Cutaneous LeishmaniasisPhase 4LowdosesbNCT00317980
Safety and Efficacy of Low-Dose Pentavalent Antimony for Treatment of Cutaneous Leishmaniasis
A Phase 4 study testing Meglumine antimoniate in people with Cutaneous Leishmaniasis, run by University of Brasilia at 1 site in Brazil.
Trial summary
The purpose of this study is to determine whether low-dose pentavalent antimony is equally effective when compared to the standard-dose regimen in patients with cutaneous leishmaniasis. The study will be done in a field clinic in the state of Bahia, Brazil. Read more about this study
- Who is it for?
- Ages 7 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Cutaneous Leishmaniasis
- What is being tested?
- Meglumine antimoniate
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 280 participants
- Where
- 1 siteBrazil
- Study dates
- Feb 2006to Dec 2008
- Phase
- Phase 4
- 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 7 to 50 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Presence of 1 to 9 cutaneous lesions clinically compatible with leishmaniasis
- Disease duration of 2 to 20 weeks
- Positive leishmanin skin test
- Parasitological diagnosis confirmed through culture or genus-specific polymerase chain reaction (PCR) for Leishmania spp
Who cannot join
- History of past episode of leishmaniasis
- Mucosal disease
- Disseminated disease
- Use of drugs with anti-leishmanial activity
- Contraindications for using pentavalent antimony:
- pregnancy
Show all 12Show fewer
- renal failure
- heart failure
- hepatic failure
- Other diseases:
- active tuberculosis
- hanseniasis
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Núcleo de Medicina Tropical, University of Brasilia
Brasília, Federal District, 70904-970
About this study
Official title: Phase IV Randomized Controlled Clinical Trial to Evaluate the Safety and Efficacy of Low-Dose Pentavalent Antimony Compared to the Standard Dose in Patients With Cutaneous Leishmaniasis Caused by Leishmania (Viannia)Braziliensis
The purpose of this study is to determine whether low-dose pentavalent antimony is equally effective when compared to the standard-dose regimen in patients with cutaneous leishmaniasis. The study will be done in a field clinic in the state of Bahia, Brazil.
Read the detailed description
The first-choice drug for the treatment of cutaneous leishmaniasis in Brazil is the pentavalent antimonial meglumine antimoniate. The treatment with meglumine antimoniate is toxic and at least some of the more relevant adverse events associated with that drug are dose-dependent. Recently, some research developed in Brazil has shown evidence that lower doses of pentavalent antimony are equally efficacious as compared to the standard-dose regimen. That evidence has been obtained in patients from the State of Rio de Janeiro who were infected by Leishmania (Viannia) braziliensis. The purpose of the study is to evaluate the safety and efficacy of the low-dose pentavalent antimony regimen in patients with cutaneous leishmaniasis infected by Leishmania (Viannia) braziliensis living in a rural area of the State of Bahia, Brazil, where cutaneous leishmaniasis is highly endemic. The usefulness of the study is based on the possibility to reduce the toxicity observed during treatment and the treatment costs.
The main comparison of the therapeutic response is going to be made between two groups composed of an equal number of properly randomized patients with localized cutaneous leishmaniasis treated with any of the following drug schemes:
- Meglumine antimoniate (calculated dose based on the concentration of pentavalent antimony) 5 mg/kg/d intravenous for 20 days
- Meglumine antimoniate (calculated dose based on the concentration of pentavalent antimony) 15 mg/kg/d intravenous for 20 days
The clinical outcomes of cure or failure will be evaluated until the third month of follow-up.
- Conditions
- Cutaneous Leishmaniasis
- Being tested
- Meglumine antimoniate
- Keywords
- Cutaneous leishmaniasis, Leishmania braziliensis, Pentavalent antimony, Meglumine antimoniate
- Medical subject headings
- Leishmaniasis, Cutaneous
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Meglumine antimoniateDrug
Also called Glucantime
Meglumine antimoniate 5mg/kg/d for 20 days
Meglumine antimoniateDrug
Also called Glucantime
Meglumine antimoniate 15 mg/kg/d for 20 days
| Study group | Role | What they receive |
|---|---|---|
| Low dose | Experimental | Meglumine antimoniate 5 mg/kg/d for 20 days Receives: Drug: Meglumine antimoniate |
| Standard dose | Active comparator | Meglumine antimoniate 15 mg/kg/d for 20 days Receives: Drug: Meglumine antimoniate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of clinically cured patients at the third month after treatment
Measured: Three months after treatment
Proportion of patients with epithelialized lesions
Measured: Three months after treatment
Secondary outcomes (3)
Proportion of patients with adherence to the protocol prescribed drug
Measured: 30 days
Proportion of patients with adverse events
Measured: 30 days after treatment
Proportion of patients with late failure after the first three months of follow-up
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2006 (estimated)
- Study startFeb 2006
- Primary completionMar 2008
- Study completionDec 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Cutaneous 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 280 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Brasilia
- Sponsor type
- University, hospital or other
- Collaborators
- Ministry of Health, Brazil
- Investigators
- Gustavo S Romero, MD, Principal investigator, University of Brasilia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00317980
- Sponsor's protocol ID
- NMT-LD-CP-2006
- Acronym
- Lowdosesb
- Status last verified
- Jan 2009
- First submitted
- 21 Apr 2006
- Last updated
- 22 Jan 2009
- Results posted
- No
- Data monitoring committee
- No
Publications
Oliveira-Neto MP, Schubach A, Mattos M, Goncalves-Costa SC, Pirmez C. Treatment of American cutaneous leishmaniasis: a comparison between low dosage (5 mg/kg/day) and high dosage (20 mg/kg/day) antimony regimens. Pathol Biol (Paris). 1997 Jun;45(6):496-9.
PubMed 9309267Oliveira-Neto MP, Schubach A, Mattos M, Goncalves-Costa SC, Pirmez C. A low-dose antimony treatment in 159 patients with American cutaneous leishmaniasis: extensive follow-up studies (up to 10 years). Am J Trop Med Hyg. 1997 Dec;57(6):651-5. doi: 10.4269/ajtmh.1997.57.651.
PubMed 9430521
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase IV Randomized Controlled Clinical Trial to Evaluate the Safety and Efficacy of Low-Dose Pentavalent Antimony Compared to the Standard Dose in Patients With Cutaneous Leishmaniasis Caused by Leishmania (Viannia)Braziliensis
- ClinicalTrials.gov ID
- NCT00317980
- Acronym / sponsor ID
- Lowdosesb / NMT-LD-CP-2006
- Conditions
- Cutaneous Leishmaniasis
- Keywords
- Cutaneous leishmaniasis, Leishmania braziliensis, Pentavalent antimony, Meglumine antimoniate
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 280 participants (actual)
- Lead sponsor
- University of BrasiliaUniversity, hospital or other
- Collaborators
- Ministry of Health, Brazil
- Study start
- Feb 2006
- Primary completion
- Mar 2008 (actual)
- Study completion
- Dec 2008 (actual)
- First posted
- 25 Apr 2006 (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.
The purpose of this study is to determine whether low-dose pentavalent antimony is equally effective when compared to the standard-dose regimen in patients with cutaneous leishmaniasis. The study will be done in a field clinic in the state of Bahia, Brazil.
Detailed description
The first-choice drug for the treatment of cutaneous leishmaniasis in Brazil is the pentavalent antimonial meglumine antimoniate. The treatment with meglumine antimoniate is toxic and at least some of the more relevant adverse events associated with that drug are dose-dependent. Recently, some research developed in Brazil has shown evidence that lower doses of pentavalent antimony are equally efficacious as compared to the standard-dose regimen. That evidence has been obtained in patients from the State of Rio de Janeiro who were infected by Leishmania (Viannia) braziliensis. The purpose of the study is to evaluate the safety and efficacy of the low-dose pentavalent antimony regimen in patients with cutaneous leishmaniasis infected by Leishmania (Viannia) braziliensis living in a rural area of the State of Bahia, Brazil, where cutaneous leishmaniasis is highly endemic. The usefulness of the study is based on the possibility to reduce the toxicity observed during treatment and the treatment costs.
The main comparison of the therapeutic response is going to be made between two groups composed of an equal number of properly randomized patients with localized cutaneous leishmaniasis treated with any of the following drug schemes:
- Meglumine antimoniate (calculated dose based on the concentration of pentavalent antimony) 5 mg/kg/d intravenous for 20 days
- Meglumine antimoniate (calculated dose based on the concentration of pentavalent antimony) 15 mg/kg/d intravenous for 20 days
The clinical outcomes of cure or failure will be evaluated until the third month of follow-up.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Low dose | Experimental | Drug: Meglumine antimoniateMeglumine antimoniate 5 mg/kg/d for 20 days |
| Standard dose | Active comparator | Drug: Meglumine antimoniateMeglumine antimoniate 15 mg/kg/d for 20 days |
Who may qualify
- Ages
- 7 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- Presence of 1 to 9 cutaneous lesions clinically compatible with leishmaniasis
- Disease duration of 2 to 20 weeks
- Positive leishmanin skin test
- Parasitological diagnosis confirmed through culture or genus-specific polymerase chain reaction (PCR) for Leishmania spp
Key exclusion criteria (12 listed)
- History of past episode of leishmaniasis
- Mucosal disease
- Disseminated disease
- Use of drugs with anti-leishmanial activity
- Contraindications for using 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 |
|---|---|---|
| Meglumine antimoniateAlso: GlucantimeMeglumine antimoniate 5mg/kg/d for 20 days | Drug | Low dose |
| Meglumine antimoniateAlso: GlucantimeMeglumine antimoniate 15 mg/kg/d for 20 days | Drug | Standard dose |
Primary outcome
Proportion of clinically cured patients at the third month after treatment
Time frame: Three months after treatment
Proportion of patients with epithelialized lesions
Time frame: Three months after treatment
3 secondary outcomes
Proportion of patients with adherence to the protocol prescribed drug
Time frame: 30 days
Proportion of patients with adverse events
Time frame: 30 days after treatment
Proportion of patients with late failure after the first three months of follow-up
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jan 2009.
- Background: PubMed 9309267Oliveira-Neto MP, Schubach A, Mattos M, Goncalves-Costa SC, Pirmez C. Treatment of American cutaneous leishmaniasis: a comparison between low dosage (5 mg/kg/day) and high dosage (20 mg/kg/day) antimony regimens. Pathol Biol (Paris). 1997 Jun;45(6):496-9.
- Background: PubMed 9430521Oliveira-Neto MP, Schubach A, Mattos M, Goncalves-Costa SC, Pirmez C. A low-dose antimony treatment in 159 patients with American cutaneous leishmaniasis: extensive follow-up studies (up to 10 years). Am J Trop Med Hyg. 1997 Dec;57(6):651-5. doi: 10.4269/ajtmh.1997.57.651.
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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.
Gustavo S Romero, MD principal investigator
University of Brasilia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Meglumine antimoniate in people with Cutaneous Leishmaniasis, run by University of Brasilia 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 4 inclusion and 12 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: finished, as of the sponsor's last update on 22 Jan 2009. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of clinically cured patients at the third month after treatment (time frame: Three months after treatment). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00317980, which also lists 2 linked publications.
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 22 Jan 2009.