Cohort of Patients Infected by an Arbovirus
Ključne riječi
Sažetak
Opis
Principal objective To identify demographic, clinical, biological, virologic, immunologic and genetic factors associated with or predictive of severe complications of arbovirus infections (shock, internal bleeding, organ failure, death) in a cohort of children and adults with confirmed arbovirus infections, in France.
Secondary objective
To identify demographic, clinical, biological, virologic, immunologic and genetic factors predictive of altered quality of life after confirmed an acute arbovirus infection. Onset of specific complications:
- Hemorrhagic fever (dengue :WHO criteria..)
- Neurological disorders (West Nile virus infection, Zika virus infection, Japanese encephalitis…)
- Chronic chikungunya (persistent musculoskeletal symptoms for more than three months after symptoms onset)
Datumi
| Posljednja provjera: | 12/31/2018 |
| Prvo podneseno: | 02/22/2010 |
| Predviđena prijava predata: | 04/05/2010 |
| Prvo objavljeno: | 04/07/2010 |
| Zadnje ažuriranje poslato: | 07/21/2019 |
| Posljednje ažuriranje objavljeno: | 07/23/2019 |
| Stvarni datum početka studija: | 05/31/2010 |
| Procijenjeni datum primarnog završetka: | 06/30/2021 |
| Predviđeni datum završetka studije: | 06/30/2021 |
Stanje ili bolest
Intervencija / liječenje
Other: biological sample collection
Other: quality of life questionnaire EuroQol®
Other: Health Assessment Questionnaire - MDHAQ and RAPID3
Faza
Kriteriji prihvatljivosti
| Polovi podobni za studiranje | All |
| Metoda uzorkovanja | Non-Probability Sample |
| Prihvaća zdrave volontere | Da |
| Kriterijumi | INCLUSION CRITERIA : 1. Adult, child or newborn. 2. Consulting a participating hospital center (emergency room, full hospitalization, day hospitalization, or outpatient visit). 3. Arbovirosis suspected or confirmed biologically: A suspected case of arbovirus infection is defined by: - The combination of clinical and biological signs observed on the day of enrollment or during the previous 7 days: fever (reported by the patient or family, or documented) and two or more of the following signs: headache, rash, myalgia, arthralgia, abdominal pain, hemorrhage, thrombocytopenia, or - Children under 6 years: the report (by family or documented) of a fever on the day of enrollment or within 7 previous days, possibly accompanied by a of pain greater than or equal to 4/10 on hetero assessment scale age age-appropriate A case of arbovirus infection confirmed biologically is defined by: - RT-PCR arbovirus positive in plasma or urine (Zika virus infection), or by detection of the NS1 antigen (dengue), or an appearance or an significant increase (multiplication of the title by four) of the G immunoglobulin directed against arbovirus in question on an early taken serum ( during the first week following the start of symptoms) and another taken at least 10 days later.. 4. Symptom onset within the seven days before the enrollment visit or within 21 days for severe forms of the disease.Possibility of follow-up throughout study period. 5. Patient or holder of parental authority registered in the French medical social security national program 6. Acceptance to participate in the study and in follow-up; informed consent of the patient (adult and minor in age to express his desire) or a legal representative (for minors, and patients unable to sign the consent form). EXCLUSION CRITERIA : 1. Newborn with a weight < 2.5 kg the days of enrollment 2. Suspected arbovirosis whose symptom onset date more than 7 days or 21 days for severe forms of the disease.Clinical diagnosis of another infection as arbovirosis 3. Confirmed Malaria Access 4. No follow-up possible after the first visit 5. Refusal to participate to the study 6. Patient or holder of parental authority not registered in the French medical social security national program |
Ishod
Primarne mjere ishoda
1. Occurrence, during follow-up (for 12 weeks following symptom onset), of shock, internal bleeding, failure of one or several organs or systems (brain, heart, lung, liver, kidney, clotting system), or death. [12 weeks]
Sekundarne mjere ishoda
1. Specific complications: Onset of hemorrhagic fever (dengue) Onset of encephalitis or neurological disorders (West Nile virus, Japanese encephalitis, Zika virus) Onset of chronic form (Chikungunya) [12 weeks]
