Child, Only Clinical Trial
Official title:
A Multi-country, Two-arm, Open-label, Superiority, Randomised Controlled Trial to Study the Performance of a Rapid Triage Test Compared to Standard of Care (IMCI-based) to Guide Admission/Discharge Decisions During the First Clinical Assessment of Children With Fever
The overall aim of the study is to provide evidence that introducing soluble triggering receptor expressed on myeloid cells-1 (sTREM-1) evaluation at triaging (first clinical assessment), in combination with IMCI-based guidelines (SoC), is a viable strategy to enhance rapid and accurate identification of febrile children at increased risk of life-threatening infections compared to IMCI-based strategies alone (SoC), and to demonstrate whether this results in enhanced decisions of admission/referral vs discharge, and enhanced overall health outcome of children with acute fever in sub-Saharan Africa.
Status | Not yet recruiting |
Enrollment | 5212 |
Est. completion date | March 1, 2027 |
Est. primary completion date | December 1, 2026 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 2 Months to 60 Months |
Eligibility | Inclusion Criteria: - Age =2 months and <60 months - Written informed consent from the child's parent or caregiver - History of fever for =7 days OR hypothermia (i.e., axillary temperature <35.5ºC) OR suspected severe infection (e.g., in children with moderate or severe acute malnutrition). - Lives within the catchment area of the study facility and must intend to continue to reside there for the duration of the study - For the RTI sub-study only: presence of respiratory symptoms compatible with RTI. Exclusion Criteria: - Weight less than 2.5kg - Main reason for consultation is an injury, trauma or acute poisoning - Enrolled in another clinical trial testing a new drug - Enrolled in a vaccine trial in the last 3 months. - Any other condition determined by the investigators that makes it unlikely that the participant would complete the study |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Barcelona Institute for Global Health |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Secondary consultations or admission | Proportion of secondary consultations or admissions on day 91 (month 3) among the two study arms | Up to day 91 | |
Other | Mortality | Proportion of mortality on day 91 (month 3) among the two study arms. | Up to day 91 | |
Primary | Appropriateness of discharge | The primary outcome is the proportion of "appropriateness of discharge" according to the first clinical assessment of febrile children aged 2-<60 months compared among the 2 study arms.
Inappropriate discharge is defined as a composite of (fulfilling at least one of the following): Presence at baseline of World Health Organization (WHO)-proposed danger signs in discharged children; OR Presence of WHO-proposed danger signs on day 3 post-discharge; OR Requirement for additional visit at the health facility or admission at day 7; OR Death on day 7 post-discharge. The absence of any of these endpoints will be considered an appropriate discharge. |
Up to day 7 | |
Secondary | Secondary consultations or admissions | Proportion of secondary consultations or admissions on day 7 and day 28 among the two study arms. | Up to day 28 | |
Secondary | Mortality | Proportion of mortality on day 7 and day 28 among the two study arms. | Up to day 28 | |
Secondary | Referrals to higher level facilities | Proportion of referrals of mild infections to higher level facilities at day 7 and day 28 among the two study arms. | Up to day 28 | |
Secondary | Severe disease | Proportion of participants diagnosed with severe disease as described in IMCI (i.e. very severe diseases, severe pneumonia, severe dehydration, severe persistent diarrhoea, very severe febrile diseases, severe complicated measles, complicated severe acute malnutrition, mastoiditis, and severe anaemia), at day 3 and day 7 among the two study arms. | Up to day 7 | |
Secondary | Symptoms duration | Median time to symptoms resolution among the two study arms until day 28. | Up to day 28 | |
Secondary | Hospital stay length | Median length of hospital stay among the two study arms until day 28 | Up to day 28 | |
Secondary | Serious adverse events | Proportion of serious adverse events (SAEs) at day 3, day 7, and day 28, among the two study arms. | Up to day 28 |
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