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

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

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ISRCTN
Registry ID
ISRCTN12162708
Enrollment
230
Registered
2024-04-25
Start date
2024-03-15
Completion date
Unknown
Last updated
2026-04-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diagnosis of malarial, viral and bacterial infections among children with fever Infections and Infestations

Interventions

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

Sponsors

University of Ghana
Lead Sponsor

Eligibility

Sex/Gender
All
Age
1 Months to 15 Years

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
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

Countries

Ghana

Contacts

Public ContactFlavia Bawa
fkbawa@st.ug.edu.gh+233 (0)540295710

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Apr 23, 2026