APLAUD Trial (Antibiotics vs PLacebo for Acute Uncomplicated Diverticulitis)

Официальное название

Comparing Placebo Versus Antibiotics for Acute Uncomplicated Diverticulitis

Обзор

The goal of this clinical trial is to determine whether antibiotics improve recovery from acute uncomplicated diverticulitis (AUD) in racially and ethnically diverse United States clinical practice. The main questions it seeks to answer are: * What is the feasibility for completing a subsequent definitive efficacy trial of antibiotics vs. placebo to treat AUD? * What are the needs for successful recruitment of racial and ethnic subgroups? * What are the effects of a placebo compared to antibiotics for AUD on a range of key patient-centric efficacy and safety endpoints? * How do such effects differ by race and ethnicity? Researchers will compare a placebo to antibiotics to see if AUD can be treated without using antibiotics. Participants will: * Take two antibiotics or a matching placebo every day for 10 days * Receive analgesia, gastric protection, diet modifications, and a follow-up * Submit daily photos of pills to the study team to verify adherence

Вмешательства

• Препарат Amoxicillin-Clavulanate 875 Mg-125 Mg Oral Tablet
  amoxicillin-clavulanate:1 tablet \[875 mg amoxicillin; 125 mg clavulanic acid\] every 8 hours
• Препарат Placebo
  A placebo matching the antibiotic arm's treatment regimen will be administered for 10 days
• Препарат Metronidazole
  metronidazole: 500 mg every 12 hours
• Препарат Cefuroxime
  cefuroxime: 500 mg every 12 hours

Первичные конечные точки

• Recruitment Rate [Срок оценки: From enrollment through study completion, an average of 2 years.]
• Adherence [Срок оценки: From enrollment through study completion, an average of 2 years]
• Data completeness [Срок оценки: From enrollment through study completion, an average of 2 years]
• Retention [Срок оценки: From enrollment through study completion, an average of 2 years]
• Acceptability [Срок оценки: Collected at 14 days and 6 months]
• Cross over [Срок оценки: From enrollment through study completion, an average of 2 years]

Вторичные конечные точки (12)

• Barratt Simplified Measure of Social Status (BSMSS) [Срок оценки: Collected at the time of enrollment]
• Brief Health Literacy Scale (BHLS) [Срок оценки: Collected at enrollment]
• Patient-Reported Outcomes Measurement Information System-10 (PROMIS-10) [Срок оценки: Collected at the time of enrollment, 30 days, and 6 months]
• Diverticulitis quality of life (DV-QOL) instrument [Срок оценки: Collected at enrollment, then 14 and 30 days into the study.]
• Patient-Reported Outcomes Measurement Information System, Gastrointestinal [Срок оценки: Collected at enrollment and 14 days into study]
• Time to normalization of abdominal pain intensity [Срок оценки: Collected at enrollment, daily for 30 days, and at 6 months]
• Rate of Progression to Complicated Diverticulitis [Срок оценки: Collected at enrollment, 14 days, 30 days, and 6 months]
• Rate of persistent diverticulitis at 30 days [Срок оценки: Collected 30 days from enrollment]
• Rate of diverticulitis-related hospitalization, percutaneous drainage and colectomy [Срок оценки: From enrollment through study completion, an average of 2 years]
• Mortality [Срок оценки: From enrollment through study completion, an average of 2 years]
• Adverse Drug Events [Срок оценки: From enrollment through study completion, an average of 2 years]
• Return to normal activity [Срок оценки: From enrollment through study completion, an average of 2 years]

Критерии участия

Критерии включения

• Patients presenting to the emergency department with left-sided uncomplicated diverticulitis
• Radiologic score (moderate diverticulitis per Ambrosetti classification)
• Age 18-90
• Access to a smartphone with internet access.

Критерии исключения

• Complicated diverticulitis (abscess, free air, peritonitis)- severe diverticulitis by Ambrosetti classification
• Diverticulitis other than left colon
• Contraindication to use of study medication (ie advanced renal failure or allergy to all antibiotics used in the study)
• Concurrent cancer diagnosis
• Concurrent IBD Diagnosis
• Any other disease process with life expectancy < 6 months
• Concurrent chronic pain diagnosis.
• Women in pregnancy or breastfeeding
• Antibiotic treatment for any reason in the last 3 weeks
• Diagnosis of prior episode of acute diverticulitis in the past 3 months
• Significant comorbidities: diabetes mellitus with organic involvement (retinopathy, angiopathy, nephropathy), emergency assistance for a cardiogenic event in the last 3 months (acute myocardial infarction, angina, heart failure), decompensation of chronic liver disease in the last 3 months (Child ≥ B) and end-stage renal disease.
• Immunodepression: the absence, and immunodepression is the presence, of any of the following: active neoplastic disease, hematologic malignancy, human immunodeficiency virus long-term corticosteroid treatment, immunosuppressant therapy (20mg pred (or equivalent) for >2 weeks), transplant, splenectomy and genetic immunodeficiency
• Previous colectomy
• Patients with dementia, memory disorders or other cognitive impairment that would impact their ability to provide informed consent or otherwise participate in the trial

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Четверное слепое

Основная цель

Лечение

Центры проведения

США · 1 центр

• Vanderbilt University Medical Center Emergency Department — Nashville

Публикации

• W. B. The Barratt Simplified Measure of Social Status (BSMSS) measuring SES. 2006. Accessed 8/11/22, https://www.wbarratt.indstate.edu/socialclass/Barratt Simplifed Measure of Social Status.pdf
• Harris PA, Taylor R, Thielke R, Payne J, Gonzalez N, Conde JG. Research electronic data capture (REDCap)--a metadata-driven methodology and workflow process for providing translational research informatics support. J Biomed Inform. 2009 Apr;42(2):377-81. doi: 10.1016/j.jbi.2008.08.010. Epub 2008 Sep 30. PMID 18929686
• Reilly MC, Zbrozek AS, Dukes EM. The validity and reproducibility of a work productivity and activity impairment instrument. Pharmacoeconomics. 1993 Nov;4(5):353-65. doi: 10.2165/00019053-199304050-00006. PMID 10146874
• Spiegel BM, Hays RD, Bolus R, Melmed GY, Chang L, Whitman C, Khanna PP, Paz SH, Hays T, Reise S, Khanna D. Development of the NIH Patient-Reported Outcomes Measurement Information System (PROMIS) gastrointestinal symptom scales. Am J Gastroenterol. 2014 Nov;109(11):1804-14. doi: 10.1038/ajg.2014.237. Epub 2014 Sep 9. PMID 25199473
• Hays RD, Bjorner JB, Revicki DA, Spritzer KL, Cella D. Development of physical and mental health summary scores from the patient-reported outcomes measurement information system (PROMIS) global items. Qual Life Res. 2009 Sep;18(7):873-80. doi: 10.1007/s11136-009-9496-9. Epub 2009 Jun 19. PMID 19543809
• Cella D, Riley W, Stone A, Rothrock N, Reeve B, Yount S, Amtmann D, Bode R, Buysse D, Choi S, Cook K, Devellis R, DeWalt D, Fries JF, Gershon R, Hahn EA, Lai JS, Pilkonis P, Revicki D, Rose M, Weinfurt K, Hays R; PROMIS Cooperative Group. The Patient-Reported Outcomes Measurement Information System (PROMIS) developed and tested its first wave of adult self-reported health outcome item banks: 2005- PMID 20685078
• Chew LD, Bradley KA, Boyko EJ. Brief questions to identify patients with inadequate health literacy. Fam Med. 2004 Sep;36(8):588-94. PMID 15343421
• Spiegel BM, Reid MW, Bolus R, Whitman CB, Talley J, Dea S, Shahedi K, Karsan H, Teal C, Melmed GY, Cohen E, Fuller G, Yen L, Hodgkins P, Erder MH. Development and validation of a disease-targeted quality of life instrument for chronic diverticular disease: the DV-QOL. Qual Life Res. 2015 Jan;24(1):163-79. doi: 10.1007/s11136-014-0753-1. Epub 2014 Jul 25. PMID 25059533

Идентификаторы

NCT: NCT07492134 · 251398 · 1R01DK141523-01A1

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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