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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.
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1 | Experimental | Pentavalent antimonial, 20mg/kg/day, 28 days, IV, plus N-acetylcysteine (NAC), effervescent tablets of 600mg, tid, po. |
|
| Group 2 | Active Comparator | Pentavalent antimonial, 20mg/kg/day, 28 days |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| N-acetylcysteine | Drug | N-acetylcysteine (NAC), effervescent tablets of 600mg, tid, po, 28 days |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Patient recovery from the visceral leishmaniasis after treatment | 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. | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Immune response of visceral leishmaniasis patients after proposed treatment | 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. | one year |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Roque P Almeida, MD, PhD | Contact | 5579-21051806 | roquepacheco@uol.com.br | |
| Enaldo V Melo, MD | Contact | 5579-21051700 | evm.estatistica@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Roque P Almeida, MD, PhD | Hospital Universitário | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital | Recruiting | Aracaju | Sergipe | 49060-100 | Brazil |
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| ID | Term |
|---|---|
| D007898 | Leishmaniasis, Visceral |
| ID | Term |
|---|---|
| D007896 | Leishmaniasis |
| D056986 | Euglenozoa Infections |
| D011528 | Protozoan Infections |
| D010272 | Parasitic Diseases |
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| ID | Term |
|---|---|
| D000111 | Acetylcysteine |
| ID | Term |
|---|---|
| D003545 | Cysteine |
| D000603 | Amino Acids, Sulfur |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
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| Pentavalent antimonial |
| Drug |
Pentavalent antimonial, 20mg/kg/day, 28 days, IV |
|
| D007239 |
| Infections |
| D000079426 | Vector Borne Diseases |
| D000596 |
| Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |