03134nas a2200361   4500000000100000008004100001260001300042653003000055653001100085653001100096653001000107653002300117653001200140653000900152653002500161653002200186653003000208653001400238653004200252653003200294653002200326100002000348700002000368700001000388700001400398245007900412856005900491300002900550490001300579050003200592520213400624022001402758       2000                            d  c2000 Dec10aDrug Therapy, Combination10aFemale10aHumans10aIndia10aLeprostatic Agents10aleprosy10aMale10aMycobacterium leprae10aPatient Selection10aPredictive Value of Tests10aPrognosis10aRandomized Controlled Trials as Topic10aSensitivity and Specificity10aTreatment Outcome1 aVijayakumaran P1 aKrishnamurthy P1 aRao P1 aDeclerq E00aChemoprophylaxis against leprosy: expectations and methodology of a trial.  uhttp://leprev.ilsl.br/pdfs/2000/v71s1/pdf/v71s1a08.pdf  aS37-40; discussion S40-10 v71 Suppl  aInfolep Library - available3 a<p>Because of the great efficacy of multidrug therapy (MDT), it had been hoped that the widespread use of MDT would bring about a rapid decrease of the incidence of leprosy. To the present, a decrease of incidence has not been observed, possibly because of the long incubation period of the disease, and because general implementation of MDT is still recent. Other reasons, such as environmental sources of infection or the role of healthy carriers in transmitting Mycobacterium leprae, cannot be excluded. Therefore, one must seek alternative or supplementary strategies, such as chemoprophylaxis. Household contacts of leprosy patients are at greater risk of developing leprosy than is the general population. Therefore, a randomized, controlled trial of chemoprophylaxis, using a single 10 mg/kg dose of rifampicin, or a placebo, is planned in nine projects in India, among the household contacts of newly detected leprosy patients. Based upon assumptions of a protective efficacy of the chemoprophylaxis of 50%, an annual incidence of 2 per 1000 contacts, a desired power of the study of 90%, and a level of significance of 95%, 15,000 household contacts will be allocated randomly by household to each arm of the study, and followed for 5 years. Considered as household contacts will be all persons living in the same household as an index case and sharing the same kitchen. Pregnant women and infants will be excluded. To be certain that transmission of the organisms from the index case cannot occur once the prophylaxis is administered, rifampicin will be administered 2 months after diagnosis of the index case. Diagnosis of leprosy will be clinical, and confirmed independently. Although household contacts usually constitute only a small proportion of the new patients detected in a control programme, their high-risk status makes them particularly appropriate for a study of the potential effect of chemoprophylaxis. Following the trial, one could evaluate the usefulness and feasibility of using the same strategy in other population-groups, based on the number of persons necessary to treat to prevent one case.</p>  a0305-7518