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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores the best use of antibiotics for children with mild pneumonia acquired outside of a hospital. It compares two approaches: Immediate Antibiotic Prescribing, where antibiotics are given right away, and Safety Net Antibiotic Prescribing (SNAP), where antibiotics are administered only if the child does not improve after three days or worsens sooner. The goal is to determine if the "watch and wait" method can reduce unnecessary antibiotic use while still aiding recovery. Children with doctor-diagnosed pneumonia symptoms, who can be treated at home, are suitable for this trial. Participants will be randomly assigned to one of the two groups and monitored for 14 days. As an unphased trial, this study offers an opportunity to contribute to important research that could enhance treatment strategies for children with pneumonia.

Do I have to stop taking my current medications for the trial?

The trial does not specify if you need to stop taking your current medications. However, if you have taken antibiotics in the past 7 days, you cannot participate.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Previous studies showed that giving antibiotics immediately to children with respiratory infections, such as mild pneumonia, resulted in about 84.5% of parents administering antibiotics for 5-7 days. Notably, 50.7% of these parents reported no problems or side effects during this period. This suggests that antibiotics, when given immediately, are generally well-tolerated by most children.

In contrast, the Safety Net Antibiotic Prescribing (SNAP) strategy involves administering antibiotics only if the child does not improve in 3 days or worsens. This approach can help avoid unnecessary side effects. Using antibiotics when not needed can cause issues like rashes or other side effects in children. Therefore, SNAP reduces the chance of these side effects by ensuring antibiotics are given only when truly necessary.

Both strategies aim to manage mild pneumonia safely. Immediate antibiotics are usually safe but can lead to unnecessary side effects. SNAP may help avoid these side effects by limiting antibiotic use. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about these antibiotic prescribing strategies for pneumonia in children because they aim to optimize antibiotic use and potentially reduce unnecessary medication. The Safety Net Antibiotic Prescribing (SNAP) approach stands out by providing a prescription but instructing parents to hold off on using it unless the child doesn't improve within 72 hours or gets worse. This method could help reduce antibiotic overuse, which is a common issue with immediate antibiotic prescribing where treatment starts right away. By potentially lowering antibiotic resistance and side effects, these strategies could redefine how we manage pediatric pneumonia.

What evidence suggests that this trial's treatments could be effective for pneumonia in children?

Research has shown that while giving antibiotics immediately to children with pneumonia is common, it is not always necessary. A study involving over 100,000 children found that many who did not receive antibiotics still recovered. In this trial, participants will be randomized into different treatment arms. One arm will follow the Immediate Antibiotic Prescribing approach, administering antibiotics right after the initial visit. Another arm will use the Safety Net Antibiotic Prescribing (SNAP) strategy, which involves waiting to see if symptoms improve before giving antibiotics. Early results suggest this method can reduce unnecessary antibiotic use without affecting recovery. The trial compares both approaches to determine the best way to treat mild pneumonia in children while minimizing antibiotic use. ^{2 3 4 5 6}

Who Is on the 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

Are You a Good Fit for This Trial?

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.

Parent/guardian of child enrolled in the trial

I am showing signs of a lung infection.

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11522934/

Outpatient Antibiotic Use and Treatment Failure Among ... In this cohort study of 103 854 children with pneumonia treated in an outpatient setting, 20% did not receive antibiotics. Treatment failure was uncommon.

2. pcori.org pcori.org/research-results/2024/comparing-effectiveness-two-antibiotic-treatment-strategies-children-pneumonia-outpatient-settings

Comparing the Effectiveness of Two Antibiotic Treatment ... This study compares the effectiveness of two approaches to antibiotic treatment in the outpatient setting for children with pneumonia.

3. respiratory-therapy.com respiratory-therapy.com/public-health/pediatrics/pediatric-care/12-million-study-compare-instant-vs-delayed-antibiotics-child-pneumonia/

Comparing Instant vs Delayed Antibiotics in Child Pneumonia The study will compare immediate antibiotic prescribing with a delayed approach to determine how to best manage mild pneumonia in children.

4. clinicalfutures.research.chop.edu clinicalfutures.research.chop.edu/investigating-antibiotic-treatment-strategies-children-pneumonia-outpatient-settings-0

Research In Practice Blog - Clinical Futures The study will compare two approaches for treating mild pneumonia in young children: The first approach involves immediately prescribing and ...

5. cidrap.umn.edu cidrap.umn.edu/antimicrobial-stewardship/researchers-study-delayed-antibiotic-strategy-kids-mild-pneumonia

Researchers to study delayed antibiotic strategy for kids ... Lurie Children's Hospital of Chicago announced last week that it has been awarded $12 million to study a new strategy for prescribing antibiotics in young ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11003315/

Outcomes of antibiotic treatment for respiratory infections in ... In the group prescribed antibiotics, 84.5% of parents reported giving antibiotics for 5-7 days, and 50.7% reported no difficulties. Adverse ...