Q Herpen II, Post outbreak screening in a Q fever high incidence area for late consequences of Q fever including chronic Q Fever.

Q Herpen II, Post outbreak screening in a Q fever high incidence area for late consequences of Q fever including chronic Q Fever. - Q Herpen II

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON38602

Enrollment

2200

Registered

2013-11-19

Start date

2014-02-01

Completion date

Unknown

Last updated

2024-04-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Q fever

Interventions

None listed

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Resides in the postal code area 5373 and is 18 years of age or older and of sound mind and judgement

Exclusion criteria

Exclusion criteria: Living outside postal code area 5373 or younger than 18 years of age or not of sound mind and judgement

Design outcomes

Primary

Measure	Time frame
1. IgG phase I antibody titre as measured with IFA (seroprevalence of C.burnetii) 2. Presence (or not) of possible chronic Q fever* with a safety margin for those with a risk factor (see comment below). 3. Presence (or not) of severe fatigue/other morbidity of those that have or have not been infected with C. burnetii There is no international consensus on the definition of chronic Q fever (Wielders et al 2013) and different IFA antibody titre cut-off point are applied. "Possible" chronic Q fever is defined by the Dutch Q fever Consensus Group as an IFA antibody titre against IgG phase I of C. burnetii >=1:1024 (Wegdam-Blans et al. 2012). The diagnosis possible* or proven chronic Q fever can only be made after referral to a Q fever centre as this requires PCR test results, and a specialist medical assessment of clinical symptoms, risk factors and diagnostic imaging results, in addition to the IFA titre. In this study (as in other current studies) we apply a safety margin for those with a known risk factor with an IgG phase I >= 1:512 (one IFA titration step lower).	—

Measure

Time frame

1. IgG phase I antibody titre as measured with IFA (seroprevalence of C.burnetii) 2. Presence (or not) of *possible* chronic Q fever* with a safety margin for those with a risk factor (see comment below). 3. Presence (or not) of severe fatigue/other morbidity of those that have or have not been infected with C. burnetii *There is no international consensus on the definition of chronic Q fever (Wielders et al 2013) and different IFA antibody titre cut-off point are applied. "Possible" chronic Q fever is defined by the Dutch Q fever Consensus Group as an IFA antibody titre against IgG phase I of C. burnetii >=1:1024 (Wegdam-Blans et al. 2012). The diagnosis *possible* or *proven* chronic Q fever can only be made after referral to a Q fever centre as this requires PCR test results, and a specialist medical assessment of clinical symptoms, risk factors and diagnostic imaging results, in addition to the IFA titre. In this study (as in other current studies) we apply a safety margin for those with a known risk factor with an IgG phase I >= 1:512 (one IFA titration step lower).

—

Secondary

Measure	Time frame
1. Height of cytokine response to C. burnetii as measured by IFNg test 2. Health status as measured by scores in NCSI and EQ-5D Other study parameters: Characteristics of participants, including age, sex, ses, comorbidity, and proximity to putative source(s) (farms). Information on these variables will be related to the outcome measures described under the primary and secundary study parameters.	—

Countries

Netherlands

Outcome results