This study aims to evaluate clinical outcomes and antibiotic prescription patterns following the use of diagnostic algorithms, point of care (PoC) rapid diagnostic tests, and behaviour change interventions in cases of acute febrile illnesses in children, adolescents and adults presenting at out patient clinics in lower and middle income countries. The study is to be implemented in 2 phases- the first run from 2020 to 2021 and the 2nd phase from 2021 to 2022 to include COVID-19 PoCTs.
Who can participate
Age range
6 Months – 65 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Patients presenting with fever with no focus/RTI:
* Children (6 months to \<12 years) and adolescents (12 years to less than 18 years old) of both sexes .
* Presenting with an acute febrile illness defined as temperature of \>37.5°C or history of fever within the last 7 days with no focus or suspected RTI.
* Parent/guardian providing written informed consent for their children if less than 18 years of age.
* Obtain assent for adolescent between 12 and less than 18 years old
* Willing to provide blood and other samples and adhere to study procedures explained in the consent forms following the protocol.
* Available and willing to return for follow-up visit at the health facility on day 7 (+/- 2 days).
Exclusion Criteria:
* o Children and adolescents from 6 months to less than 18 years old presenting with chronic febrile illness (fever lasting more than 7 days).
* Patients with acute febrile illness outside the allowed age range for the site.
* Severely ill patients requiring hospital admission or referral as assessed by the study clinicians.
* Anyone refusing consent to the study or not able to attend the health centre for follow-up (adults, the children of parents/guardians, or adolescents who refuse or are missed when asking for consent).
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Proportion of acute febrile cases with favorable clinical outcomes at day 7
Timeframe: Day 7
2
Antibiotic prescription rates in acute fever cases
Timeframe: Day 0
Trial details
NCT IDNCT04081051
SponsorFoundation for Innovative New Diagnostics, Switzerland