Klinisk prøve på Kryptosporidiose - Klinisk prøveregister

Studieoversikt

Status

Rekruttering

Forhold

Kryptosporidiose

Studietype

Observasjonsmessig

Registrering (Antatt)

30

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiekontakt

Navn: Novartis Pharmaceuticals
Telefonnummer: +41613241111
E-post: novartis.email@novartis.com

Studer Kontakt Backup

Navn: Novartis Pharmaceuticals

Studiesteder

Kenya
- Nyanza
  - Kisumu, Nyanza, Kenya, 40100
    - Rekruttering
    - Novartis Investigative Site
Malaysia
- - Kuala Lumpur, Malaysia, 56000
    - Rekruttering
    - Novartis Investigative Site
- Pahang
  - Kuantan, Pahang, Malaysia, 25200
    - Rekruttering
    - Novartis Investigative Site
Zambia
- - Lusaka, Zambia, 10101
    - Rekruttering
    - Novartis Investigative Site

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

Barn

Tar imot friske frivillige

Nei

Prøvetakingsmetode

Ikke-sannsynlighetsprøve

Studiepopulasjon

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

Beskrivelse

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.

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

Antall grupper / kohorter

1

Kohorter og intervensjoner

Gruppe / Kohort
Cryptosporidiosis Cohort Pediatric participants with diarrhea due to Cryptosporidium infection.

Hva måler studien?

Primære resultatmål

Resultatmål	Tiltaksbeskrivelse	Tidsramme
Number and Percentage of Participants by Chronicity of Diarrhea Tidsramme: 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 Tidsramme: 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 Tidsramme: Baseline, Days 3, 7, 14 and up to Day 21		Baseline, Days 3, 7, 14 and up to Day 21

Sekundære resultatmål

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

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Novartis Pharmaceuticals

Etterforskere

Studieleder: Novartis Pharmaceuticals, Novartis Pharmaceuticals

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

9. januar 2026

Primær fullføring (Antatt)

19. mai 2027

Studiet fullført (Antatt)

19. mai 2027

Datoer for studieregistrering

Først innsendt

29. juni 2026

Først innsendt som oppfylte QC-kriteriene

15. juli 2026

Først lagt ut (Faktiske)

21. juli 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)