[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100639711":3},{"organization":4,"armGroups":7,"interventions":21,"overallOfficials":41,"centralContacts":45,"locations":52,"responsibleParty":68,"collaborators":50,"id":70,"slug":71,"hasResults":72,"nctId":73,"briefTitle":74,"officialTitle":75,"acronym":76,"eligibilityCriteria":77,"healthyVolunteers":72,"sex":78,"minAge":79,"maxAge":80,"enrollmentInfo":81,"targetDuration":50,"studyType":84,"phases":85,"briefSummary":87,"conditions":88,"keywords":90,"overallStatus":96,"whyStopped":50,"lastUpdateSubmitDate":97,"lastUpdatePostDateStruct":98,"startDateStruct":101,"completionDateStruct":103,"leadSponsor":105,"locationsCount":106},{"fullName":5,"class":6},"Montefiore Medical Center","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"No-Antibiotic Group","EXPERIMENTAL","Participants randomized to this arm will be discharged from the Emergency Department with symptomatic treatment only, without antibiotics. The regimen consists of oral ibuprofen 400 mg every 8 hours and\u002For oral acetaminophen 1 g every 8 hours for symptom control, a liquid diet advancing as tolerated, and standardized return precautions. Participants will receive a patient handout with medication instructions, follow-up schedule, and a dedicated contact number for questions or adverse events.",[13],"Drug: Symptomatic treatment (ibuprofen and acetaminophen)",{"label":15,"type":16,"description":17,"interventionNames":18},"Standard Antibiotic Therapy","ACTIVE_COMPARATOR","Participants randomized to this arm will be discharged from the Emergency Department with standard outpatient antibiotic therapy in addition to symptomatic treatment. The regimen consists of oral amoxicillin\u002Fclavulanate 875\u002F125 mg every 12 hours for 7 days, plus oral ibuprofen 400 mg every 8 hours and\u002For oral acetaminophen 1 g every 8 hours for symptom control, a liquid diet advancing as tolerated, and standardized return precautions. Participants with a documented or self-reported penicillin or beta-lactam allergy will receive oral ciprofloxacin 500 mg every 12 hours plus oral metronidazole 500 mg every 8 hours for 7 days instead of amoxicillin\u002F clavulanate. Participants will receive a patient handout with medication instructions, follow-up schedule, and a dedicated contact number for questions or adverse events.",[13,19,20],"Drug: Amoxicillin-clavulanate","Drug: Ciprofloxacin plus metronidazole",[22,29,35],{"type":23,"name":24,"description":25,"armGroupLabels":26,"otherNames":27},"DRUG","Symptomatic treatment (ibuprofen and acetaminophen)","Oral ibuprofen 400 mg every 8 hours and\u002For oral acetaminophen 1 g every 8 hours, taken as needed for pain control for up to 7 days, combined with a liquid diet advancing as tolerated and standardized return precautions. This symptomatic regimen is administered to participants in both study arms.",[9,15],[28],"Pain control regimen",{"type":23,"name":30,"description":31,"armGroupLabels":32,"otherNames":33},"Amoxicillin-clavulanate","Oral amoxicillin\u002Fclavulanate 875\u002F125 mg every 12 hours for 7 days, administered to participants in the antibiotic arm who do not have a documented or self-reported penicillin or beta-lactam allergy. Administered in addition to the symptomatic treatment regimen.",[15],[34],"Augmentin",{"type":23,"name":36,"description":37,"armGroupLabels":38,"otherNames":39},"Ciprofloxacin plus metronidazole","Oral ciprofloxacin 500 mg every 12 hours plus oral metronidazole 500 mg every 8 hours for 7 days, administered to participants in the antibiotic arm who have a documented or self-reported penicillin or beta-lactam allergy. Administered in addition to the symptomatic treatment regimen as an alternative to amoxicillin\u002Fclavulanate.",[15],[40],"Cipro plus Flagyl",[42],{"name":43,"affiliation":5,"role":44},"James Taylor, MD","PRINCIPAL_INVESTIGATOR",[46],{"name":47,"role":48,"phone":49,"phoneExt":50,"email":51},"Yeisson Rivero Moreno, MD","CONTACT","19178075141",null,"yriveromor@montefiore.org",[53],{"facility":5,"status":50,"city":54,"state":55,"zip":56,"country":57,"countryCode":58,"cosmosGeoPoint":59,"geoPoint":64,"contacts":65},"The Bronx","New York","10467","United States","US",{"type":60,"coordinates":61},"Point",[62,63],-73.86641,40.84985,{"lat":63,"lon":62},[66],{"name":47,"role":48,"phone":67,"phoneExt":50,"email":51},"917-807-5141",{"type":69,"investigatorFullName":50,"investigatorTitle":50,"investigatorAffiliation":50,"oldNameTitle":50,"oldOrganization":50},"SPONSOR","100639711","phase-4-non-antibiotic-management-in-acute-uncomplicated-diverticulitis-100639711",false,"NCT07625267","Non-antibiotic Management in Acute Uncomplicated Diverticulitis","Non-antibiotic Management in Acute Uncomplicated Diverticulitis: Randomized Open Label-controlled Trial","NAMAD","Inclusion Criteria:\n\n* Left-sided diverticulitis, primary or recurrent\n* Signs of diverticulitis on CT-confirmed Hinchey (0 or 1a based on CT final report)\n* White Blood Cell (WBC) count \\\u003C15,000mm\\^3\n* Controlled symptoms in the ED (i.e., Pain score \\\u003C5 on VAS scale, tolerating PO intake, no fever)\n\nExclusion Criteria:\n\n* Signs of complicated diverticulitis on CT with abscess, fistula, free air, Micro perforation, or signs of other diagnosis on CT Abdomen and pelvis\n* Inflammatory bowel disease\n* American Society for Anesthesiologists (ASA) physical status classification of \\>=3\n* Immunocompromised patient; (i.e., haematological malignancies, AIDS patients with low CD4+ counts, transplantation, chemotherapy, splenectomy, long-term corticosteroid use and genetic disorders such as severe combined immunodeficiency\n* Pregnancy\n* Ongoing antibiotic therapy or in the previous 2 weeks\n* High fever, affected general condition, peritonitis or sepsis\n* Subjects who do not have the capacity to consent","ALL","18 Years","80 Years",{"count":82,"type":83},556,"ESTIMATED","INTERVENTIONAL",[86],"PHASE4","Diverticulitis is a common condition that causes swelling and pain in part of the colon (the large intestine). Doctors classify it as \"mild\" when there are no serious complications.\n\nFor many years, doctors in the United States have treated mild diverticulitis with antibiotics. New studies from Europe suggest that many people with mild diverticulitis may not need antibiotics and can get better with just pain medicines. But this approach has not been tested in the United States, where antibiotics are still the standard treatment.\n\nThe goal of this clinical trial is to find out if people with mild diverticulitis can be safely treated at home without antibiotics. The main questions it aims to answer are:\n\n* Are people treated without antibiotics admitted to the hospital more often than people treated with antibiotics?\n* Do people treated without antibiotics have more emergency room visits, worsening of their disease, or need for surgery?\n\nResearchers will compare two groups of people who come to the emergency department with mild diverticulitis to see if treatment without antibiotics is as safe as treatment with antibiotics.\n\nParticipants will:\n\n* Be sent home with pain medicines (ibuprofen and acetaminophen) only, or with pain medicines plus an antibiotic taken by mouth for 7 days\n* Follow a liquid diet and slowly return to normal food as they feel better\n* Come back to clinic for a check-up at 1 to 2 weeks\n* Answer phone calls about their health at 4 weeks, 3 months, and 6 months",[89],"Acute Uncomplicated Diverticulitis",[91,92,93,94,95],"Diverticulitis, Colonic","Anti-Bacterial Agents","Outpatients","Watchful Waiting","Acute Disease","NOT_YET_RECRUITING","2026-05-26",{"date":99,"type":100},"2026-06-04","ACTUAL",{"date":102,"type":83},"2026-07-01",{"date":104,"type":83},"2028-06-30",{"name":5,"class":6},1]