Localized Cutaneous LeishmaniasisPhase 4SboldNCT00818818
Low-dose Pentavalent Antimony Treatment of Cutaneous Leishmaniasis in Old Age Patients
A Phase 4 study testing Meglumine antimoniate in people with Localized Cutaneous Leishmaniasis, run by University of Brasilia at 1 site in Brazil.
Trial summary
This study was designed to evaluate the effect of low doses of pentavalent antimony (meglumine antimoniate) to treat cutaneous leishmaniasis ulcers in patients older than 65 years. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Localized Cutaneous Leishmaniasis
- What is being tested?
- Meglumine antimoniate
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 13 participants
- Where
- 1 siteBrazil
- Study dates
- Aug 2008to Apr 2010
- 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 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Age > 65 years
- Permanent residence in the endemic area
- Availability of a caregiver for dependent patients
Who cannot join
- Mucosal disease caused by leishmaniasis
- Disseminated cutaneous disease
- Severe cardiac, renal or hepatic disorders
- Active cancer
- Active tuberculosis
- Leprosy
Show all 12Show fewer
- HIV positive
- Total bilirubin > 1.5mg/dL
- Urea and creatinin > 1.5 times the upper normal level
- Alkaline phosphatase and aminotransferases > 2.5 times the upper normal level
- Lipase and amylase > 1.5 the upper normal level
- Hemoglobin < 5 g/dL of
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Health Center Unit of Corte de Pedra
Corte de Pedra, Presidente Tancredo Neves, Bahia State, 45416 - 000
About this study
Official title: Low-dose Pentavalent Antimony Treatment of Cutaneous Leishmaniasis in Old Age Patients Infected With Leishmania (Viannia) Braziliensis in Bahia State, Brazil. An Open Uncontrolled Trial.
This study was designed to evaluate the effect of low doses of pentavalent antimony (meglumine antimoniate) to treat cutaneous leishmaniasis ulcers in patients older than 65 years. The hypothesis is that older patients may have a positive response with a lower dose of pentavalent antimony, avoiding the frequent adverse events observed with the standard dose. The design is that of an open uncontrolled trial enrolling 20 patients infected with the parasite Leishmania braziliensis in an endemic area of the State of Bahia, Brazil. The endpoint of cure or therapeutic failure will be evaluated at the third month of follow-up after treatment to avoid the impact of spontaneous cure as a confounding factor.
- Conditions
- Localized Cutaneous Leishmaniasis
- Being tested
- Meglumine antimoniate
- Keywords
- Leishmaniasis, Cutaneous leishmaniasis, Leishmania braziliensis, Pentavalent antimonial, Glucantime
- Medical subject headings
- Leishmaniasis, 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
5mg/kg/d of pentavalent antimony, IV, for 20 consecutive days
| Study group | Role | What they receive |
|---|---|---|
| Meglumine antimoniate | Experimental | Treated with 5mg/kg/d of pentavalent antimony (meglumine antimoniate) intravenously for 20 consecutive days. Receives: Drug: Meglumine antimoniate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical cure
Clinical cure defined as the complete epithelialization of the ulcerated lesions without any inflamatory sign (erythema, edema, disquamation)
Measured: Three months after treatment
Secondary outcomes (3)
Adverse events rate - day 7
Biochemical abnormalities detected in serum samples for: SGOT, SGPT, amilase, creatinin, ureia and glycemia, or any sign or symptom experienced during the first week of treatment
Measured: 7th day
Adverse events rate - day 14
Biochemical abnormalities detected in serum samples for: SGOT, SGPT, amilase, creatinin, ureia and glycemia, or any sign or symptom experienced during the second week of treatment
Measured: 14th day
Total Adverse events rate
Biochemical abnormalities detected in serum samples for: SGOT, SGPT, amilase, creatinin, ureia and glycemia, or any sign or symptom experienced during the whole treatment
Measured: 20th day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jan 2009 (estimated)
- Study startAug 2008
- Primary completionJan 2010
- Study completionApr 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Localized 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Brasilia
- Sponsor type
- University, hospital or other
- Investigators
- Julia S Ampuero-Vela, MD, MSc, Principal investigator, Faculty of Medicine, University of BrasiliaGustavo Adolfo S Romero, MD, PhD, Study chair, Faculty of Medicine, University of Brasilia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00818818
- Sponsor's protocol ID
- lowdoseaging
- Acronym
- Sbold
- Status last verified
- Oct 2010
- First submitted
- 6 Jan 2009
- Last updated
- 8 Oct 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Low-dose Pentavalent Antimony Treatment of Cutaneous Leishmaniasis in Old Age Patients Infected With Leishmania (Viannia) Braziliensis in Bahia State, Brazil. An Open Uncontrolled Trial.
- ClinicalTrials.gov ID
- NCT00818818
- Acronym / sponsor ID
- Sbold / lowdoseaging
- Conditions
- Localized Cutaneous Leishmaniasis
- Keywords
- Leishmaniasis, Cutaneous leishmaniasis, Leishmania braziliensis, Pentavalent antimonial, Glucantime
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- University of BrasiliaUniversity, hospital or other
- Study start
- Aug 2008
- Primary completion
- Jan 2010 (actual)
- Study completion
- Apr 2010 (actual)
- First posted
- 8 Jan 2009 (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 was designed to evaluate the effect of low doses of pentavalent antimony (meglumine antimoniate) to treat cutaneous leishmaniasis ulcers in patients older than 65 years. The hypothesis is that older patients may have a positive response with a lower dose of pentavalent antimony, avoiding the frequent adverse events observed with the standard dose. The design is that of an open uncontrolled trial enrolling 20 patients infected with the parasite Leishmania braziliensis in an endemic area of the State of Bahia, Brazil. The endpoint of cure or therapeutic failure will be evaluated at the third month of follow-up after treatment to avoid the impact of spontaneous cure as a confounding factor.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Meglumine antimoniate | Experimental | Drug: Meglumine antimoniateTreated with 5mg/kg/d of pentavalent antimony (meglumine antimoniate) intravenously for 20 consecutive days. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (3 listed)
- Age > 65 years
- Permanent residence in the endemic area
- Availability of a caregiver for dependent patients
Key exclusion criteria (12 listed)
- Mucosal disease caused by leishmaniasis
- Disseminated cutaneous disease
- Severe cardiac, renal or hepatic disorders
- Active cancer
- Active tuberculosis
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: Glucantime5mg/kg/d of pentavalent antimony, IV, for 20 consecutive days | Drug | Meglumine antimoniate |
Primary outcome
Clinical cure
Time frame: Three months after treatment
Clinical cure defined as the complete epithelialization of the ulcerated lesions without any inflamatory sign (erythema, edema, disquamation)
3 secondary outcomes
Adverse events rate - day 7
Time frame: 7th day
Adverse events rate - day 14
Time frame: 14th day
Total Adverse events rate
Time frame: 20th day
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 8 Oct 2010.
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Localized Cutaneous Leishmaniasis
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.
Julia S Ampuero-Vela, MD, MSc principal investigator
Faculty of Medicine, University of Brasilia
Gustavo Adolfo S Romero, MD, PhD study chair
Faculty of Medicine, 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 Localized 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 3 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 8 Oct 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.
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?
Clinical cure (time frame: Three months after treatment). 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 Oct 2010.