Oral azithromycin versus its combination with miltefosine for the treatment of experimental Old World cutaneous leishmaniasis.

Leishmaniasis is one of the neglected infectious diseases included in the World Health Organization's list of the top guns of antimicrobial resistance. Miltefosine is the first and the only available oral effective therapy for leishmaniasis. For fear of its potential resistance, identification of alternative, effective and safe drugs is urgently needed. Therefore, in view of azithromycin promising activity against a number of Leishmania species, this work was carried out to evaluate the efficacy of oral azithromycin alone versus its combination with miltefosine against experimental Old World Cutaneous leishmaniasis thus, can provide another alternative oral therapy or for the first time an oral combination therapy for leishmaniasis. The experiment were carried out on Swiss strain albino mice which were treated either with miltefosine for 20 days, Azithromycin for 20 days or both drugs in combination therapy for shorter duration of 10 days. Efficacy of azithromycin mono and combination therapy with miltefosine was evaluated clinically, parasitologically and by examination of the cutaneous lesions by Transmission Electron Microscopy. The current work demonstrated superior activity of oral azithromycin over oral miltefosine in the treatment of experimentally infected mice with Leishmania major (MHOM/IL/81/FEBNI). Unfortunately, oral combination therapy of azithromycin and miltefosine for short duration though, induced dramatic clinical improvement yet, relapse rapidly developed after cessation of therapy. Oral azithromycin could be a promising oral antileishmanial agent. Further research is recommended to investigate its leishmanicidal activity against other Leishmania species thus; another alternative oral therapy for leishmaniasis can be rapidly available.