Klinisk forsøg med Kryptosporidiose - Kliniske forsøgsregister

Studieoversigt

Status

Rekruttering

Betingelser

Kryptosporidiose

Undersøgelsestype

Observationel

Tilmelding (Anslået)

30

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

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

Undersøgelse 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

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

Barn

Tager imod sunde frivillige

Ingen

Prøveudtagningsmetode

Ikke-sandsynlighedsprøve

Studiebefolkning

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

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Antal grupper/kohorter

1

Kohorter og interventioner

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

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål	Foranstaltningsbeskrivelse	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	Foranstaltningsbeskrivelse	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

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Novartis Pharmaceuticals

Efterforskere

Studieleder: Novartis Pharmaceuticals, Novartis Pharmaceuticals

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

9. januar 2026

Primær færdiggørelse (Anslået)

19. maj 2027

Studieafslutning (Anslået)

19. maj 2027

Datoer for studieregistrering

Først indsendt

29. juni 2026

Først indsendt, der opfyldte QC-kriterier

15. juli 2026

Først opslået (Faktiske)

21. juli 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)