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Lassa Fever Clinical Course and Prognostic Factors in Nigeria (LASCOPE)

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ClinicalTrials.gov Identifier: NCT03655561
Recruitment Status : Recruiting
First Posted : August 31, 2018
Last Update Posted : August 31, 2018
Sponsor:
Collaborators:
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
Information provided by (Responsible Party):
Denis Malvy, Alliance for International Medical Action

Brief Summary:
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.

Condition or disease Intervention/treatment
Lassa Fever Lassa Virus Infection Pregnancy Complications Acute Kidney Injury Acute Kidney Failure Coma Other: Non interventional research

Detailed Description:

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.


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Study Type : Observational [Patient Registry]
Estimated Enrollment : 1200 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 60 Days
Official Title: Observational Cohort Study of Lassa Fever Clinical Course and Prognostic Factors in an Epidemic Context in Nigeria
Actual Study Start Date : April 5, 2018
Estimated Primary Completion Date : June 30, 2022
Estimated Study Completion Date : June 30, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fever

Group/Cohort Intervention/treatment
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
Other: Non interventional research
Participants are receiving the standard of care according to Nigerian Center for Disease Control (NCDC) Standard Operating Procedures for Lassa fever case management. This include the administration of intravenous ribavirin for Lassa confirmed cases as well as critically-ill Lassa suspected cases.

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
Other: Non interventional research
Participants are receiving the standard of care according to Nigerian Center for Disease Control (NCDC) Standard Operating Procedures for Lassa fever case management. This include the administration of intravenous ribavirin for Lassa confirmed cases as well as critically-ill Lassa suspected cases.




Primary Outcome Measures :
  1. Overall mortality [ Time Frame: 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.


Secondary Outcome Measures :
  1. Acute kidney injury [ Time Frame: Within 60 days after admission ]
    Acute kidney injury or failure according to RIFLE criteria

  2. Mother status at the end of pregnancy [ Time Frame: Delivery ]
    Is the mother dead or alive at the end of pregnancy

  3. Type of pregnancy termination [ Time Frame: Delivery ]
    Spontaneous delivery, induced delivery, cesarean section, medical interruption, miscarriage

  4. Pregnancy complications [ Time Frame: Delivery ]
    Reporting any type of pregnancy complications

  5. Newborn status at birth [ Time Frame: Birth ]
    Is the newborn dead or alive

  6. Newborn status at day 30 [ Time Frame: Day 30 after birth ]
    Is the newborn dead or alive

  7. Newborn status at day 60 [ Time Frame: Day 60 after birth ]
    Is the newborn dead or alive


Biospecimen Retention:   Samples With DNA
Leftover blood, urine, milk and any other bodily fluid samples. Option for genetic analyses regarding immunity against infectious diseases.


Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

All the patients admitted in an isolation ward of one of the participating sites (tertiary hospitals) in Nigeria for a suspected or already RT-PCR confirmed diagnosis of Lassa fever during the study period are eligible to participate in LASCOPE.

The newborns from women infected by Lassa virus (RT-PCR confirmed) during their pregnancy are also eligible to participate, with the mother's agreement.

Criteria

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:


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03655561


Contacts
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Contact: Alexandre Duvignaud, MD, MSc +33557822220 alex.duvignaud@gmail.com
Contact: Marie Jaspard, MD, MSc +22521755960 marie.jaspard@coral.alima.ngo

Locations
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Nigeria
Owo Federal Medical Centre (Owo FMC) Recruiting
Owo, Ondo, Nigeria, PMB 1053
Contact: Oladele O Ayodeji, MD    +2348035094545    femiayodeji@yahoo.com   
Contact: Ijeoma C Etafo, MD    +2348062077773    eziunorijeoma2014@yahoo.com   
Sponsors and Collaborators
Alliance for International Medical Action
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
Investigators
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Principal Investigator: Denis Malvy, MD, PhD Inserm 1219 - Infectious Diseases in Ressource Limited Countries
Principal Investigator: Oladele O Ayodeji, MD Owo Federal Medical Centre

Additional Information:

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Responsible Party: Denis Malvy, Professor of Infectious Diseases and Tropical Medicine, Alliance for International Medical Action
ClinicalTrials.gov Identifier: NCT03655561     History of Changes
Other Study ID Numbers: LAS001
First Posted: August 31, 2018    Key Record Dates
Last Update Posted: August 31, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: IPD underlying results in scientific publications will be made available through the deposition of a datafile in a public data repository.
Supporting Materials: Study Protocol
Time Frame: Upon publication of related scientific works (undefined duration).
Access Criteria: Free access.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Denis Malvy, Alliance for International Medical Action:
Lassa fever
Lassa virus
Nigeria
Pregnancy
Acute kidney injury

Additional relevant MeSH terms:
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Fever
Acute Kidney Injury
Virus Diseases
Renal Insufficiency
Pregnancy Complications
Lassa Fever
Body Temperature Changes
Signs and Symptoms
Kidney Diseases
Urologic Diseases
Arenaviridae Infections
RNA Virus Infections
Hemorrhagic Fevers, Viral