Ensaio clínico em Criptosporidiose - Registro de Ensaios Clínicos

Visão geral do estudo

Status

Recrutamento

Condições

Criptosporidiose

Tipo de estudo

Observacional

Inscrição (Estimado)

30

Contactos e Locais

Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.

Contato de estudo

Nome: Novartis Pharmaceuticals
Número de telefone: +41613241111
E-mail: novartis.email@novartis.com

Estude backup de contato

Nome: Novartis Pharmaceuticals

Locais de estudo

Malásia
- - Kuala Lumpur, Malásia, 56000
    - Recrutamento
    - Novartis Investigative Site
- Pahang
  - Kuantan, Pahang, Malásia, 25200
    - Recrutamento
    - Novartis Investigative Site
Quênia
- Nyanza
  - Kisumu, Nyanza, Quênia, 40100
    - Recrutamento
    - Novartis Investigative Site
Zâmbia
- - Lusaka, Zâmbia, 10101
    - Recrutamento
    - Novartis Investigative Site

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

Filho

Aceita Voluntários Saudáveis

Não

Método de amostragem

Amostra Não Probabilística

População do estudo

Pediatric participants presenting with diarrhea and testing positive for Cryptosporidium by QuikChek™ and microscopy.

Descrição

Inclusion criteria:

Age 6 months to 59 months with diarrhea according to the World Health Organization (WHO) criteria (≥3 loose stools daily for at least 2 days)
QuikChek™ and Stool microscopy positive for Cryptosporidium at screening
Acute (<7 days), prolonged (lasting 7-13 days), persistent (lasting 14-28 days) or chronic (lasting >28 days) diarrheal illness (≥3 loose stools daily, as defined by WHO) at screening
Normal nutritional status, mildly-to-moderately acutely malnourished, or severely acutely malnourished according to WHO definitions (number of participants with severe acute malnutrition will be capped) at screening
Parent or primary caregiver is willing to provide informed consent and to comply with study procedures, including provision of whole stool samples at the scheduled time points and willing to be followed up to 21 days

Exclusion criteria:

Bloody diarrhea, defined as diarrhea with visible blood in stool as observed by the study team member performing the screening or reported by parent/primary caregiver
Other morbidity requiring emergency medical care in an intensive care setting at the time of screening
Coincident non-enteric infection including upper or lower respiratory infection at screening
Any participant whose parent or primary caregiver is unwilling or unable to cooperate with study procedures, in the investigator's opinion
If the parent/primary caregiver managing care of the patient has travel plans out of the study area that would preclude clinic or in-home study visits during the expected study follow-up period

Other protocol-defined inclusion/exclusion criteria may apply.

Plano de estudo

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

Como o estudo é projetado?

Detalhes do projeto

Número de grupos/coortes

1

Coortes e Intervenções

Grupo / Coorte
Cryptosporidiosis Cohort Pediatric participants with diarrhea due to Cryptosporidium infection.

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado	Descrição da medida	Prazo
Number and Percentage of Participants by Chronicity of Diarrhea Prazo: Baseline	Diarrhea chronicity categories: Acute (<7 days) Prolonged (7-13 days) Persistent (14-28 days) Chronic (>28 days)	Baseline
Number and Percentage of Participants by Severity of Dehydration Prazo: Baseline, Days 3, 7, 14 and up to Day 21	Dehydration severity categories: None Some Severe	Baseline, Days 3, 7, 14 and up to Day 21
Time to Resolution of Diarrhea and Dehydration Prazo: Baseline, Days 3, 7, 14 and up to Day 21		Baseline, Days 3, 7, 14 and up to Day 21

Medidas de resultados secundários

Medida de resultado	Descrição da medida	Prazo
Association of Diarrheal Chronicity With Age Prazo: Baseline	Association of diarrheal chronicity with age will be assessed using the Kruskal-Wallis test.	Baseline
Association of Diarrheal Chronicity With Height Prazo: Baseline	Association of diarrheal chronicity with height will be assessed using the Kruskal-Wallis test.	Baseline
Association of Diarrheal Chronicity With Weight Prazo: Baseline	Association of diarrheal chronicity with weight will be assessed using the Kruskal-Wallis test.	Baseline
Association of Diarrheal Chronicity With Sex Prazo: Baseline	Association of diarrheal chronicity with sex will be assessed using the Fisher exact test.	Baseline
Association of Diarrheal Chronicity With HIV Status Prazo: Baseline	Association of diarrheal chronicity with HIV status will be assessed using the Fisher exact test.	Baseline
Association of Diarrheal Chronicity With Malnutrition Prazo: Baseline	Association of diarrheal chronicity with malnutrition will be assessed using the Fisher exact test.	Baseline
Association of Diarrheal Chronicity With Growth Faltering Prazo: Baseline	Association of diarrheal chronicity with growth faltering will be assessed using the Fisher exact test.	Baseline
Association of Diarrheal Chronicity With Early Weaning Prazo: Baseline	Association of diarrheal chronicity with early weaning will be assessed using the Fisher exact test.	Baseline
Association of Diarrheal Chronicity With Non-Exclusive Breast Feeding Prazo: Baseline	Association of diarrheal chronicity with early non-exclusive breast feeding will be assessed using the Fisher exact test.	Baseline
Association of Dehydration Severity With Age Prazo: Baseline, Days 3, 7, 14 and up to Day 21	Association of dehydration severity with age will be assessed using the Kruskal-Wallis test.	Baseline, Days 3, 7, 14 and up to Day 21
Association of Dehydration Severity With Height Prazo: Baseline, Days 3, 7, 14 and up to Day 21	Association of dehydration severity with height will be assessed using the Kruskal-Wallis test.	Baseline, Days 3, 7, 14 and up to Day 21
Association of Dehydration Severity With Weight Prazo: Baseline, Days 3, 7, 14 and up to Day 21	Association of dehydration severity with weight will be assessed using the Kruskal-Wallis test.	Baseline, Days 3, 7, 14 and up to Day 21
Association of Dehydration Severity With Sex Prazo: Baseline, Days 3, 7, 14 and up to Day 21	Association of dehydration severity with sex will be assessed using the Fisher exact test.	Baseline, Days 3, 7, 14 and up to Day 21
Association of Dehydration Severity With HIV Status Prazo: Baseline, Days 3, 7, 14 and up to Day 21	Association of dehydration severity with HIV status will be assessed using the Fisher exact test.	Baseline, Days 3, 7, 14 and up to Day 21
Association of Dehydration Severity With Malnutrition Prazo: Baseline, Days 3, 7, 14 and up to Day 21	Association of dehydration severity with malnutrition will be assessed using the Fisher exact test.	Baseline, Days 3, 7, 14 and up to Day 21
Association of Dehydration Severity With Growth Faltering Prazo: Baseline, Days 3, 7, 14 and up to Day 21	Association of dehydration severity with growth faltering will be assessed using the Fisher exact test.	Baseline, Days 3, 7, 14 and up to Day 21
Association of Dehydration Severity With Early Weaning Prazo: Baseline, Days 3, 7, 14 and up to Day 21	Association of dehydration severity with early weaning will be assessed using the Fisher exact test.	Baseline, Days 3, 7, 14 and up to Day 21
Association of Dehydration Severity With Non-Exclusive Breast Feeding Prazo: Baseline, Days 3, 7, 14 and up to Day 21	Association of dehydration severity with early non-exclusive breast feeding will be assessed using the Fisher exact test.	Baseline, Days 3, 7, 14 and up to Day 21
Number of Oocysts Prazo: Baseline, Days 3, 7, 14 and up to Day 21		Baseline, Days 3, 7, 14 and up to Day 21
Proportion of Participants Shedding Oocysts Prazo: Baseline, Days 3, 7, 14 and up to Day 21		Baseline, Days 3, 7, 14 and up to Day 21
Number of Participants by Parasite Presence Measured by Microscopy and the QuikChek™ Cryptosporidium Rapid Diagnostic Test (RDT) Prazo: Baseline, Days 3, 7, 14 and up to Day 21		Baseline, Days 3, 7, 14 and up to Day 21
Number of Participants Screened for Each Site by Time of Year Prazo: Baseline	Number of participants screened (i.e., present with diarrheal illness) for each site by time of year (i.e., per season).	Baseline
Number of Participants Enrolled for Each Site by Time of Year Prazo: Baseline	Number of participants enrolled (i.e., Cryptosporidium positive) for each site by time of year (i.e., per season).	Baseline

Colaboradores e Investigadores

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Patrocinador

Novartis Pharmaceuticals

Investigadores

Diretor de estudo: Novartis Pharmaceuticals, Novartis Pharmaceuticals

Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo (Real)

9 de janeiro de 2026

Conclusão Primária (Estimado)

19 de maio de 2027

Conclusão do estudo (Estimado)

19 de maio de 2027

Datas de inscrição no estudo

Enviado pela primeira vez

29 de junho de 2026

Enviado pela primeira vez que atendeu aos critérios de CQ

15 de julho de 2026

Primeira postagem (Real)

21 de julho de 2026

Atualizações de registro de estudo

Última Atualização Postada (Real)