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AZithromycin/metronidAZole Therapy for Crohn's Disease (PAZAZ Trial)
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.
- Crohn's Disease
PAZAZ Trial Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Side effects data
From 2016 Phase 4 trial • 8 Patients • NCT01833897PAZAZ Trial Design
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Who is running the clinical trial?
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- You have used or are currently using biologic therapy.You have a type of Crohn's disease that causes strictures, fistulas, or complications in the intestines or surrounding areas.You have had surgery to remove part of your intestine.You had a procedure called fecal microbial transplantation within the past 35 days before the start of the study.You have a medical history of Cockayne Syndrome.You are allergic or have a bad reaction to azithromycin or metronidazole.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
- Group 1: Standard of Care
- Group 2: Standard of Care + Antibiotics
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Frequently Asked Questions
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."
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."
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."
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."
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."
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."
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"
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."
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."
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