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Lassa Fever Clinical Course and Prognostic Factors in Nigeria

Yalnız qeydiyyatdan keçmiş istifadəçilər məqalələri tərcümə edə bilərlər
Giriş / Qeydiyyatdan keçin
Bağlantı panoya saxlanılır
Statusİşə qəbul
Sponsorlar
Alliance for International Medical Action
Əməkdaşlar
Institut National de la Santé Et de la Recherche Médicale, France
University of Oxford
Owo Federal Medical Center
Irrua Specialist Teaching Hospital
Bernhard Nocht Institute for Tropical Medicine
University Hospital, Bordeaux
University of Bordeaux
PACCI Program
African coaLition for Epidemic Research, Response and Training

Açar sözlər

Mücərrəd

The ivestigators propose to conduct a nationwide (Nigeria), prospective, non-interventional cohort study describing the clinical course, biological characteristics, case management and outcomes in patients hospitalized for a suspected or confirmed diagnosis of Lassa fever in tertiary medical facilities situated in the most affected Nigerian states. Special focuses will be made on situations at risk of bad outcome such as pregnancies, acute kidney injury and electrolytic imbalance in patients with confirmed Lassa fever. Participants for which the diagnosis of Lassa fever will be finally excluded by RT-PCR will constitute the control group.

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

Lassa Fever
Lassa Virus Infection
Pregnancy Complications
Acute Kidney Injury
Acute Kidney Failure
Coma

Müdaxilə / müalicə

Other: Non interventional research

Faza

-

Qol Qrupları

QolMüdaxilə / 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 CinslərAll
Nümunə götürmə metoduProbability Sample
Sağlam Könüllüləri qəbul edirBəli
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).]

Mortality rate among participants assessed at final visit.

İkincili Nəticə Tədbirləri

1. Acute kidney injury [Within 60 days after admission]

Acute kidney injury or failure according to RIFLE criteria

2. Mother status at the end of pregnancy [Delivery]

Is the mother dead or alive at the end of pregnancy

3. Type of pregnancy termination [Delivery]

Spontaneous delivery, induced delivery, cesarean section, medical interruption, miscarriage

4. Pregnancy complications [Delivery]

Reporting any type of pregnancy complications

5. Newborn status at birth [Birth]

Is the newborn dead or alive

6. Newborn status at day 30 [Day 30 after birth]

Is the newborn dead or alive

7. Newborn status at day 60 [Day 60 after birth]

Is the newborn dead or alive

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