Antibiotic Strategies for Pneumonia in Children

(STAMPP Trial)

Recruiting at 3 trial locations

Overseen By Julia Szymczak, PhD

Age: < 18

Sex: Any

Trial Phase: Academic

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

Must not be taking: Antibiotics

Disqualifiers: Chronic lung disease, Immunocompromised, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 4

Duration: 14 days

2000 Participants Needed

Trial Summary

What is the purpose of this trial?

The goal of this clinical trial is to determine if a "watch and wait" antibiotic strategy, called Safety Net Antibiotic Prescribing (SNAP), can safely reduce unnecessary antibiotic use while ensuring that children diagnosed with community-acquired pneumonia get better from their illness. The main aims of this study are: * To compare the effectiveness of SNAP versus immediate antibiotic prescribing in children with mild community-acquired pneumonia (CAP) * To identify which patient groups benefit most from the SNAP strategy * To identify factors that shape implementation of each prescribing strategy. Researchers will compare the SNAP strategy (where parents or guardians are instructed to give antibiotics only if their child is not improving after 72 hours, or sooner if they are worsening) to the immediate antibiotic prescribing strategy (where parents or guardians are instructed to give the antibiotics right after their healthcare visit) to see if one strategy is more effective than the other. Participants will be randomly assigned to either the immediate antibiotic group or the SNAP group at enrollment. Participation lasts 14 days with follow-up surveys at 4, 7, and 14 days after enrollment.

Research Team

Todd Florin, MD, MSCE

Principal Investigator

Ann & Robert H Lurie Children's Hospital of Chicago

Julia Szymczak, PhD

Principal Investigator

University of Utah

Eligibility Criteria

This trial is for children with mild community-acquired pneumonia. It's testing if waiting up to 72 hours before using antibiotics (SNAP) is as effective and safe as giving them immediately. Children who are not improving or worsen should start antibiotics sooner.

Inclusion Criteria

My doctor plans to treat my pneumonia with antibiotics.

I am showing signs of a lung infection.

Parent/guardian of child enrolled in the trial

Exclusion Criteria

I have not taken antibiotics in the last 7 days.

I have been diagnosed with a severe form of pneumonia.

Oxygen saturation below 90%, if measured

Timeline

Screening

Participants are screened for eligibility to participate in the trial

During routine visits

Treatment

Participants are assigned to either the SNAP strategy or immediate antibiotic prescribing strategy

14 days

Initial visit for enrollment

Follow-up

Participants are monitored for safety and effectiveness after treatment

14 days

Surveys on Days 4, 7, and 14

Treatment Details

Interventions

• Immediate Antibiotic Prescribing
• Safety Net Antibiotic Prescribing (SNAP)

Trial Overview The STAMPP trial compares two strategies: SNAP, a 'watch and wait' approach to antibiotic use in children with pneumonia, versus immediate antibiotic treatment upon diagnosis. The study aims to see which method works best for recovery without unnecessary medication.

Participant Groups

Group I: Safety Net Antibiotic Prescribing (SNAP) Experimental Treatment 1 Intervention

For participants randomized to this arm, a prescription is provided, but the patient is instructed not to take the antibiotic unless the child is not improving at 72 hours or sooner if getting worse.

Group II: Immediate Antibiotic Prescribing Active Control 1 Intervention

For participants randomized to this arm, a prescription is filled and the antibiotic is administered right after the index visit.

Who Is Running the Clinical Trial?

Ann & Robert H Lurie Children's Hospital of Chicago

Lead Sponsor

Trials

275

Recruited

5,182,000+

Patient-Centered Outcomes Research Institute

Collaborator

Trials

592

Recruited

27,110,000+