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Efficacy and safety of bacteriophage therapy in severe and refractory bacterial infections in children: a single-arm study

Efficacy and safety of bacteriophage therapy in severe and refractory bacterial infections in children: a single-arm study

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500101222
Enrollment
Unknown
Registered
2025-04-22
Start date
2025-04-30
Completion date
Unknown
Last updated
2025-04-28

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

Conditions

Severe drug-resistant bacterial infections in children

Interventions

Sponsors

Children's Hospital of Fudan University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
No minimum to 18 Years

Inclusion criteria

Inclusion criteria: 1. children with multidrug-resistant bacterial infection (based on the drug sensitivity test results of our hospital or other hospitals above grade 3a); 2. the pathogenic bacteria infected by the patient should meet one of the following conditions: (1) The pathogen was pandrug resistant bacteria (PDR); (2) The pathogen was carbapenem resistant organisms (CRO); (3) Pathogenic bacteria are sensitive to key antibiotics in vitro, but the antibiotic treatment is clinically ineffective or ineffective (ineffective effect is defined as the clinical efficacy is not obvious, the condition is not improved or worsened, and microbiological treatment is ineffective (pathogenic bacteria cannot be cleared)); (4) The use of key sensitive antibiotics by pathogenic bacteria is limited (such as organ toxicity or patients allergic to this antibiotic); 3. be able to screen at least one lytic phage (not required for virtual matching);

Exclusion criteria

Exclusion criteria: 1. there is no other route of administration except intravenous administration; 2. patients judged by the investigator to be unsuitable for participation in this study.

Design outcomes

Primary

MeasureTime frame
Target bacterial clearance rate;

Secondary

MeasureTime frame
Clinical outcome;

Countries

China

Contacts

Public ContactGangfeng Yan

Children's Hospital of Fudan University

gangfeng_yan@fudan.edu.cn+86 159 0060 3082

Outcome results

None listed

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