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:

* Usual resident of study community or student enrolled in study school;
* Willingness of adult aged 18 years and above or parent/guardian to provide written informed consent;
* Provision of written assent to participate from children aged 8 years and above.

Exclusion Criteria:

* Visitor to household at time of household visits;
* Refusal of informed consent;
* Refusal to assent by children aged 8 years and above.
C: Inclusion Criteria:

* children attending any one of the participating study health centres for their routine 12-month growth and development visit
* children living in or near the study area

Exclusion Criteria:

* children who are attending the clinic for suspected STH infection
* children who have received deworming treatment in the six months prior to randomization
* parents planning to move outside of the study area within the next 12 months
* children under 12 months of age or 14 months of age or older
* children with serious congenital or chronic medical conditions and who would be considered by the attending staff not to benefit from deworming
D: Inclusion Criteria:

* Participants must not be or have been on highly active antiretroviral therapy.
* Participants must have CD4 count \> 350 cells/mm3 in order to be enrolled in the randomized controlled trial.
* Participants must be at least 18 years of age.
* Participants must be able and willing to participate and give written informed consent.
* Participants must be able and willing to return for the scheduled follow-up visits.

Exclusion Criteria:

• Participants must not be pregnant at the time of enrollment (by urine HCG testing).

Answer: A