Immune Response, Treatment, Visceral Leishmaniasis
Conditions
Keywords
Visceral leishmaniasis, N-acetylcysteine, Antimony, Immune response
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
Interventions
DRUGN-acetylcysteine
N-acetylcysteine (NAC), effervescent tablets of 600mg, tid, po, 28 days
DRUGPentavalent antimonial
Pentavalent antimonial, 20mg/kg/day, 28 days, IV
Sponsors
Hospital Universitário Professor Edgard Santos
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
ALL
Age
2 Years to 50 Years
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 * AIDS * History of allergy to NAC and/or pentavalent antimony
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Patient recovery from the visceral leishmaniasis after treatment | 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
| Measure | Time frame | Description |
|---|---|---|
| Immune response of visceral leishmaniasis patients after proposed treatment | one year | Evaluation of the Immune response: peripheral blood mononuclear cells of patients are being obtained in ficoll-Hypaque gradient and stimulated in vitro with soluble antigen of L. chagasi to evaluate the production of cytokines (IFN-g, TNF-a. IL-10, TGF-b) before treatment, 15, 45, 180 and 360 days afterwards. |
Countries
Brazil
Contacts
Primary ContactRoque P Almeida, MD, PhD
Backup ContactEnaldo V Melo, MD
Outcome results
None listed