whooping cough (pertussis)
Conditions
Interventions
None listed
Sponsors
Radboud Universitair Medisch Centrum
Eligibility
Age
12 Years to 99 Years
Inclusion criteria
Inclusion criteria: For index case (= patient): • Laboratory-confirmed pertussis • Attending any grade in a pre-trade (grades 1-4) or standard (grades 1-5 or 1-6) high-school in Gelderland, Utrecht, Overijssel, Noord-Brabant • At least 12 years of age For contacts (= healthy subject) : • Be one of at least 8 contacts among the cluster of consenting contacts in the same school as the index case • At least 12 years of age • No recorded diagnosis of pertussis prior to study start • Regular daily attendance to the same school as index case over the study period.
Exclusion criteria
Exclusion criteria: Participants with contact with any individual of increased risk in their immediate surroundings as defined by the national guidelines (https://lci.rivm.nl/richtlijnen/kinkhoest).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| In order to evaluate feasibility of the full-scale study as per the primary objective of the pilot study the following endpoints will be collected: Recruitment rate: number of index case contacts consenting to participate among the school*s eligible population of index case contacts. In addition, each eligible student who refuses to enrol will be offered to volunteer the reason for refusal. Retention rate: number of participants completing the follow-up period among all consenting participants, and duration of follow-up completed for each participant. In addition, each participant who exits the study before end of follow-up will be offered to volunteer a reason for exiting. Compliance rate: number of follow-up visits and procedures completed by participants who complete the expected follow-up period or less. In addition, participants who miss/refuse follow-up visits and procedures will be offered to volunteer a reason. Data collection rate: number of valid results/complete datasets by each participant. | — |
Secondary
| Measure | Time frame |
|---|---|
| - Data collection on participants (e.g. gender, age, vaccination status, presentation and evolution of clinical symptoms, etc) - Detection of B. pertussis infection, defined as at least one time point or multiple consecutive time points with positive PCR - Immune markers: descriptive analysis of cellular and humoral immune markers in blood and mucosal lining fluid | — |
Countries
Netherlands
Outcome results
None listed