Antibiotics as an Adjuvant in Patients With Acute Severe Ulcerative Colitis (AAASUC)
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|ClinicalTrials.gov Identifier: NCT03794765|
Recruitment Status : Completed
First Posted : January 7, 2019
Last Update Posted : December 11, 2020
|Condition or disease||Intervention/treatment||Phase|
|Ulcerative Colitis Inflammatory Bowel Diseases Acute Severe Colitis||Drug: Ceftriaxone Drug: Metronidazole Other: Placebo infusion||Phase 2|
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 shall be assessed for inclusion into the study. Patients who fulfil the eligibility criteria will be randomised into two groups.
Group A will include patients in the intervention arm. They will be given intravenous antibiotics for three days. Injection ceftriaxone 1 gm will be prepared by reconstitution of the crystallized powder form in 100 ml of normal saline. This preparation will then be infused slowly over thirty minutes, after intradermal testing for hypersensitivity. Inj ceftriaxone 1gm IV will be given twelve hourly. Injection metronidazole 500 mg is available from pharmacies in solutions of 100 ml. It will be infused slowly over thirty minutes, three times per day, after intradermal testing for hypersensitivity. Both the drugs will be given for five days. In addition, they will receive the standard of care mentioned below.
Group B will include patients from the placebo arm. They will be given the standard of care as mentioned below. In addition, they will be infused 0.9 % saline of similar quantity, colour, and from similarly shaped bottles, for three days after sensitivity testing with the saline.
Detailed history and examination shall be done for all the patients. History regarding the stool output, any systemic symptoms, prior treatment history and history regarding any precipitant for the acute episode shall be taken. Examination will include vitals (pulse rate, blood pressure, temperature), general physical examination as well as an abdominal examination. All patients will undergo blood investigations on all three days. This includes a complete blood counts, kidney function tests, serum electrolytes, albumin, C-reactive protein, osteopontin, blood culture. Stool routine microscopic examination, fecal calprotectin, stool assay for clostridium difficile toxin will be done. X ray abdomen will be done on all three days to monitor the diameter of transverse colon. Patients will undergo an unprepared sigmoidoscopy with minimal air insufflation and mucosal biopsy. Biopsies will be taken for histological examination. Procalcitonin, fecal calprotectin and CRP shall be repeated on day 3 of admission.
All patients will be prescribed the standard treatment for acute severe colitis, which includes intravenous steroids (Inj Hydrocortisone 100 mg IV QID or Inj Methyprednisolone 60 mg iv OD), anticoagulation, (Inj Unfractionated heparin 5000 IU S/C BD), intravenous fluid supplementation and correction of electrolytes. Patients will be allowed orally and will be prescribed a diet of 25-30 kcal /kg/day.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||50 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Investigator, Outcomes Assessor)|
|Official Title:||Use of Antibiotics as an Adjuvant in Patients With Acute Severe Ulcerative Colitis: A Randomised Trial|
|Actual Study Start Date :||April 1, 2019|
|Actual Primary Completion Date :||March 4, 2020|
|Actual Study Completion Date :||April 4, 2020|
Standard of Care (steroids, prophylactic anticoagulation, oral nutrition) And Antibiotics (Inj Ceftriaxone 1 gram intravenous twice daily And Inj Metronidazole 500 mg intravenous thrice daily) for initial 48 hours
Injection ceftriaxone 1 gm will be prepared by reconstitution of the crystallised powder form in 100 ml of normal saline. This preparation will then be infused slowly over thirty minutes, after intradermal testing for hypersensitivity. Inj ceftriaxone 1gm IV will be given twelve hourly.
Injection metronidazole 500 mg is available from pharmacies in solutions of 100 ml. It will be infused slowly over thirty minutes, three times per day
Placebo Comparator: Placebo
Standard of care (steroids, prophylactic anticoagulation, oral nutrition) And Placebo infusions similar to the active drugs
Other: Placebo infusion
Similar placebo infusion
- Clinical response as defined by the Oxford's criteria [ Time Frame: 48 hours ]Patients will be defined as complete responders, partial responders or non-responders
- Proportion needing second line therapy [ Time Frame: 28 days ]Second line therapy : Intravenous Infliximab, Intravenous cyclosporine or others
- Proportion needing colectomy [ Time Frame: 28 days ]Number of patients in each group needing colectomy
- Mortality [ Time Frame: 28 days ]Number of patients in having mortality
- Duration of hospital stay [ Time Frame: 28 days ]Length of hospital stay in each group
- Change in serum CRP levels [ Time Frame: 48 hours ]
- Change in Mayo disease severity index [ Time Frame: 48 hours ]
- Patients with Reduction in fecal calprotectin by >100 mcg/mg [ Time Frame: 48 hours ]Number of patients in each group having the predefined decline in fecal calprotectin
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03794765
|Postgraduate Institute of Medical Education and Research|
|Chandigarh, India, 160012|
|Principal Investigator:||Vishal Sharma||Postgraduate Institute of Medical Education and Research|
|Principal Investigator:||Shubhra Mishra||Postgraduate Institute of Medical Education and Research|