Lassa Fever Clinical Course and Prognostic Factors in Nigeria
Ключавыя словы
Рэферат
Апісанне
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.
Даты
| Апошняя праверка: | 12/31/2019 |
| Упершыню прадстаўлена: | 08/29/2018 |
| Меркаваная колькасць заявак прадстаўлена: | 08/29/2018 |
| Першае паведамленне: | 08/30/2018 |
| Апошняе абнаўленне адпраўлена: | 01/06/2020 |
| Апошняе абнаўленне апублікавана: | 01/08/2020 |
| Фактычная дата пачатку даследавання: | 04/04/2018 |
| Разліковая дата першаснага завяршэння: | 06/29/2022 |
| Разліковая дата завяршэння даследавання: | 06/29/2022 |
Стан альбо хвароба
Ўмяшанне / лячэнне
Other: Non interventional research
Фаза
Групы ўзбраенняў
| Рука | Ўмяшанне / лячэнне |
|---|---|
| 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 |
Крытэрыі прыдатнасці
| Пол, прыдатны для навучання | All |
| Метад адбору проб | Probability Sample |
| Прымае здаровых валанцёраў | Так |
| Крытэрыі | 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 |
Вынік
Першасныя вынікі
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).]
Меры другаснага выніку
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]
