[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT06494072":3,"trial-entities:NCT06494072":132,"trial-summary:NCT06494072":136},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":20,"study_type":26,"primary_purpose":27,"phases":28,"enrollment_info":30,"interventions":33,"primary_outcomes":81,"secondary_outcomes":86,"sex":90,"minimum_age":91,"maximum_age":92,"healthy_volunteers":15,"eligibility_criteria":93,"std_ages":97,"locations":100,"central_contacts":121,"overall_officials":127,"references":130,"see_also_links":131},"NCT06494072","PRO00046965","Short Versus Standard of Care Antibiotic Duration for Children Hospitalized for CAP","Short Versus Standard of Care Antibiotic Duration for Hospitalized Children With Uncomplicated Community-acquired Pneumonia: a Non-inferiority, Randomized Controlled Trial.","RECRUITING","2028-05","2026-02","2026-03-02","2024-08-22","Medical College of Wisconsin","OTHER",false,"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.\n\nThe main questions it aims to answer are:\n\n* Does a 5 day course work as well as standard (longer) courses of antibiotics for treating community acquired pneumonia in children?\n* Does a 5 day course cause less antibiotic side effects compared to a standard (longer) course of antibiotics in children with community acquired pneumonia?\n\nParticipants will\n\n* be randomly assigned to either receive 5 total days or a total duration decided by the treating physician\n* receive a brief follow up questionnaire regarding clinical symptoms, follow up care\u002Fantibiotics, and side effects via phone or email at days 5 and 14 from the start of antibiotics\n\nResearchers will compare the experimental group (receiving 5 days duration) with the control group (standard duration) to see if 5 days is as successful as a standard duration.","This is an open label, randomized, non-inferiority clinical trial to determine if a 5-day antibiotic course works as well compared to a standard antibiotic course (usually 7-10 days of antibiotics) in hospitalized children who are aged 3 months to less than 18 years old, with uncomplicated community acquired pneumonia.\n\nWe will recruit 150 participants meeting inclusion\u002Fexclusion criteria. Participants will be randomized to one of the study groups. In the experimental group, the participant will receive a total antibiotic course of 5 days. In the other group (control group), participants will receive the standard-of-care antibiotic course (the duration will be decided by the primary treating physician in this group). The selection of antibiotic therapy will be made by the treating physician, generally in accordance with the institutional clinical practice guideline on community acquired pneumonia, prior to enrollment in the study. Other medical care, aside from the treatment duration, will be the same and will be guided by the primary treating doctor. The primary treating doctor will also decide when the participant is medically ready for discharge from the hospital.\n\nDuring the consenting process, a member of the research team will verify the contact numbers or email of the parent(s)\u002Fguardian of participant to be used after discharge for follow-up communication. Every participant's parent\u002Fguardian will receive a text message\u002Femail questionnaire on day 5 and day 14 after the start of antibiotics to assess for clinical improvement, side effect(s) to the antibiotics, recurrence of fever, or need for additional antibiotics or other medical care. Participants parent(s)\u002Fguardian will be contacted by phone for additional information if there is concern for a failure or significant medical concern.\n\nThe primary objective of this study is to compare the failure rate between a short course (5-days) and standard antibiotic course (usually 7-10 days of antibiotics) of antibiotics in hospitalized children with uncomplicated pneumonia. Failure will be defined as the clinical need for additional antibiotic treatment, emergency department visit or readmission to the hospital for a suspected lower respiratory tract infection within 14 days of treatment initiation.\n\nThe secondary objective will compare the rate of adverse drug events between short and long-course durations of antibiotic therapy in children hospitalized for CAP. Adverse drug events include any allergic reaction such as skin rash, itching or other and\u002For abdominal symptoms such as vomiting, stomach pain and diarrhea.\n\nData will be summarized by n (%) or mean and standard deviation (SD) or median and interquartile range (IQR). Continuous variables will be compared by t-test while categorical variables will be compared by Chi-square or Fisher's exact test. A 95% CI will be calculated for the difference in failure rate between the shorter antibiotic course (5-day) group and the standard course group. Non-inferiority will be declared if the 95% CI lies below 10%. P\\\u003C0.05 will be considered statistically significant. Data will be analyzed by SAS version 9.4 (SAS Institute Inc., Cary, NC) and SPSS version 28.0 (IBM Corp., Armonk, NY).",[19],"Community Acquired Pneumonia in Children",[21,22,23,24,25],"inpatient","pediatric","hospitalized","community acquired pneumonia.","antibiotic duration","INTERVENTIONAL","TREATMENT",[29],"PHASE4",{"count":31,"type":32},236,"ESTIMATED",[34,41,47,51,57,63,69,75],{"type":35,"name":36,"description":37,"armGroupLabels":38},"DRUG","Ampicillin for Injection","Ampicillin is an intravenous antibiotic commonly used in the initial treatment of children hospitalized with community-acquired pneumonia.",[39,40],"Short course antibiotic duration","Standard of care antibiotic duration",{"type":35,"name":42,"description":43,"armGroupLabels":44,"otherNames":45},"Ceftriaxone for Injection","Ceftriaxone is an intravenous antibiotic commonly used in the initial treatment of children hospitalized with community-acquired pneumonia.",[39,40],[46],"Rocephin",{"type":35,"name":48,"description":49,"armGroupLabels":50},"Amoxicillin","Amoxicillin is an oral antibiotic commonly used in the treatment of children hospitalized with community-acquired pneumonia to complete the antibiotic course after discharge.",[39,40],{"type":35,"name":52,"description":53,"armGroupLabels":54,"otherNames":55},"Ampicillin \u002F Sulbactam Injection","Ampicillin\u002FSulbactam is an intravenous antibiotic commonly used in the initial treatment of children hospitalized with community-acquired pneumonia.",[39,40],[56],"Unasyn",{"type":35,"name":58,"description":59,"armGroupLabels":60,"otherNames":61},"Amoxicillin-clavulanate","Amoxicillin-clavulanate is an oral antibiotic commonly used in the treatment of children hospitalized with community-acquired pneumonia to complete the antibiotic course after discharge.",[39,40],[62],"Augmentin",{"type":35,"name":64,"description":65,"armGroupLabels":66,"otherNames":67},"Clindamycin","Clindamycin is an antibiotic that can be given intravenously or orally that is sometimes used in the treatment of children hospitalized or discharged with community-acquired pneumonia.",[39,40],[68],"Cleocin",{"type":35,"name":70,"description":71,"armGroupLabels":72,"otherNames":73},"Cefprozil","Cefprozil is an oral antibiotic sometimes used in the treatment of children hospitalized with community-acquired pneumonia to complete the antibiotic course after discharge.",[39,40],[74],"Cefzil",{"type":35,"name":76,"description":77,"armGroupLabels":78,"otherNames":79},"Levofloxacin","Levofloxacin is an antibiotic that can be given intravenously or orally that is sometimes used in the treatment of children hospitalized or discharged with community-acquired pneumonia.",[39,40],[80],"Levaquin",[82],{"measure":83,"description":84,"timeFrame":85},"Treatment failure rate","Treatment failure is defined as the clinical need for additional antibiotic treatment, an emergency department (ED) visit, or readmission to the hospital for a suspected lower respiratory tract infection within 14 days of treatment initiation.","14 days from the first dose antibiotics",[87],{"measure":88,"description":89,"timeFrame":85},"Adverse drug event rate","Adverse drug events include allergic reactions, skin rash, abdominal symptoms (such as vomiting, stomach pain, or diarrhea), or other plausible associated complaints described by the parent(s)\u002Fguardian.","ALL","3 Months","18 Years",{"inclusion":94,"exclusion":95,"raw_text":96},[],[],"Inclusion Criteria (ALL of the following must be met):\n\n1. Children aged 3 months to \\\u003C18 years old\n2. Hospitalized in either the acute care or the pediatric intensive care units\n3. Clinically diagnosed with uncomplicated bacterial community acquired pneumonia (as determined by the treating physician)\n4. Radiological findings suggestive of pneumonia (such as consolidation, lobar or interstitial infiltrates)\n5. Achieved clinical stability within 72 hours from the first antibiotic dose (clinical stability includes being off supplemental oxygen\u002Fventilatory support and temperature remaining \\\u003C 38 Celsius).\n\nExclusion Criteria (presence of ANY of the following will exclude a potential participant):\n\n1. Hemodynamic instability at any point during hospitalization that required inotropic support\n2. Requirement of respiratory support \\> 72 hours\n3. Presence of a parapneumonic effusion \\>10 mm on decubitus x-ray or greater than ¼ of hemithorax opacified on chest imaging\n4. Need for chest tube placement\n5. Extrapulmonary involvement (ie: another infection located outside of the lungs) except for otitis media if the planned treatment is ≤ 5 days\n6. Pneumonia caused by known staphylococcus aureus identified from culture (blood, bronchoalveolar aspirate, tracheal aspirate, or pleural fluid)\n7. Antibiotic course started \\>72 hours after admission\n8. Antibiotics used for \\> 24 hours within the 2 weeks prior to admission\n9. Chronic respiratory illness other than asthma or reactive airway disease\n10. Immunocompromised patient (primary or secondary)\n11. Primary physician refusal\n12. Parent refusal\n13. Non-English speakers\n14. Pregnant or lactating female\n15. Participant will become ≥ 18 years old at or before the time of day 14 follow up\n16. Inability to adhere to follow up",[98,99],"CHILD","ADULT",[101],{"facility":102,"status":8,"city":103,"state":104,"zip":105,"country":106,"contacts":107,"geoPoint":118},"Childrens Wisconsin","Milwaukee","Wisconsin","53226","United States",[108,113,115],{"name":109,"role":110,"phone":111,"email":112},"Michelle Mitchell, MD","CONTACT","4143377070","mimitchell@mcw.edu",{"name":109,"role":114},"PRINCIPAL_INVESTIGATOR",{"name":116,"role":117},"khaled al zubaidi, MD","SUB_INVESTIGATOR",{"lat":119,"lon":120},43.0389,-87.90647,[122,124],{"name":109,"role":110,"phone":123,"email":112},"414-337-7070",{"name":125,"role":110,"phone":123,"email":126},"Khaled AL zubaidi, MD","kalzubaidi@mcw.edu",[128],{"name":129,"affiliation":13,"role":114},"Michelle Mitchell",[],[],{"nct_id":4,"conditions":133,"biomarkers":135},[134],"Community-Acquired Pneumonia",[],{"nct_id":4,"found":137,"summary":138,"prompt_version":148},true,{"design":139,"status":140,"heading":141,"summary":142,"follow_up":143,"word_count":144,"commitments":145,"compensation":146,"drugs_mentioned":147},"This is an open-label, randomized study aiming to enroll 236 participants. Participants will be assigned by chance to either a 5-day antibiotic course or a standard-length course.","completed","Antibiotic Duration for Children Hospitalized with Pneumonia","This study is looking at whether a shorter, 5-day course of antibiotics works as well as the usual 7-14 day course for children hospitalized with uncomplicated community-acquired pneumonia (a lung infection caught outside of a hospital). Researchers want to see if drugs like ampicillin, ceftriaxone, amoxicillin, ampicillin\u002Fsulbactam, and amoxicillin-clavulanate can be given for a shorter time without affecting treatment success. They also want to know if a shorter course causes fewer side effects. Children aged 3 months to 18 years who are hospitalized with this type of pneumonia can join. The study will measure if the treatment is successful 14 days after the first antibiotic dose. The current recruitment status is unclear.","Participants will be followed up for treatment failure rate at 14 days from the first dose of antibiotics.",112,"Participants will receive antibiotics, with the specific drugs and initial duration decided by their doctor. Other medical care will be guided by the primary treating doctor.","Not stated in the trial record.",[48,58],"v2"]