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NCT05318235: VIOOL
Virus Interactions in the Respiratory Tract; a Cohort Study With Children
trial testing No intervention in Respiratory Tract Infections in 229 participants. Completed in 23 April 2024.
23 April 2024
Quick facts
| Lead sponsor | UMC Utrecht |
|---|---|
| Status | Completed |
| Study type | OBSERVATIONAL |
| Enrollment | 229 |
| Start date | 15 September 2021 |
| Primary completion | 23 April 2024 |
| Estimated completion | 23 April 2024 |
| Sites | 1 location across Netherlands |
Drugs / interventions tested
- No intervention
Conditions studied
- Respiratory Tract Infections — all drugs for Respiratory Tract Infections →
- Coinfection — all drugs for Coinfection →
Sponsor
UMC Utrecht — full company profile →
Who can join
Adults 6 Weeks to 4, any sex, with Respiratory Tract Infections or Coinfection. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Rationale: Prevention of virus induced acute respiratory infection (ARI) is a public health priority. As different respiratory virus infections can interact with each other, occurrence of one virus may influence occurrence of other virus infections. Such interactions can have implications for the effects of vaccination on non-target diseases. In this project, we will quantify such interactions between respiratory viruses by longitudinally studying a cohort of young children. Objective: To quantify the strength and direction of interactions between important respiratory virus infections in young children. Study design: This is a prospective observational cohort study. Study population: Children between 6 weeks and 4 years of age residing in the Utrecht area of the Netherlands. Main study parameters/endpoints: Frequency, timing and sequences of occurrence of respiratory virus infections will be studied for each participant using weekly collected nasal specimens during 16 weeks follow-up. Detection will be based on PCR testing for a panel of common respiratory viruses. From these data, estimation of virus interaction parameters will be based on self-controlled-case series analysis. Nature and extend of the burden and risks associated with participation, benefit and group relatedness: This study is observational in nature. There will be no direct benefit to research participants. The study includes biological sampling. The results of the tests done on these samples may not contribute to improving the participant's health. Minimal inconvenience and discomfort to the participant may arise from study visits and biological sampling.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT05318235
- Europe PMC full search
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT05318235 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by UMC Utrecht
- Last refreshed: 9 May 2024
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05318235.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing