Please select the eligibility criteria that correspond to the clinical trial below.
Title: Efficacy and Safety of Single, Double and Triple Dose Pentamidine (7mg/kg) for Patients With Cutaneous Leishmaniasis Caused by L. Guyanensis: a Pilot Study
Brief Summary: Introduction: Up to the present, have been few studies with pentamidine in the Americas; and there is no consensus regarding the dose used.

Objectives: To evaluate the use of pentamidine in single dose, double and triplo in the treatment of cutaneous leishmaniasis.

Methods: Clinical trial of phase II pilot study with 159 patients. Pentamidine will be used at a dose of 7 mg/kg, in three arms: single dose, double dose and triple dose. They will be also assessed the safety and adverse effects. The sic will be reviewed one, two and six months after the end of the treatments.


Options:
A: Inclusion Criteria:

* Patients with mucosal leishmaniasis confirmed by a positive smear, in vitro culture or PCR test

Exclusion Criteria:

* Mucosal leishmaniasis must not involve the vocal cords or cause respiratory distress, and there must be no evidence of other disease.
B: Inclusion Criteria:

* Gender: Male or female
* Age: \>12 yrs of age
* Presentation: 1-to-2 ulcerative lesions, each \< 30 mm in largest diameter and with a total lesion area \<900 mm2.
* Parasitology: Parasitological confirmation of the lesion will be made by visualization or culture of Leishmania from the biopsy or aspirate of the lesion.

Exclusion Criteria:

* Previous treatment for leishmaniasis with Sb, pentamidine, amphotericin B, miltefosine, imidazoles, allopurinol in the last 3 months.
* Other diseases that would be likely in the PI's opinion to interact, either positively or negatively, with treatment.
C: Inclusion Criteria:

* Newly diagnosed cutaneous leishmaniasis (untreated) with localized lesions ( without maximum 6 injuries ) and Direct Examination positive : amastigotes display in tissue samples ;
* Age: 16-64 years;
* Sex: male and female patients to eligible ;
* Disease Clinical Evolution not longer than 3 months .

Exclusion Criteria:

* AST \> 3 times the upper limit of normal;
* ALT \> 3 times the upper limit of normal;
* Alkaline phosphatase \> 3 times the upper limit of normal;
* Serum creatinine and urea \> 1.5 times the upper limit of normality;
* Blood glucose above 110 mg / dl;
* Evidence of serious underlying disease ( heart , kidney , liver or lung);
* protein and / or caloric severe malnutrition;
* Any uncompensated or uncontrolled condition like active tuberculosis, malignant disease , severe malaria , HIV, leprosy , systemic fungal disease (histoplasmosis, paracoccidioidomycosis) or any other infectious disease;
* Pregnant women or who are breastfeeding;
* Lack of ability or willingness to provide informed consent (patient and / or parent / legal representative); lack of availability for the visits or to comply with study procedures.
D: Inclusion Criteria:

* Subjects with a diagnosis of CL based on the presence of typical skin lesions and a positive Montenegro skin test
* Evidence of helminthic infection by parasitological examination of first stool sample
* Males or females between 13 and 50 years of age
* Maximum of 3 ulcers with no more than 2 body regions involved
* Period of 15 to 60 days from the onset of the first ulcer
* Subject agreement to follow-up visits and therapy
* Ability to give informed consent

Exclusion Criteria:

* Pregnancy
* Breastfeeding mothers
* Presence of mucosal disease
* History of prior treatment with antimonial drugs.
* History of prior treatment with anthelminthic drugs within the last 6 months.
* History of allergy to pentavalent antimony or antihelminthic
* Presence of underlying disease which affects the immune response, such as HIV and diabetes mellitus

Answer: C