Supportive Treatment and Antibiotics for Mild Pediatric Pneumonia

NCT05726253 | Completed Early Phase 1 DMC FDA Drug

• 1 other identifier: 2023-5696
• Study Type: interventional
• Target: 2
• Locations: 1 country
• Sites: 1

Brief Summary

National guidelines make two recommendations for treatment of young children with mild pneumonia - one to avoid routine antibiotics and another to use narrow-spectrum antibiotics. No studies have compared the effectiveness of these two approaches. This pilot study will evaluate study processes and feasibility of a future clinical trial that proposes to test whether low-risk children managed as outpatients with mild community-acquired pneumonia (CAP) treated with supportive treatment without antibiotics will have a similar clinical response, with fewer adverse effects, compared with those treated with a supportive treatment plan that includes antibiotics.

Conditions

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

Keywords

Pediatrics; Pediatric CAP; Pediatric Pneumonia; Antibiotic Use

Outcome Measures

Primary Outcomes (1)

• Enrollment Rate Per Month

  Total number of participants enrolled divided by the total number of active enrollment months

  Measured at completion of pilot trial (6 months)

Secondary Outcomes (3)

• Consent Rate

  Measured at completion of pilot trial (6 months)

• Lost to Follow-Up at Day 7

  Measured at completion of pilot trial (6 months)

• Lost to Follow-Up at Day 21

  Measured at completion of pilot trial (6 months)

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Randomization to receive either oral placebo or amoxicillin for a standard course (7 days)

Drug: Supportive Care + Placebo (no antibiotics)

Amoxicillin

ACTIVE COMPARATOR

Randomization to receive either oral amoxicillin or placebo for a standard course (7 days)

Drug: Supportive Care + Amoxicillin

Interventions

Supportive Care + Amoxicillin DRUG

Participants will be randomized to receive oral amoxicillin for a standard course (7 days)

Amoxicillin

Supportive Care + Placebo (no antibiotics) DRUG

Participants will be randomized to receive oral placebo for a standard course (7 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 any 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 tactile temperature at home or measured temperature ≥38ºC rectal, ≥37.7ºC oral, or ≥37.5ºC axillary, and
• Clinician diagnosis of CAP,
• Intention to treat as an outpatient after ED/primary care visit, and
• Mild disease, defined as lack of respiratory distress per adapted Pediatric Infectious Diseases Society/Infectious Diseases Society of America criteria: none of the following: dyspnea, concerning retractions per treating clinician, grunting, nasal flaring, apnea, altered mental status, SpO2\<93% in room air, or respiratory rate \>50 breaths per minute for ages 12-24 months or respiratory rate \> 40 breaths per minute if age\>24 months.

You may not qualify if:

• Hospitalization within one-month preceding study visit; or
• Incomplete immunization status (\<2 doses of Hib and pneumococcal vaccines); or
• Chronic complex medical conditions (chronic heart disease followed by cardiology, chronic lung disease (not including asthma), congenital airway or lung malformations, cystic fibrosis, tracheostomy tube, requiring positive-pressure ventilation, neuromuscular disorders affecting the lungs or chest wall); or
• Conditions that compromise the immune system (HIV with CD4 count less than 400, primary immunodeficiency, asplenia, sickle cell disease, receipt of hematopoietic stem cell or solid organ transplant, cancer on active chemotherapy, immunosuppressive agents, daily corticosteroids for more than 7 consecutive days in past 14 days); or
• Systemic antibiotic receipt (more than 1 dose) within the previous two weeks of CAP diagnosis; or
• Radiographic findings of a consolidation of a concerning size or complexity in the view of the treating clinician; or
• Radiographic findings of complicated pneumonia (pleural effusion larger than trace in size, empyema, \[complex/septated collection\] 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
• Diagnosed with pneumonia in the previous month; or
• Provider diagnosis of aspiration pneumonia; or
• Severe (type 1) 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
• Current enrollment in another clinical trial of an investigational agent; or
• Previous enrollment in this trial; or

Sponsors & Collaborators

• Ann & Robert H Lurie Children's Hospital of Chicago: lead

Study Sites (1)

Ann & Robert H Lurie Children's Hospital of Chicago

Chicago, Illinois, 60610, United States

Location

MeSH Terms

Conditions

Pneumonia; Community-Acquired Pneumonia

Interventions

Palliative Care; Amoxicillin

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Patient Care; Therapeutics; Health Services; Health Care Facilities Workforce and Services; Ampicillin; Penicillin G; Penicillins; beta-Lactams; Lactams; Amides; Organic Chemicals; Sulfur Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

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 Trial

Study Record Dates

• First Submitted: February 3, 2023
• First Posted: February 13, 2023
• Study Start: January 9, 2023
• Primary Completion: December 31, 2023
• Study Completion: December 31, 2023
• Last Updated: February 15, 2024

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)