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Study to phages for prevention and treatment of difficult-to-treat resistant Pseudomonas aeruginosa infection

Study to engineer phages for prevention and treatment of difficult-to-treat resistant Pseudomonas aeruginosa infection

Status
Active, not recruiting
Phases
Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400094545
Enrollment
Unknown
Registered
2024-12-24
Start date
2025-01-15
Completion date
Unknown
Last updated
2025-01-06

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

Conditions

Pseudomonas aeruginosa

Interventions

Control group:According to the guidelines and clinical diagnosis and treatment routine, the corresponding treatment will be continued, including antibiotics, bronchodilators, expectorants, nutritional

Sponsors

Shenzhen University General Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. Age 18-80 years old; 2. Bronchiectasis were diagnosed according to the 2020 Chinese Expert Consensus criteria for bronchiectasis; COPD Diagnosis according to 2023 GOLD Global Initiative criteria for Chronic Obstructive Pulmonary Disease; 3. Lower respiratory tract secretions or bronchoalveolar lavage fluid culture pathogen Pseudomonas aeruginosa (Positive judgment according to the expert Consensus 2022 standard for Diagnosis and Treatment of lower respiratory tract infections of Pseudomonas aeruginosa in China: Bronchial aspiration (>=10^5CFU/mL), bronchoalveolar lavage (>=10^4CFU/mL), protective brush specimen (>=10^3CFU/mL); In patients with lower respiratory tract infection, PA positive in pleural fluid culture and blood culture can be considered positive after exclusion of contamination. Clinical suspicion of PA infection is high, routine examination is negative, especially the empirical antibacterial treatment is not effective, positive diagnosis can be made with the help of molecular diagnosis results such as second-generation sequencing, gene chip, PCR, etc. Patients with repeated positive culture of PA should be tested for drug sensitivity at least once every 3 days); 4. The pathogenic bacteria infected by the patient should meet one of the following conditions and the bactericidal test of in vitro is positive: (1) The pathogenic bacteria meet the diagnostic criteria of DTR-PA (see above); (2) The pathogen is sensitive to the key antibiotic in vitro, but the antibiotic treatment is ineffective for 7 days (failing to achieve the goal of eliminating the pathogen/improving clinical symptoms); (3) The use of critical sensitive antimicrobials by pathogens is limited (such as organ toxicity or patients with allergic reactions to antimicrobials); 5. Can be administered by aerosol inhalation or bronchoscopic perfusion; 6. The subjects and their family members (or guardians) should fully read, understand and sign the informed consent.

Exclusion criteria

Exclusion criteria: 1. Severe abnormal vital sians during screening; 2. Bacterial infection can be effectively controlled by antimicrobial therapy; 3. Those who cannot tolerate aerosol inhalation or bronchoscopy infusion; 4. Subjectand their family members (or guardian) refuse to participate; 5. Patients unsuitable by the investigator toparticipate in the study, such as pregnant or lactating women.

Design outcomes

Primary

MeasureTime frame
Clinical symptoms improvement;

Secondary

MeasureTime frame
Bacterial clearance or reduction;Temperature;Blood routine;C-reactive protein;Procalcitonin;Inflammatory cytokine spectrum;Pulmonary function;Blood gas analysis;Chest imaging results;

Countries

China

Contacts

Public ContactBai Changqing

Shenzhen University General Hospital

morrow309@163.com+86 139 1089 5979

Outcome results

None listed

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