10 patients with NDMs onychomycosis treated with amphotericin B in 30% DMSO.

10 patients with NDMs onychomycosis treated with 30% DMSO.

Fungal Infection

Onychomycosis

Fungus, Nail

amphotericin B in 30% DMSO was given to patients in active comparators group for continuous 12 weeks.

amphotericin B in 30% DMSO

30% DMSO was given to patients in placebo comparators group for continuous 12 weeks.

30% DMSO

Department of Dermatology Siriraj Hospital

Topical Amphotericin B in 30% Dimethylsulphoxide in Treating of Non-dermatophytes Onychomycosis

Comparison of Effectiveness of Topical Amphotericin B in 30% Dimethylsulphoxide and 30% Dimethylsulphoxide in Treating of Non-dermatophytes Onychomycosis: Randomized Double Blind Controlled Trial Pilot Study

Effectiveness was evaluated by patients who had negative on mycological laboratory (mycological cure) as percentage.

Median time to mycological cure were defined as time (days, months or years) that had negative on mycological laboratory

Clinical cure was defined as the patients had complete clinical improvement or having <10% nail involvement.

Median time to clinical cure were defined as time (days, months or years) that had clinical improvement of the affected nails.

Side effects was assessed by the percentage of patients developed any side effect such as erythema, burning sensation, pain.

Mahidol University

Randomized double blind controlled trial pilot study

Double blind controlled trial between participants, drug preparing team, doctors, investigators, and outcome assessors.

Meglumine antimoniate 20 mg/kg/day for 30 continuous days

Meglumine antimoniate 5 mg/kg/day for up to 120 continuous days according to clinical cure

Mucosal Leishmaniasis

Mucocutaneous Leishmaniasis

Meglumine antimoniate (Aventis, São Paulo, Brazil) is stored and ministered under actual conditions employed by the health services in Brazil. Each patient will be included in one of two treatment groups with meglumine antimoniate IM:
High continuous dose: 20 mg/kg/day for 30 continuous days.
Low continuous dose 5 mg/kg/day for up to 120 continuous days.
There will be no cross-over between the groups for the purpose of this study. The data from those patients who require permanent discontinuation of a scheme will be assessed in the group that were randomized, ie, by intention to treat
Arms: High continuous dose, Low continuous dose

Meglumine antimoniate

Oswaldo Cruz Foundation - IPEC/FIOCRUZ

Low Antimonial Dosage in American Mucosal Leishmaniasis

Phase III Clinical Trial for Mucosal or Mucocutaneous Leishmaniasis. Comparison Between the Standard and Alternative Antimonial Schemes

This study is designed to evaluate the efficacy of high and low doses of meglumine antimoniate in the treatment of mucosal or mucocutaneous leishmaniasis.

This study is designed to evaluate the safety of hig and low doses of meglumine antimoniate in the treatment of mucosal or mucocutaneous leishmaniasis.

ASchubach

Senior Researcher

Oswaldo Cruz Foundation

Rio de Janeiro State Research Supporting Foundation (FAPERJ)

Conselho Nacional de Desenvolvimento Científico e Tecnológico

All consented subjects who meet all inclusion and no exclusion criteria will enter this open label protocol and be treated with 20 mg/kg once daily intravenously with SSG.

All consented subjects who meet all inclusion and no exclusion criteria will enter this open label protocol and be treated with 20 mg/kg once daily intravenously with SSG.
Sodium Stibogluconate (SSG): 100 mg/ml/vial. Treatment for laboratory-confirmed leishmaniasis with SSG 20mg/kg/d intravenously (IV) for 10 days or 20 days for less responsive; visceral leishmaniasis will be treated with SSG 20mg/kg/d IV for 28 days as a second line of therapy for those failing or intolerant of Ambisome; and mucosal leishmaniasis will be treated with SSG 20mg/kg/d IV for 28 days.

SSG 20 mg/kg

Sex: Female, Male

Race (NIH/OMB)

All subjects must be willing to locate to the WRAMC area during treatment

Region of Enrollment

Lesion data - Duration since onset

Lesion data - Number of lesions

The primary safety endpoint is the frequency of complications of therapy

The Primary Safety Endpoint - Frequency of Complications of Therapy

Improvement of lesions for cutaneous leishmanias, resolution of fever and lab abnormalities for visceral leishmaniasis and regression of mucosal lesions for mucocutaneous disease.

Improvement of Lesions, Resolution of Fever and Lab Abnormalities for Visceral Leishmaniasis and Regression of Mucosal Lesions .

Overall Study

Naomi Aronson, MD

Leishmaniasis

100 mg/ml/vial. Treatment for laboratory-confirmed leishmaniasis with SSG 20mg/kg/d intravenously (IV) for 10 days or 20 days for less responsive; visceral leishmaniasis will be treated with SSG 20mg/kg/d IV for 28 days as a second line of therapy for those failing or intolerant of Ambisome; and mucosal leishmaniasis will be treated with SSG 20mg/kg/d IV for 28 days.

Sodium Stibogluconate (SSG)

Walter Reed Army Medical Center

Sodium Stibogluconate Treatment of Leishmaniasis

U.S. Army Medical Research and Development Command

All consented subjects who meet all inclusion and no exclusion criteria will enter this open label protocol and be treated with Sodium Stibogluconate (SSG).

All consented subjects who meet all inclusion and no exclusion criteria will enter this open label protocol and be treated with Sodium Stibogluconate (SSG).
Sodium Stibogluconate (SSG): 100 mg/ml/vial. Treatment for laboratory-confirmed leishmaniasis with SSG 20mg/kg/d intravenously (IV) for 10 days or 20 days; visceral leishmaniasis will be treated with SSG 20mg/kg/d IV for 28 days as a second line of therapy for those failing or intolerant of Ambisome; and mucosal leishmaniasis will be treated with SSG 20mg/kg/d IV for 28 days.

Due to low enrollment the protocol was amended to remove efficacy objective and only collect safety data for subjects. No data entry or statistical analyses of patient data including age data was conducted.

Age, Customized

Due to low enrollment the protocol was amended to remove efficacy objective and only collect safety data for subjects. No data entry or statistical analyses of patient data including gender data was conducted.

Sex/Gender, Customized

Race and Ethnicity Not Collected

The safety of Pentostam (SSG) treatment was evaluated through the daily assessment of AEs during treatment. Additionally, clinical laboratory tests including serum chemistry (glucose, electrolytes, blood urea nitrogen [BUN], creatinine, alanine aminotransferase [ALT], aspartate aminotransferase [AST], total bilirubin, alkaline phosphatase [ALK], amylase, and lipase) and hematology (hemoglobin, hematocrit, platelets, and white blood cells with differential); vital signs measurements; electrocardiograms (ECGs); and physical examinations were performed at screening and prior to Pentostam infusion on Days (± 2) 5, 10, 15, 20, 25, and 28 (Days 25 and 28 for patients with visceral or mucocutaneous leishmaniasis only). At the completion of Pentostam treatment, patients were encouraged to arrange follow-up at 2, 6, and 12 months after treatment; however, follow-up was not required.

Treatment Only

Number of Participants That Discontinued Due to Adverse Experience, by Type of Adverse Experience

Number of Participants Experiencing Serious or Unexpected Adverse Events, by Type of Serious or Unexpected Adverse Events

Roseanne A. Resnner, MD

100 mg/ml/vial. Treatment for laboratory-confirmed leishmaniasis with SSG 20mg/kg/d intravenously (IV) for 10 days or 20 days; visceral leishmaniasis will be treated with SSG 20mg/kg/d IV for 28 days as a second line of therapy for those failing or intolerant of Ambisome; and mucosal leishmaniasis will be treated with SSG 20mg/kg/d IV for 28 days.

Walter Reed National Military Medical Center

Use of Sodium Stibogluconate as a Treatment for Leishmaniasis

Department of Defense Protocol for the Use of Sodium Stibogluconate (Pentostam) as a Treatment for Leishmaniasis

Miltefosine 2.5 mg/Kg/day with a maximum dose of 150 mg PO day.

Glucantime® 20 mg /Kg /day for 20 days (intramuscular)

One session of local heat using a thermotherapy device at 50 celsius degrees during 30 seconds.

Miltefosine

Glucantime®

Thermotherapy

Total

Complete Clinical response: Initial cure plus the absence of recurrences or mucosal lesions for 6 months after the end of treatment.
Note: nitial cure: Complete re-epithelialization of all ulcers and complete disappearance of the induration up to 3 months after the end of treatment.

Complete Clinical Response

Reactivation of the lesion at the original site after cure or mucosal compromise during follow-up.

Recurrence

At least 50% increase in lesion size at the end of treatment, absence of clinical response at 6 weeks, or any sign of lesion activity 3 months after the end of treatment

leishmaniasis/headache

Topical Amphotericin B in 30% Dimethylsulphoxide in Treating of Non-dermatophytes Onychomycosis

Low Antimonial Dosage in American Mucosal Leishmaniasis

Sodium Stibogluconate Treatment of Leishmaniasis

Use of Sodium Stibogluconate as a Treatment for Leishmaniasis

Efficacy and Safety of Miltefosine or Thermotherapy for Cutaneous Leishmaniasis in Colombia.

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