Study for Evaluation of the Immune Response of Visceral Leishmaniasis Patients Treated With Antimonial Pentavalent Associated to N-Acetylcysteine
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Enrollment
- 40
- Locations
- 1
- Primary Endpoint
- Patient recovery from the visceral leishmaniasis after treatment
Study Overview
Brief Summary
This study is designed to evaluate the immune and therapeutic responses of visceral leishmaniasis patients using N-acetylcysteine (NAC) as an adjuvant therapy to pentavalent antimony.
Detailed Description
In this study we intend to evaluate the immune and therapeutic responses of patients with visceral leishmaniasis N-acetylcysteine (NAC) as an adjuvant to standard treatment with pentavalent antimony, compared to treatment with antimonial only through a blind randomized clinical trial. Our hypothesis is that patients treated with NAC associated with pentavalent atimonial have a rapid changing of the immune responses, towards TH1, and clinical improvement when compared to patients who will use only the standard treatment
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Basic Science
- Masking
- Single (Investigator)
Eligibility Criteria
- Ages
- 2 Years to 50 Years (Child, Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Age 2 to 50 years
- •Diagnosis of visceral leishmaniasis
Exclusion Criteria
- •Other acute or chronic diseases
- •Use of immunosuppressive drugs
- •History of allergy to NAC and/or pentavalent antimony
Arms & Interventions
Group 1
Pentavalent antimonial, 20mg/kg/day, 28 days, IV, plus N-acetylcysteine (NAC), effervescent tablets of 600mg, tid, po.
Intervention: N-acetylcysteine (Drug)
Group 2
Pentavalent antimonial, 20mg/kg/day, 28 days
Intervention: Pentavalent antimonial (Drug)
Outcomes
Primary Outcomes
Patient recovery from the visceral leishmaniasis after treatment
Time Frame: 6 months
The cure is defined in the patient with reduced spleen and liver. Absence of fever for more than 15 days after treatment, weight gain, normalization of globulins and resolution of leukopenia and anemia.
Secondary Outcomes
- Immune response of visceral leishmaniasis patients after proposed treatment(one year)