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

Primary Purpose

Visceral Leishmaniasis, Immune Response, Treatment

Status
Unknown status
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
N-acetylcysteine
Pentavalent antimonial
Sponsored by
Hospital Universitário Professor Edgard Santos
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Visceral Leishmaniasis focused on measuring Visceral leishmaniasis, N-acetylcysteine, Antimony, Immune response

Eligibility Criteria

2 Years - 50 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Group 1

Group 2

Arm Description

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

Pentavalent antimonial, 20mg/kg/day, 28 days

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Full Information

First Posted
June 7, 2010
Last Updated
June 7, 2010
Sponsor
Hospital Universitário Professor Edgard Santos
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1. Study Identification

Unique Protocol Identification Number
NCT01138956
Brief Title
Immune Response of Visceral Leishmaniasis PatientsTreated With Antimonial Plus N-Acetylcysteine
Acronym
VLNAC
Official Title
Study for Evaluation of the Immune Response of Visceral Leishmaniasis Patients Treated With Antimonial Pentavalent Associated to N-Acetylcysteine
Study Type
Interventional

2. Study Status

Record Verification Date
April 2010
Overall Recruitment Status
Unknown status
Study Start Date
April 2010 (undefined)
Primary Completion Date
June 2011 (Anticipated)
Study Completion Date
December 2011 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
Hospital Universitário Professor Edgard Santos

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Visceral Leishmaniasis, Immune Response, Treatment
Keywords
Visceral leishmaniasis, N-acetylcysteine, Antimony, Immune response

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Group 1
Arm Type
Experimental
Arm Description
Pentavalent antimonial, 20mg/kg/day, 28 days, IV, plus N-acetylcysteine (NAC), effervescent tablets of 600mg, tid, po.
Arm Title
Group 2
Arm Type
Active Comparator
Arm Description
Pentavalent antimonial, 20mg/kg/day, 28 days
Intervention Type
Drug
Intervention Name(s)
N-acetylcysteine
Intervention Description
N-acetylcysteine (NAC), effervescent tablets of 600mg, tid, po, 28 days
Intervention Type
Drug
Intervention Name(s)
Pentavalent antimonial
Intervention Description
Pentavalent antimonial, 20mg/kg/day, 28 days, IV
Primary Outcome Measure Information:
Title
Patient recovery from the visceral leishmaniasis after treatment
Description
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.
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Immune response of visceral leishmaniasis patients after proposed treatment
Description
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.
Time Frame
one year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
2 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Roque P Almeida, MD, PhD
Phone
5579-21051806
Email
roquepacheco@uol.com.br
First Name & Middle Initial & Last Name or Official Title & Degree
Enaldo V Melo, MD
Phone
5579-21051700
Email
evm.estatistica@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Roque P Almeida, MD, PhD
Organizational Affiliation
Hospital Universitário
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital
City
Aracaju
State/Province
Sergipe
ZIP/Postal Code
49060-100
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Roque P Almeida, MD, PhD
Phone
5579-21051806
Email
roquepacheco@uol.com.br
First Name & Middle Initial & Last Name & Degree
Enaldo V Melo, MD
Phone
5579-21051700
Email
evm.estatistica@gmail.com
First Name & Middle Initial & Last Name & Degree
Angela M Silva, MD,PhD

12. IPD Sharing Statement

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

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