Cutaneous LeishmaniasisPhase 3NCT00487253
Oral Miltefosine for the Treatment of Pediatric Cutaneous Leishmaniasis in Colombia
A Phase 3 study testing Miltefosine and Meglumine antimoniate in people with Cutaneous Leishmaniasis, run by Centro Internacional de Entrenamiento e Investigaciones Médicas.
Trial summary
The purpose of this randomized, open label clinical trial is to determine if oral miltefosine is a safe and effective alternative, compared with parenteral meglumine antimoniate for the treatment of pediatric Cutaneous caused by L. Viannia species in Colombia. Read more about this study
- Who is it for?
- Ages 2 to 12 years
- Conditions the study is for
- Cutaneous Leishmaniasis
- What is being tested?
- Miltefosine and Meglumine antimoniate
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- No sites listed yet
- Study dates
- Jul 2007to Dec 2010
- Phase
- Phase 3
- 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 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 2 to 12 years of age (inclusive)
- Parasitologically confirmed CL
- Availability to receive supervised treatment for 28 days (i.e., directly observed therapy, to ensure the therapy is appropriately administered and received - e.g., the miltefosine is "swallowed")
- Availability to return for follow-up visits for at least 6 months after treatment is initiated
Who cannot join
- Weight under 10kg
- Previous use of SbV, miltefosine or other antileishmanial therapy
- Simultaneous mucosal lesions suggestive of or proven to be mucosal leishmaniasis
- If a girl, ability to reproduce (history of menarche)
- Relative or absolute contraindications for the use of SbV drugs or miltefosine, including history of cardiac, renal or hepatic disease
- Patients with pretreatment haemoglobin <10g/dl or blood urea nitrogen (BUN), serum creatinine, ALT, AST or amylase values that exceed the upper limit of normal
- If living in Malaria endemic areas (eg. Tumaco) only: A positive malaria thick smear
About this study
Official title: Randomized Clinical Trial of the Efficacy and Tolerability of Oral Miltefosine Versus Parenteral Antimony for the Treatment of Pediatric Cutaneous Leishmaniasis in Colombia
The purpose of this randomized, open label clinical trial is to determine if oral miltefosine is a safe and effective alternative, compared with parenteral meglumine antimoniate for the treatment of pediatric Cutaneous caused by L. Viannia species in Colombia.
- Conditions
- Cutaneous Leishmaniasis
- Being tested
- Miltefosine, Meglumine antimoniate
- Keywords
- Cutaneous Leishmaniasis, Leishmania Viannia, Pediatric, Miltefosine, Randomized, Colombia
- Medical subject headings
- Leishmaniasis, Cutaneous
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MiltefosineDrug
Also called Miltefosine cap 10mg and 50mg, Impavido® (Zentaris)
Oral Miltefosine, dosage 1,5mg -2,5mg/kg/day, during 28 days.
Meglumine antimoniateDrug
Also called Glucantime® of Aventis: Amp of 5ml (83mg/ml).
Parenteral meglumine antimoniate Amp of 5ml (83mg/ml). Dosage: 20mg/kg/day one doses IM, during 20 days.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Active comparator | Oral administration of Miltefosine, doses: 1,5mg to 2,5mg/kg/day, during 28 days.
presentation: capsulas 10mg and 50mg Miltefosine (Impavido®) Receives: Drug: Miltefosine |
| Group 2 | Active comparator | Administration of Parenteral meglumine antimoniate, Glucantime® Amp 5ml (83mg/ml). Dosage:20mg/kg/day, during 20 days. Receives: Drug: Meglumine antimoniate |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary outcome measure will be the proportion of "Therapeutic Failures" diagnosed during the final (week 26) visit or before, according to defined clinical criteria.
Measured: 26 weeks (6 months)
Evidence of clinical or laboratory toxicity during the treatment period.
Measured: During the treatment period (20 or 28 days)
Secondary outcomes (1)
Proportion of patients with "parasitologic" response 26 weeks after the initiation of treatment.
Measured: 26 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2007 (estimated)
- Study startJul 2007
- Primary completionFeb 2010
- Study completionDec 2010 (estimated)
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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centro Internacional de Entrenamiento e Investigaciones Médicas
- Sponsor type
- University, hospital or other
- Collaborators
- Instituto Colombiano para el Desarrollo de la Ciencia y la Tecnología (COLCIENCIAS), INS, Instituto Nacional de Dermatología Centro dermatológico Federico Lleras Acosta
- Investigators
- Luisa Consuelo Rubiano, MD, MSc, Principal investigator, Centro Internacional de Entrenamiento e Investigaciones Médicas
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00487253
- Sponsor's protocol ID
- 50100119
- Status last verified
- Feb 2010
- First submitted
- 14 Jun 2007
- Last updated
- 17 Feb 2010
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Castro MDM, Cossio A, Velasco C, Osorio L. Risk factors for therapeutic failure to meglumine antimoniate and miltefosine in adults and children with cutaneous leishmaniasis in Colombia: A cohort study. PLoS Negl Trop Dis. 2017 Apr 5;11(4):e0005515. doi: 10.1371/journal.pntd.0005515. eCollection 2017 Apr.
PubMed 28379954Rubiano LC, Miranda MC, Muvdi Arenas S, Montero LM, Rodriguez-Barraquer I, Garcerant D, Prager M, Osorio L, Rojas MX, Perez M, Nicholls RS, Gore Saravia N. Noninferiority of miltefosine versus meglumine antimoniate for cutaneous leishmaniasis in children. J Infect Dis. 2012 Feb 15;205(4):684-92. doi: 10.1093/infdis/jir816. Epub 2012 Jan 11.
PubMed 22238470
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Clinical Trial of the Efficacy and Tolerability of Oral Miltefosine Versus Parenteral Antimony for the Treatment of Pediatric Cutaneous Leishmaniasis in Colombia
- ClinicalTrials.gov ID
- NCT00487253
- Acronym / sponsor ID
- 50100119
- Conditions
- Cutaneous Leishmaniasis
- Keywords
- Cutaneous Leishmaniasis, Leishmania Viannia, Pediatric, Miltefosine, Randomized, Colombia
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Centro Internacional de Entrenamiento e Investigaciones MédicasUniversity, hospital or other
- Collaborators
- Instituto Colombiano para el Desarrollo de la Ciencia y la Tecnología (COLCIENCIAS), INS, Instituto Nacional de Dermatología Centro dermatológico Federico Lleras Acosta
- Study start
- Jul 2007
- Primary completion
- Feb 2010 (actual)
- Study completion
- Dec 2010 (estimated)
- First posted
- 18 Jun 2007 (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 randomized, open label clinical trial is to determine if oral miltefosine is a safe and effective alternative, compared with parenteral meglumine antimoniate for the treatment of pediatric Cutaneous caused by L. Viannia species in Colombia.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Active comparator | Drug: MiltefosineOral administration of Miltefosine, doses: 1,5mg to 2,5mg/kg/day, during 28 days. presentation: capsulas 10mg and 50mg Miltefosine (Impavido®) |
| Group 2 | Active comparator | Drug: Meglumine antimoniateAdministration of Parenteral meglumine antimoniate, Glucantime® Amp 5ml (83mg/ml). Dosage:20mg/kg/day, during 20 days. |
Who may qualify
- Ages
- 2 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 2 to 12 years of age (inclusive)
- Parasitologically confirmed CL
- Availability to receive supervised treatment for 28 days (i.e., directly observed therapy, to ensure the therapy is appropriately administered and received - e.g., the miltefosine is "swallowed")
- Availability to return for follow-up visits for at least 6 months after treatment is initiated
Key exclusion criteria (7 listed)
- Weight under 10kg
- Previous use of SbV, miltefosine or other antileishmanial therapy
- Simultaneous mucosal lesions suggestive of or proven to be mucosal leishmaniasis
- If a girl, ability to reproduce (history of menarche)
- Relative or absolute contraindications for the use of SbV drugs or miltefosine, including history of cardiac, renal or hepatic disease
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 |
|---|---|---|
| MiltefosineAlso: Miltefosine cap 10mg and 50mg, Impavido® (Zentaris)Oral Miltefosine, dosage 1,5mg -2,5mg/kg/day, during 28 days. | Drug | Group 1 |
| Meglumine antimoniateAlso: Glucantime® of Aventis: Amp of 5ml (83mg/ml).Parenteral meglumine antimoniate Amp of 5ml (83mg/ml). Dosage: 20mg/kg/day one doses IM, during 20 days. | Drug | Group 2 |
Primary outcome
The primary outcome measure will be the proportion of "Therapeutic Failures" diagnosed during the final (week 26) visit or before, according to defined clinical criteria.
Time frame: 26 weeks (6 months)
Evidence of clinical or laboratory toxicity during the treatment period.
Time frame: During the treatment period (20 or 28 days)
1 secondary outcome
Proportion of patients with "parasitologic" response 26 weeks after the initiation of treatment.
Time frame: 26 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2010.
- Derived from this study: PubMed 28379954Castro MDM, Cossio A, Velasco C, Osorio L. Risk factors for therapeutic failure to meglumine antimoniate and miltefosine in adults and children with cutaneous leishmaniasis in Colombia: A cohort study. PLoS Negl Trop Dis. 2017 Apr 5;11(4):e0005515. doi: 10.1371/journal.pntd.0005515. eCollection 2017 Apr.
- Derived from this study: PubMed 22238470Rubiano LC, Miranda MC, Muvdi Arenas S, Montero LM, Rodriguez-Barraquer I, Garcerant D, Prager M, Osorio L, Rojas MX, Perez M, Nicholls RS, Gore Saravia N. Noninferiority of miltefosine versus meglumine antimoniate for cutaneous leishmaniasis in children. J Infect Dis. 2012 Feb 15;205(4):684-92. doi: 10.1093/infdis/jir816. Epub 2012 Jan 11.
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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.
Luisa Consuelo Rubiano, MD, MSc principal investigator
Centro Internacional de Entrenamiento e Investigaciones Médicas
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Miltefosine and Meglumine antimoniate in people with Cutaneous Leishmaniasis, run by Centro Internacional de Entrenamiento e Investigaciones Médicas.
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 7 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 17 Feb 2010. Status can change between updates, so confirm with the study contact before making plans.
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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
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?
The primary outcome measure will be the proportion of "Therapeutic Failures" diagnosed during the final (week 26) visit or before, according to defined clinical criteria. (time frame: 26 weeks (6 months)). 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 NCT00487253, 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 17 Feb 2010.