Evaluation of Safety and Efficacy of Phage Therapy for Drug-resistant Bacterial Infections: An Ex… (NCT07382271) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Evaluation of Safety and Efficacy of Phage Therapy for Drug-resistant Bacterial Infections: An Exploratory, Prospective Single-arm Study
6 participantsStarted 2026-02
Plain-language summary
This study is an investigator-initiated, single-center, exploratory clinical trial designed to evaluate the safety and efficacy of phage therapy in patients with urinary tract infections caused by drug-resistant bacteria.
Eligible patients aged 18 to 65 years will receive the phage cocktail intervention according to a predefined dosage regimen, with a treatment course of 2 to 3 days and a follow-up period of 2 to 4 weeks after treatment. The primary outcome measures include the incidence of adverse events during treatment, the pathogen clearance rate, and the improvement of clinical symptoms (e.g., fever, local inflammation).
The purpose of this study is to provide a scientific basis for the subsequent clinical application of this phage cocktail, and to explore a novel therapeutic option for patients with drug-resistant bacterial infections who have shown poor responses to conventional antibiotic therapy. All participants will undergo standardized medical monitoring throughout the trial, and their rights and safety will be fully protected by the Institutional Review Board (IRB) during the entire process.
Who can participate
Age range
18 Years – 65 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Pathogenic bacteria are resistant to key antibiotics:
. The pathogenic bacteria are sensitive to key antibiotics in vitro, but treatment with such antibiotics is ineffective or shows insignificant efficacy (the patient's target bacterial infection persists for 7 days or more, and the infection cannot be eradicated despite antibiotic administration during this period).
. The use of key antibiotics to which the pathogenic bacteria are sensitive is restricted (e.g., potential organ toxicity caused by the antibiotics, or the patient is allergic to such antibiotics).
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Pathogen Clearance Rate
Timeframe: Baseline (pre-treatment); Days 1, 3, 5, 7 post-treatment
Trial details
NCT IDNCT07382271
SponsorThe Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School