Does additional clofazimine for MB cases at high risk of ENL improve their prognosis/outcome over 2 years?

eprosy Research Initiative0 sites0 target enrollmentStarted: TBDLast updated: November 24, 2021

Trial Snapshot

No summary available.

•1) Smear positives cases, i.e. smear positive at diagnosis within 24 months of starting Multibacillary Multidrug Therapy (MBMDT)(as new case, returned defaulter or relapse), i.e. on 12 m fixed duration MBMDT or within 12m of completion of 12m Fixed Duration (FDMBMDT) or on 24m FDMBMDT.
•2) People who have or previously had ENL, ENL as defined in ENLIST publications, at any time in past, confirmed by Doctor (physical exam or clinic records), or currently.
•3) 1st episode of ENL or recurrent episode (after interval without treatment of >27 days), i.e. exclude chronic ENL (symptoms of ENL and /or treatment for ENL for 24 weeks or more without any interval of >27days)
•4) over 18 years old up to 60 years
•5)minimum weight 40 kg or BMI >18.5

•1)Type 1 reaction, i.e. currently (may occur in BB, BL cases) A past history of type one reaction already fully treated and resolved would not exclude case.
•2)Cannot understand about study or lives too far away to attend regularly for follow up, i.e. unable to give truly informed voluntary consent or to cooperate with all assessments
•3) Chronic bowel disorder, (e.g. chronic amebic dysentery, ulcerative colitis, irritable bowel syndrome, suspected intestinal TB, malabsorption syndrome etc).
•4) Other serious illness likely to interfere with safety or compliance, e.g. HIV, chronic moderate/severe renal impairment, Tb, cancer, uncontrolled type 1 diabetes.
•5) Serious adverse effects of steroids in past such as standard regimen in field would not be safe (e.g. GI haemorrhage, glaucoma, steroid-induced psychosis)

Sponsor

eprosy Research Initiative