Randomized Controlled Study on the Safety and Efficacy of Phage Cocktail in the Treatment of Multidrug-Resistant Bacterial Skin Infections

May 27, 2026 updated by: First Affiliated Hospital Xi'an Jiaotong University

This study addresses the increasingly severe global public health challenge of antibiotic resistance, focusing on exploring phage therapy as a potential treatment strategy for multidrug-resistant bacterial skin infections. Bacteriophages, with advantages such as high specificity, low propensity for inducing resistance, and minimal side effects, have shown promise in preliminary clinical research for scenarios like chronic wound infections, demonstrating potential in reducing bacterial load and promoting healing. To this end, the study is designed as a prospective, double-blind, non-inferiority randomized controlled clinical trial, aiming to systematically evaluate the efficacy and safety of phage therapy compared to a placebo or standard treatment in patients with multidrug-resistant bacterial skin infections.

The study plans to enroll patients aged 18 to 75 years, clinically diagnosed with a skin infection and with a wound area between 4 and 225 square centimeters. The infection must not involve deep tissue and should be suitable for topical treatment. All enrolled cases must have pathogenic bacteria detected in secretions or wound samples, and these bacteria must be resistant to key antibiotics (such as carbapenems) or show poor response to antibiotic therapy despite *in vitro* sensitivity. Patients who have received systemic antibacterial treatment within 72 hours before enrollment with no significant improvement may also be included. Participants of childbearing potential must agree to use effective contraception during the study and voluntarily provide written informed consent.

Exclusion criteria primarily include: infections that can be effectively controlled by existing antimicrobials, or pathogens that are insensitive to the phage cocktail used in the study; pregnant or lactating women; patients whose infection symptoms have improved after using antimicrobials within 72 hours before enrollment; those receiving long-term or high-dose corticosteroids, immunosuppressants, chemotherapy, or other treatments that may interfere with the results; participation in other antimicrobial-related clinical trials within the past month; presence of severe wound infections (e.g., necrotizing fasciitis), chronic inflammatory skin diseases, multiple limb ulcers, non-removable implants, or gangrene; anticipated need for amputation surgery; history of clear allergic diseases, immune deficiency (including HIV positivity), mental disorders, or epilepsy; and any other condition deemed by the investigator as unsuitable for participation. These strict inclusion and exclusion criteria aim to select an appropriate target population, ensuring the scientific rigor and credibility of the study results.

Study Overview

Status

Enrolling by invitation

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

150

Phase

  • Early Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Shaanxi
      • Xi'an, Shaanxi, China, 710061
        • The First Affiliated Hospital Of Xi'an Jiaotong University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • (1) Aged 18 to 75 years, regardless of gender.

    (2) Clinically diagnosed with a skin infection, with an infected wound area of 4-225 cm².

    (3) The infection does not involve deep tissues, is suitable for topical treatment, and is not expected to require surgical intervention.

    (4) Pathogenic bacteria are detected in secretions or wound samples.

    (5) The pathogen is resistant to key antibiotics (such as carbapenems, etc.), or, despite being susceptible in vitro, shows poor response to antibiotic therapy.

    (6) Patients who have received systemic antibacterial therapy within 72 hours prior to enrollment without significant improvement may also be included.

    (7) Subjects of childbearing potential must agree to use effective contraception during the study period.

    (8) Voluntarily sign the informed consent form, and are willing and able to comply with the requirements of the study protocol.

Exclusion Criteria:

  • (1) The infection can be effectively controlled by available antimicrobial agents, or the causative pathogen is insensitive to the phage cocktail used in this study.

    (2) Pregnant or breastfeeding women. (3) Patients who have used antimicrobial agents within 72 hours prior to enrollment and have shown improvement in infection symptoms.

    (4) Patients currently receiving prolonged or high-dose corticosteroids, immunosuppressants, chemotherapy, or other treatments that may interfere with the study results.

    (5) Patients who have participated in other clinical trials related to antimicrobial agents within the past month.

    (6) Patients with severe wound infections (e.g., necrotizing fasciitis), chronic inflammatory skin diseases, multiple limb ulcers, non-removable implants, or gangrene, among other conditions.

    (7) Patients expected to require amputation surgery. (8) Patients with a documented history of allergic disorders, immunodeficiency (including HIV positivity), mental disorders, or epilepsy.

    (9) Any other condition deemed by the investigator as unsuitable for participation in this study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Bacteriophage Treatment Group
Receive bacteriophage cocktail therapy for 7 days, combined with antibiotic therapy and conventional treatment.
Biological: Bacteriophage Treatment
Bacteriophage therapy for skin and soft tissue infections typically involves the targeted application of bacteriophage preparations directly to the infected site. Bacteriophage therapy for skin infections involves topical application of phage cocktails to the infected site. These phages specifically target and lyse drug-resistant bacteria, can penetrate biofilms, and are often used alongside standard wound care. Treatment is typically administered daily for 1-2 weeks, focusing on reducing bacterial load and promoting healing with minimal disruption to normal flora.
Placebo Comparator: Placebo Group
Receive 0.9% normal saline (placebo) for 7 days, combined with antibiotic therapy and conventional treatment.
Drug: Placebo treatment using 0.9% normal saline

In this double-blind clinical trial, 0.9% normal saline serves as the placebo, designed to be indistinguishable from the active bacteriophage cocktail in formulation, packaging, and appearance. It is administered identically: following standard wound cleaning, a measured volume is applied topically to the wound and covered with the same sterile dressing.

The treatment schedule-frequency, duration, and concomitant background care including systemic antibiotics and routine wound management-is strictly standardized across all participants. This ensures any outcome difference is attributable only to the topical agent.

Sterile, single-use saline meeting pharmacopeial standards is used to prevent contamination. Blinded researchers assess efficacy and safety at predefined intervals by monitoring wound parameters, bacterial load, and adverse events, maintaining trial integrity for a valid evaluation of the phage therapy's specific effect.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Clinical Cure Rate at End of Treatment
Time Frame: From enrollment to the end of the 7-day treatment period.
Defined as the proportion of patients achieving complete resolution of infection-related clinical symptoms without requiring additional antimicrobial intervention.
From enrollment to the end of the 7-day treatment period.
Microbiological Eradication Rate
Time Frame: From enrollment to Day 14 (7 days post-treatment).
The proportion of patients with eradication (or reduction below the detection limit) of the baseline pathogen, as confirmed by wound culture.
From enrollment to Day 14 (7 days post-treatment).

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Wound Size Reduction
Time Frame: From enrollment to Day 7, Day 14, and Day 28.
The relative percentage reduction in wound area from baseline, assessed via standardized measurement.
From enrollment to Day 7, Day 14, and Day 28.
Time to Cessation of Exudate
Time Frame: From enrollment through Day 28 follow-up.
The number of days from treatment initiation until the wound stops producing exudate.
From enrollment through Day 28 follow-up.
Incidence of Treatment-Emergent Adverse Events
Time Frame: From enrollment through Day 28 post-treatment.
Recording of local or systemic adverse events considered related or potentially related to the study treatment.
From enrollment through Day 28 post-treatment.
Recurrence/Reinfection Rate within Follow-up
Time Frame: From the end of treatment through the Day 28 follow-up visit.
The proportion of patients with recurrence or new infection by the same pathogen at the original or adjacent site after initial clinical success.
From the end of treatment through the Day 28 follow-up visit.
Patient-reported Pain Score
Time Frame: From enrollment to Day 7, Day 14, and Day 28.
Change in wound pain intensity as evaluated by the patient using a Visual Analog Scale.
From enrollment to Day 7, Day 14, and Day 28.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

First Affiliated Hospital Xi'an Jiaotong University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 15, 2025

Primary Completion (Estimated)

October 31, 2027

Study Completion (Estimated)

May 1, 2028

Study Registration Dates

First Submitted

May 27, 2026

First Submitted That Met QC Criteria

May 27, 2026

First Posted (Actual)

June 2, 2026

Study Record Updates

Last Update Posted (Actual)

June 2, 2026

Last Update Submitted That Met QC Criteria

May 27, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2025YFC3408505

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

IPD (Individual Participant Data) may not be shared due to several key reasons. First, ethical and privacy restrictions are primary concerns. Informed consent forms often do not include provisions for broad public data sharing, and even anonymized data carries a risk of participant re-identification. Second, legal and data transfer agreements governing the original study frequently prohibit redistribution of raw data to third parties. Third, intellectual property and strategic considerations, such as plans for future publications, secondary analyses by the research team, or potential commercial applications, can lead researchers to retain exclusive access. Finally, technical and resource barriers, including the lack of standardized formats and the cost of preparing complex datasets for sharing, present significant practical obstacles to making IPD publicly available.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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