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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
QUADRUPLE
Enrollment
2
Participants will be randomized to receive oral amoxicillin for a standard course (7 days)
Participants will be randomized to receive oral placebo for a standard course (7 days)
Ann & Robert H Lurie Children's Hospital of Chicago
Chicago, Illinois, United States
Enrollment Rate Per Month
Total number of participants enrolled divided by the total number of active enrollment months
Time frame: Measured at completion of pilot trial (6 months)
Consent Rate
Number of eligible participants approached regarding trial participation who provided informed consent to participate in the trial compared with number of participants approached for participation
Time frame: Measured at completion of pilot trial (6 months)
Lost to Follow-Up at Day 7
Number of enrolled participants who did not complete the Day 7 follow-up visit
Time frame: Measured at completion of pilot trial (6 months)
Lost to Follow-Up at Day 21
Number of enrolled participants who did not complete the Day 21 follow-up visit
Time frame: Measured at completion of pilot trial (6 months)
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.