Klinische Studien zur Kryptosporidiose - Register für klinische Studien

Studienübersicht

Status

Rekrutierung

Bedingungen

Kryptosporidiose

Studientyp

Beobachtungs

Einschreibung (Geschätzt)

30

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienkontakt

Name: Novartis Pharmaceuticals
Telefonnummer: +41613241111
E-Mail: novartis.email@novartis.com

Studieren Sie die Kontaktsicherung

Name: Novartis Pharmaceuticals

Studienorte

Kenia
- Nyanza
  - Kisumu, Nyanza, Kenia, 40100
    - Rekrutierung
    - Novartis Investigative Site
Malaysia
- - Kuala Lumpur, Malaysia, 56000
    - Rekrutierung
    - Novartis Investigative Site
- Pahang
  - Kuantan, Pahang, Malaysia, 25200
    - Rekrutierung
    - Novartis Investigative Site
Sambia
- - Lusaka, Sambia, 10101
    - Rekrutierung
    - Novartis Investigative Site

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

Kind

Akzeptiert gesunde Freiwillige

Nein

Probenahmeverfahren

Nicht-Wahrscheinlichkeitsprobe

Studienpopulation

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

Beschreibung

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.

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

Anzahl der Gruppen / Kohorten

1

Kohorten und Interventionen

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

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme	Maßnahmenbeschreibung	Zeitfenster
Number and Percentage of Participants by Chronicity of Diarrhea Zeitfenster: 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 Zeitfenster: 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 Zeitfenster: Baseline, Days 3, 7, 14 and up to Day 21		Baseline, Days 3, 7, 14 and up to Day 21

Sekundäre Ergebnismessungen

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

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

Novartis Pharmaceuticals

Ermittler

Studienleiter: Novartis Pharmaceuticals, Novartis Pharmaceuticals

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Tatsächlich)

9. Januar 2026

Primärer Abschluss (Geschätzt)

19. Mai 2027

Studienabschluss (Geschätzt)

19. Mai 2027

Studienanmeldedaten

Zuerst eingereicht

29. Juni 2026

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

15. Juli 2026

Zuerst gepostet (Tatsächlich)

21. Juli 2026

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)