Essais cliniques sur Cryptosporidiose - Registre des essais cliniques

Aperçu de l'étude

Statut

Recrutement

Les conditions

Cryptosporidiose

Type d'étude

Observationnel

Inscription (Estimé)

30

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Coordonnées de l'étude

Nom: Novartis Pharmaceuticals
Numéro de téléphone: +41613241111
E-mail: novartis.email@novartis.com

Sauvegarde des contacts de l'étude

Nom: Novartis Pharmaceuticals

Lieux d'étude

Kenya
- Nyanza
  - Kisumu, Nyanza, Kenya, 40100
    - Recrutement
    - Novartis Investigative Site
Malaisie
- - Kuala Lumpur, Malaisie, 56000
    - Recrutement
    - Novartis Investigative Site
- Pahang
  - Kuantan, Pahang, Malaisie, 25200
    - Recrutement
    - Novartis Investigative Site
Zambie
- - Lusaka, Zambie, 10101
    - Recrutement
    - Novartis Investigative Site

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

Enfant

Accepte les volontaires sains

Non

Méthode d'échantillonnage

Échantillon non probabiliste

Population étudiée

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

La description

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.

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

Nombre de groupes / cohortes

1

Cohortes et interventions

Groupe / Cohorte
Cryptosporidiosis Cohort Pediatric participants with diarrhea due to Cryptosporidium infection.

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats	Description de la mesure	Délai
Number and Percentage of Participants by Chronicity of Diarrhea Délai: 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 Délai: 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 Délai: Baseline, Days 3, 7, 14 and up to Day 21		Baseline, Days 3, 7, 14 and up to Day 21

Mesures de résultats secondaires

Mesure des résultats	Description de la mesure	Délai
Association of Diarrheal Chronicity With Age Délai: Baseline	Association of diarrheal chronicity with age will be assessed using the Kruskal-Wallis test.	Baseline
Association of Diarrheal Chronicity With Height Délai: Baseline	Association of diarrheal chronicity with height will be assessed using the Kruskal-Wallis test.	Baseline
Association of Diarrheal Chronicity With Weight Délai: Baseline	Association of diarrheal chronicity with weight will be assessed using the Kruskal-Wallis test.	Baseline
Association of Diarrheal Chronicity With Sex Délai: Baseline	Association of diarrheal chronicity with sex will be assessed using the Fisher exact test.	Baseline
Association of Diarrheal Chronicity With HIV Status Délai: Baseline	Association of diarrheal chronicity with HIV status will be assessed using the Fisher exact test.	Baseline
Association of Diarrheal Chronicity With Malnutrition Délai: Baseline	Association of diarrheal chronicity with malnutrition will be assessed using the Fisher exact test.	Baseline
Association of Diarrheal Chronicity With Growth Faltering Délai: Baseline	Association of diarrheal chronicity with growth faltering will be assessed using the Fisher exact test.	Baseline
Association of Diarrheal Chronicity With Early Weaning Délai: 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 Délai: 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 Délai: 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 Délai: 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 Délai: 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 Délai: 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 Délai: 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 Délai: 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 Délai: 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 Délai: 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 Délai: 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 Délai: 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 Délai: 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) Délai: 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 Délai: 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 Délai: Baseline	Number of participants enrolled (i.e., Cryptosporidium positive) for each site by time of year (i.e., per season).	Baseline

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

Novartis Pharmaceuticals

Les enquêteurs

Directeur d'études: Novartis Pharmaceuticals, Novartis Pharmaceuticals

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Réel)

9 janvier 2026

Achèvement primaire (Estimé)

19 mai 2027

Achèvement de l'étude (Estimé)

19 mai 2027

Dates d'inscription aux études

Première soumission

29 juin 2026

Première soumission répondant aux critères de contrôle qualité

15 juillet 2026

Première publication (Réel)

21 juillet 2026

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)