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The efficacy and safety of elacyclin-based combination regimens compared with the best available therapy for multi-drug resistant bacterial infections in solid organ transplant recipients: A multicenter, retrospective observational study

The efficacy and safety of elacyclin-based combination regimens compared with the best available therapy for multi-drug resistant bacterial infections in solid organ transplant recipients: A multicenter, retrospective observational study

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2500103187
Enrollment
Unknown
Registered
2025-05-26
Start date
2025-06-01
Completion date
Unknown
Last updated
2025-06-02

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

Conditions

Multi-drug resistant bacterial infection in recipients of solid organ transplantation

Interventions

Elacycline group:NA
BAT Group:NA

Sponsors

The First Affiliated Hospital of Guangzhou Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 100 Years

Inclusion criteria

Inclusion criteria: 1. >=18 years old. 2. Patients who have received solid organ transplants (liver, kidney, lung, heart) in the past and have been treated with at least one type of immunosuppressant for a long time (such as glucocorticoids, calcaren inhibitors, anti-cell proliferation drugs, rapamycin target protein inhibitors, etc.). 3. Infections caused by known or highly suspected multi-drug resistant pathogenic bacteria (MDR). MDR conforms to the definition in the "Chinese Expert Consensus on the Prevention and Control of Nosocomial Infections Caused by Multi-Drug Resistant Bacteria". 4. Combination regimens based on eracycline or BAT are used as first-line treatment regimens. 5. If the combination regimen is based on elacycline, patients in the treatment group need to be treated with elacycline for =4 days. 6. The clinical outcomes of the cases were complete, and the data could meet the requirements for treatment outcome evaluation (clinical outcomes, microbiological outcomes, and comprehensive efficacy evaluation).

Exclusion criteria

Exclusion criteria: 1. Simple urinary tract or intracranial infection. 2. The culture drug sensitivity shows that the microbial pathogen is not sensitive to etracycline (refer to the MIC breakpoint of ChinaCAST).

Design outcomes

Primary

MeasureTime frame
30-day all-cause mortality rate;

Secondary

MeasureTime frame
Clinical effective rate;30-day infection recurrence rate;Coefficient of variation of tacrolimus blood concentration during treatment;The types and severity of adverse drug reactions;

Countries

China

Contacts

Public ContactJu Chunrong

The Datansha Campus of the First Affiliated Hospital of Guangzhou Medical University

juchunrong@126.com+86 159 1576 1346

Outcome results

None listed

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