Antibiotics as an Adjuvant in Patients With Acute Severe Ulcerative Colitis

Phase 2 Completed 50 enrolled Post Graduate Institute of Medical Education and Research, Chandigarh

RandomizedParallel-groupTriple-blindTreatment

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

Timeline

Start: 2019-04-01
Primary completion: 2020-03-04
Completion: 2020-04-04

Outcome

Missed primary endpoint

paper Complete response on day three was attained by 7 (28%) in the antibiotic and 6 (24%) standard of care group (p = 1.00). PMID 33245002 ↗

Publications

Results 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.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Ceftriaxone	Other / unclassified	1 g	Intravenous
Subject	Metronidazole	Small molecule	500 mg	Intravenous