Procalcitonin to Reduce Antibiotic Use in Pediatric Pneumonia

• Status: Not yet recruiting
• Trial end date: 2022-06-30
• Target enrollment: 0
• Participant gender: All

Summary

This pilot study will evaluate study processes and feasibility of a future large-scale clinical trial that proposes to test whether low-risk children managed as outpatients with community-acquired pneumonia (CAP) and procalcitonin (PCT) levels <0.25 ng/mL treated with placebo have a similar clinical response to those treated with antibiotics and fewer adverse effects.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Ann & Robert H Lurie Children's Hospital of Chicago
• Collaborators: Children's Hospital Medical Center, Cincinnati; Children's Hospital of Philadelphia; University of Utah
• Treatments: Amoxicillin

Criteria

Inclusion Criteria:

1. Age 12-71 months; and

2. Diagnosis of CAP, defined using established criteria:

1. Signs and symptoms of lower respiratory tract infection (LRTI), defined as one or more of the following:

• new or different cough; or

• new or different sputum production; or

• chest pain; or

• dyspnea/shortness of breath; or

• documented tachypnea; or

• abnormal findings consistent with LRTI on physical examination (e.g., crackles/rales, rhonchi, wheezing) and

2. Fever, defined as temperature greater than or equal to 38 degrees C, and

3. ED clinician diagnosis of CAP, including intention to treat with antibiotics, and

4. Chest radiography suspicious for CAP

3. Treatment as an outpatient after ED visit.

4. Procalcitonin < 0.25 ng/mL

Exclusion Criteria:

1. Hospitalization within 7 days preceding study visit; or

2. Sustained oxygen saturations <90% with appropriate waveform on oximeter; or

3. Incomplete immunization status (<3 doses of Hib and pneumococcal vaccines; or

4. Chronic complex medical conditions (chronic heart disease, chronic lung disease (not including asthma), congenital airway or lung malformations, cystic fibrosis, chronic renal disease, protein-losing enteropathy, genetic syndromes, neurocognitive deficits, or metabolic disorders); or

5. Conditions that compromise the immune system (HIV, primary immunodeciency, asplenia, sickle cell disease, receipt of hematopoietic stem cell or solid organ trans- plant, immunosuppressive agents, daily corticosteroids for more than 7 consecutive days in past 14 days) ; or

6. Systemic antibiotic receipt within the previous 7 days of CAP diagnosis; or

7. Radiographic findings of complicated pneumonia (moderate-to-large pleural effusion, empyema, abscess, necrotic lung disease) ; or

8. Pneumonia known to be due to bacterial source at the time of enrollment, as documented by blood culture or PCR if available, or another clear source of bacterial infection requiring immediate antibiotics; or

9. Toxic clinical appearance, sepsis, or critical illness as determined by clinical team at ED presentation; or

10. Diagnosed with pneumonia in previous 6 months; or

11. Provider diagnosis of bronchiolitis, bronchitis, or aspiration pneumonia; or

12. Concomitant asthma exacerbation requiring systemic corticosteroids; or

13. Severe drug allergy to amoxicillin; or

14. Any other condition that in the judgement of investigators or the clinical team could affect safety of the subject; or

15. No access to a telephone or video technology for follow-up; or

16. Current enrollment in another clinical trial of an investigational agent; or

17. Previous enrollment in this trial.