Lassa Fever Clinical Course and Prognostic Factors in Nigeria
Açar sözlər
Mücərrəd
Təsvir
The LASCOPE project refers to a nationwide, prospective, non-interventional cohort study describing the clinical course, biological characteristics, case management and outcomes in patients hospitalized for a suspected or already RT-PCR confirmed diagnosis of Lassa fever in tertiary medical facilities situated in the most affected Nigerian states. The project will start during the 2018 Lassa fever season and is intended to be extended to at least three sites throughout Nigeria on a 3 years period.
The investigators will try to depict the pathophysiological mechanisms underlying the conditions associated to a fatal outcome in patients with RT-PCR confirmed Lassa fever, with a special focus on pregnancies, acute renal injury and electrolytic imbalance.
Population and setting - Participants will be recruited in tertiary reference hospitals for Lassa fever case management in the Nigerian States identified to have the highest burden, including Owo Federal Medical Center (OFMC), Owo, Ondo State as a pilot site (list to be completed according to the outbreak dynamics).
Inclusion criteria - All the patients hospitalized for suspected or already RT-PCR confirmed Lassa fever will be eligible (no age restriction). Newborns from mothers participating in the study will also be eligible.
Sample size - Given the descriptive purpose of the study, there is no pre-determined sample size.
Follow-up - After informed consent collection, data concerning the patient's life habits, contacts, disease history, clinical and biological status, management and outcome will be collected anonymously upon admission and throughout the hospital stay. The follow-up will end 60 days after admission (60 days after delivery for pregnant women and 60 days after birth for newborns) with a phone call or a home visit (or an outpatient visit at hospital if needed).
Leftover biological samples, if any, will be stored for further analysis with the participant's agreement. The biobank will be registered once constituted and further use of stored samples will be subject to material transfer agreements.
Tarixlər
| Son Doğrulandı: | 12/31/2019 |
| İlk təqdim: | 08/29/2018 |
| Təxmini qeydiyyat təqdim edildi: | 08/29/2018 |
| İlk Göndərmə: | 08/30/2018 |
| Son Yeniləmə Göndərildi: | 01/06/2020 |
| Son Yeniləmə Göndərildi: | 01/08/2020 |
| Həqiqi Təhsilin Başlama Tarixi: | 04/04/2018 |
| Təxmini İlkin Tamamlanma Tarixi: | 06/29/2022 |
| Təxmini İşin Tamamlanma Tarixi: | 06/29/2022 |
Vəziyyət və ya xəstəlik
Müdaxilə / müalicə
Other: Non interventional research
Faza
Qol Qrupları
| Qol | Müdaxilə / müalicə |
|---|---|
| Confirmed Lassa fever cases Participants with a clinical presentation consistent with acute Lassa virus disease and a positive result for Lassa specific RT-PCR obtained before or after inclusion | |
| Non-Lassa cases (controls) Participants with a clinical presentation consistent with acute Lassa virus disease but subsequently found to have a negative result for Lassa specific RT-PCR |
Uyğunluq Kriteriyaları
| Təhsilə Uyğun Cinslər | All |
| Nümunə götürmə metodu | Probability Sample |
| Sağlam Könüllüləri qəbul edir | Bəli |
| Kriteriyalar | Inclusion Criteria: - EITHER admission (inpatient) for suspected or already RT-PCR confirmed Lassa fever OR newborn from woman infected with Lassa virus during pregnancy - AND written informed consent of the patient or his/her legal representative (specific procedures for: immature minors, mature minors, incapable adults and unconscious adults; witnessed consent in case of illiteracy) Exclusion Criteria: - None |
Nəticə
İlkin nəticə tədbirləri
1. Overall mortality [60 days after admission (day 60 after delivery for pregnant women and day 60 after birth for newborns from infected pregnant women).]
İkincili Nəticə Tədbirləri
1. Acute kidney injury [Within 60 days after admission]
2. Mother status at the end of pregnancy [Delivery]
3. Type of pregnancy termination [Delivery]
4. Pregnancy complications [Delivery]
5. Newborn status at birth [Birth]
6. Newborn status at day 30 [Day 30 after birth]
7. Newborn status at day 60 [Day 60 after birth]
