Supportive Treatment and Antibiotics for Mild Pediatric Pneumonia

NCT ID: NCT05726253

Last Updated: 2024-02-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: EARLY_PHASE1
• Total Enrollment: 2 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-01-09
• Study Completion Date: 2023-12-31

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.

Detailed Description

This pilot clinical trial is a randomized, placebo-controlled, double-blinded trial assessing the feasibility of comparing supportive care+amoxicillin to supportive care without antibiotics (i.e., placebo) in children 12 months to <6 years of age who present to the ED with community-acquired pneumonia (CAP) and who will be treated as outpatients.

This trial will enroll over a 6-month period and take place at Ann and Robert H. Lurie Children's Hospital of Chicago. Clinical research coordinators (CRCs) will screen for and enroll eligible children.

Through an online system, participants will be randomized to a 7-day course of either amoxicillin (80-100 mg/kg divided BID up to 4,000 mg/day) or matching placebo. All patients will receive a supportive care treatment bundle that includes antipyretics, honey, and saline spray, in addition to instructions on how to manage lower respiratory infections.

The guardians of participants will be asked to complete an online daily symptom diary during the first 6 days after the initial study visit. Participants will have daily telehealth evaluations by clinicians for the first three days after the index study visit. The primary outcome will be assessed at day 7, using telehealth technology. A final follow-up, performed by site research staff, by telephone call, will occur at Day 21 to assess overall disease course and secondary outcomes.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: QUADRUPLE

Study Groups

Placebo

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

Group Type: PLACEBO_COMPARATOR

Supportive Care + Placebo (no antibiotics)

Intervention Type: DRUG

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

Amoxicillin

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

Group Type: ACTIVE_COMPARATOR

Supportive Care + Amoxicillin

Intervention Type: DRUG

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

Interventions

Supportive Care + Amoxicillin

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

Intervention Type: DRUG

Supportive Care + Placebo (no antibiotics)

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

Intervention Type: DRUG

Eligibility 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 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

2. Fever, defined as tactile temperature at home or measured temperature ≥38ºC rectal, ≥37.7ºC oral, or ≥37.5ºC axillary, and

3. Clinician diagnosis of CAP,

3. Intention to treat as an outpatient after ED/primary care visit, and

4. 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.

Exclusion Criteria

1. Hospitalization within one-month preceding study visit; or

2. Incomplete immunization status (<2 doses of Hib and pneumococcal vaccines); or

3. 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

4. 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

5. Systemic antibiotic receipt (more than 1 dose) within the previous two weeks of CAP diagnosis; or

6. Radiographic findings of a consolidation of a concerning size or complexity in the view of the treating clinician; or

7. Radiographic findings of complicated pneumonia (pleural effusion larger than trace in size, empyema, [complex/septated collection] 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. Diagnosed with pneumonia in the previous month; or

10. Provider diagnosis of aspiration pneumonia; or

11. Severe (type 1) drug allergy to amoxicillin; or

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

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

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

15. Previous enrollment in this trial; or

16. Parent/guardian non-English or non-Spanish speaking; or

17. Known allergy to milk and/or red dye.

• Minimum Eligible Age: 12 Months
• Maximum Eligible Age: 71 Months
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ann & Robert H Lurie Children's Hospital of Chicago

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Ann & Robert H Lurie Children's Hospital of Chicago

Chicago, Illinois, United States

Countries

United States

Other Identifiers

2023-5696

Identifier Type: -

Identifier Source: org_study_id