Study on Seroprevalence and Risk Factors of Coxiella Burnetii (Q Fever) in the South of Reunion Island

q Fever Clinical Trial

— E-Q-RUN  

Official title:

Study on Seroprevalence and Risk Factors of Coxiella Burnetii (Q Fever) in the South of Reunion Island

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02898402
• Other study ID #: 2013/CHU/04
• Status: Completed
• Phase: N/A
• First received: September 8, 2016
• Last updated: September 8, 2016
• Start date: January 2014
• Est. completion date: January 2015

Study information

• Verified date: September 2016
• Source: Centre Hospitalier Universitaire de la Réunion
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Comité consultatif sur le traitement de l'information en matière de recherche dans le domaine de la santé
• Study type: Observational

Clinical Trial Summary

Emergent and infectious diseases are a public health priority on Reunion Island. Amongst public health threats, the infection due to Coxiella burnetii (Q fever) seems to have appeared on Reunion island in 2007 with two hospitalised confirmed cases (one death) and one probable case with a goat farmer.

According to the investigator, the diffusion of C. burnetti is more ancient and such diagnosis have been made in the last 30 years with 80 positive serologies identified between 2005 and 2011.

Considering the high epidemic power of this disease, its often silent clinical expression and its life-threatening condition, the principal investigator wishes to perform a sero-epidemiological study in order to establish or to reject the risk of emergence of Q fever in Reunion island.

The study will be performed on pregnant women because Q fever is responsible for particular complications during pregnancy and because the number of pregnancy followed on Reunion island is stable from one year to the other. The pregnant women population presenting the same exposure criteria as the general population, this population will be used to extrapolate to the general population of the island.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 3500
• Est. completion date: January 2015
• Est. primary completion date: January 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• all pregnant women coming to the two maternity hospitals located in the south of Reunion island during inclusion period who have been informed and gave consent to participate to the study.

Exclusion Criteria:

• women aged less than 18 years old.

• women who did not give their consent

• women for whom it is not possible to perform the blood sample.

Study Design

Observational Model: Ecologic or Community, Time Perspective: Prospective

Related Conditions & MeSH terms

• Fever
• Q Fever

Intervention

Procedure:
• blood sample and questionnaire
In addition to normal blood sample performed at entry before delivery, an extra 5 ml blood sample will be taken to establish Q fever serodiagnosis and a short questionnaire will be filled in for clinical and epidemiological data.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de la Réunion

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	prevalence of Coxiella burnetii infection in general population in the south of Reunion island	Q fever seroprevalence obtained from blood samples taken on pregnant women hospitalised for delivery will be used to extrapolate to Reunion island general population Q fever seroprevalence.	at inclusion	No