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AZithromycin/metronidAZole Therapy for Crohn's Disease (PAZAZ Trial)

Phase 2
Recruiting
Led By Johan E Van Limbergen, MD, PhD
Research Sponsored by University of North Carolina, Chapel Hill
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up week 52
Awards & highlights

PAZAZ Trial Summary

This trial is testing whether adding antibiotics to the standard of care for Crohn's disease helps prevent relapse for people whose microbiome profile puts them at increased risk of early relapse.

Eligible Conditions
  • Crohn's Disease

PAZAZ Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~week 52
This trial's timeline: 3 weeks for screening, Varies for treatment, and week 52 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Feasibility of multinational microbiome-randomized trial
Percent of Subjects with Sustained Remission
Secondary outcome measures
Change in C-Reactive Protein (CRP) Levels in Blood over Baseline to Week 52
Change in Fecal Calprotectin Levels in Stool over Baseline to Week 52
Change in IMPACT-III Score over Baseline to Week 52
+1 more

Side effects data

From 2016 Phase 4 trial • 8 Patients • NCT01833897
38%
sedation
25%
headache
13%
phosphenes
13%
hypomania
100%
80%
60%
40%
20%
0%
Study treatment Arm
Ketamine and DCS Treatment

PAZAZ Trial Design

2Treatment groups
Experimental Treatment
Group I: Standard of Care + AntibioticsExperimental Treatment3 Interventions
SOC induction (nutritional therapy) for up to 12 weeks, as assigned by the treating gastroenterologist prior to study entry. Azithromycin (weeks 4-12) Metronidazole (weeks 4-12)
Group II: Standard of CareExperimental Treatment1 Intervention
SOC induction (nutritional therapy) for up to 12 weeks, as assigned by the treating gastroenterologist prior to study entry.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Azithromycin
2018
Completed Phase 4
~274950
Metronidazole
2011
Completed Phase 4
~4360

Find a Location

Who is running the clinical trial?

University of North Carolina, Chapel HillLead Sponsor
1,501 Previous Clinical Trials
4,186,822 Total Patients Enrolled
Crohn's and Colitis FoundationOTHER
43 Previous Clinical Trials
28,105 Total Patients Enrolled
University of AmsterdamOTHER
40 Previous Clinical Trials
23,998 Total Patients Enrolled

Media Library

Standard of Care Clinical Trial Eligibility Overview. Trial Name: NCT04186247 — Phase 2
Standard of Care 2023 Treatment Timeline for Medical Study. Trial Name: NCT04186247 — Phase 2
Crohn's Disease Research Study Groups: Standard of Care, Standard of Care + Antibiotics
Crohn's Disease Clinical Trial 2023: Standard of Care Highlights & Side Effects. Trial Name: NCT04186247 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does this research protocol accept individuals aged 25 or over?

"This clinical trial is enrolling participants between the ages of 3 and 17 years old."

Answered by AI

Are there a significant number of healthcare facilities in the US conducting this experiment?

"Patients may enroll in this medical trial at IWK Health Centre (Halifax), North carolina Children's Hospital (Chapel Hill) and UCSF Benioff Children’s Hospital (San Francisco). Additionally, there are 5 other locations that offer enrollment for the study."

Answered by AI

What is the current number of participants involved in this clinical experiment?

"To conduct this clinical trial, 20 qualified patients must be recruited across two locations: IWK Health Centre in Halifax and North carolina Children's Hospital in Chapel Hill."

Answered by AI

Is this research actively enrolling participants?

"Affirmative. According to the clinicaltrials.gov listing, this research study is searching for volunteers and began on August 13th 2021. It was last modified April 19th 2022, with a goal of enlisting 20 patients from 5 different medical sites."

Answered by AI

What is the primary aim of this research endeavor?

"The primary purpose of this 52-week experiment is to measure the amount of sustained remission amongst participants. Secondary goals include assessing subjects' quality of life through IMPACT III questionnaires, their Crohn's disease activity with PCDAI scores and inflammation levels via C-Reactive Protein measurements. All individuals over 9 years old will be asked to complete these tests at baseline, 12 weeks in, 24 weeks in and near the end of data collection."

Answered by AI

What other research studies have been conducted with Standard of Care as the basis?

"The Standard of Care was initially investigated in 2003 by the College of Medicine at University of Malawi. To date, there are 680 studies that have been completed and 103 current clinical trials recruiting patients - notably a great number located in Halifax, North carolina."

Answered by AI

Who is eligible to participate in this clinical experiment?

"This clinical trial is in search of 20 participants aged 3 to 17 suffering from ileocolitis. The required criteria for acceptance are as follows: a stated commitment to comply with all study protocols, signed consent forms (and assent form if applicable), mild-to-moderate disease symptoms according to PCDAI score (greater than 10 or 7.5 excluding the height item) and lower than 37.5; additionally, fecal calprotectin levels must be greater than 250 µg/g within the 30 days prior to Week 0 examination--if an endoscopy does not occur during this time period then it can take place"

Answered by AI

What ailments are generally treated through the conventional treatment protocol?

"Standard of Care is applicable for individuals with genus chlamydia, adult patients and those suffering from candidal vulvovaginitis."

Answered by AI

Are the procedures accepted by Standard of Care compliant with FDA regulations?

"Based on the available data, Standard of Care is considered safe and was given a rating of 2. This indicates that while there are some studies confirming its safety profile, no trials have confirmed any efficacy yet."

Answered by AI
~5 spots leftby Apr 2025