Investigating whether a new test can be used to differentiate between viruses, malaria and bacteria as causes of fever among children in Ghana

ISRCTN	ISRCTN12162708
DOI	https://doi.org/10.1186/ISRCTN12162708
Secondary identifying numbers	NIHR134694

Submission date: 06/03/2024
Registration date: 25/04/2024
Last edited: 11/03/2025

Recruitment status: No longer recruiting
Overall study status: Ongoing
Condition category: Infections and Infestations

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Background and study aims
This study will evaluate a new test for the cause of fever in African children. There is an unmet need for diagnostic tests that can be used in African countries where resources are scarce. Most of the time, when children have a fever, the only test available is a malaria test. If this test is negative, they often receive antibiotic treatment because tests to distinguish between other causes of infection (e.g., bacteria or viruses) are unavailable. The aim of this study is to use how the human immune system responds to infection to tell which type of infection someone has. The researchers will detect genes that are turned on and off in the blood which are specific to either bacterial, viral, or malaria infection.

Who can participate?
Children between the ages of 1 month and 15 years presenting to the recruiting facilities with fever

What does the study involve?
The study will record participant data, some of which include the clinician’s notes on the signs/symptoms, medications, and preexisting conditions, and demographic information such as age, sex, location, and ethnicity. In addition to this, the researchers will request the results of laboratory tests run for routine healthcare. They will also take about a spoonful of blood for laboratory testing for the study.

What are the possible benefits and risks of participating?
There are no direct benefits to taking part in this study. However, it is hoped that the information gained from this study may someday make it easier and faster for doctors to diagnose individuals infected with germs that cause illness and fever. This study will benefit the scientific community by providing information for future use in the evaluation of this new test. There is minimal risk associated with the collection of a blood specimen. The participant may experience some mild pain, discomfort, and/or bruising. These risks are no greater for this study than for routine testing from blood samples. Well-trained laboratory personnel will perform this according to standard guidelines to minimize the possible risks.

Where is the study run from?
The West Africa Centre for Cell Biology of Infectious Pathogens at the University of Ghana (Ghana)

When is the study starting and how long is it expected to run for?
August 2022 to August 2026

Who is funding the study?
The study is funded by the NIHR (NIHR-Global Health Research Group's Digital Diagnostics for African Health Systems, project reference NIHR134694) using UK International Development funding from the UK Government to support global health research. The views expressed are those of the authors and not necessarily those of the NIHR or the UK government.

Who is the main contact?
Flavia Kaduni Bawa, fkbawa@st.ug.edu.gh

Contact information

Mrs Flavia Bawa
Public, Scientific

West Africa Centre for Cell Biology of Infectious Pathogens
Department of Biochemistry, Cell and Molecular Biology
University of Ghana
Accra
LG54
Ghana

ORCID ID	0000-0002-0027-2917
Phone	+233 (0)540295710
Email	fkbawa@st.ug.edu.gh

Prof Aubrey Cunnington
Principal Investigator

Section of Paediatric Infectious Disease and Centre for Paediatrics and Child Health
Imperial College London
London
W2 1PG
United Kingdom

ORCID ID	0000-0002-1305-3529
Phone	+44 (0)2075943695
Email	a.cunnington@imperial.ac.uk

Dr Samuel Duodu
Scientific

West Africa Centre for Cell Biology of Infectious Pathogens
Department of Biochemistry, Cell and Molecular Biology
University of Ghana
Accra
LG54
Ghana

ORCID ID	0000-0003-2791-8949
Phone	+233 (0)243279353
Email	saduodu@ug.edu.gh

Dr Effua Usuf
Scientific

Medical Research Council Unit The Gambia at the London School of Hygiene & Tropical Medicine
Atlantic Boulevard
Fajara
Banjul
PO Box 273
Gambia

ORCID ID	0000-0002-6515-7186
Phone	+220 (0)4495835
Email	eusuf@mrc.gm

Dr Jethro Herberg
Scientific

Section of Paediatric Infectious Diseases
Department of Infectious Diseases
Imperial College London
Wright-Fleming Institute
Norfolk Place
London
W2 1PG
United Kingdom

ORCID ID	0000-0001-6941-6491
Phone	+44 (0)20 7594 3990
Email	j.herberg@imperial.ac.uk

Study information

Study design	Multicenter cross-sectional study
Primary study design	Observational
Secondary study design	Cross sectional study
Study setting(s)	Hospital
Study type	Diagnostic
Participant information sheet	Not available in web format. please use contact details to request a participant information
Scientific title	Evaluating the potential of a Lacewing host-response assay to distinguish between malaria, bacterial and viral infection as causes of acute childhood febrile illness in The Gambia and Ghana
Study acronym	LacewingAFI
Study objectives	The measurement of the expression of a small number of genes in blood using a point-of-care molecular diagnostic test can be used to distinguish between viruses, bacteria and malaria infections
Ethics approval(s)	1. Approved 09/10/2023, Ghana Health Service Ethics Review Committee (Research and Development Division, Ghana Health Service, Accra, MB190, Ghana; +233 (0)302681109; ethics.research@ghs.gov.gh), ref: GHS-ERC: 017/06/23 2. Approved 29/06/2023, Ethics Committee for Basic and Applied Sciences (Ethics Committee for Basic and Applied Sciences, University of Ghana, Accra, LG1195, Ghana; +233 (0)302213820; ethicscbas@ug.edu.gh), ref: ECBAS 038/ 22-23
Health condition(s) or problem(s) studied	Diagnosis of malarial, viral and bacterial infections among children with fever
Intervention	Clinical samples will be obtained from participants recruited from the hospitals and stored samples from previous ethically approved studies. These will be tested for host signature transcripts using a benchtop reverse transcription loop-mediated isothermal amplification (RT-LAMP) assay and the Lacewing device. The diagnostic performance, sensitivity and specificity of the device will be assessed by comparing results with gold standards such as microscopy, bacterial cultures, and molecular diagnostics (for example TaqMan array card).
Intervention type	Device
Pharmaceutical study type(s)	Not Applicable
Phase	Not Applicable
Drug / device / biological / vaccine name(s)	Lacewing
Primary outcome measure	Diagnostic accuracy will be measured using the area under the receiver operator curve (AUC) for the results of the Lacewing device compared against reference standard (blood film microscopy, sterile site culture, and molecular pathogen detection), assessed at the time of clinical presentation.
Secondary outcome measures	1. The prevalence of different types of infection classified by gene expression test will be assessed for samples collected at time of clinical presentation 2. The usability of the test will be evaluated through stakeholder engagements on the day that the primary outcome is measured
Overall study start date	01/08/2022
Completion date	31/08/2026

Eligibility

Participant type(s)	Patient
Age group	Child
Lower age limit	1 Month
Upper age limit	15 Years
Sex	Both
Target number of participants	230
Total final enrolment	353
Key inclusion criteria	1. The participant is between the ages of 1 month and 15 years 2. Participant has a reported fever or recorded fever of ≥37.5°C in the past 24 hours and is suspected by a clinician to have an infection 3. Parental permission and child assent have been obtained
Key exclusion criteria	1. Children aged 16 years or older 2. Children without recorded/reported fever. 3. Inability to provide informed consent. 4. Children with fever from a suspected hospital-acquired infection 5. Children suspected by clinicians to have a high-consequence infectious disease such as viral haemorrhagic fever 6. Children with known HIV or other immunodeficiency
Date of first enrolment	15/03/2024
Date of final enrolment	10/03/2025

Locations

Countries of recruitment

Ghana

Study participating centres

Ledzokuku-Krowor Municipal Hospital

Ghana Health Service
Teshie-Tsuibleoo
Accra
GZ-103-2962
Ghana

Oda Government Hospital

Ghana Health Service
Akyem-Oda
Oda
P O Box 16
Ghana

Kintampo Municipal Hospital

Ghana Health Service
Kintampo
PO Box 192
Ghana

War Memorial Hospital

Ghana Health Service
Navrongo
PO Box 34
Ghana

Sponsor information

University of Ghana
University/education

PO Box LG 25
Legon
Accra
LG25
Ghana

Phone	+233 (0)302 213850
Email	pad@ug.edu.gh
Website	https://www.ug.edu.gh/
"ROR"	https://ror.org/01r22mr83

Funders

Funder type

Government

NIHR Global Health Research Group on Digital Diagnostics for Africa

No information available

Results and Publications

Intention to publish date	20/06/2026
Individual participant data (IPD) Intention to share	Yes
IPD sharing plan summary	Available on request
Publication and dissemination plan	Planned publication in a high-impact peer-reviewed journal
IPD sharing plan	The datasets generated during and/or analysed during the current study will be available upon request from Prof. Aubrey Cunnington (a.cunnington@imperial.ac.uk) or Dr. Samuel Duodu (Sa.duodu@ug.edu.gh)

Editorial Notes

11/03/2025: The recruitment end date was changed from 15/03/2025 to 10/03/2025.
07/02/2025: The recruitment end date was changed from 15/02/2025 to 15/03/2025.
10/12/2024: The recruitment end date was changed from 15/12/2024 to 15/02/2025.
10/06/2024: Internal review.
07/03/2024: Study's existence confirmed by the Ghana Health Service Ethics Review Committee.