Please select the eligibility criteria that correspond to the clinical trial below.
Title: Empiric Antihelminthic Therapy Combined With Antimony in the Treatment of Cutaneous Leishmaniasis: A Randomized Controlled Trial in Subjects Co-Infected With Helminths and Leishmania Brasiliensis
Brief Summary: The purpose of this project is to investigate the efficacy of early, empiric anti-helminthic therapy combined with standard pentavalent antimony in the treatment of subjects co-infected with helminths and cutaneous leishmaniasis caused by L. brasiliensis. The study hypothesis is that early intervention with antihelminthic therapy will improve response rates to antimony in subjects with cutaneous leishmaniasis.


Options:
A: 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
B: Inclusion Criteria:

* Subject with a confirmed infection due to L. braziliensis by polymerase chain reaction assay
* Subject has a lesion that satisfies the following criteria:
* ulcerative in character
* ulcer size equal or more than 0.5 cm and 3 cm (Longest diameter)
* not located on the ear, face, close to mucosal membranes, joints or on a location that in the opinion of the PI is difficult to maintain application of study drug topically.
* Subject with up to 3 lesions.
* Duration of lesion less than 3 months by patient history
* Subject able to give written informed consent and that the opinion of the investigator, the subject is capable of understanding and complying with the protocol

Exclusion Criteria:

* Female with a positive serum pregnancy test at screening or who is breast feeding, lactating or female at fertile age who does not agree to take appropriate contraception during treatment period up to Day 45.
* History of clinically significant medical problems or treatment that might interact, either negatively or positively, with topical treatment of leishmaniasis including any immunocompromising condition.
* Within 8 weeks (56 days) of starting study treatments, received treatment for leishmaniasis with any medication including antimonials likely, in the opinion of the PI, to modify the course of the Leishmania infection
* Has diagnosis or suspected diagnosis of mucocutaneous leishmaniasis based on physical exam.
* History of known or suspected hypersensitivity or idiosyncratic reactions to amphotericin
* Has laboratory values at screening as follow: Haemoglobin below 10 grams, Serum creatinine above normal level, alanine aminotransferase and or aspartate aminotransferase 3 times above normal range
C: Eligibility Criteria.

Inclusion criteria:

1. Cutaneous leishmaniasis with parasitological diagnosis by one or more of the following methods: direct examination (scraping or imprint), histopathology, culture, immunohistochemistry, or PCR.
2. History of exposure in an endemic area of Rio de Janeiro
3. Absence of prior treatment with meglumine antimoniate

Exclusion criteria:

1. women who do not use contraceptives or do it inadequately
2. pregnant
3. under 13
4. prior treatment with meglumine antimoniate
5. use of immunosuppressive therapy (steroids, cancer chemotherapy) or medicines for tuberculosis or leprosy.
6. presence of changes in baseline clinical adverse effect level equivalent to\> G3
7. presence of changes in baseline laboratory adverse effect level equivalent to\> G2
8. presence of baseline electrocardiographic changes equivalent to an adverse effect level\> G4 and / or baseline QTc\> 0.46 ms (equivalent to AS level G1).
D: Inclusion Criteria:

* Men and women between 18 and 50 years old
* Cutaneous ulcers of more than two weeks of evolution
* Positive parasitological diagnosis for CL
* Patients that voluntarily agree to participate in the study and sign the informed consent.
* Disposition to attend all the visits punctually (initial, treatment and follow-up)
* Acceptation of not using any other treatment for CL while in the study

Exclusion Criteria:

* Pregnant women
* Presence of any condition or disease that compromises the patient immunologically (i.e. diabetes, cancer, etc.) or, any other, that, based on the judgment of the researcher, could alter the course of CL.
* Diffuse CL or more than five active lesions.
* Mucocutaneous leishmaniasis (no lesion must be located less than 2 cm from the nasal, uro-genital, and/or anal mucous membranes or from the edge of the lips).
* Visceral leishmaniasis
* Complete or incomplete treatment with antimony compounds in the last three months.
* Patients with history of hepatic, renal or cardiovascular disease.
* Mentally or neurologically disabled patients that are considered not fit to approve their participation in the study.

Answer: A