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Study on the treatment of pan-drug resistant Klebsiella pneumoniae urinary tract infection with phage and compound trimethoprim

Study on the treatment of pan-drug resistant Klebsiella pneumoniae urinary tract infection with phage and compound trimethoprim

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2000036243
Enrollment
Unknown
Registered
2020-08-22
Start date
2020-09-01
Completion date
Unknown
Last updated
2020-09-07

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

Case series+Compound trimethoprim: Phage administration+Compound trimethoprim

Sponsors

Shanghai Public Health Clinical Center
Lead Sponsor

Eligibility

Sex/Gender
All
Age
1 Years to 90 Years

Inclusion criteria

Inclusion criteria: 1. Aged 1-90 years old patients with multidrug-resistant bacterial infection (based on the drug susceptibility testing in our hospital or other 3A hospitals); 2. The pathogenic bacteria resistants to all existing antibiotics or it is only sensitives to within 2 types of antibiotics, and the antibiotic treatment is ineffective (ineffective is defined as repeated infection of the same pathogen, or the antibiotic treatment is effective but cant be discontinued); 3. At least one phage can be screened to lyse the pathogenic bacteria; 4. The phages can be administrated through spraying, inhaling or intubation-perfusion; 5. The patient and his/her guardian are fully read, understand and sign the informed consent statement.

Exclusion criteria

Exclusion criteria: 1. The patient suffers from acute or malignant cardio-cerebrovascular diseases* (*such as acute coronary syndrome, atrial fibrillation, ventricular fibrillation, severe arrhythmia, acute myocarditis, aortic dissection, cerebral hemorrhage, cerebral thrombosis, etc.); 2. The patient have other severe conditions that can not be effectively controlled besides MDR-bacterial infection (such as malignant tumor, etc.); 3. The infection can be effectively controlled by antibiotic treatment; 4. The phage can be only administrated via intravenous administration; 5. The patient is not suitable to involved in this study, determined by the researcher.

Design outcomes

Primary

MeasureTime frame
Bacterial isolation, identification and drug sensitivity tests;Phage-typing;Urine Routine (Infection indices);

Secondary

MeasureTime frame
Blood Routine (Infection indices);

Countries

China

Contacts

Public ContactZeng Yigang
zengyigang@shphc.org.cn+86 18017138143

Outcome results

None listed

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