Status:
COMPLETED
Antibiotics as an Adjuvant in Patients With Acute Severe Ulcerative Colitis
Lead Sponsor:
Post Graduate Institute of Medical Education and Research, Chandigarh
Conditions:
Ulcerative Colitis
Inflammatory Bowel Diseases
Eligibility:
All Genders
13+ years
Phase:
PHASE2
Brief Summary
The study is planned as a randomised control trial to study the adjuvant use of antibiotics (ceftriaxone and metronidazole) to achieve a clinical response in hospitalised patients with acute severe ul...
Detailed Description
All patients with active ulcerative colitis who present to the Outpatient department or the emergency services of PGIMER shall be screened. Those patients who have acute severe ulcerative colitis shal...
Eligibility Criteria
Inclusion
- Acute severe ulcerative colitis as described in European Crohn's and Colitis Organisation (ECCO) guidelines (adapted from Truelove and Witts)
Exclusion
- Patients who deny consent
- Age\<=12 years
- Pregnant or lactating women
- Severe uncontrolled comorbidities like diabetes mellitus, hypertension, coronary artery disease, chronic liver disease, chronic kidney disease, etc
- History of antibiotic use in the past one month, excluding those who may have received a single dose of antibiotic in past 24 hrs
- History of hypersensitivity or contraindication to steroids or the test drugs
- Presence of toxic megacolon as defined by transverse colon diameter more than 5.5cm on abdominal X-ray
- Patients with evidence of sepsis or active infection
Key Trial Info
Start Date :
April 1 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 4 2020
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT03794765
Start Date
April 1 2019
End Date
April 4 2020
Last Update
December 11 2020
Active Locations (1)
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1
Postgraduate Institute of Medical Education and Research
Chandigarh, India, 160012