Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Antibiotics as an Adjuvant in Patients With Acute Severe Ulcerative Colitis (AAASUC)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03794765
Recruitment Status : Completed
First Posted : January 7, 2019
Last Update Posted : December 11, 2020
Sponsor:
Information provided by (Responsible Party):
Vishal Sharma, Postgraduate Institute of Medical Education and Research

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 ulcerative colitis

Condition or disease Intervention/treatment Phase
Ulcerative Colitis Inflammatory Bowel Diseases Acute Severe Colitis Drug: Ceftriaxone Drug: Metronidazole Other: Placebo infusion Phase 2

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 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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Antibiotic
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
Drug: Ceftriaxone
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.

Drug: Metronidazole
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




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. Proportion needing second line therapy [ Time Frame: 28 days ]
    Second line therapy : Intravenous Infliximab, Intravenous cyclosporine or others

  2. Proportion needing colectomy [ Time Frame: 28 days ]
    Number of patients in each group needing colectomy

  3. Mortality [ Time Frame: 28 days ]
    Number of patients in having mortality

  4. Duration of hospital stay [ Time Frame: 28 days ]
    Length of hospital stay in each group

  5. Change in serum CRP levels [ Time Frame: 48 hours ]
  6. Change in Mayo disease severity index [ Time Frame: 48 hours ]
  7. 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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   13 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

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


Locations
Layout table for location information
India
Postgraduate Institute of Medical Education and Research
Chandigarh, India, 160012
Sponsors and Collaborators
Postgraduate Institute of Medical Education and Research
Investigators
Layout table for investigator information
Principal Investigator: Vishal Sharma Postgraduate Institute of Medical Education and Research
Principal Investigator: Shubhra Mishra Postgraduate Institute of Medical Education and Research
Publications of Results:
Layout table for additonal information
Responsible Party: Vishal Sharma, Assistant Professor, Postgraduate Institute of Medical Education and Research
ClinicalTrials.gov Identifier: NCT03794765    
Other Study ID Numbers: NK/5147/DM
First Posted: January 7, 2019    Key Record Dates
Last Update Posted: December 11, 2020
Last Verified: December 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Vishal Sharma, Postgraduate Institute of Medical Education and Research:
Antibiotics
Ceftriaxone
Metronidazole
Additional relevant MeSH terms:
Layout table for MeSH terms
Colitis
Colitis, Ulcerative
Inflammatory Bowel Diseases
Ulcer
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Colonic Diseases
Intestinal Diseases
Pathologic Processes
Metronidazole
Ceftriaxone
Anti-Infective Agents
Anti-Bacterial Agents
Antiprotozoal Agents
Antiparasitic Agents