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The clinical research of phage therapy for multidrug-resistant bacterial infections

The clinical research of phage therapy for multidrug-resistant bacterial infections

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400084544
Enrollment
Unknown
Registered
2024-05-20
Start date
2024-05-22
Completion date
Unknown
Last updated
2024-05-27

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

Conditions

Multi-drug resistant bacterial infections

Interventions

Sponsors

Shanghai Donglei Brain Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
14 Years to 120 Years

Inclusion criteria

Inclusion criteria: 1. Patients over 14 years of age with multi-drug resistant bacterial infections; 2. The pathogenic bacteria infecting the patient should meet one of the following conditions: (1) The pathogenic bacteria are fully resistant to antibiotics; (2) Pathogenic bacteria are resistant to key antibiotics (see WHO's 2017 publication of 12 classes of superbugs ); (3) Pathogenic bacteria are sensitive to key antibiotics in vitro but this antibiotic treatment is ineffective or ineffective (ineffective or ineffective antibiotic treatment is defined as the patient's failure to achieve clearance of pathogenic bacteria/improvement in clinical symptoms after 2 courses (14 days) of treatment with sensitive antibiotics); (4) Pathogenic bacteria limited to the use of key sensitive antibiotics (e.g. organ toxicity or patients allergic to this antibiotic); 3. Ability to screen for at least one lytic phage; 4. Ability to administer the drug by spraying, topical application, nebulized inhalation, perfusion, local injection or catheter at the site of infection; 5. Subjects and family members (or guardians) fully read, understand and sign the informed consent form.

Exclusion criteria

Exclusion criteria: 1. Bacterial infection can be effectively controlled by antibiotic therapy; 2. No other route of administration other than intravenous administration; 3. Patients who are judged by the investigator to be unsuitable for participation in this study.

Design outcomes

Primary

MeasureTime frame
The target strain was completely cleared or the load decreased without clinical symptoms;

Secondary

MeasureTime frame
Significant improvement of clinical symptoms;

Countries

China

Contacts

Public ContactZhuying Cai

Shanghai Donglei Brain Hospital

czy224@yeah.net+86 139 1721 8088

Outcome results

None listed

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