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| Name | Class |
|---|---|
| Instituto Colombiano para el Desarrollo de la Ciencia y la Tecnología (COLCIENCIAS) | OTHER_GOV |
| INS | UNKNOWN |
| Instituto Nacional de Dermatología Centro dermatológico Federico Lleras Acosta | UNKNOWN |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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®) |
|
| Group 2 | Active Comparator | Administration of Parenteral meglumine antimoniate, Glucantime® Amp 5ml (83mg/ml). Dosage:20mg/kg/day, during 20 days. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Miltefosine | Drug | Oral Miltefosine, dosage 1,5mg -2,5mg/kg/day, during 28 days. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 26 weeks (6 months) | |
| Evidence of clinical or laboratory toxicity during the treatment period. | During the treatment period (20 or 28 days) |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of patients with "parasitologic" response 26 weeks after the initiation of treatment. | 26 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Luisa Consuelo Rubiano, MD, MSc | Centro Internacional de Entrenamiento e Investigaciones Médicas | Principal Investigator |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28379954 | Derived | 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. | |
| 22238470 | Derived |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Feb 2, 2011 | |
| Reset | Feb 23, 2011 | |
| Release | Oct 13, 2011 | |
| Reset | Nov 18, 2011 | |
| Release | Nov 18, 2011 | |
| Unrelease | Yes | |
| Release | Nov 19, 2011 | |
| Reset | Dec 21, 2011 | |
| Release | Sep 4, 2012 | |
| Reset | Oct 3, 2012 | |
| Release | Mar 26, 2015 | |
| Reset | Apr 27, 2015 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Feb 2, 2011 | Feb 23, 2011 | |||
| Oct 13, 2011 |
| ID | Term |
|---|---|
| D016773 | Leishmaniasis, Cutaneous |
| ID | Term |
|---|---|
| D007896 | Leishmaniasis |
| D056986 | Euglenozoa Infections |
| D011528 | Protozoan Infections |
| D010272 | Parasitic Diseases |
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| ID | Term |
|---|---|
| C039128 | miltefosine |
| D000077485 | Meglumine Antimoniate |
| ID | Term |
|---|---|
| D008536 | Meglumine |
| D013012 | Sorbitol |
| D013402 | Sugar Alcohols |
| D000438 | Alcohols |
| D009930 |
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| Meglumine antimoniate | Drug | Parenteral meglumine antimoniate Amp of 5ml (83mg/ml). Dosage: 20mg/kg/day one doses IM, during 20 days. |
|
|
| Rubiano 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. |
| Nov 18, 2011 |
| Nov 18, 2011 | Yes |
| Nov 19, 2011 | Dec 21, 2011 |
| Sep 4, 2012 | Oct 3, 2012 |
| Mar 26, 2015 | Apr 27, 2015 |
| D007239 |
| Infections |
| D012876 | Skin Diseases, Parasitic |
| D000079426 | Vector Borne Diseases |
| D012874 | Skin Diseases, Infectious |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| Organic Chemicals |
| D006595 | Hexosamines |
| D000606 | Amino Sugars |
| D002241 | Carbohydrates |