RBR-3kjd8x Clinical trial comparing the utilization of Itraconazole and of Pentamidine for the treatment of Cutaneous…

Date of registration: 02/11/2020 ^(mm/dd/yyyy)
Last approval date : 02/11/2020 ^(mm/dd/yyyy)

Study type:

Interventional

Scientific title:

Trial identification

• UTN code: U1111-1243-0077

• Public title:

  en

  Clinical trial comparing the utilization of Itraconazole and of Pentamidine for the treatment of Cutaneous Leishmaniasis in Amazonas

  pt-br

  Ensaio clínico comparando o uso do Itraconazol e da Pentamidina para o tratamento de Leishmaniose de Pele no estado do Amazonas

• Scientific acronym:

• Public acronym:
• Secondaries identifiers:
  • CAAE: 09164819.0.0000.0005
    Issuing authority: Plataforma Brasil
  • Parecer: 3.310.092
    Issuing authority: Comitê de Ética em Pesquisa da Fundação de Medicina Tropical Doutor Heitor Vieira Dourado

Sponsors

• Primary sponsor: Fund. de Medicina Tropical Dr Heitor Vieira Dourado
• Secondary sponsor:
  • Institution: Universidade do Estado do Amazonas
• Supporting source:
  • Institution: Conselho Nacional de Desenvolvimento Científico e Tecnológico

Health conditions

• Health conditions:

  en

  Cutaneous Leishmaniasis

  pt-br

  Leishmaniose Cutânea

• General descriptors for health conditions:

  en

  L00-L99 XII - Diseases of the skin and subcutaneous tissue

  pt-br

  L00-L99 XII - Doenças da pele e do tecido subcutâneo

• Specific descriptors:

Interventions

• Interventions:

  en

  Experimental group: 110 patients with cutaneous leishmaniasis will receive itraconazole, 400mg/day, via oral intake, during 60 days. Control group: 110 patients with cutaneous leishmaniasis will receive Pentamidine, 7mg/Kg, via intravenous or deep intramuscular injection, 1x/week, during 3 weeks.

  pt-br

  Grupo experimental: 110 pacientes com leishmaniose cutânea receberão Itraconazol, 400mg/dia, via oral, por 60 dias. Grupo controle: 110 pacientes com leishmaniose cutânea receberão Pentamidina, 7mg/Kg, intravenosa ou intramuscular profunda, 1x/semana, por 3 semanas.

• Descriptors:

  en

  D03.383.129.799.550 Itraconazole

  pt-br

  D03.383.129.799.550 Itraconazol

  es

  D03.383.129.799.550 Itraconazol

  en

  D02.078.100.700 Pentamidine

  pt-br

  D02.078.100.700 Pentamidina

  es

  D02.078.100.700 Pentamidina

Recruitment

• Study status: Not yet recruiting
• Countries
  • Brazil
• Date first enrollment: 02/17/2020 ^(mm/dd/yyyy)
• Date last enrollment: 01/29/2021 ^(mm/dd/yyyy)

• Target sample size:	Gender:	Minimum age:	Maximum age:
  210	-	18 Y	65 Y

• Inclusion criteria:

  en

  Patients with Ulcerated Cutaneous Leishmaniasis, not previously treated; diagnosed through at least one of the following tests: direct examinations of the lesion, biopsy of the lesion, culture or polimerase chain reactions (PCR) positives to Leishmania guyanensis; age of 18-65 years old; both genders; presenting at least 1 to 3 ulcerated lesions, in any localization; lesion diameter between 1-5 cm; clinical evolution not inferior to 1 month and not superior to 3 months.

  pt-br

  Serao incluidos pacientes com Leishmaniose Cutanea Ulcerada nao tratada; com diagnostico laboratorial obtido por meio de pelo menos um dos seguintes exames: exame direto da lesao, biopsia da lesao, cultura ou reação em cadeia da polimerase (PCR) positivos para Leishmania guyanensis; idade entre 18 a 65 anos; sexo masculino e feminino; presenca de no mínimo 1 a 3 lesoes ulceradas, em qualquer localizacao; diametro das lesoes variando entre 1 e 5 cm; evolucao clinica da doenca nao inferior a 1 mes e nao superior a 3 meses.

• Exclusion criteria:

  en

  Evidence of severe underlying disease (heart, kidney, liver, lung) or malignant disease; immunodeficient or HIV-infected patients; severe protein and / or caloric malnutrition; any active and uncontrolled infectious disease, such as tuberculosis, leprosy, systemic fungal disease (histoplasmosis, paracoccidioidomycosis); pregnant or nursing women; history of previous treatment for leishmaniasis; inability or willingness to provide informed consent (patient and / or / legal representative); lack of availability for visits or to comply with study procedures; patients participating in another ongoing clinical study.

  pt-br

  Evidencia de doenca subjacente grave (cardiaca, renal, hepatica, pulmonar) ou doenca maligna; pacientes com imunodeficiencia ou portadores de HIV; desnutricao proteica e/ou calorica grave; qualquer doenca infectocontagiosa em atividade e nao-controlada, como tuberculose, hanseniase, doenca fungica sistemica (histoplasmose, paracoccidioidomicose); mulheres gravidas ou que estejam amamentando; historico de tratamento anterior para leishmaniose; falta de capacidade ou de vontade de fornecer o consentimento informado (paciente e/ou /representante legal); ausencia de disponibilidade para as visitas ou para cumprir os procedimentos do estudo; pacientes que participem de outro estudo clinico em andamento.

Study type

• Study design:

• Expanded access program	Purpose	Intervention assignment	Number of arms	Masking type	Allocation	Study phase
  	Treatment	Parallel	2	Open	Randomized-controlled	N/A

Outcomes

• Primary outcomes:

  en

  Initial healing rate

  pt-br

  Taxa de cura inicial

  en

  Clinical examination to evaluate the initial healing rate. Initial healing will be considered the complete epithelialization of the cutaneous lesions, in the absence of any inflammatory signs, 2 months after the drug treatment, by means visual clinical evaluation (physical medical exam).

  pt-br

  Avaliar a taxa de cura inicial, por meio do exame clínico. Será considerado cura inicial a cicatrização total das lesões cutâneas, com completa epitelização de todas as úlceras e ausência de qualquer sinal de reação inflamatória, 2 meses após o final do tratamento, constatada por meio de avaliação clínica visual (exame físico médico).

• Secondary outcomes:

  en

  Final healing rate

  pt-br

  Taxa de cura final

  en

  Clinical examination to evaluate the final healing rate. Final healing will be considered the complete epithelialization of the cutaneous lesions, in the absence of any inflammatory signs, 6 months after the drug treatment, by means of visual clinical evaluation (physical medical exam).

  pt-br

  Avaliar a taxa de cura final, por meio do exame clínico. Será considerado cura final a cicatrização total das lesões cutâneas, com completa epitelização de todas as úlceras e ausência de qualquer sinal de reação inflamatória, 6 meses após o final do tratamento, constatada por meio de avaliação clínica visual (exame físico médico).

Contacts

• Public contact
  • Full name: Melissa de Sousa Melo Cavalcante
  • • Address: Av. Pedro Teixeira s/n
    • City: MANAUS / Brazil
    • Zip code: 69040-000
  • Phone: +55-092-981165000
  • Email: melfsmelo@hotmail.com
  • Affiliation: Fund. de Medicina Tropical Dr Heitor Vieira Dourado
   
• Scientific contact
  • Full name: Melissa de Sousa Melo Cavalcante
  • • Address: Av. Pedro Teixeira s/n
    • City: MANAUS / Brazil
    • Zip code: 69040-000
  • Phone: +55-092-981165000
  • Email: melfsmelo@hotmail.com
  • Affiliation: Fund. de Medicina Tropical Dr Heitor Vieira Dourado
   
• Site contact
  • Full name: Melissa de Sousa Melo Cavalcante
  • • Address: Av. Pedro Teixeira s/n
    • City: MANAUS / Brazil
    • Zip code: 69040-000
  • Phone: +55-092-981165000
  • Email: melfsmelo@hotmail.com
  • Affiliation: Fund. de Medicina Tropical Dr Heitor Vieira Dourado
   

Additional links:

• Download in ICTRP format