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โ† Trials
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Short Versus Standard of Care Antibiotic Duration for Children Hospitalized for CAP

RecruitingPhase 4Ages 3 Months - 18 YearsAllMedical College of Wisconsin
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In plain words

What the trial is, and whether it could suit you

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? * Does a 5 day course cause less antibiotic side effects compared to a standard (longer) course of antibiotics in children with community acquired pneumonia? Participants will * be randomly assigned to either receive 5 total days or a total duration decided by the treating physician * receive a brief follow up questionnaire regarding clinical symptoms, follow up care/antibiotics, and side effects via phone o

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
Inclusion Criteria (ALL of the following must be met): 1. Children aged 3 months to \<18 years old 2. Hospitalized in either the acute care or the pediatric intensive care units 3. Clinically diagnosed with uncomplicated bacterial community acquired pneumonia (as determined by the treating physician) 4. Radiological findings suggestive of pneumonia (such as consolidation, lobar or interstitial infiltrates) 5. 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). Exclusion Criteria (presence of ANY of the following will exclude a potential participant): 1. Hemodynamic instability at any point during hospitalization that required inotropic support 2. Requirement of respiratory support \> 72 hours 3. Presence of a parapneumonic effusion \>10 mm on decubitus x-ray or greater than ยผ of hemithorax opacified on chest imaging 4. Need for chest tube placement 5. Extrapulmonary involvement (ie: another infection located outside of the lungs) except for otitis media if the planned treatment is โ‰ค 5 days 6. Pneumonia caused by known staphylococcus aureus identified from culture (blood, bronchoalveolar aspirate, tracheal aspirate, or pleural fluid) 7. Antibiotic course started \>72 hours after admission 8. Antibiotics used for \> 24 hours within the 2 weeks prior to admission 9. Chronic respiratory illness other than asthma or reactive airway disease 10. Immunocompromised patient (primary or secondary) 11. Primary physician refusal 12. Parent refusal 13. Non-English speakers 14. Pregnant or lactating female 15. Participant will become โ‰ฅ 18 years old at or before the time of day 14 follow up 16. Inability to adhere to follow up
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What it tests

  • Ampicillin for Injection
  • Ceftriaxone for Injection
  • Amoxicillin
  • Ampicillin / Sulbactam Injection
  • Amoxicillin-clavulanate
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Where

1 site
Childrens Wisconsin
Milwaukee, United States
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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