NCT03794765

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Apr 2019

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 4, 2019

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 7, 2019

Completed
3 months until next milestone

Study Start

First participant enrolled

April 1, 2019

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 4, 2020

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

April 4, 2020

Completed
Last Updated

December 11, 2020

Status Verified

December 1, 2020

Enrollment Period

11 months

First QC Date

January 4, 2019

Last Update Submit

December 9, 2020

Conditions

Ulcerative ColitisInflammatory Bowel DiseasesAcute Severe Colitis

Keywords

AntibioticsCeftriaxoneMetronidazole

Outcome Measures

Primary Outcomes (1)

  • Clinical response as defined by the Oxford's criteria

    Patients will be defined as complete responders, partial responders or non-responders

    48 hours

Secondary Outcomes (7)

  • Proportion needing second line therapy

    28 days

  • Proportion needing colectomy

    28 days

  • Mortality

    28 days

  • Duration of hospital stay

    28 days

  • Change in serum CRP levels

    48 hours

  • +2 more secondary outcomes

Study Arms (2)

Antibiotic

EXPERIMENTAL

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: CeftriaxoneDrug: Metronidazole

Placebo

PLACEBO COMPARATOR

Standard of care (steroids, prophylactic anticoagulation, oral nutrition) And Placebo infusions similar to the active drugs

Other: Placebo infusion

Interventions

CeftriaxoneDRUG

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.

Antibiotic
MetronidazoleDRUG

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

Antibiotic
Placebo infusionOTHER

Similar placebo infusion

Placebo

Eligibility Criteria

Age13 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Acute severe ulcerative colitis as described in European Crohn's and Colitis Organisation (ECCO) guidelines (adapted from Truelove and Witts)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Postgraduate Institute of Medical Education and Research

Chandigarh, 160012, India

Location

Related Publications (1)

  • Mishra S, Mandavdhare HS, Singh H, Choudhury A, Shah J, Ram S, Kalsi D, Samanta J, Prasad KK, Sharma AK, Dutta U, Sharma V. Adjuvant use of combination of antibiotics in acute severe ulcerative colitis: A placebo controlled randomized trial. Expert Rev Anti Infect Ther. 2021 Jul;19(7):949-955. doi: 10.1080/14787210.2021.1856656. Epub 2020 Dec 14.

    PMID: 33245002RESULT

MeSH Terms

Conditions

Colitis, UlcerativeInflammatory Bowel Diseases

Interventions

CeftriaxoneMetronidazole

Condition Hierarchy (Ancestors)

ColitisGastroenteritisGastrointestinal DiseasesDigestive System DiseasesColonic DiseasesIntestinal Diseases

Intervention Hierarchy (Ancestors)

CefotaximeCephacetrileCephalosporinsbeta-LactamsLactamsAmidesOrganic ChemicalsThiazinesSulfur CompoundsHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsNitroimidazolesNitro CompoundsImidazolesAzolesHeterocyclic Compounds, 1-Ring

Study Officials

  • Vishal Sharma

    Post Graduate Institute of Medical Education and Research, Chandigarh

    PRINCIPAL INVESTIGATOR

  • Shubhra Mishra

    Post Graduate Institute of Medical Education and Research, Chandigarh

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

January 4, 2019

First Posted

January 7, 2019

Study Start

April 1, 2019

Primary Completion

March 4, 2020

Study Completion

April 4, 2020

Last Updated

December 11, 2020

Record last verified: 2020-12

Locations

IN(1)