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Efficacy and safety of bacteriophage in treating severe drug-resistant lower respiratory tract infections in children: a randomized controlled trial

Efficacy and safety of bacteriophage in treating severe drug-resistant lower respiratory tract infections in children: a randomized controlled trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500099778
Enrollment
Unknown
Registered
2025-03-28
Start date
2025-04-15
Completion date
Unknown
Last updated
2025-03-31

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
28 Days to 18 Years

Inclusion criteria

Inclusion criteria: 1. The patient is over 28 days old but under 18 years old; 2. Acute lower respiratory tract infection, with a pathogen infection cycle of less than 3 months; 3. The pathogenic bacteria causing pulmonary infection in patients should meet one of the following conditions: (1) The pathogenic bacteria are pan resistant bacteria (PDR); (2) Pathogenic bacteria are resistant to carbapenem resistant organisms (CRO); (3) Pathogenic bacteria are sensitive to key antibiotics outside the body, but this antibiotic treatment is clinically ineffective or ineffective (ineffective is defined as clinical efficacy is not significant, the condition does not improve or worsens, and microbiological treatment is ineffective (pathogenic bacteria cannot be cleared)); (4) Pathogenic bacteria have limited use of key sensitive antibiotics (such as organ toxicity or patients allergic to this antibiotic); 4. Capable of screening at least one lytic bacteriophage (virtual typing not required);

Exclusion criteria

Exclusion criteria: 1. Cannot be administered by nebulization inhalation; 2. Patients who have been determined by the researchers 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