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Anti-bacterial

Short-course treatment for Community-acquired 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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up before day 30
Awards & highlights

PRESTO-2 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.Check my eligibility
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.See study design
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.

PRESTO-2 Trial Eligibility Criteria

Inclusion Criteria

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

PRESTO-2 Trial 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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Consent success
Losses to followup
Open-label antibiotic use
Secondary outcome measures
Proportion of participants who develop complicated pneumonia
Proportion of participants with drug-related AEs (any severity)
Proportion of participants with late clinical response
+4 more

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

PRESTO-2 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does this medical study include individuals above the age of 40?

"To qualify for enrollment in this research study, participants must be at least 6 months old but not older than 18 years."

Answered by AI

Are there currently ongoing patient enrollments for this clinical trial?

"Indeed, the details on clinicaltrials.gov highlight that this study is currently seeking participants. The trial was originally listed on April 17th, 2024 and last modified on April 18th, 2024. It aims to enroll a total of 75 patients across one designated site."

Answered by AI

What is the current capacity for patient enrollment in this clinical trial?

"Affirmative. The details on clinicaltrials.gov imply that this investigation is actively seeking participants. Originally shared on April 17, 2024, the information was last revised on April 18, 2024. A total of 75 individuals are sought from one site for enrollment in this study."

Answered by AI

Am I eligible to be a part of this medical study?

"The research team aims to enroll 75 patients aged between half a year and 18 years who have contracted community-acquired pneumonia. In addition, prospective participants must exhibit confirmed rapid breathing rates (>60 bpm for those under one year old, >50 bpm for ages 1-2, >40 bpm for ages 2-4, and >30 bpm for individuals over four); cough during examination or reported in their medical history; increased respiratory effort during physical assessment; or abnormal lung sounds (e.g., localized crackles, bronchial breath sounds) indicative of community-acquired pneumonia."

Answered by AI

Has the short-duration therapy been sanctioned by the FDA?

"Short-course treatment has been assessed with a safety rating of 3 by our team, reflecting its Phase 4 status and approved nature."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Optimizing Care for Children Hospitalized With Community-acquired Pneumonia: Short-course Therapy
Jeffrey Pernica 2024. "Optimizing Care for Children Hospitalized With Community-acquired Pneumonia: Short-course Therapy". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06125340.
~50 spots leftby Nov 2025
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