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Compares treatment options for Community Acquired Pneumonia in Children
Official title Short Versus Standard of Care Antibiotic Duration for Children Hospitalized for CAP
ClinicalTrials.gov ID: NCT06494072
What this study is testing
What is Ampicillin for Injection?
Ampicillin for Injection is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for community acquired pneumonia in children.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The goal of this open label, randomized, non-inferiority clinical trial is to compare the treatment success of a 5 day antibiotic course versus a standard antibiotic course (usually 7-14 days of antibiotics) in hospitalized children aged 3 months to 18 years, with uncomplicated community acquired pneumonia. The main questions it aims to answer are: Does a 5 day course work as well as standard (longer) courses of antibiotics for treating community acquired pneumonia in children?
- Phase 4: studies an already-approved treatment
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 3 to 18
You may be able to join if
- (ALL of the following must be met):
- Children aged 3 months to \<18 years old
- Hospitalized in either the acute care or the pediatric intensive care units
- Clinically diagnosed with uncomplicated bacterial community acquired pneumonia (as determined by the treating physician)
- Radiological findings suggestive of pneumonia (such as consolidation, lobar or interstitial infiltrates)
You likely can't join if
- (presence of ANY of the following will exclude a potential participant):
- Hemodynamic instability at any point during hospitalization that required inotropic support
- 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
- Need for chest tube placement
- Extrapulmonary involvement (ie: another infection located outside of the lungs) except for otitis media if the planned treatment is ≤ 5 days
See the full eligibility criteria
- (ALL of the following must be met):
- Children aged 3 months to \<18 years old
- Hospitalized in either the acute care or the pediatric intensive care units
- Clinically diagnosed with uncomplicated bacterial community acquired pneumonia (as determined by the treating physician)
- Radiological findings suggestive of pneumonia (such as consolidation, lobar or interstitial infiltrates)
- Achieved clinical stability within 72 hours from the first antibiotic dose (clinical stability includes being off supplemental oxygen/ventilatory support and temperature remaining \< 38 Celsius).
- (presence of ANY of the following will exclude a potential participant):
- Hemodynamic instability at any point during hospitalization that required inotropic support
- 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
- Need for chest tube placement
- Extrapulmonary involvement (ie: another infection located outside of the lungs) except for otitis media if the planned treatment is ≤ 5 days
- Pneumonia caused by known staphylococcus aureus identified from culture (blood, bronchoalveolar aspirate, tracheal aspirate, or pleural fluid)
- Antibiotic course started \>72 hours after admission
- Antibiotics used for \> 24 hours within the 2 weeks prior to admission
- Chronic respiratory illness other than asthma or reactive airway disease
- Immunocompromised patient (primary or secondary)
- Primary physician refusal
- Parent refusal
- Non-English speakers
- Pregnant or lactating female
- Participant will become ≥ 18 years old at or before the time of day 14 follow up
- Inability to adhere to follow up
The study team makes the final eligibility decision.
Where it's taking place
- Milwaukee, Wisconsin, United States
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 3 months to 18 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Milwaukee, Wisconsin, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.