This pilot study is designed to evaluate the feasibility of field activities and if necessary adjust the methods for the full-scale study. Primary Objective: to evaluate the recruitment, retention and compliance rates for a prospective cohort study…
ID
Source
Brief title
Condition
- Bacterial infectious disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
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 outcome
- 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
Background summary
Decades after the introduction of whole-cell and acellular pertussis vaccines
many countries, including the Netherlands, has seen an increase in pertussis
incdience. To develop novel, improved pertussis vaccines, it is essential that
immunological biomarkers of protection are identified.
The Dutch healtcare system is well-suited to rapidly and efficiently detect
local outbreaks of pertussis. As a consequence of the relatively recent
introduction of acellular pertussis vaccines (in 2005), Dutch high-school
adolescents comprise a mixed population of individuals who were either
vaccinated during infancy with the 'old' whole-cell or with the 'new' acellular
pertussis vaccines. To identify immunological biomarkers of protection, we want
to initiate an epidemiological investigation of pertussis transmission and
colonisation amongst high-school students and their immune markers. Before a
larger, full-scale study can be started, the current protocol has been designed
as a pilot study.
Study objective
This pilot study is designed to evaluate the feasibility of field activities
and if necessary adjust the methods for the full-scale study.
Primary Objective:
to evaluate the recruitment, retention and compliance rates for a prospective
cohort study, and to assess the feasibility of sampling procedures, frequency
and information collection for the aim of optimizing the proposed full-scale
study.
Secondary Objective(s):
to descriptively analyse study outcomes (colonization, disease and immune
markers) to support powering analyses of full-scale study
Study design
This is a community-based, monocenter, prospective observational cohort pilot
study with invasive procedures.
Study burden and risks
Holding an arm when taking a blood sample may feel uncomfortable and the
puncture of the needle may be a bit painful and a bruise may occur. If desired
an anesthetic cream/spray/plaster will be used so that the puncture will hardly
be felt. The collection of nasal fluid can cause sneezing and watery eyes. This
is of a temporary nature and there are no major risks associated with
participation.
Philips van Leydenlaan 15
Nijmegen 6525EX
NL
Philips van Leydenlaan 15
Nijmegen 6525EX
NL
Listed location countries
Age
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
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
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL72245.091.19 |
| Other | Wordt geregistreerd bij clinicaltrials.gov |