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An exploratory clinical study of bacteriophages in the treatment of pulmonary drug-resistant bacterial infection

An exploratory clinical study of bacteriophages in the treatment of pulmonary drug-resistant bacterial infection

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500098670
Enrollment
Unknown
Registered
2025-03-12
Start date
2025-03-12
Completion date
Unknown
Last updated
2025-03-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pulmonary infection

Interventions

Lung resistant bacterial infection group:Phages treatment

Sponsors

Shanghai Pudong Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
14 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. Patients over 14 years old with multidrug-resistant bacterial infection; 2. The pathogenic bacteria infected by the patient should meet one of the following conditions: (1) The pathogen is fully resistant to antibiotics; (2) pathogenic resistance to key antibiotics*; (3) The pathogen is susceptible to key antibiotics in vitro, but the treatment of this antibiotic is ineffective or ineffective (the effect is not obvious defined as recurrent infection of the target bacteria in the patient for two weeks or more, during which continuous antibiotic treatment cannot be cleared); (4) limited use of key sensitive antibiotics by pathogenic bacteria (e.g., organ toxicity or allergy to this antibiotic); 3. Able to screen at least one lytic phage#; 4. Able to be sprayed, applied externally, inhaled by nebulization, perfusion, local injection, diversion or oral administration by the foci of infection; 5. Subjects and their families (or guardians) fully read, understand and sign the informed consent form. *Pathogenic bacteria and key antibiotics: Acinetobacter baumannii, Pseudomonas aeruginosa, Klebsiella pneumoniae, Escherichia coli, Stenotrophomonas maltophila: carbapenem or third-generation cephalosporin resistance; Enterococcus faecium, Enterococcus faecalis: vancomycin resistance; Staphylococcus aureus, Staphylococcus haemolyticus: Methicillin resistance. Note: The phage library of drug-resistant bacteria other than the above has not been established or improved in this project, and patients with such bacterial infections cannot be enrolled, or they need to be treated after de novo screening of lysed phages by patient pathogens. #, while carrying out routine personalized phage matching, the type and corresponding phage can be predicted according to the epidemiological data of the subject's bacterial infection, and the empirical phage formula is used to preemptively treat.

Exclusion criteria

Exclusion criteria: 1.Bacterial infection can be effectively controlled by antibiotic treatment 2.There is no other route of administration except intravenous administration 3.Patients who were determined by the investigators to be unsuitable for participating in this study

Design outcomes

Primary

MeasureTime frame
Pathogen;

Secondary

MeasureTime frame
Clinical signs and symptoms;

Countries

China

Contacts

Public ContactZiqiang Zhang

Shanghai Pudong Hospital

zzq1419@126.com+86 187 2133 5536

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026