Acute Uncomplicated DiverticulitisPhase 2NCT07492134
APLAUD Trial (Antibiotics vs PLacebo for Acute Uncomplicated Diverticulitis)
A Phase 2 study testing Amoxicillin-Clavulanate 875 Mg-125 Mg Oral Tablet, Metronidazole and Cefuroxime in people with Acute Uncomplicated Diverticulitis, run by Vanderbilt University Medical Center at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Acute Uncomplicated Diverticulitis
- What is being tested?
- Amoxicillin-Clavulanate 875 Mg-125 Mg Oral Tablet, Metronidazole and Cefuroxime
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Jul 2026to 1 Oct 2028
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 14Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Vanderbilt University Medical Center Emergency Department
Nashville, Tennessee, 37235
Alexander T Hawkins, MD, MPH, +1 (615)343-4612, alex.hawkins@vumc.org
About this study
Official title: Comparing Placebo Versus Antibiotics for Acute Uncomplicated Diverticulitis
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.
Read more
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
- Conditions
- Acute Uncomplicated Diverticulitis
- Being tested
- Amoxicillin-Clavulanate 875 Mg-125 Mg Oral Tablet, Placebo, Metronidazole, Cefuroxime
- Keywords
- Acute uncomplicated diverticulitis, Antibiotic stewardship, Antimicrobial resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Amoxicillin-Clavulanate 875 Mg-125 Mg Oral TabletDrug
amoxicillin-clavulanate:1 tablet [875 mg amoxicillin; 125 mg clavulanic acid] every 8 hours
PlaceboDrug
A placebo matching the antibiotic arm's treatment regimen will be administered for 10 days
MetronidazoleDrug
metronidazole: 500 mg every 12 hours
CefuroximeDrug
cefuroxime: 500 mg every 12 hours
| Study group | Role | What they receive |
|---|---|---|
| Antibiotic | Active comparator | The primary antibiotic choice will be amoxicillin-clavulanate (1 tablet [875 mg amoxicillin; 125 mg clavulanic acid] every 8 hours). If the subject has an allergy or contraindication to the primary antibiotic, we will administer cefuroxime [500 mg] every 12 hours plus metronidazole [500 mg] every 12 hours. Receives: Drug: Amoxicillin-Clavulanate 875 Mg-125 Mg Oral Tablet; Drug: Metronidazole; Drug: Cefuroxime |
| Placebo | Experimental | A placebo matching the antibiotic arm's treatment regimen will be administered for 10 days Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recruitment Rate
Patients recruited per week
Measured: From enrollment through study completion, an average of 2 years.
Adherence
Percent of patients completing the course of antibiotics/placebo
Measured: From enrollment through study completion, an average of 2 years
Data completeness
Percentage of participants for whom a complete data set was collected
Measured: From enrollment through study completion, an average of 2 years
Retention
Percentage of patients completing all study activities
Measured: From enrollment through study completion, an average of 2 years
Acceptability
Measured by the Acceptability of Intervention Measure (AIM). Four-question survey with scores ranging from 4 (least acceptable) to 20 (most acceptable).
Measured: Collected at 14 days and 6 months
Cross over
Defined as the number of placebo subjects that ended up being treated with antibiotics
Measured: From enrollment through study completion, an average of 2 years
Secondary outcomes (13)
Barratt Simplified Measure of Social Status (BSMSS)
BSMSS provides an education, occupation, and overall proxy score for socioeconomic status. Scored on a scale of 8-66, with higher scores indicating higher socioeconomic status.
Measured: Collected at the time of enrollment
Brief Health Literacy Scale (BHLS)
3-item questionnaire, scored on a scale of 1-5 with 5 being the highest degree of health literacy
Measured: Collected at enrollment
Patient-Reported Outcomes Measurement Information System-10 (PROMIS-10)
The PROMIS-10 assesses an individual's mental health (four items) and physical health (four items) domains. The total raw scores are translated into standardized T-scores with a mean of 50 and a SD of 10
Measured: Collected at the time of enrollment, 30 days, and 6 months
Diverticulitis quality of life (DV-QOL) instrument
This instrument was designed and validated to measure patient-reported burden of diverticular disease. It is a 17-question survey of patient-reported burden of disease focused on those with uncomplicated diverticular disease. The survey has raw scores 0-68, with higher scores indicating greater impact of diverticulitis on the patient's quality of life. The raw scores are scaled to a 10-point scale.
Measured: Collected at enrollment, then 14 and 30 days into the study.
Patient-Reported Outcomes Measurement Information System, Gastrointestinal
5 item survey that assesses abdominal pain, scored 5-25 with higher scores indicating more severe abdominal pain
Measured: Collected at enrollment and 14 days into study
Time to normalization of abdominal pain intensity
11-point numerical rating scale (NRS) from 0 (no pain) to 10 (worst possible pain) that asks subjects daily to rate their worst abdominal pain over the past 24-hours
Measured: Collected at enrollment, daily for 30 days, and at 6 months
Rate of Progression to Complicated Diverticulitis
Captured via review of the EMR and any follow up CT scans
Measured: Collected at enrollment, 14 days, 30 days, and 6 months
Rate of persistent diverticulitis at 30 days
DV-QOL scores below the patient acceptable symptom state threshold of 3.2/10
Measured: Collected 30 days from enrollment
Rate of diverticulitis-related hospitalization, percutaneous drainage and colectomy
Collected from EMR and patient queries
Measured: From enrollment through study completion, an average of 2 years
Mortality
Obtained from Social Security Administration Death Master File
Measured: From enrollment through study completion, an average of 2 years
Adverse Drug Events
Including, but not limited to rash, diarrhea, urticaria and anaphylaxis will be captured using self-reported surveys with review of the EMR
Measured: From enrollment through study completion, an average of 2 years
Return to normal activity
For subjects who currently are employed, the researchers will ask baseline information about past-month work absenteeism (missed work due to health) and presenteeism (impaired work due to health). The subject will complete the validated Work Productivity and Activity Impairment questionnaire. At each follow up period, the researchers will repeat these measures and inquire if they had suffered an adverse work event (firing, demotion) and if they have had to go on any leave.
This is a 6- item instrument on a visual analog scale of 0-10. Scores for each item are multiplied by 100 to calculate percentages. The WPAI calculates percentage impairment (maximum 100%) with higher numbers representing greater work impairment.
Measured: From enrollment through study completion, an average of 2 years
Recurrence
CT-proven acute diverticulitis after complete resolution of symptoms more than 2 months after initial evaluation in the ED. This will be captured by review of the EMR and direct patient query
Measured: From 8 weeks into the study through study completion, an average of 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2026
- Study start7 Jul 2026
- Primary completion1 Apr 2028 (estimated)
- Study completion1 Oct 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (21)Papers the sponsor has linked to this study.
- Other trials for Acute Uncomplicated DiverticulitisStudies of the same condition, open and under way.
- More trials run by Vanderbilt University Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Vanderbilt University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alexander Hawkins, Vanderbilt University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07492134
- Sponsor's protocol ID
- 251398
- Other IDs
- 1R01DK141523-01A1
- Status last verified
- Sep 2026
- First submitted
- 11 Mar 2026
- Last updated
- 21 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 18929686Reilly 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.
PubMed 10146874Spiegel 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.
PubMed 25199473Hays 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.
PubMed 19543809Cella 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: 2005-2008. J Clin Epidemiol. 2010 Nov;63(11):1179-94. doi: 10.1016/j.jclinepi.2010.04.011. Epub 2010 Aug 4.
PubMed 20685078Chew LD, Bradley KA, Boyko EJ. Brief questions to identify patients with inadequate health literacy. Fam Med. 2004 Sep;36(8):588-94.
PubMed 15343421Spiegel 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.
PubMed 25059533Weiner BJ, Lewis CC, Stanick C, Powell BJ, Dorsey CN, Clary AS, Boynton MH, Halko H. Psychometric assessment of three newly developed implementation outcome measures. Implement Sci. 2017 Aug 29;12(1):108. doi: 10.1186/s13012-017-0635-3.
PubMed 28851459Ribas Y, Bombardo J, Aguilar F, Jovell E, Alcantara-Moral M, Campillo F, Lleonart X, Serra-Aracil X. Prospective randomized clinical trial assessing the efficacy of a short course of intravenously administered amoxicillin plus clavulanic acid followed by oral antibiotic in patients with uncomplicated acute diverticulitis. Int J Colorectal Dis. 2010 Nov;25(11):1363-70. doi: 10.1007/s00384-010-0967-9. Epub 2010 Jun 5.
PubMed 20526718Biondo S, Golda T, Kreisler E, Espin E, Vallribera F, Oteiza F, Codina-Cazador A, Pujadas M, Flor B. Outpatient versus hospitalization management for uncomplicated diverticulitis: a prospective, multicenter randomized clinical trial (DIVER Trial). Ann Surg. 2014 Jan;259(1):38-44. doi: 10.1097/SLA.0b013e3182965a11.
PubMed 23732265Balasubramanian I, Fleming C, Mohan HM, Schmidt K, Haglind E, Winter DC. Out-Patient Management of Mild or Uncomplicated Diverticulitis: A Systematic Review. Dig Surg. 2017;34(2):151-160. doi: 10.1159/000450865. Epub 2016 Oct 5.
PubMed 27701164Ridgway PF, Latif A, Shabbir J, Ofriokuma F, Hurley MJ, Evoy D, O'Mahony JB, Mealy K. Randomized controlled trial of oral vs intravenous therapy for the clinically diagnosed acute uncomplicated diverticulitis. Colorectal Dis. 2009 Nov;11(9):941-6. doi: 10.1111/j.1463-1318.2008.01737.x. Epub 2008 Nov 7.
PubMed 19016815Stollman N, Smalley W, Hirano I; AGA Institute Clinical Guidelines Committee. American Gastroenterological Association Institute Guideline on the Management of Acute Diverticulitis. Gastroenterology. 2015 Dec;149(7):1944-9. doi: 10.1053/j.gastro.2015.10.003. Epub 2015 Oct 8. No abstract available.
PubMed 26453777Qaseem A, Etxeandia-Ikobaltzeta I, Lin JS, Fitterman N, Shamliyan T, Wilt TJ; Clinical Guidelines Committee of the American College of Physicians*; Crandall CJ, Cooney TG, Cross JT Jr, Hicks LA, Maroto M, Mustafa RA, Obley AJ, Owens DK, Tice J, Williams JW Jr; Clinical Guidelines Committee of the American College of Physicians. Diagnosis and Management of Acute Left-Sided Colonic Diverticulitis: A Clinical Guideline From the American College of Physicians. Ann Intern Med. 2022 Mar;175(3):399-415. doi: 10.7326/M21-2710. Epub 2022 Jan 18.
PubMed 35038273
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparing Placebo Versus Antibiotics for Acute Uncomplicated Diverticulitis
- ClinicalTrials.gov ID
- NCT07492134
- Acronym / sponsor ID
- 251398
- Conditions
- Acute Uncomplicated Diverticulitis
- Keywords
- Acute uncomplicated diverticulitis, Antibiotic stewardship, Antimicrobial resistance
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Vanderbilt University Medical CenterUniversity, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Study start
- 7 Jul 2026 (actual)
- Primary completion
- 1 Apr 2028 (estimated)
- Study completion
- 1 Oct 2028 (estimated)
- First posted
- 25 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Antibiotic | Active comparator | Drug: Amoxicillin-Clavulanate 875 Mg-125 Mg Oral Tablet, Drug: Metronidazole, Drug: CefuroximeThe primary antibiotic choice will be amoxicillin-clavulanate (1 tablet [875 mg amoxicillin; 125 mg clavulanic acid] every 8 hours). If the subject has an allergy or contraindication to the primary antibiotic, we will administer cefuroxime [500 mg] every 12 hours plus metronidazole [500 mg] every 12 hours. |
| Placebo | Experimental | Drug: PlaceboA placebo matching the antibiotic arm's treatment regimen will be administered for 10 days |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (14 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Amoxicillin-Clavulanate 875 Mg-125 Mg Oral Tabletamoxicillin-clavulanate:1 tablet [875 mg amoxicillin; 125 mg clavulanic acid] every 8 hours | Drug | Antibiotic |
| PlaceboA placebo matching the antibiotic arm's treatment regimen will be administered for 10 days | Drug | Placebo |
| Metronidazolemetronidazole: 500 mg every 12 hours | Drug | Antibiotic |
| Cefuroximecefuroxime: 500 mg every 12 hours | Drug | Antibiotic |
Primary outcome
Recruitment Rate
Time frame: From enrollment through study completion, an average of 2 years.
Patients recruited per week
Adherence
Time frame: From enrollment through study completion, an average of 2 years
Percent of patients completing the course of antibiotics/placebo
Data completeness
Time frame: From enrollment through study completion, an average of 2 years
Percentage of participants for whom a complete data set was collected
Retention
Time frame: From enrollment through study completion, an average of 2 years
Percentage of patients completing all study activities
Acceptability
Time frame: Collected at 14 days and 6 months
Measured by the Acceptability of Intervention Measure (AIM). Four-question survey with scores ranging from 4 (least acceptable) to 20 (most acceptable).
Cross over
Time frame: From enrollment through study completion, an average of 2 years
Defined as the number of placebo subjects that ended up being treated with antibiotics
13 secondary outcomes
Barratt Simplified Measure of Social Status (BSMSS)
Time frame: Collected at the time of enrollment
Brief Health Literacy Scale (BHLS)
Time frame: Collected at enrollment
Patient-Reported Outcomes Measurement Information System-10 (PROMIS-10)
Time frame: Collected at the time of enrollment, 30 days, and 6 months
Diverticulitis quality of life (DV-QOL) instrument
Time frame: Collected at enrollment, then 14 and 30 days into the study.
Patient-Reported Outcomes Measurement Information System, Gastrointestinal
Time frame: Collected at enrollment and 14 days into study
Time to normalization of abdominal pain intensity
Time frame: Collected at enrollment, daily for 30 days, and at 6 months
Rate of Progression to Complicated Diverticulitis
Time frame: Collected at enrollment, 14 days, 30 days, and 6 months
Rate of persistent diverticulitis at 30 days
Time frame: Collected 30 days from enrollment
Rate of diverticulitis-related hospitalization, percutaneous drainage and colectomy
Time frame: From enrollment through study completion, an average of 2 years
Mortality
Time frame: From enrollment through study completion, an average of 2 years
Adverse Drug Events
Time frame: From enrollment through study completion, an average of 2 years
Return to normal activity
Time frame: From enrollment through study completion, an average of 2 years
Recurrence
Time frame: From 8 weeks into the study through study completion, an average of 2 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2026.
- BackgroundW. 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
- Background: PubMed 18929686Harris 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.
- Background: PubMed 10146874Reilly 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.
- Background: PubMed 25199473Spiegel 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.
- Background: PubMed 19543809Hays 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.
- Background: PubMed 20685078Cella 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: 2005-2008. J Clin Epidemiol. 2010 Nov;63(11):1179-94. doi: 10.1016/j.jclinepi.2010.04.011. Epub 2010 Aug 4.
- Background: PubMed 15343421Chew LD, Bradley KA, Boyko EJ. Brief questions to identify patients with inadequate health literacy. Fam Med. 2004 Sep;36(8):588-94.
- Background: PubMed 25059533Spiegel 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.
- Background: PubMed 28851459Weiner BJ, Lewis CC, Stanick C, Powell BJ, Dorsey CN, Clary AS, Boynton MH, Halko H. Psychometric assessment of three newly developed implementation outcome measures. Implement Sci. 2017 Aug 29;12(1):108. doi: 10.1186/s13012-017-0635-3.
- Background: PubMed 20526718Ribas Y, Bombardo J, Aguilar F, Jovell E, Alcantara-Moral M, Campillo F, Lleonart X, Serra-Aracil X. Prospective randomized clinical trial assessing the efficacy of a short course of intravenously administered amoxicillin plus clavulanic acid followed by oral antibiotic in patients with uncomplicated acute diverticulitis. Int J Colorectal Dis. 2010 Nov;25(11):1363-70. doi: 10.1007/s00384-010-0967-9. Epub 2010 Jun 5.
- Background: PubMed 23732265Biondo S, Golda T, Kreisler E, Espin E, Vallribera F, Oteiza F, Codina-Cazador A, Pujadas M, Flor B. Outpatient versus hospitalization management for uncomplicated diverticulitis: a prospective, multicenter randomized clinical trial (DIVER Trial). Ann Surg. 2014 Jan;259(1):38-44. doi: 10.1097/SLA.0b013e3182965a11.
- Background: PubMed 27701164Balasubramanian I, Fleming C, Mohan HM, Schmidt K, Haglind E, Winter DC. Out-Patient Management of Mild or Uncomplicated Diverticulitis: A Systematic Review. Dig Surg. 2017;34(2):151-160. doi: 10.1159/000450865. Epub 2016 Oct 5.
- Individual participant dataSharing planned: Undecided
Related trials for Acute Uncomplicated Diverticulitis
Not yet recruiting
Improving the Treatment of Acute Uncomplicated Diverticulitis in Routine Care
Diverticulitis
Enrolling by invitation
Effectiveness and Safety of Outpatient Treatment of Uncomplicated Acute Diverticulitis Without Antibiotics
Diverticulitis, Colonic
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Vanderbilt University Medical Center Emergency Department
Nashville, United States
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Amoxicillin-Clavulanate 875 Mg-125 Mg Oral Tablet, Metronidazole and Cefuroxime in people with Acute Uncomplicated Diverticulitis, run by Vanderbilt University Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 21 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recruitment Rate (time frame: From enrollment through study completion, an average of 2 years.). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07492134, which also lists 21 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Sep 2026.