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

NCT ID: NCT01138956

Last Updated: 2010-06-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-04-30

Study Completion Date

2011-12-31

Brief Summary

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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.

Detailed Description

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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

Conditions

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Visceral Leishmaniasis Immune Response Treatment

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

SINGLE

Investigators

Study Groups

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Group 1

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

Group Type EXPERIMENTAL

N-acetylcysteine

Intervention Type DRUG

N-acetylcysteine (NAC), effervescent tablets of 600mg, tid, po, 28 days

Group 2

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

Group Type ACTIVE_COMPARATOR

Pentavalent antimonial

Intervention Type DRUG

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

Interventions

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N-acetylcysteine

N-acetylcysteine (NAC), effervescent tablets of 600mg, tid, po, 28 days

Intervention Type DRUG

Pentavalent antimonial

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

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

2 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hospital Universitário Professor Edgard Santos

OTHER

Sponsor Role lead

Responsible Party

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Universidade Federal de Sergipe

Principal Investigators

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Roque P Almeida, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Hospital Universitário

Locations

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University Hospital

Aracaju, Sergipe, Brazil

Site Status RECRUITING

Countries

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Brazil

Central Contacts

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Roque P Almeida, MD, PhD

Role: CONTACT

5579-21051806

Enaldo V Melo, MD

Role: CONTACT

5579-21051700

Facility Contacts

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Roque P Almeida, MD, PhD

Role: primary

5579-21051806

Enaldo V Melo, MD

Role: backup

5579-21051700

Other Identifiers

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VLNAC

Identifier Type: -

Identifier Source: org_study_id

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