Ignite Creation Date:
2026-03-26 @ 3:19 PM
Ignite Modification Date:
2026-03-31 @ 12:45 PM
Study NCT ID:
NCT07492134
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-03-25
First Post:
2026-03-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
APLAUD Trial (Antibiotics vs PLacebo for Acute Uncomplicated Diverticulitis)
Sponsor:
Vanderbilt University Medical Center
Organization:
Study Overview
Official Title:
Comparing Placebo Versus Antibiotics for Acute Uncomplicated Diverticulitis
Status:
NOT_YET_RECRUITING
Status Verified Date:
2026-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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. 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
* 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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 1R01DK141523-01A1 | NIH | None | https://reporter.nih.gov/quic… | View |