ABSTRACT
BACKGROUND: Paromomycin-based topical treatments were shown to be effective in curing cutaneous leishmaniasis (CL) lesions caused by Leishmania major in Tunisia. Cure rates of an index lesion were approximately 80%. As a follow on, we conducted a similar Phase 3 trial in Panama to demonstrate the efficacy of these treatments against New World species. The primary objective was to determine if a combination topical cream (paromomycin-gentamicin) resulted in statistically superior final clinical cure rates of an index lesion compared to a paromomycin alone topical cream for the treatment of CL, primarily caused by Leishmania panamensis. METHODS: We conducted a randomized, double blind, Phase 3 trial of topical creams for the treatment of CL caused by Leishmania spp. Three hundred ninety nine patients with one to ten CL lesions were treated by topical application once daily for 20 days. The primary efficacy endpoint was percentage of subjects with clinical cure of an index lesion confirmed to contain Leishmania with no relapse. RESULTS: The clinical cure of the index lesion for paromomycin-gentamicin was 79% (95% CI; 72 to 84) and for paromomycin alone was 78% (95% CI; 74 to 87) (p = 0.84). The most common adverse events considered related to study cream application were mild to moderate dermatitis, pain, and pruritus. CONCLUSIONS: Superiority of paromomycin-gentamicin was not demonstrated. However, the approximately 80% cure rates for both topical creams were similar to those demonstrated in Tunisia and previously reported with parenteral antimonials.
Subject(s)
Antiprotozoal Agents/administration & dosage , Leishmaniasis, Cutaneous/drug therapy , Paromomycin/administration & dosage , Administration, Topical , Adolescent , Adult , Aged , Child , Child, Preschool , Drug Therapy, Combination , Female , Gentamicins/administration & dosage , Humans , Leishmania major/drug effects , Leishmania major/physiology , Leishmaniasis, Cutaneous/parasitology , Male , Middle Aged , Treatment Outcome , Tunisia , Young AdultABSTRACT
This work developed a simple empirical algorithm to distinguish three Leishmania species using MALDI-TOF mass spectrometry. It suggests that complicated computer algorithms may not always be necessary for clinically useful microbiology applications.
Subject(s)
Leishmania braziliensis/chemistry , Leishmania braziliensis/classification , Leishmaniasis, Cutaneous/parasitology , Microbiological Techniques/methods , Spectrometry, Mass, Matrix-Assisted Laser Desorption-Ionization/methods , Algorithms , HumansSubject(s)
Leishmaniasis/diagnosis , Leishmaniasis/drug therapy , Antiprotozoal Agents/therapeutic use , Central America , HIV Infections/complications , HIV Infections/parasitology , Humans , Leishmaniasis, Cutaneous/diagnosis , Leishmaniasis, Cutaneous/drug therapy , Leishmaniasis, Mucocutaneous/diagnosis , Leishmaniasis, Mucocutaneous/drug therapy , Leishmaniasis, Visceral/diagnosis , Leishmaniasis, Visceral/drug therapy , North America , South AmericaABSTRACT
Baboons develop a syndrome, including eosinophilia and transient fever, after infection with carcariae of Schistosoma mansoni that is consistent with the human syndrome of acute schistosomiasis. Radiotelemetry can be used to follow the course of fever in infected baboons. Individual variations in intensity of disease were noted in baboons. These symptoms and signs were more closely linked to the onset of oviposition by the newly matured worms than they were to the presence of migrating schistosoma or maturing worms. The baboon is concluded to be a suitable and useful model for human acute schistosomiasis mansoni