Immune Response of Visceral Leishmaniasis PatientsTreated With Antimonial Plus N-Acetylcysteine

Not Applicable

• Conditions: Visceral Leishmaniasis; Immune Response; Treatment
• Interventions: Drug: Pentavalent antimonial; Drug: N-acetylcysteine

• Registration Number: NCT01138956
• Lead Sponsor: Hospital Universitário Professor Edgard Santos

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 Timeline

• Status Verified: 2010-04
• Study Start: 2010-04
• Study First Submitted: 2010-06-07
• Study First Submitted QC: 2010-06-07
• Last Update Submitted: 2010-06-07
• Study First Posted: 2010-06-08
• Last Update Posted: 2010-06-08
• Primary Completion: 2011-06
• Study Completion: 2011-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 40

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group 2	Pentavalent antimonial	Pentavalent antimonial, 20mg/kg/day, 28 days
Group 1	N-acetylcysteine	Pentavalent antimonial, 20mg/kg/day, 28 days, IV, plus N-acetylcysteine (NAC), effervescent tablets of 600mg, tid, po.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

University Hospital; 🇧🇷 Aracaju, Sergipe, Brazil