Visceral LeishmaniasisVLNACNCT01138956
Immune Response of Visceral Leishmaniasis PatientsTreated With Antimonial Plus N-Acetylcysteine
A study testing N-acetylcysteine and Pentavalent antimonial in people with Visceral Leishmaniasis and Immune Response, run by Hospital Universitário Professor Edgard Santos at 1 site in Brazil.
Trial 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. Read more about this study
- Who is it for?
- Ages 2 to 50 years
- Conditions the study is for
- Visceral Leishmaniasis, Immune Response, Treatment
- What is being tested?
- N-acetylcysteine and Pentavalent antimonial
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteBrazil
- Study dates
- Apr 2010to Dec 2011
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 to 50 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Age 2 to 50 years
- Diagnosis of visceral leishmaniasis
Who cannot join
- Other acute or chronic diseases
- Use of immunosuppressive drugs
- AIDS
- History of allergy to NAC and/or pentavalent antimony
Trial locations and contacts
1 site in 1 country.
Brazil1 site, 1 recruiting
- Recruiting
University Hospital
Aracaju, Sergipe, 49060-100
Roque P Almeida, MD, PhD, 5579-21051806, roquepacheco@uol.com.br
Enaldo V Melo, MD, 5579-21051700, evm.estatistica@gmail.com
About this study
Official title: Study for Evaluation of the Immune Response of Visceral Leishmaniasis Patients Treated With Antimonial Pentavalent Associated to N-Acetylcysteine
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.
Read the 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
- Conditions
- Visceral Leishmaniasis, Immune Response, Treatment
- Being tested
- N-acetylcysteine, Pentavalent antimonial
- Keywords
- Visceral leishmaniasis, N-acetylcysteine, Antimony, Immune response
- Medical subject headings
- Leishmaniasis, Visceral
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
N-acetylcysteineDrug
N-acetylcysteine (NAC), effervescent tablets of 600mg, tid, po, 28 days
Pentavalent antimonialDrug
Pentavalent antimonial, 20mg/kg/day, 28 days, IV
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Experimental | Pentavalent antimonial, 20mg/kg/day, 28 days, IV, plus N-acetylcysteine (NAC), effervescent tablets of 600mg, tid, po. Receives: Drug: N-acetylcysteine |
| Group 2 | Active comparator | Pentavalent antimonial, 20mg/kg/day, 28 days Receives: Drug: Pentavalent antimonial |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 months
Secondary outcomes (1)
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.
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2010 (estimated)
- Study startApr 2010
- Primary completionJun 2011 (estimated)
- Study completionDec 2011 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Visceral LeishmaniasisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital Universitário Professor Edgard Santos
- Sponsor type
- University, hospital or other
- Investigators
- Roque P Almeida, MD, PhD, Principal investigator, Hospital Universitário
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01138956
- Sponsor's protocol ID
- VLNAC
- Acronym
- VLNAC
- Status last verified
- Apr 2010
- First submitted
- 7 Jun 2010
- Last updated
- 8 Jun 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study for Evaluation of the Immune Response of Visceral Leishmaniasis Patients Treated With Antimonial Pentavalent Associated to N-Acetylcysteine
- ClinicalTrials.gov ID
- NCT01138956
- Acronym / sponsor ID
- VLNAC / VLNAC
- Conditions
- Visceral Leishmaniasis, Immune Response, Treatment
- Keywords
- Visceral leishmaniasis, N-acetylcysteine, Antimony, Immune response
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Hospital Universitário Professor Edgard SantosUniversity, hospital or other
- Study start
- Apr 2010
- Primary completion
- Jun 2011 (estimated)
- Study completion
- Dec 2011 (estimated)
- First posted
- 8 Jun 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Experimental | Drug: N-acetylcysteinePentavalent antimonial, 20mg/kg/day, 28 days, IV, plus N-acetylcysteine (NAC), effervescent tablets of 600mg, tid, po. |
| Group 2 | Active comparator | Drug: Pentavalent antimonialPentavalent antimonial, 20mg/kg/day, 28 days |
Who may qualify
- Ages
- 2 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- Age 2 to 50 years
- Diagnosis of visceral leishmaniasis
Key exclusion criteria (4 listed)
- Other acute or chronic diseases
- Use of immunosuppressive drugs
- AIDS
- History of allergy to NAC and/or pentavalent antimony
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| N-acetylcysteineN-acetylcysteine (NAC), effervescent tablets of 600mg, tid, po, 28 days | Drug | Group 1 |
| Pentavalent antimonialPentavalent antimonial, 20mg/kg/day, 28 days, IV | Drug | Group 2 |
Primary outcome
Patient recovery from the visceral leishmaniasis after treatment
Time frame: 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.
1 secondary outcome
Immune response of visceral leishmaniasis patients after proposed treatment
Time frame: one year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jun 2010.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Roque P Almeida, MD, PhD principal investigator
Hospital Universitário
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing N-acetylcysteine and Pentavalent antimonial in people with Visceral Leishmaniasis and Immune Response, run by Hospital Universitário Professor Edgard Santos at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 Jun 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Roque P Almeida, MD, PhD (5579-21051806, roquepacheco@uol.com.br), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient recovery from the visceral leishmaniasis after treatment (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jun 2010.