MedTrace Logo

APLAUD Trial (Antibiotics vs PLacebo for Acute Uncomplicated Diverticulitis)

NCT07492134 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2026-04-21

No results posted yet for this study

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

Conditions

  • Acute Uncomplicated Diverticulitis

Interventions

DRUG

Amoxicillin-Clavulanate 875 Mg-125 Mg Oral Tablet

amoxicillin-clavulanate:1 tablet \[875 mg amoxicillin; 125 mg clavulanic acid\] every 8 hours

DRUG

Placebo

A placebo matching the antibiotic arm's treatment regimen will be administered for 10 days

DRUG

Metronidazole

metronidazole: 500 mg every 12 hours

DRUG

Cefuroxime

cefuroxime: 500 mg every 12 hours

Sponsors & Collaborators

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
90 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-04-01
Primary Completion
2028-04-01
Completion
2028-10-01
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07492134 on ClinicalTrials.gov