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Anti-bacterial

Short-Course Antibiotics for Childhood Pneumonia (PRESTO-2 Trial)

Phase 4
Recruiting
Research Sponsored by Jeffrey Pernica
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Must have at least one of the following: documented tachypnoea, cough on exam or by history, increased work of breathing on exam, or auscultatory findings consistent with CAP
Be younger than 65 years old
Must not have
Supplemental oxygen use or fever within the past 24 h
Malignancy
Timeline
Screening 3 weeks
Treatment Varies
Follow Up before day 30
Awards & highlights
Drug Has Already Been Approved
Pivotal Trial

Summary

This trial aims to compare short-course (3-5 days) versus standard-duration (8-10 days) antibiotic therapy for children hospitalized with community-acquired pneumonia (CAP). There is more evidence for

Who is the study for?
This trial is for children hospitalized with community-acquired pneumonia (CAP) who show signs like fast breathing, coughing, and increased effort to breathe. They must have physical exam findings that match CAP. Children without these specific symptoms or other criteria will not be eligible.
What is being tested?
The study is testing if a short course of antibiotics (3-5 days) is as effective as the standard longer treatment (8-10 days) in children with CAP. Some kids will get Amoxicillin while others may receive a placebo to compare outcomes.
What are the potential side effects?
Amoxicillin can cause side effects such as allergic reactions, diarrhea, nausea, vomiting, and rash. The severity varies from child to child; some might experience no side effects at all.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have symptoms like rapid breathing, coughing, or difficulty breathing that suggest pneumonia.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have used supplemental oxygen or had a fever in the last 24 hours.
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I have been diagnosed with cancer.
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I have a long-term lung condition.
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My child is on blood thinners or certain antibiotics.
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I am not currently taking antibiotics.
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I have a heart condition from birth that needs treatment or limits my physical activity.
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I have a weakened immune system.
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I was diagnosed with pneumonia in the last 2 weeks.
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I have not participated in this trial before.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~before day 30
This trial's timeline: 3 weeks for screening, Varies for treatment, and before day 30 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Consent success
Losses to followup
Open-label antibiotic use
Secondary study objectives
Proportion of participants who develop complicated pneumonia
Proportion of participants with late clinical response

Side effects data

From 2015 Phase 2 & 3 trial • 149 Patients • NCT01968460
20%
NAUSEA
16%
SOMNOLENCE
10%
DIZZINESS
8%
fatigue
8%
tremor
6%
insomnia
4%
orthostatic hypotension
4%
nasopharyngitis
2%
ACUTE MYOCARDIAL INFARCTION
2%
headache
100%
80%
60%
40%
20%
0%
Study treatment Arm
P2B001 Treatment A
P2B001 Treatment B
Placebo

Awards & Highlights

Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Short-course treatmentExperimental Treatment1 Intervention
5 days of placebo (after participants already received 3-5 days of antibiotics)
Group II: Standard-duration treatmentActive Control1 Intervention
5 days of amoxicillin (after participants already received 3-5 days of antibiotics)
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Placebo
1995
Completed Phase 3
~2670

Find a Location

Who is running the clinical trial?

Jeffrey PernicaLead Sponsor
2 Previous Clinical Trials
151 Total Patients Enrolled
1 Trials studying Community-acquired Pneumonia
75 Patients Enrolled for Community-acquired Pneumonia
JeffreyLead Sponsor
1 Previous Clinical Trials
75 Total Patients Enrolled
1 Trials studying Community-acquired Pneumonia
75 Patients Enrolled for Community-acquired Pneumonia
~43 spots leftby Nov 2025
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