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Randomized controlled trial of an optimized strategy of the CRE decolonization in critically ill and high-risk patients

Randomized controlled trial of an optimized strategy of the CRE decolonization in critically ill and high-risk patients

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2000035578
Enrollment
Unknown
Registered
2020-08-14
Start date
2020-10-13
Completion date
Unknown
Last updated
2021-03-30

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

Conditions

Carbapenem resistant enterobacteriaceae colonization

Interventions

Standard treatment group:No antibiotics and probiotics intervention treatment should be given, and the patients should be routinely treated with the primary disease.
Probiotic group:Take peiphicam orally twice a day, 3 pills at a time

Sponsors

Ruijin Hospital affiliated to Shanghai Jiao Tong University Medical College
Lead Sponsor

Eligibility

Sex/Gender
Male

Inclusion criteria

Inclusion criteria: 1. Aged 18 to 85 years; 2. Intestinal carbapenem-resistant enterobacter spp. colonization: Rectal swab examination showed positive culture results of Klebsiella pneumoniae, but no clinical symptoms of infection were found; 3. The patient or its legal representative agrees to participate in the clinical trial, comply with all study activities, and sign a written informed consent; 4. Drug sensitivity test was carried out on the purified isolates, and the results suggested CRE.As follows: carbapenem type 2 antibiotic: any of meropenem, imipenem or doripenem, MIC>=4 g/ mL or inhibitory zone <=19mm. 5. High-risk patients with secondary infection: patients who had been in intensive care unit (ICU) for a long time in the first 6 months of enrollment. Non-remission patients with leukemia or lymphoma, patients with solid organ or stem cell transplantation, patients with neutropenia, or patients receiving immunosuppressive therapy (including large doses of systemic steroids for 2 weeks).

Exclusion criteria

Exclusion criteria: 1. Patients with polybacterial infection in ICU composed of carbapenems sensitive gram-negative bacteria; 2. Patients who received excessive myxins 96 hours before enrollment, were known to be allergic to myxins or carbapenem drugs, and had seizures previously caused by carbapenem drugs; 3. Patients who have not been treated with carbapenems but have been diagnosed as having epilepsy requiring antiepileptic therapy; 4. Patients requiring treatment for more than 14 days for endovascular infections, including endocarditis, osteomyelitis, artificial joint infections, meningitis and/or other central nervous system infections; 5. Patients who are participating in other clinical trials before enrollment; 6. Pregnant or breastfeeding patients.

Design outcomes

Primary

MeasureTime frame
Secondary CRE infection rate;

Secondary

MeasureTime frame
28-day mortality rate;the rate of decolonization;The duration of mechanical ventilation;The production of resistant bacteria;

Countries

China

Contacts

Public ContactLiu Jialin

Ruijin Hospital affiliated to Shanghai Jiao Tong University Medical College

liujialin77@163.com+86 13916321955

Outcome results

None listed

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