, or doxycycline will not be eligible. Children will not be eligible to participate more than once.

Treatment and study plan

Novel Care Pathway

Other

The novel care pathway will follow a decision tree based on several criteria to stratify patients in an appropriate risk category. Patients with large radiographic lobar consolidation OR POC CRP > 60mg/L will be deemed 'appreciable risk' while patients with CRP < 20mg/L will be deemed 'low risk'. Patients with CRP between 20 - 60mg/L will be evaluated further, as follows: if they have an oxygen saturation of <95%, they will be 'appreciable risk', and if not, there are further decision points: if they are not tachypneic, they will be 'low risk'; if they are tachypneic and less than 1 year of age, they will be 'appreciable risk'; if they are tachypneic, over 1 year of age, but with either complete PCV13 immunization OR detectable wheezing as per the ED clinician, they will be classified as 'low risk'. Appreciable-risk participants will be given a prescription for antibiotics at ED discharge.

Primary outcomes

  1. Treatment with antibiotics for community-acquired pneumonia

    Time frame: Day 0-14

    The proportion of participants who receive antibiotics specifically targeting community-acquired pneumonia will be assessed at follow-up visits (as per participant caregiver report) and compared between phases of the study (control phase and intervention phase)

Secondary outcomes

  1. Clinical cure

    Time frame: Day 14-21

    Cure defined by 1) symptoms improving as per caregiver report, 2) failure to be hospitalized for community-acquired pneumonia, and 3) lack of receipt of additional antimicrobials specifically for the treatment of community-acquired pneumonia

  2. Re-presentation to the ED

    Time frame: Day 0-30

    The number of participants in each phase with unscheduled ED visits before day 30 will be compared.

  3. Treatment with broad-spectrum antibiotic therapy for community-acquired pneumonia

    Time frame: Day 0-30

    The proportion of participants who receive broad-spectrum antibiotics (ie. amoxicillin/clavulanate, cephalosporins, azithromycin, fluoroquinolones) specifically targeting community-acquired pneumonia will be assessed at follow-up visits (as per participant caregiver report) and compared between phases of the study (control phase and intervention phase)

  4. Occurence of drug-related adverse events

    Time frame: Day 0-30

  5. Development of complicated CAP before day 30

    Time frame: day 0-30

    (i.e. pleural effusion or PICU admission)

  6. Number of days of missed work (caregiver)

    Time frame: Day 14-21

  7. Number of missed days of school/daycare (participant)

    Time frame: Day 14-21

  8. Caregiver satisfaction with the care plan

    Time frame: Day of enrolment, day 2-5, day 14-21 and day 30 follow-up

    This will be measured using a previously validated scale (Likert scale evaluating satisfaction with each of: overall care, doctor's diagnosis, and antibiotic treatment plan)

  9. Failure to achieve clinical cure in those who have CRP<20 mg/L

    Time frame: Day 0-30

  10. Level of serum procalcitonin that effectively rules out the need for antimicrobials

    Time frame: Day 0-30

    (i.e. the level below which 97.5% of participants experience clinical cure without before prescribed antimicrobials)

  11. Treatment with Mycoplasma-active antibiotics for those in whom Mycoplasma is detected

    Time frame: Day 0-14

  12. Unscheduled visits to primary care (eg family MD, nurse practitioner, physician assistant) before day 30 post-enrolment

    Time frame: Day 0-30

  13. Hospitalization for CAP

    Time frame: Day 0-30

  14. Development of complicated CAP (ie pleural effusion or PICU admission)

    Time frame: Day 0-30

Sponsors and collaborators

Lead sponsor

Hamilton Health Sciences Corporation

Other

Registry information

Official study title

Promoting Optimal Treatment for Community-acquired Pneumonia in the Emergency Room (PIONEER): a Prospective, Before-after, Cohort Study

Acronym: PIONEER

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Nov 9, 2021
Registry last updated
Apr 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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