Phage TherapyEarly Phase 1NCT07619924

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

A Early Phase 1 study testing Bacteriophage Treatment in people with Phage Therapy and Bacteriophage Therapy, run by First Affiliated Hospital Xi'an Jiaotong University at 1 site in China.

Enrolling by invitation

Enrolling by invitation. The study team selects and invites participants, usually from an existing group of patients.

Sites and contacts

Official record

Search all trials

Trial summary

Who is it for?: Ages 18 to 75 years
Conditions the study is for: Phage Therapy, Bacteriophage Therapy, Skin and Soft Tissue Infections
What is being tested?: Bacteriophage Treatment
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 150 participants
Where: 1 siteChina
Study dates: 15 Jan 2025to May 2028
Phase: Early Phase 1
Are there results?: Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 75 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

(1) Aged 18 to 75 years, regardless of gender.
Clinically diagnosed with a skin infection, with an infected wound area of 4-225 cm².
The infection does not involve deep tissues, is suitable for topical treatment, and is not expected to require surgical intervention.
Pathogenic bacteria are detected in secretions or wound samples.
The pathogen is resistant to key antibiotics (such as carbapenems, etc.), or, despite being susceptible in vitro, shows poor response to antibiotic therapy.
Patients who have received systemic antibacterial therapy within 72 hours prior to enrollment without significant improvement may also be included.
Subjects of childbearing potential must agree to use effective contraception during the study period.
Voluntarily sign the informed consent form, and are willing and able to comply with the requirements of the study protocol.

Who cannot join

(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.
Pregnant or breastfeeding women. (3) Patients who have used antimicrobial agents within 72 hours prior to enrollment and have shown improvement in infection symptoms.
Patients currently receiving prolonged or high-dose corticosteroids, immunosuppressants, chemotherapy, or other treatments that may interfere with the study results.
Patients who have participated in other clinical trials related to antimicrobial agents within the past month.
Patients with severe wound infections (e.g., necrotizing fasciitis), chronic inflammatory skin diseases, multiple limb ulcers, non-removable implants, or gangrene, among other conditions.
Patients expected to require amputation surgery. (8) Patients with a documented history of allergic disorders, immunodeficiency (including HIV positivity), mental disorders, or epilepsy.
Any other condition deemed by the investigator as unsuitable for participation in this study.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

China1 site

The First Affiliated Hospital of Xi'an Jiaotong University
Xi'an, Shaanxi, 710061

Other trials in China

About this study

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.

Conditions: Phage Therapy, Bacteriophage Therapy, Skin and Soft Tissue Infections
Being tested: Bacteriophage Treatment, Placebo treatment using 0.9% normal saline
Medical subject headings: Soft Tissue Infections

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Bacteriophage TreatmentBiological
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 treatment using 0.9% normal salineDrug
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.

Study groups in NCT07619924
Study group	Role	What they receive
Bacteriophage Treatment Group	Experimental	Receive bacteriophage cocktail therapy for 7 days, combined with antibiotic therapy and conventional treatment. Receives: Biological: Bacteriophage Treatment
Placebo Group	Placebo comparator	Receive 0.9% normal saline (placebo) for 7 days, combined with antibiotic therapy and conventional treatment. Receives: Drug: Placebo treatment using 0.9% normal saline

What is being measured

The primary outcome is the main question the study is designed to answer.

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

Secondary outcomes (5)

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

15 Jan 2025May 2028

First posted2 Jun 2026
Study start15 Jan 2025
Primary completion31 Oct 2027 (estimated)
Study completionMay 2028 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (12)Papers the sponsor has linked to this study.
Other trials for Phage TherapyStudies of the same condition, open and under way.
More trials run by First Affiliated Hospital Xi'an Jiaotong UniversityThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Early Phase 1
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 150 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT07619924
Sponsor's protocol ID: 2025YFC3408505
Status last verified: May 2026
First submitted: 27 May 2026
Last updated: 2 Jun 2026
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No: 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.

Publications

GBD 2021 Antimicrobial Resistance Collaborators. Global burden of bacterial antimicrobial resistance 1990-2021: a systematic analysis with forecasts to 2050. Lancet. 2024 Sep 28;404(10459):1199-1226. doi: 10.1016/S0140-6736(24)01867-1. Epub 2024 Sep 16.
PubMed 39299261
Green SI, Clark JR, Santos HH, Weesner KE, Salazar KC, Aslam S, Campbell JW, Doernberg SB, Blodget E, Morris MI, Suh GA, Obeid K, Silveira FP, Filippov AA, Whiteson KL, Trautner BW, Terwilliger AL, Maresso A. A Retrospective, Observational Study of 12 Cases of Expanded-Access Customized Phage Therapy: Production, Characteristics, and Clinical Outcomes. Clin Infect Dis. 2023 Oct 13;77(8):1079-1091. doi: 10.1093/cid/ciad335.
PubMed 37279523
Khatami A, Lin RCY, Petrovic-Fabijan A, Alkalay-Oren S, Almuzam S, Britton PN, Brownstein MJ, Dao Q, Fackler J, Hazan R, Horne B, Nir-Paz R, Iredell JR. Bacterial lysis, autophagy and innate immune responses during adjunctive phage therapy in a child. EMBO Mol Med. 2021 Sep 7;13(9):e13936. doi: 10.15252/emmm.202113936. Epub 2021 Aug 9.
PubMed 34369652
Ding X, Tang Q, Xu Z, Xu Y, Zhang H, Zheng D, Wang S, Tan Q, Maitz J, Maitz PK, Yin S, Wang Y, Chen J. Challenges and innovations in treating chronic and acute wound infections: from basic science to clinical practice. Burns Trauma. 2022 May 21;10:tkac014. doi: 10.1093/burnst/tkac014. eCollection 2022.
PubMed 35611318
Kohler T, Luscher A, Falconnet L, Resch G, McBride R, Mai QA, Simonin JL, Chanson M, Maco B, Galiotto R, Riat A, Civic N, Docquier M, McCallin S, Chan B, van Delden C. Personalized aerosolised bacteriophage treatment of a chronic lung infection due to multidrug-resistant Pseudomonas aeruginosa. Nat Commun. 2023 Jun 27;14(1):3629. doi: 10.1038/s41467-023-39370-z.
PubMed 37369702
Dedrick RM, Freeman KG, Nguyen JA, Bahadirli-Talbott A, Smith BE, Wu AE, Ong AS, Lin CT, Ruppel LC, Parrish NM, Hatfull GF, Cohen KA. Potent antibody-mediated neutralization limits bacteriophage treatment of a pulmonary Mycobacterium abscessus infection. Nat Med. 2021 Aug;27(8):1357-1361. doi: 10.1038/s41591-021-01403-9. Epub 2021 Jul 8.
PubMed 34239133
Pirnay JP, Djebara S, Steurs G, Griselain J, Cochez C, De Soir S, Glonti T, Spiessens A, Vanden Berghe E, Green S, Wagemans J, Lood C, Schrevens E, Chanishvili N, Kutateladze M, de Jode M, Ceyssens PJ, Draye JP, Verbeken G, De Vos D, Rose T, Onsea J, Van Nieuwenhuyse B; Bacteriophage Therapy Providers; Bacteriophage Donors; Soentjens P, Lavigne R, Merabishvili M. Personalized bacteriophage therapy outcomes for 100 consecutive cases: a multicentre, multinational, retrospective observational study. Nat Microbiol. 2024 Jun;9(6):1434-1453. doi: 10.1038/s41564-024-01705-x. Epub 2024 Jun 4.
PubMed 38834776
Liu M, Hernandez-Morales A, Clark J, Le T, Biswas B, Bishop-Lilly KA, Henry M, Quinones J, Voegtly LJ, Cer RZ, Hamilton T, Schooley RT, Salka S, Young R, Gill JJ. Comparative genomics of Acinetobacter baumannii and therapeutic bacteriophages from a patient undergoing phage therapy. Nat Commun. 2022 Jun 30;13(1):3776. doi: 10.1038/s41467-022-31455-5.
PubMed 35773283
Sulakvelidze A, Alavidze Z, Morris JG Jr. Bacteriophage therapy. Antimicrob Agents Chemother. 2001 Mar;45(3):649-59. doi: 10.1128/AAC.45.3.649-659.2001. No abstract available.
PubMed 11181338
Mu A, McDonald D, Jarmusch AK, Martino C, Brennan C, Bryant M, Humphrey GC, Toronczak J, Schwartz T, Nguyen D, Ackermann G, D'Onofrio A, Strathdee SA, Schooley RT, Dorrestein PC, Knight R, Aslam S. Assessment of the microbiome during bacteriophage therapy in combination with systemic antibiotics to treat a case of staphylococcal device infection. Microbiome. 2021 Apr 14;9(1):92. doi: 10.1186/s40168-021-01026-9.
PubMed 33853672
Schooley RT, Biswas B, Gill JJ, Hernandez-Morales A, Lancaster J, Lessor L, Barr JJ, Reed SL, Rohwer F, Benler S, Segall AM, Taplitz R, Smith DM, Kerr K, Kumaraswamy M, Nizet V, Lin L, McCauley MD, Strathdee SA, Benson CA, Pope RK, Leroux BM, Picel AC, Mateczun AJ, Cilwa KE, Regeimbal JM, Estrella LA, Wolfe DM, Henry MS, Quinones J, Salka S, Bishop-Lilly KA, Young R, Hamilton T. Development and Use of Personalized Bacteriophage-Based Therapeutic Cocktails To Treat a Patient with a Disseminated Resistant Acinetobacter baumannii Infection. Antimicrob Agents Chemother. 2017 Sep 22;61(10):e00954-17. doi: 10.1128/AAC.00954-17. Print 2017 Oct.
PubMed 28807909
Chan BK, Stanley GL, Kortright KE, Vill AC, Modak M, Ott IM, Sun Y, Wurstle S, Grun CN, Kazmierczak BI, Rajagopalan G, Harris ZM, Britto CJ, Stewart J, Talwalkar JS, Appell CR, Chaudary N, Jagpal SK, Jain R, Kanu A, Quon BS, Reynolds JM, Teneback CC, Mai QA, Shabanova V, Turner PE, Koff JL. Personalized inhaled bacteriophage therapy for treatment of multidrug-resistant Pseudomonas aeruginosa in cystic fibrosis. Nat Med. 2025 May;31(5):1494-1501. doi: 10.1038/s41591-025-03678-8. Epub 2025 Apr 29.
PubMed 40301561

Interested in taking part?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See sites and contacts

Not yet recruitingEarly Phase 1
Oral Aeromonas sp. MTB Phage Therapy for Pouchitis in Patients With Ulcerative Colitis (UC)
Pouchitis, UC - Ulcerative Colitis
RecruitingPhase 1
Bacteriophages for Adults With Cystic Fibrosis and Chronic Achromobacter Lung Infection
Cystic Fibrosis (CF), Achromobacter Infection
RecruitingObservational study
Establishing Personalized Phage Therapy and Its Comparative Cost in Difficult-to-treat Infections (EPHICACI)
Musculoskeletal Infection, Chronic Rhinosinusitis (Diagnosis)
RecruitingPhase 2
A Study of LBP-EC01 in the Treatment of Acute Uncomplicated UTI Caused by Drug Resistant E. Coli (ELIMINATE Trial)
Urinary Tract Infections
RecruitingObservational study
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All Phage Therapy trials

Study at a glance

From the registry record, last updated by the sponsor on 2 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Randomized Controlled Study on the Safety and Efficacy of Phage Cocktail in the Treatment of Multidrug-Resistant Bacterial Skin Infections
ClinicalTrials.gov ID: NCT07619924
Acronym / sponsor ID: 2025YFC3408505
Conditions: Phage Therapy, Bacteriophage Therapy, Skin and Soft Tissue Infections
Phase: Early Phase 1
Study type: Interventional
Recruitment status: Enrolling by invitation
Enrolment: 150 participants (estimated)
Lead sponsor: First Affiliated Hospital Xi'an Jiaotong UniversityUniversity, hospital or other
Study start: 15 Jan 2025 (actual)
Primary completion: 31 Oct 2027 (estimated)
Study completion: May 2028 (estimated)
First posted: 2 Jun 2026 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Bacteriophage Treatment Group	Experimental	Biological: Bacteriophage TreatmentReceive bacteriophage cocktail therapy for 7 days, combined with antibiotic therapy and conventional treatment.
Placebo Group	Placebo comparator	Drug: Placebo treatment using 0.9% normal salineReceive 0.9% normal saline (placebo) for 7 days, combined with antibiotic therapy and conventional treatment.

Who may qualify

Ages: 18 to 75 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (8 listed)

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

Key exclusion criteria (7 listed)

(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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Bacteriophage TreatmentBacteriophage 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.	Biological	Bacteriophage Treatment Group
Placebo treatment using 0.9% normal salineIn 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.	Drug	Placebo Group

Primary outcome

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.
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.

5 secondary outcomes

Wound Size Reduction
Time frame: From enrollment to Day 7, Day 14, and Day 28.
Time to Cessation of Exudate
Time frame: From enrollment through Day 28 follow-up.
Incidence of Treatment-Emergent Adverse Events
Time frame: 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.
Patient-reported Pain Score
Time frame: From enrollment to Day 7, Day 14, and Day 28.

Results and safety

This study is still under way. Results are not available in the source record yet.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 2 Jun 2026.
Background: PubMed 39299261GBD 2021 Antimicrobial Resistance Collaborators. Global burden of bacterial antimicrobial resistance 1990-2021: a systematic analysis with forecasts to 2050. Lancet. 2024 Sep 28;404(10459):1199-1226. doi: 10.1016/S0140-6736(24)01867-1. Epub 2024 Sep 16.
Background: PubMed 37279523Green SI, Clark JR, Santos HH, Weesner KE, Salazar KC, Aslam S, Campbell JW, Doernberg SB, Blodget E, Morris MI, Suh GA, Obeid K, Silveira FP, Filippov AA, Whiteson KL, Trautner BW, Terwilliger AL, Maresso A. A Retrospective, Observational Study of 12 Cases of Expanded-Access Customized Phage Therapy: Production, Characteristics, and Clinical Outcomes. Clin Infect Dis. 2023 Oct 13;77(8):1079-1091. doi: 10.1093/cid/ciad335.
Background: PubMed 34369652Khatami A, Lin RCY, Petrovic-Fabijan A, Alkalay-Oren S, Almuzam S, Britton PN, Brownstein MJ, Dao Q, Fackler J, Hazan R, Horne B, Nir-Paz R, Iredell JR. Bacterial lysis, autophagy and innate immune responses during adjunctive phage therapy in a child. EMBO Mol Med. 2021 Sep 7;13(9):e13936. doi: 10.15252/emmm.202113936. Epub 2021 Aug 9.
Background: PubMed 35611318Ding X, Tang Q, Xu Z, Xu Y, Zhang H, Zheng D, Wang S, Tan Q, Maitz J, Maitz PK, Yin S, Wang Y, Chen J. Challenges and innovations in treating chronic and acute wound infections: from basic science to clinical practice. Burns Trauma. 2022 May 21;10:tkac014. doi: 10.1093/burnst/tkac014. eCollection 2022.
Background: PubMed 37369702Kohler T, Luscher A, Falconnet L, Resch G, McBride R, Mai QA, Simonin JL, Chanson M, Maco B, Galiotto R, Riat A, Civic N, Docquier M, McCallin S, Chan B, van Delden C. Personalized aerosolised bacteriophage treatment of a chronic lung infection due to multidrug-resistant Pseudomonas aeruginosa. Nat Commun. 2023 Jun 27;14(1):3629. doi: 10.1038/s41467-023-39370-z.
Background: PubMed 34239133Dedrick RM, Freeman KG, Nguyen JA, Bahadirli-Talbott A, Smith BE, Wu AE, Ong AS, Lin CT, Ruppel LC, Parrish NM, Hatfull GF, Cohen KA. Potent antibody-mediated neutralization limits bacteriophage treatment of a pulmonary Mycobacterium abscessus infection. Nat Med. 2021 Aug;27(8):1357-1361. doi: 10.1038/s41591-021-01403-9. Epub 2021 Jul 8.
Background: PubMed 38834776Pirnay JP, Djebara S, Steurs G, Griselain J, Cochez C, De Soir S, Glonti T, Spiessens A, Vanden Berghe E, Green S, Wagemans J, Lood C, Schrevens E, Chanishvili N, Kutateladze M, de Jode M, Ceyssens PJ, Draye JP, Verbeken G, De Vos D, Rose T, Onsea J, Van Nieuwenhuyse B; Bacteriophage Therapy Providers; Bacteriophage Donors; Soentjens P, Lavigne R, Merabishvili M. Personalized bacteriophage therapy outcomes for 100 consecutive cases: a multicentre, multinational, retrospective observational study. Nat Microbiol. 2024 Jun;9(6):1434-1453. doi: 10.1038/s41564-024-01705-x. Epub 2024 Jun 4.
Background: PubMed 35773283Liu M, Hernandez-Morales A, Clark J, Le T, Biswas B, Bishop-Lilly KA, Henry M, Quinones J, Voegtly LJ, Cer RZ, Hamilton T, Schooley RT, Salka S, Young R, Gill JJ. Comparative genomics of Acinetobacter baumannii and therapeutic bacteriophages from a patient undergoing phage therapy. Nat Commun. 2022 Jun 30;13(1):3776. doi: 10.1038/s41467-022-31455-5.
Background: PubMed 11181338Sulakvelidze A, Alavidze Z, Morris JG Jr. Bacteriophage therapy. Antimicrob Agents Chemother. 2001 Mar;45(3):649-59. doi: 10.1128/AAC.45.3.649-659.2001. No abstract available.
Background: PubMed 33853672Mu A, McDonald D, Jarmusch AK, Martino C, Brennan C, Bryant M, Humphrey GC, Toronczak J, Schwartz T, Nguyen D, Ackermann G, D'Onofrio A, Strathdee SA, Schooley RT, Dorrestein PC, Knight R, Aslam S. Assessment of the microbiome during bacteriophage therapy in combination with systemic antibiotics to treat a case of staphylococcal device infection. Microbiome. 2021 Apr 14;9(1):92. doi: 10.1186/s40168-021-01026-9.
Background: PubMed 28807909Schooley RT, Biswas B, Gill JJ, Hernandez-Morales A, Lancaster J, Lessor L, Barr JJ, Reed SL, Rohwer F, Benler S, Segall AM, Taplitz R, Smith DM, Kerr K, Kumaraswamy M, Nizet V, Lin L, McCauley MD, Strathdee SA, Benson CA, Pope RK, Leroux BM, Picel AC, Mateczun AJ, Cilwa KE, Regeimbal JM, Estrella LA, Wolfe DM, Henry MS, Quinones J, Salka S, Bishop-Lilly KA, Young R, Hamilton T. Development and Use of Personalized Bacteriophage-Based Therapeutic Cocktails To Treat a Patient with a Disseminated Resistant Acinetobacter baumannii Infection. Antimicrob Agents Chemother. 2017 Sep 22;61(10):e00954-17. doi: 10.1128/AAC.00954-17. Print 2017 Oct.
Results publication: PubMed 40301561Chan BK, Stanley GL, Kortright KE, Vill AC, Modak M, Ott IM, Sun Y, Wurstle S, Grun CN, Kazmierczak BI, Rajagopalan G, Harris ZM, Britto CJ, Stewart J, Talwalkar JS, Appell CR, Chaudary N, Jagpal SK, Jain R, Kanu A, Quon BS, Reynolds JM, Teneback CC, Mai QA, Shabanova V, Turner PE, Koff JL. Personalized inhaled bacteriophage therapy for treatment of multidrug-resistant Pseudomonas aeruginosa in cystic fibrosis. Nat Med. 2025 May;31(5):1494-1501. doi: 10.1038/s41591-025-03678-8. Epub 2025 Apr 29.
Related InfoLink provided by the sponsor.
Individual participant dataSharing planned: No. 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.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Early Phase 1 study testing Bacteriophage Treatment in people with Phage Therapy and Bacteriophage Therapy, run by First Affiliated Hospital Xi'an Jiaotong University at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: enrolling by invitation, as of the sponsor's last update on 2 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Clinical Cure Rate at End of Treatment (time frame: From enrollment to the end of the 7-day treatment period.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07619924, which also lists 12 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jun 2026.