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Thursday, October 24, 2019

FW: (LML) COLEP and MALTALEP trials

 

 

Leprosy Mailing List – October 24,  2019

Ref.:  (LML) COLEP and MALTALEP trials

From:  Pieter AM Schreuder


Dear colleagues,

 

It seems to be necessary to point out again that LML is an open forum and anyone, also those not directly involved in research settings, may offer his/her weighted opinion, based on sound argumentation (if possible backed up by references from articles published in well-known journals, but own, well-argued experiences and opinions are very much welcome).  All voices should be heard, from patients and patient organisations, fieldworkers, supervisors and state coordinators, leprosy clinics and hospitals, universities, research projects, NGOs, leprosy workers still active or retired, to those  in Geneva and New Delhi.


The main objective of the LML is to share information on the disease Leprosy and its control with e-mail and Internet users around the world. Like is stated on internet: Leprosy Mailing List is a free moderated email list that allows all persons interested in this theme to share ideas, information, experiences, questions.


We are very unhappy with finger pointing as happened a few times the past weeks. How strongly one disagrees with somebody's writings, keep to arguments and do not let one to be distracted by feelings of misrepresentations. We may assume that the 'truth' will come out eventually (at least in the scientific world; in politics we start doubting that).

 

It is not always easy to keep up with all kind of trials and its abbreviations. SDR (single dose rifampicin) and PEP (post-exposure prophylaxis). Therefore, we would like to point out the differences between the COLEP (contacts of leprosy patients) and MALTALEP (Order of Malta-Grants-for-Leprosy-Research, and many other foundations and associations supporting this research project). For a good understanding: COLEP only administered SDR to contacts of leprosy patients (no BCG involved!); MALTALEP compared the effect of BCG vaccination followed by SDR to BCG vaccination alone):

 

1.    The COLEP trial was a very large Randomized Controlled Trial (RCT) demonstrating the effect of Single Dose Rifampicin (SDR) as post-exposure prophylaxis for contacts of leprosy patients (Three common misinterpretations of the COLEP trial. JH Richardus and WC Smith. Lepr Rev (2018) 89, 173-175. See annex).

 

2.    The MALTALEP trial compared the efficacy of bacillus Calmette–Guérin (BCG) vaccination  followed by single dose rifampicin (SDR) with BCG vaccination alone in preventing leprosy in household contacts and next-door neighbours of newly diagnosed leprosy patients in Bangladesh (Effectiveness of single-dose rifampicin after BCG vaccination to prevent leprosy in close contacts of patients with newly diagnosed leprosy: A cluster randomized controlled trial. Renate Richardus et al. International Journal of Infectious Diseases 88 (2019) 65-72. See annex).

 

As one may remember, the BCG trials of the past had different outcomes in different parts of the world. In India something like 25%, in Malawi 50%, etc. It is well-known (but not well understood) that contact with environmental bacteria may affect the effect of BCG. One may assume that this different efficacy of BCG vaccination may influence the outcome of BCG PEP in different parts of the world. It is also known that BCG vaccination of contacts after index case diagnosis may increased the adjusted rate of developing clinical manifestations of leprosy temporarily (PLoS Negl Trop Dis. 2012;6(6):e1711. doi: 0.1371/journal.pntd.0001711. Epub 2012 Jun 19).

 

Regards,

 

Pieter AM Schreuder

Editor LML


LML - S Deepak, B Naafs, S Noto and P Schreuder

LML blog link: http://leprosymailinglist.blogspot.it/

Contact: Dr Pieter Schreuder << editorlml@gmail.com

 

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