Procalcitonin to Reduce Antibiotic Use in Pediatric Pneumonia

NCT04963764 | Completed Early Phase 1 Results DMC FDA Drug

• 1 other identifier: 1R34HL153474-01
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 3

Brief 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.

Conditions

Pneumonia; Pediatric Respiratory Diseases; Antibiotic Use; Community-acquired Pneumonia

Keywords

Pediatrics; Pediatric CAP; Pediatric Pneumonia; Antibiotic Use

Outcome Measures

Primary Outcomes (1)

• Total Pilot Trial Enrollment

  Number of patients enrolled in Stage 2 (Randomized Pilot Trial) per site

  Day 7

Secondary Outcomes (4)

• Consent Rate for Stage 1 (Procalcitonin Ascertainment)

  Measured at completion of pilot trial (6 months)

• Rate of Eligible Participants for Stage 2 (Randomized Pilot Trial)

  Measured at completion of pilot trial (6 months)

• Consent Rate for Stage 2 (Randomized Pilot Trial)

  Measured at completion of pilot trial (6 months)

• Lost to Follow-Up at Day 7

  Day 7

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Randomization to receive either oral placebo or amoxicillin for a standard course (10 days)

Drug: Placebo

Amoxicillin

ACTIVE COMPARATOR

Randomization to receive either oral amoxicillin or placebo for a standard course (10 days)

Drug: Amoxicillin

Interventions

Amoxicillin DRUG

Participants will be randomized to receive oral amoxicillin for a standard course (10 days)

Amoxicillin

Placebo DRUG

Participants will be randomized to receive oral placebo for a standard course (10 days)

Placebo

Eligibility Criteria

• Age: 12 Months - 71 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Age 12-71 months; and
• Diagnosis of CAP, defined using established criteria:
• 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
• Fever, defined as temperature greater than or equal to 38 degrees C, and
• ED clinician diagnosis of CAP, including intention to treat with antibiotics, and
• Chest radiography suspicious for CAP
• Treatment as an outpatient after ED visit.
• Procalcitonin \< 0.25 ng/mL

You may not qualify if:

• Hospitalization within 7 days preceding study visit; or
• Sustained oxygen saturations \<90% with appropriate waveform on oximeter; or
• Incomplete immunization status (\<3 doses of Hib and pneumococcal vaccines; or
• 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
• 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
• Systemic antibiotic receipt within the previous 7 days of CAP diagnosis; or
• Radiographic findings of complicated pneumonia (moderate-to-large pleural effusion, empyema, abscess, necrotic lung disease) ; or
• 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
• Toxic clinical appearance, sepsis, or critical illness as determined by clinical team at ED presentation; or
• Diagnosed with pneumonia in previous 6 months; or
• Provider diagnosis of bronchiolitis, bronchitis, or aspiration pneumonia; or
• Concomitant asthma exacerbation requiring systemic corticosteroids; or
• Severe drug allergy to amoxicillin; or
• Any other condition that in the judgement of investigators or the clinical team could affect safety of the subject; or
• No access to a telephone or video technology for follow-up; or

Sponsors & Collaborators

• Ann & Robert H Lurie Children's Hospital of Chicago: lead
• Children's Hospital of Philadelphia: collaborator
• Children's Hospital Medical Center, Cincinnati: collaborator
• University of Utah: collaborator

Study Sites (3)

Ann & Robert H Lurie Children's Hospital of Chicago

Chicago, Illinois, 60610, United States

Location

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, 45229, United States

Location

The Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, 19104, United States

Location

MeSH Terms

Conditions

Pneumonia; Community-Acquired Pneumonia

Interventions

Amoxicillin

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Lung Diseases; Respiratory Tract Diseases; Community-Acquired Infections

Intervention Hierarchy (Ancestors)

Ampicillin; Penicillin G; Penicillins; beta-Lactams; Lactams; Amides; Organic Chemicals; Sulfur Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Limitations and Caveats

Enrollment occurred during the COVID-19 pandemic when pediatric pneumonia numbers were lower than current (and pre-pandemic) numbers, which significantly affected enrollment.

Results Point of Contact

• Title: Dr. Todd Florin
• Organization: Ann & Robert H. Lurie Children's Hospital of Chicago

edpneumoniaresearch@luriechildrens.org

312-227-6080

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Pilot Feasibility Study

Study Record Dates

• First Submitted: June 16, 2021
• First Posted: July 15, 2021
• Study Start: October 18, 2021
• Primary Completion: May 27, 2022
• Study Completion: May 27, 2022
• Last Updated: February 15, 2024
• Results First Posted: February 15, 2024

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)