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Targeted Bacterionophage Therapy for Multidrug-Resistant Pseudomonas aeruginosa Infections in Refractory Cases

Targeted Bacterionophage Therapy for Multidrug-Resistant Pseudomonas aeruginosa Infections in Refractory Cases

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500096948
Enrollment
Unknown
Registered
2025-02-10
Start date
2025-02-10
Completion date
Unknown
Last updated
2025-02-17

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

Conditions

Pseudomonas aeruginosa

Interventions

Sponsors

Shenzhen Third People's Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. Patients with Multidrug-Resistant Bacterial Infections: These patients must have undergone drug susceptibility testing at our hospital or at other hospitals of grade 3 or above.The test results should be based on the available evidence; 2. Pathogenic Bacteria Infections: The bacteria causing the infection should meet one of the following conditions: Total Antibiotic Resistance: The pathogenic bacterial pair exhibits resistance to all antibiotics. Resistance to Key Antibiotics: The pathogenic bacteria are resistant to key antibiotics. In Vitro Sensitivity but In Vivo Resistance: The pathogenic bacteria are sensitive to key antibiotics in vitro but ineffective in vivo (defined as recurrent infection of the patient's target bacteria for two months or more with continuous, unclear treatment periods). Use of Sensitive Antibiotics: Pathogenic bacteria are subject to the use of antibiotics to which they are sensitive (e.g., in patients with organ toxicity or hypersensitivity to these antibiotics); 3. Phage Therapy:At least one lytic phage must be available for screening; 4.The phage therapy can be administered through various methods, including spraying, external application, atomized inhalation, perfusion, and topical administration via infection foci or catheters; 5. Informed Consent:Subjects and their families (or guardians) should fully read, understand, and sign the consent form.

Exclusion criteria

Exclusion criteria: 1. Bacterial Infections:Can be effectively managed with antibiotic therapy; 2. Phage Therapy:No suitable phage found to be effective against the infection; 3. Administration Routes for Bacteriophages:No viable administration routes available, or the potential routes (such as nebulized inhalation, catheterization, perfusion, or wet compresses) are contraindicated; 4. Patient Refusal:The patient declines to undergo bacteriophage therapy; 5. Study Eligibility:Patients deemed unsuitable for study participation by the investigator.

Design outcomes

Primary

MeasureTime frame
Patient survival and safety;

Secondary

MeasureTime frame
Clinical symptoms improvement;Bacterial clearance or reduction; Temperature;Blood routine;C-reactive protein;Procalcitonin;Inflammatory cytokine spectrum;Clinical imaging indicators;The effective rate of phage treatment for 2 weeks is that the number of sputum (urine, drainage) smears and cultures of target bacteria and the negative conversion ratio are reported.;

Countries

China

Contacts

Public ContactLu Hongzhou

The Third People's Hospital of Shenzhen

luhongzhou@szsy.sustech.edu.cn+86 755 6123 8920

Outcome results

None listed

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