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effect of Gut antibiotic-resistant bacteria testing on liver failure patients with infections.

Does guiding decisions on gut colonizing bacteria and Xpert Carba-R improve outcomes in hospitalized cirrhosis patients with bacterial infections- a pragmatic randomized trial(Xpert-Gut Trial) - Xpert-GUT Trial

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2023/02/049479
Enrollment
200
Registered
2023-02-06
Start date
Unknown
Completion date
Unknown
Last updated
2024-04-01

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

Conditions

Health Condition 1: K74- Fibrosis and cirrhosis of liver

Interventions

Intervention1: Surveillance swab and Carba-R guided medical care: Hospitalised cirrhosis patients admitted with the infection will undergo rectal swab testing as per the standard protocol outlined bel

Sponsors

PGIMER
Lead Sponsor
Cepheid India
Collaborator

Eligibility

Inclusion criteria

Inclusion criteria: The adult patient of any gender with cirrhosis and bacterial infection as per EASL criteria at admission, patient or his/her legally acceptable representative (if applicable) willing to give written informed consent.

Exclusion criteria

Exclusion criteria: 1. Patients with a history of significant non-hepatic diseases with impaired short-term prognosis (heart failure NYHA Grade III/IV, COPD GOLD C or above). 2. Patients with current non-hepatic malignancies including solid tumours and hematologic disorders. 3. Patients with hepatocellular carcinoma, except for patients with early HCC (BCLC-0 or BCLC-A) or patients with previous history of HCC and absence of recurrence 2 years after treatment. 4. TIPS insertion within 6 months prior to study inclusion. 5. Immunosuppressive drug users other than steroids for alcohol associated hepatitis and autoimmune liver disease 6. Patients with HIV infection based on positive ELISA test, previous organ transplantation, and known immunodeficiency state. 7. Patients treated with Ceftazidime-avibactam, aztreonam, colistin, and polymyxin B within last 3 months.

Design outcomes

Primary

MeasureTime frame
Compare the impact of guiding medical care of infected cirrhosis patients at admission using rectal swab cultures and Xpert Carba R, as compared to standard of care alone (SOC) on Overall survival at 28-daysTimepoint: day 28

Secondary

MeasureTime frame
Change in disease severity scores between groupsTimepoint: day 0,7,14,21,28;Evolution of organ failures between the groupsTimepoint: day 0,7,14,21,28;Length of hospital stay between groupsTimepoint: day 0,7,14,21,28;Resolution of index infection between groupsTimepoint: day 0,7,14,21,28

Countries

India

Contacts

Public ContactDr Nipun Verma

PGIMER, chandigarh

nipun29j@gmail.com9914208562

Outcome results

None listed

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