Immune Response of Visceral Leishmaniasis PatientsTreated With Antimonial Plus N-Acetylcysteine
VLNAC
Study for Evaluation of the Immune Response of Visceral Leishmaniasis Patients Treated With Antimonial Pentavalent Associated to N-Acetylcysteine
1 other identifier
interventional
40
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Apr 2010
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2010
CompletedFirst Submitted
Initial submission to the registry
June 7, 2010
CompletedFirst Posted
Study publicly available on registry
June 8, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2011
CompletedJune 8, 2010
April 1, 2010
1.2 years
June 7, 2010
June 7, 2010
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Secondary Outcomes (1)
Immune response of visceral leishmaniasis patients after proposed treatment
one year
Study Arms (2)
Group 1
EXPERIMENTALPentavalent antimonial, 20mg/kg/day, 28 days, IV, plus N-acetylcysteine (NAC), effervescent tablets of 600mg, tid, po.
Group 2
ACTIVE COMPARATORPentavalent antimonial, 20mg/kg/day, 28 days
Interventions
Eligibility Criteria
You may qualify if:
- Age 2 to 50 years
- Diagnosis of visceral leishmaniasis
You may not qualify if:
- Other acute or chronic diseases
- Use of immunosuppressive drugs
- AIDS
- History of allergy to NAC and/or pentavalent antimony
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University Hospital
Aracaju, Sergipe, 49060-100, Brazil
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Roque P Almeida, MD, PhD
Hospital Universitário
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- INVESTIGATOR
- Purpose
- BASIC SCIENCE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
June 7, 2010
First Posted
June 8, 2010
Study Start
April 1, 2010
Primary Completion
June 1, 2011
Study Completion
December 1, 2011
Last Updated
June 8, 2010
Record last verified: 2010-04