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The clinical research of precise phage therapy for superbug infection

The clinical research of precise phage therapy for superbug infection

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2000036801
Enrollment
Unknown
Registered
2020-08-25
Start date
2020-10-01
Completion date
Unknown
Last updated
2021-08-30

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

Conditions

Drug-resistance bacterial infectious disease

Interventions

experimental group:phage

Sponsors

Shanghai Public Health Clinical Center
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 90 Years

Inclusion criteria

Inclusion criteria: 1. Aged 18-90-year-old patients with multi-drug resistant bacteria infection; 2. The pathogenic bacteria should meet one of the following conditions: 1) Pathogens are fully resistant to antibiotics; 2) Pathogens are resistant to key antibiotics (see the 12 categories of super bacteria* [1] released by WHO in 2017); 3) The pathogen is sensitive to key antibiotics in vitro, but the antibiotic treatment is ineffective or the effect is not obvious (the effect is not obvious is defined as repeated infection of the same kind of drug-resistant pathogen or the patient has antibiotic dependence and cannot stop the drug for 2 months or more); 4) Pathogens have limited use of key sensitive antibiotics (such as organ toxicity or patients allergic to this antibiotic); 3. At least one kind of lytic phage can be screened; 4. It can be administered by spraying, external application, aerosol inhalation, perfusion, local injection or diversion tube through the infected area; 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 treatment; 2. There is no other route of administration except intravenous injection; 3. Patients judged by the investigator to be unsuitable to participate in this study.

Design outcomes

Primary

MeasureTime frame
Clearance of target strain;

Secondary

MeasureTime frame
Improvement of clinical symptoms;

Countries

China

Contacts

Public ContactZhu Tongyu

Shanghai Public Health Clinical Center

zhutongyu@shphc.org.cn+86 13816002121

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Jul 29, 2026