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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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11 January 2021 |
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Main ID: |
NCT03794765 |
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Date of registration:
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04/01/2019 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Antibiotics as an Adjuvant in Patients With Acute Severe Ulcerative Colitis
AAASUC |
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Scientific title:
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Use of Antibiotics as an Adjuvant in Patients With Acute Severe Ulcerative Colitis: A Randomised Trial |
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Date of first enrolment:
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April 1, 2019 |
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Target sample size:
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50 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT03794765 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Triple (Participant, Investigator, Outcomes Assessor).
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Phase:
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Phase 2
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Countries of recruitment
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India
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Contacts
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Name:
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Shubhra Mishra |
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Address:
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Telephone:
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Email:
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Affiliation:
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Postgraduate Institute of Medical Education and Research |
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Name:
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Vishal Sharma |
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Address:
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Telephone:
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Email:
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Affiliation:
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Postgraduate Institute of Medical Education and Research |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Acute severe ulcerative colitis as described in European Crohn's and Colitis
Organisation (ECCO) guidelines (adapted from Truelove and Witts)
Exclusion Criteria:
- 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
Age minimum:
13 Years
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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Acute Severe Colitis
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Inflammatory Bowel Diseases
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Ulcerative Colitis
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Intervention(s)
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Drug: Ceftriaxone
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Drug: Metronidazole
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Other: Placebo infusion
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Primary Outcome(s)
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Clinical response as defined by the Oxford's criteria
[Time Frame: 48 hours]
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Secondary Outcome(s)
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Change in serum CRP levels
[Time Frame: 48 hours]
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Proportion needing second line therapy
[Time Frame: 28 days]
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Change in Mayo disease severity index
[Time Frame: 48 hours]
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Mortality
[Time Frame: 28 days]
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Proportion needing colectomy
[Time Frame: 28 days]
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Duration of hospital stay
[Time Frame: 28 days]
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Patients with Reduction in fecal calprotectin by >100 mcg/mg
[Time Frame: 48 hours]
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Secondary ID(s)
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NK/5147/DM
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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