Treatment of Mucosal Bolivian Leishmaniasis

Browse trials for

• Leishmaniasis 185

Study arms

• Active comparator
  Group 1: Oral Miltefosine

  Miltefosine will be administered per os at 150 mg/day \[50 mg tid\] for 28 days. This is the standard regimen of miltefosine for persons \>45 kg.

  Drug: Group 1: Miltefosine

• Active comparator
  Group 2: Intravenous pentavalent antimony

  IV pentavalent antimony (meglumine antimoniate) will be administrated at 20 mg x kg x d during 20 consecutive days. Antimony will be diluted in 10 times its volume in 5%Dextrose in destilled water and injected IV in 20 minutes

  Drug: Group 2: Pentavalent Antimony

• Experimental
  Group 3: Intravenous liposomal amphotericin B

  LAMB will be administered IV at 3 ampules \[150 mg\] on each of days 1, 3, 5, 7, 9, 11, 13, 15, 17, 19, 21, 23, 25, and 27. Three ampules is the individual dose suggested by Aronson et al \[2016\] and equals 2.5 mg/kg/dose for a 60 kg person. 15 doses of 3 ampules (total of 2250 mg) equals 37.5 mg/kg for a 60 kg person.

  Drug: Group 3: Liposomal amphotericin B

Interventions

• DrugGroup 1: Miltefosine

  Miltefosine 50 mg pill will be administered po every 8 hours with food, during 28 days

• DrugGroup 2: Pentavalent Antimony

  will be administered by IV infusion diluted in 150 ml of DWD5% over 20 minutes

• DrugGroup 3: Liposomal amphotericin B

  3 amps (150 mg) will be administered by IV infusion iver 2 hours every other day for a total of 15 doses.

Primary outcomes

1. Healing of mucosal lesions

   The primary purpose is to perform a controlled evaluation of the cure rate of miltefosine, LAMB, and Sb for L braziliensis ML in Bolivia. Using a standarized scale we'll qualify from 0 (absent) to 3 (severe) the following items: erythema, edema/swelling, infiltration, erosion/ulceration, in five different places: nasal and perinasal skin, nasal mucosa, palate and oral mucosa, pharynx and larynx. Additionally, changes in voice quality will be registered. 63 will be the maximun score and means severe and massive compromise. clinical cure: \>90% loss of presenting severity score clinical improvement: 50%-90% loss of presenting severity score no clinical change: 25% worsening to 49% improvement in presenting severity score clinically worse: \>25% worsening of presenting score or relapse after initial improvement

   Time frame: Baseline to 12 month follow up

Secondary outcomes

1. Clinical and laboratory safety of these 3 drugs

   The secondary purpose is to determine the tolerance of these regimens. Descriptive statistics will be used to present adverse event data. Continuous variables will be presented as number of observations (n), mean, standard deviation (SD), median, minimum and maximum values. Categorical variables will be presented as counts and percentages. Adverse effects will be compared between groups by appropriate statistics. During treatment administration clinical symptoms (nausea/vomit/abdominal pain; myalgias/arthralgias; headache/dizziness) and laboratory (AST, alkaline phosphatase, lipase, creatinine, CBC) and EKG (in patients receiving antomony) will be evaluated.

   Time frame: Base line to 1 month after the end of therapy