Supportive Treatment & Antibiotics for Mild Pediatric Pneumonia

Status Completed

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT05726253
Study type	Interventional
Source	Ann & Robert H Lurie Children's Hospital of Chicago
Contact
Status	Completed
Phase	Early Phase 1
Start date	January 9, 2023
Completion date	December 31, 2023

View Details

See also
Status	Clinical Trial	Phase
Active, not recruiting	`NCT04244474` - Effect of Vitamin D Supplementation on Improvement of Pneumonic Children	Phase 1/Phase 2
Completed	`NCT05815264` - Clinical Trial of 23-valent Pneumococcal Polysaccharide Vaccine in Healthy Chinese Population Aged 2 Years and Above	Phase 1
Recruiting	`NCT04589936` - Prone Position to Improve Oxygenation in COVID-19 Patients Outside Critical Care	N/A
Completed	`NCT02905383` - The Effect of Exercise on Physical Function and Health in Older People After Discharge From Hospital	N/A
Completed	`NCT06210737` - A Study to Evaluate Persistence of Immunity of PCV13 in Healthy Population Aged 2 Months，7 Months-5 Years	Phase 4
Terminated	`NCT03944551` - Bubble Continuous Positive Airway Pressure for Children With Severe Pneumonia in Mali, Africa	N/A
Terminated	`NCT04660084` - Impact of Molecular Testing on Improved Diagnosis, Treatment and Management of CAP	N/A
Not yet recruiting	`NCT05649891` - Checklists Resuscitation Emergency Department	N/A
Withdrawn	`NCT05702788` - Efficacy and Safety of Jaktinib in Participants With Severe Novel Coronavirus Pneumonia(COVID-19)	Phase 2
Not yet recruiting	`NCT04171674` - Pharmacokinetics of High-dose Ceftobiprole in Community-acquired Pneumonia Under Mechanical Ventilation.	N/A
Active, not recruiting	`NCT03140163` - Screening for Pneumonia: A Comparison of Ultra Low Dose Chest CT [ULD-CT] and Conventional Chest Radiography [CXR]	N/A
Completed	`NCT02864420` - Hospitalization at Home: The Acute Care Home Hospital Program for Adults	N/A
Completed	`NCT02638649` - Prehospital Use of Ultrasound in Undifferentiated Shortness of Breath
Recruiting	`NCT02515565` - Physiotherapy in Patients Hospitalized Due to Pneumonia.	N/A
Completed	`NCT02105298` - Effect of Volume and Type of Fluid on Postoperative Incidence of Respiratory Complications and Outcome (CRC-Study)	N/A
Completed	`NCT01399723` - Amoxicillin Versus Benzyl Penicillin for Treatment of Children Hospitalised With Severe Pneumonia	Phase 3
Completed	`NCT01416519` - Physiotherapy Technique Decreases Respiratory Complications After Cardiac Operation	N/A
Completed	`NCT01446926` - Study of Investigational Pneumococcal Vaccine in Healthy Adults, Toddlers and Infants	Phase 1
Completed	`NCT01476995` - Prognostic Indicators as Provided by the EPIC ClearView	N/A
Completed	`NCT01416506` - Community-Acquired Pneumonia (CAP) Surveillance	N/A

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Supportive Treatment and Antibiotics for Mild Pediatric Pneumonia — STAMPP

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms