Condition category
Signs and Symptoms
Date applied
02/08/2019
Date assigned
14/10/2019
Last edited
02/10/2019
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
Not yet recruiting

Plain English Summary

Background and study aims
Fever is a common symptom that is defined as a higher than normal body temperature. It occurs most often in response to an infection. There are many infections that can cause fever. These infections can be due to many different types of germs (bacteria, viruses, parasites and fungi). ALERRT (The “African coalition for Epidemic Research, Response and Training”) is a group of health institutions that have come together to conduct research that aims to improve care and treatment for people who have an infectious disease in Africa.

Who can participate?
The FISSA study is about adults and children above two months presenting with a febrile illness and without hospitalization in the 14 last days.

What does the study involve?
The FISSA study is an observational study which aims to better understand the main causes of fever, by describing symptoms and signs of your health problem including its severity, the care received and the outcome of this care. The researcher will not influence the patient's care, but simply records what is happening. Medical staff who attend to participants will care for them in the same way as usual. A better understanding of these features will lead to development of new treatments and improve care.

What are the possible benefits and risks of participating?
The care that the participant will receive is exactly the same he/she would receive outside of the study context. It will entail no additional cost to and no blood test or additional examination will be required. The only additional study-specific procedure will be phone calls or on site visits, for which the participant will receive a mobile phone credits/units or a small cash for transportation compensation.

Where is the study run from?
The Study will take place in 16 care centers in sub Saharan Africa (8 in Western, 4 in Central and 4 in Eastern Africa). Recruitment will take place in 11 countries and 8 sites.

When is the study starting and how long is it expected to run for?
The first recruitment is planned for November 25, 2019 and the study is scheduled to last 12 months. Each participant will be followed up for 21 days.

Who is funding the study?
The FISSA Study is funded by European Union through a European and Developing Countries Clinical Trials Partnership (EDCTP) Program.

Who is the main contact?
Anani Badje
Coordinator of de Work Package 1 of ALERRT Network
anani.badje@pac-ci.org

Trial website

Contact information

Type

Public

Primary contact

Dr Anani Badje

ORCID ID

http://orcid.org/0000-0001-6627-2605

Contact details

18 BP 1954 Abidjan 18
Abidjan
Non applicable
Cote d'Ivoire
+225 40732415
anani.badje@gmail.com

Type

Scientific

Additional contact

Dr Robert Akpata

ORCID ID

Contact details

18 BP 1954 Abidjan 18
Abidjan
Non applicable
Cote d'Ivoire
+225 73929290
anani.badje@gmail.com

Additional identifiers

EudraCT number

Nil known

ClinicalTrials.gov number

Nil known

Protocol/serial number

Nil known

Study information

Scientific title

Clinical pattern, severity, management and outcome of acute febrile illness in sub-Saharan Africa

Acronym

FISSA

Study hypothesis

The field of infectious diseases is diverse and fast-moving. Researchers should be prepared to tackle diseases which pose major threats, such as HIV/AIDS, tuberculosis or malaria, but also new emerging diseases before they become major public health threats, such as viral hemorrhagic fevers. African clinical trials network for infectious diseases should be adaptable and have both a generic approach to clinical research and a specific approach depending on the disease. This implies building: (i) networks of clinical centres across as many countries as possible where professionals have been trained in clinical trials and are able to implement standard procedures, (ii) networks of regional and international institutions that bring them in contact with the best specialists in specific fields. To consolidate the setting of this network, to consolidate the setting of this network, the FISSA study is being implemented with the following objectives to document the clinical patterns, severity, management, and outcomes of febrile illnesses in clinical centers across West, Central and East Africa.

Ethics approval

Approved 26/09/2019, Comite National d'Ethique des Sciences de la Vie et de la Sante (CNESVS s/c de l’institut pasteur, 01 BP 490 Abidjan 01, Ivory Coast; +225 41 40 05 55; cnesvscotedivoire@gmail.com), ref: 106-19

Study design

Multi-center, prospective, observational cohort study

Primary study design

Observational

Secondary study design

Cohort study

Trial setting

Hospitals

Trial type

Other

Patient information sheet

Not available in web format, please use contact details to request a participant information sheet

Condition

Febrile illnesses

Intervention

After giving informed consent to participate in the study, each participant will be included and followed for 21 days. Contacts are planned for days 7, 14 and 21 after inclusion. These contacts will be made by telephone or through visits as far as possible. However, unscheduled calls or visits may be made at any time if necessary.

Intervention type

Other

Phase

Drug names

Primary outcome measure

Clinical status is measured using a three-category ordinal scale (resolved, not resolved, dead) at day 7.

Secondary outcome measures

1. Clinical status is measured using a three-category ordinal scale (resolved, not resolved, dead) at day 14 and day 21.
2. Illness severity:
2.1. In adults:
2.1.1. Ambulatory Simplified Acute Physiologic Score (ASAPS) and modified ASAPS (using ACVPU instead of Glasgow) at days 0, 7, 14 and 21.
2.1.2. Quick Sepsis Related Organ Failure Assessment (qSOFA) at days 0, 7, 14 and 21.
2.2. In children <5 years is measured using the ALgorithm for the MANAgement of Childhood illness (ALMANACH) criteria at days 0, 7, 14 and 21.
3. The proportion of subjects admitted to hospital is measured at day 21.
4. Length of stay in hospital (Initial and/or secondary hospitalization) is measured at day 21.
5. Number of secondary visits is measured at day 21.
6. Number and type of laboratory and radiology tests prescribed/actually performed measured at day 21.
7. Number and type of medications and supportive care prescribed/actually given measured at day 21.
8. Working diagnoses at admission and final diagnoses measured at day 21.
9. Patient satisfaction is measured using a questionnaire at day 21.

Overall trial start date

03/04/2018

Overall trial end date

25/11/2019

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

1. Ongoing objectively determined fever, as defined by axillary Temperature > 37,5°C , or tympanic (or oral or rectal) temperature > 38°C.
2. Contactable by the study team at days 7, 14 and 21.
3. Informed consent to participate signed by the patient (adults) or a legally acceptable representative (children or patients with impaired consciousness) with assent from the concerned, where applicable and possible

Participant type

Patient

Age group

Mixed

Gender

Both

Target number of participants

10,000

Participant exclusion criteria

1. Children under two months.
2. Hospitalization in the last 14 days.

Recruitment start date

25/11/2020

Recruitment end date

16/12/2020

Locations

Countries of recruitment

Cameroon, Central African Republic, Cote d'Ivoire, Gambia, Ghana, Guinea, Madagascar, Nigeria, Senegal, Tanzania, Uganda

Trial participating centre

Children's Hospital of Diamniadio
Diamniadio
Diamniadio
Non applicable
Senegal

Trial participating centre

CHU de Fann/Albert Royer
Dakar
Dakar
Non applicable
Senegal

Trial participating centre

Centre de Santé amélioré de Maferinyah
Maferinyah
Maferinyah
Non applicable
Guinea

Trial participating centre

CHR d'Ayamé
Ayamé
Ayamé
Non applicable
Cote d'Ivoire

Trial participating centre

Urgences du CHU de Treichville
Treichville
Non applicable
Cote d'Ivoire

Trial participating centre

St. Francis Xavier Hospital
Assin Foso
Assin Foso
Non applicable
Ghana

Trial participating centre

Federal Medical Centre of Owo
Owo
Owo
Non applicable
Nigeria

Trial participating centre

Clinical Service Department Fajara
Fajara
Fajara
Non applicable
Gambia

Trial participating centre

Les Promoteurs de la Bonne Santé
Yaoundé
Yaoundé
Non applicable
Cameroon

Trial participating centre

Obala District Hospital
Obala
Obala
Non applicable
Cameroon

Trial participating centre

Hôpital de District de Sibut
Sibut
Sibut
Non applicable
Central African Republic

Trial participating centre

Boda District Hospital
Boda
Boda
Non applicable
Central African Republic

Trial participating centre

CHU de Befelatanana
Befelatanana
Befelatanana
Non applicable
Madagascar

Trial participating centre

HDSS Moramanga
Moramanga
Moramanga
Non applicable
Madagascar

Trial participating centre

Korogwe District Hospital
Korogwe
Korogwe
Non applicable
Tanzania

Trial participating centre

Uganda Virus Research Institute Clinic
Entebbe
Entebbe
Non applicable
Uganda

Sponsor information

Organisation

EDCTP

Sponsor details

18 BP 1954 Abidjan
Abidjan
Non applicabe
Cote d'Ivoire
+225 21755960
pacci@pac-ci.org

Sponsor type

Research organisation

Website

http://www.pac-ci.org

Funders

Funder type

Research organisation

Funder name

European and Developing Countries Clinical Trials Partnership

Alternative name(s)

EDCTP

Funding Body Type

private sector organisation

Funding Body Subtype

international

Location

Netherlands

Results and Publications

Publication and dissemination plan

Once the results are considered final, arrangements will be made for the communication of the results to the community, in the most appropriate way, with the active participation of the health authorities. We are intending to ublish the description of Clinical patterns, severity, management and outcomes of febrile illnesses in sub-Saharan Africa by mid 2021.

IPD sharing statement: Researchers can request ALERRT for access to the anonymized data for well-defined research or secondary analyses via a controlled access procedure. A Data Access Committee (DAC) will be set up. This Committee will review the request and provide timely an answer to the Requestor. In case of positive evaluations data will be shared by a data sharing agreement between the Platform Host and Requestor. Data will be shared from the Platform Host to Requestor by means of secure encrypted data transfer.

Intention to publish date

30/06/2021

Participant level data

Available on request

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes

02/10/2019: Trial’s existence confirmed by Comite National d'Ethique des Sciences de la Vie et de la Sante