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Anti-bacterial

Antibiotic Therapy for Pseudomyxoma Peritonei

Phase 2
Waitlist Available
Led By Armando Sardi, M.D.
Research Sponsored by Mercy Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Hepatic function: Bilirubin ≤ 1.5 times ULN, ALT ≤ 3 times ULN, AST ≤ 3 times ULN
A negative pregnancy test for women of childbearing age with all reproductive organs intact
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 5 year
Awards & highlights

Study Summary

This trial will study whether antibiotic therapy can improve the disease progression and overall survival for patients with Pseudomyxoma Peritonei.

Who is the study for?
Adults over 21 with Pseudomyxoma Peritonei from appendiceal origin can join this trial. They must have good kidney and liver function, no severe unrelated medical issues, not be pregnant or breastfeeding, able to swallow pills, and not on conflicting medications. HIV-positive patients or those with active infections requiring IV antibiotics are excluded.Check my eligibility
What is being tested?
The study is testing the effects of an antibiotic regimen called PrevPac (Prevacid, Amoxicillin, Clarithromycin) on disease progression and survival in patients with Pseudomyxoma Peritonei. It aims to see if these antibiotics can improve long-term outcomes for these patients.See study design
What are the potential side effects?
Possible side effects of PrevPac may include digestive problems like nausea and diarrhea, changes in taste sensation, headache, skin reactions such as rash or itching. More serious but less common side effects could involve liver problems or a severe allergic reaction.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My liver tests are within the required limits.
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I am not pregnant and of childbearing age.
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I am 21 years old or older.
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My cancer originates from the appendix and can be measured by tests.
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I am mostly self-sufficient and can carry out daily activities.
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My blood tests show normal organ function and healthy blood cell counts.
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My kidney function is within the normal range.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~5 year
This trial's timeline: 3 weeks for screening, Varies for treatment, and 5 year for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Overall survival
Secondary outcome measures
Progression-free survival measured by no evidence of disease progression, i.e. tumor markers within normal limits, no radiographical evidence of disease
Other outcome measures
Analyze number of live bacteria in PMP tumor and mucin
Tolerance and safety of PrevPac administration

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: PrevPacExperimental Treatment1 Intervention
Study intervention: PrevPac (Prevacid, Amoxicillin, Clarithromycin)twice daily x 14 days for 2 courses (preoperative and post-operative). All eligible patients with a PMP diagnosis, undergoing CRS/HIPEC treatment, who consent to study participation will have a urea breath test prior to the first course of PrevPac. After surgery, when tolerated, each patient will take a second course of PrevPac. Patients will be seen for follow-up as clinically indicated until year 5.
Group II: PMP Historical ControlActive Control1 Intervention
The historical control group will consist of all PMP patients who did not receive perioperative antibiotic treatment.

Find a Location

Who is running the clinical trial?

Mercy Medical CenterLead Sponsor
20 Previous Clinical Trials
4,142 Total Patients Enrolled
2 Trials studying Pseudomyxoma Peritonei
86 Patients Enrolled for Pseudomyxoma Peritonei
Armando Sardi, M.D.Principal InvestigatorMercy Medical Center
1 Previous Clinical Trials
32 Total Patients Enrolled
Scott Merrell, PhDPrincipal InvestigatorUniformed Sciences University, Health Sciences

Media Library

Pseudomyxoma Peritonei Clinical Trial 2023: PrevPac Highlights & Side Effects. Trial Name: NCT02387203 — Phase 2
PrevPac (Anti-bacterial) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02387203 — Phase 2

Frequently Asked Questions

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

What potential risks have been linked to the PrevPac (Prevacid, Amoxicillin, Clarithromycin) medication?

"Our team at Power has assigned a rating of 2 to PrevPac (Prevacid, Amoxicillin, Clarithromycin) due to its Phase 2 trial status. This implies that there is data confirming the treatment's safety but not yet any evidence for its efficacy."

Answered by AI

Is enrollment still possible for this trial?

"The information published on clinicaltrials.gov suggests that this trial has ceased recruitment for participants, with the original posting taking place on January 1st 2015 and the last update occurring on August 30th 2022. While no longer seeking patients, there are 101 other trials open to enrollment at this time."

Answered by AI

What clinical condition is the PrevPac (Prevacid, Amoxicillin, Clarithromycin) prescription regimen most commonly prescribed for?

"PrevPac, a combination of Prevacid, Amoxicillin and Clarithromycin, can be employed to combat mycobacterial infection, lower respiratory tract infections (lrti), as well as nsaid use."

Answered by AI

How many patients have been enrolled in this clinical experiment?

"This clinical trial is no longer enrolling participants. It was first uploaded on January 1st 2015, and its most recent update occurred in August of 2022. If you are seeking alternate studies, there are currently 22 trials for pseudomyxoma peritonei that have open enrollment as well as 79 research projects looking to recruit patients using PrevPac (Prevacid, Amoxicillin, Clarithromycin)."

Answered by AI
~5 spots leftby Dec 2024