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Anti-bacterial

Short vs Standard Antibiotics for Childhood Pneumonia

Phase 4

Recruiting

Led By Michelle Mitchell

Research Sponsored by Medical College of Wisconsin

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Radiological findings suggestive of pneumonia (such as consolidation, lobar or interstitial infiltrates)

Children aged 3 months to <18 years old

Must not have

Requirement of respiratory support > 72 hours

Presence of a parapneumonic effusion >10 mm on decubitus x-ray or greater than ¼ of hemithorax opacified on chest imaging

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 14 days from the first dose antibiotics

Awards & highlights

Drug Has Already Been Approved

No Placebo-Only Group

Pivotal Trial

Summary

This trial is comparing a 5-day antibiotic treatment to the standard longer antibiotic treatment for children with community-acquired pneumonia. The goal is to see if the shorter treatment works as well and has fewer side

Who is the study for?

This trial is for hospitalized children aged 3 months to 18 years with uncomplicated community-acquired pneumonia. They must not have taken antibiotics before hospitalization and should be able to take oral medication or receive injections.

What is being tested?

The study tests if a shorter, 5-day antibiotic treatment is as effective as the standard longer course (7-14 days) in treating pneumonia in children. Participants are randomly assigned to one of the two durations and followed up through questionnaires on days 5 and 14.

What are the potential side effects?

Potential side effects from the antibiotics may include allergic reactions, digestive issues like diarrhea or nausea, rash, yeast infections, and possibly less commonly, changes in blood counts or liver enzymes.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My scans show signs of pneumonia.

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I am between 3 months and 18 years old.

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I am currently hospitalized in acute care or the pediatric ICU.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I needed help with breathing for more than 72 hours.

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I have a significant fluid buildup in my lung, confirmed by an X-ray.

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I needed medication to support my heart's pumping action during a hospital stay.

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I need a chest tube placed.

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I have pneumonia caused by staphylococcus aureus, confirmed by a culture test.

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I have a long-term lung problem that is not asthma.

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My immune system is weak due to a condition or treatment.

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I am not pregnant or breastfeeding.

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I have taken antibiotics for more than a day within the last 2 weeks.

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My parents have refused participation in the trial.

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I will be 18 years or older by the 14th day of follow-up.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 14 days from the first dose antibiotics

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~14 days from the first dose antibiotics

This trial's timeline: 3 weeks for screening, Varies for treatment, and 14 days from the first dose antibiotics for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Treatment failure rate

Secondary study objectives

Adverse drug event rate

Awards & Highlights

Drug Has Already Been Approved

The FDA has already approved this drug, and is just seeking more data.

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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 antibiotic durationExperimental Treatment8 Interventions

The participants in this group will receive a total antibiotic course of 5 days including the number of days received during their hospital admission and following hospital admission combined.

Group II: Standard of care antibiotic durationActive Control8 Interventions

Participants will receive the standard-of-care antibiotic course in this group. That is, the duration of antibiotics will be decided by the primary treating physician in this group. The antibiotic course will include the number of days received during the participant's hospital admission and following hospital admission combined.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Levofloxacin

2011

Completed Phase 4

~8180

Amoxicillin-clavulanate

2016

Completed Phase 4

~2490