Cutaneous LeishmaniasisPhase 2NCT01380301
Treatment of Cutaneous Leishmaniasis With a Combination of Miltefosine and Antimony
A Phase 2 study testing Miltefosine and antimony and Miltefosine alone in people with Cutaneous Leishmaniasis, run by Foundation Fader at 1 site in Bolivia.
Trial summary
Cutaneous leishmaniasis is endemic in the New World and, until recently, the standard treatment was pentavalent antimony. The cure rate for L panamensis in Colombia is 91%-93% and the cure rate in Bolivia is also 90%. Read more about this study
- Who is it for?
- Ages 12 to 75 years
- Conditions the study is for
- Cutaneous Leishmaniasis
- What is being tested?
- Miltefosine and antimony and Miltefosine alone
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 19 participants
- Where
- 1 siteBolivia
- Study dates
- Mar 2007to Jan 2009
- Phase
- Phase 2
- 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 12 to 75 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Parasitological confirmation
- at least 1 lesion must be ulcerative
- No specific antileishmanial therapy during the previous six months
Who cannot join
- Concomitant diseases such as Tuberculosis, HIV, diabetes, renal failure, liver disease
- abnormalities CTC 2 in blood, liver, kidney test or EKG
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Treatment of Bolivian Cutaneous Leishmaniasis With a Combination of Short Courses of Miltefosine and Antimony
Cutaneous leishmaniasis is endemic in the New World and, until recently, the standard treatment was pentavalent antimony. The cure rate for L panamensis in Colombia is 91%-93% and the cure rate in Bolivia is also 90%. Nevertheless, pentavalent antimonials have the disadvantages of multiple injections and mild-moderate clinical toxicity all of which are particularly unpleasant for a moderate clinical problem such as cutaneous leishmaniasis.
The oral agent Miltefosine has now been shown to be as effective as antimony in Colombia and Bolivia (91 and 92% respectively). Side effects seen in patients with cutaneous disease that can be specifically attributed to the drug are nausea and vomiting of mild grade in approximately 25% of patients, and low-grade elevation of creatinine also in approximately 25% of patients. A further disadvantage of miltefosine is that regimens shorter than 4 weeks have not been evaluated for cutaneous disease.
Read more
Combination therapy is now being used for many infectious diseases, such as tuberculosis, malaria, and HIV. Combination therapy offers the potential of preventing drug resistance, because organisms resistant to one of the drugs may be susceptible to the other drug; and also the potential to diminish drug therapy duration and thus side effects. These two potential benefits to some extent contradict each other: preventing resistance is best done if full courses of both drugs is used; diminishing therapy duration means using less than the full course of each drug. The optimum combination regimen is one in which sufficient amounts of both drugs are used to have high efficacy, yet the amounts are as low as possible to spare patients unnecessarily long courses of drug.
In the present protocol, the combination of a half-course of miltefosine and a half-course of antimony will be evaluated for efficacy and tolerance. The combination of miltefosine and antimony is chosen because these are now the two standard agents in Bolivia, and in vitro the combination was additive to mildly synergistic against a standard leishmania strain.
- Conditions
- Cutaneous Leishmaniasis
- Being tested
- Miltefosine and antimony, Miltefosine alone
- Keywords
- Leishmaniasis, Miltefosine, Antimony, Therapy
- Medical subject headings
- Leishmaniasis, Cutaneous, Leishmaniasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Miltefosine and antimonyDrug
Short course (half of each drug) administered simultaneously
Miltefosine aloneDrug
short course (half)
| Study group | Role | What they receive |
|---|---|---|
| Miltefosine and Antimony | Experimental | Miltefosine 1,5 to 2,5 mg x k x d during 14 days simultaneously with meglumine antimoniate 20 mg x kg x d during 10 days Receives: Drug: Miltefosine and antimony |
| Miltefosine alone | Active comparator | Miltefosine 1,5 to 2,5 mg x kg x d during 14 days Receives: Drug: Miltefosine alone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Healing of ulcers
Measured: 45 days
Secondary outcomes (1)
Clinical findings and Laboratory parameters in normal ranges
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2011 (estimated)
- Study startMar 2007
- Primary completionAug 2008
- Study completionJan 2009
Why it stopped: Low efficacy rates
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- Foundation Fader
- Sponsor type
- University, hospital or other
- Collaborators
- AB Foundation
- Investigators
- JONATHAN BERMAN, MD, PhD, Study director, AB Foundation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01380301
- Sponsor's protocol ID
- 2007-Bol-01
- Status last verified
- Jun 2011
- First submitted
- 28 Jan 2009
- Last updated
- 27 Jun 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jun 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of Bolivian Cutaneous Leishmaniasis With a Combination of Short Courses of Miltefosine and Antimony
- ClinicalTrials.gov ID
- NCT01380301
- Acronym / sponsor ID
- 2007-Bol-01
- Conditions
- Cutaneous Leishmaniasis
- Keywords
- Leishmaniasis, Miltefosine, Antimony, Therapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Low efficacy rates
- Enrolment
- 19 participants (actual)
- Lead sponsor
- Foundation FaderUniversity, hospital or other
- Collaborators
- AB Foundation
- Study start
- Mar 2007
- Primary completion
- Aug 2008 (actual)
- Study completion
- Jan 2009 (actual)
- First posted
- 27 Jun 2011 (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.
Cutaneous leishmaniasis is endemic in the New World and, until recently, the standard treatment was pentavalent antimony. The cure rate for L panamensis in Colombia is 91%-93% and the cure rate in Bolivia is also 90%. Nevertheless, pentavalent antimonials have the disadvantages of multiple injections and mild-moderate clinical toxicity all of which are particularly unpleasant for a moderate clinical problem such as cutaneous leishmaniasis.
The oral agent Miltefosine has now been shown to be as effective as antimony in Colombia and Bolivia (91 and 92% respectively). Side effects seen in patients with cutaneous disease that can be specifically attributed to the drug are nausea and vomiting of mild grade in approximately 25% of patients, and low-grade elevation of creatinine also in approximately 25% of patients. A further disadvantage of miltefosine is that regimens shorter than 4 weeks have not been evaluated for cutaneous disease.
Combination therapy is now being used for many infectious diseases, such as tuberculosis, malaria, and HIV. Combination therapy offers the potential of preventing drug resistance, because organisms resistant to one of the drugs may be susceptible to the other drug; and also the potential to diminish drug therapy duration and thus side effects. These two potential benefits to some extent contradict each other: preventing resistance is best done if full courses of both drugs is used; diminishing therapy duration means using less than the full course of each drug. The optimum combination regimen is one in which sufficient amounts of both drugs are used to have high efficacy, yet the amounts are as low as possible to spare patients unnecessarily long courses of drug.
In the present protocol, the combination of a half-course of miltefosine and a half-course of antimony will be evaluated for efficacy and tolerance. The combination of miltefosine and antimony is chosen because these are now the two standard agents in Bolivia, and in vitro the combination was additive to mildly synergistic against a standard leishmania strain.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Miltefosine and Antimony | Experimental | Drug: Miltefosine and antimonyMiltefosine 1,5 to 2,5 mg x k x d during 14 days simultaneously with meglumine antimoniate 20 mg x kg x d during 10 days |
| Miltefosine alone | Active comparator | Drug: Miltefosine aloneMiltefosine 1,5 to 2,5 mg x kg x d during 14 days |
Who may qualify
- Ages
- 12 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Parasitological confirmation
- at least 1 lesion must be ulcerative
- No specific antileishmanial therapy during the previous six months
Key exclusion criteria (2 listed)
- Concomitant diseases such as Tuberculosis, HIV, diabetes, renal failure, liver disease
- abnormalities CTC 2 in blood, liver, kidney test or EKG
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 |
|---|---|---|
| Miltefosine and antimonyShort course (half of each drug) administered simultaneously | Drug | Miltefosine and Antimony |
| Miltefosine aloneshort course (half) | Drug | Miltefosine alone |
Primary outcome
Healing of ulcers
Time frame: 45 days
1 secondary outcome
Clinical findings and Laboratory parameters in normal ranges
Time frame: 28 days
Results and safety
The study was stopped early (reason given: Low efficacy rates). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jun 2011.
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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.
JONATHAN BERMAN, MD, PhD study director
AB Foundation
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Miltefosine and antimony and Miltefosine alone in people with Cutaneous Leishmaniasis, run by Foundation Fader at 1 site in Bolivia.
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 2 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: stopped early, as of the sponsor's last update on 27 Jun 2011. 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 Bolivia. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 was stopped early (reason given: Low efficacy rates). Results are not available in the source record.
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?
Healing of ulcers (time frame: 45 days). 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 27 Jun 2011.