Clinical study on intestinal decolonization of carbapenem resistant gram-negative bacilli in the liver transplantation recipients

Status

Recruiting

Phases

Early Phase 1

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR2100050981

Enrollment

Unknown

Registered

2021-09-09

Start date

2021-09-01

Completion date

Unknown

Last updated

2022-05-16

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

Conditions

None listed

Interventions

Experimental group:Oral colistin sulfate 500,000 units three times a day for 7 days

Control group:None

Eligibility

Sex/Gender

All

Age

18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. From September 2021 to August 2022, the recipient patients who are going to undergo liver transplantation at the General Surgery Liver Transplantation Center of Huashan Hospital Affiliated to Fudan University, aged 18-75 years, no gender limit. 2. Model score of end-stage liver disease (MELD score) <25 points. 3. Anal swab screening was performed on the day of admission or the next day, and the CR-GNB strain (Including Enterobacteriaceae, Acinetobacter, Pseudomonas) was cultured from the anal swab, and the CR-GNB strain was sensitive to colistin. 4. Voluntarily signed the informed consent form for the study.

Exclusion criteria

Exclusion criteria: 1. Patients who cannot be administered orally or via indwelling gastric tube; 2. Patients allergic to colistin sulfate; 3. Patients with obvious systemic infection (such as lung infection, abdominal infection, bloodstream infection, etc.) at the time of screening and need to be combined with systemic antibiotics; 4. Diarrhea symptoms exist at the time of screening (unformed stools >= 4 times a day); 5. The patient's CCR calculated by the CG formula is less than 60ml/min, or there are drugs that may have an impact on renal function in the necessary concomitant drugs known to the patient; 6. Cardiac function NYHA class III or above; 7. Patients with myasthenia gravis or other disease states with neuromuscular junction blockade, or patients with other drugs that may cause neuromuscular junction blockade.

Design outcomes

Primary

Measure	Time frame
Incidence of carbapenem-resistant gram-negative bacilli infection;	—

Secondary

Measure	Time frame
All-cause mortality;Attributed mortality;	—

Countries

China

Contacts

Public ContactHu Fupin

Huashan Hospital Affiliated to Fudan University

hufupin@163.com+86 13601809508

Outcome results