Status:
COMPLETED
Advancing Access to Diagnostic Innovation Essential for UHC and AMR Prevention
Lead Sponsor:
Foundation for Innovative New Diagnostics, Switzerland
Collaborating Sponsors:
University of Oxford
Indian Council of Medical Research
Conditions:
Acute Febrile Illness
Eligibility:
All Genders
6-65 years
Phase:
NA
Brief Summary
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 interven...
Detailed Description
Background and rationale. 'Just-in-case' antibiotic prescribing practices is one of the causes of inadequate management of 'acute febrile illnesses' and AMR in Low- and Middle-income Countries (LMICs)...
Eligibility Criteria
Inclusion
- 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
- 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).
Key Trial Info
Start Date :
August 31 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 30 2022
Estimated Enrollment :
17294 Patients enrolled
Trial Details
Trial ID
NCT04081051
Start Date
August 31 2020
End Date
September 30 2022
Last Update
December 5 2023
Active Locations (8)
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1
IRSS-DRCO/Clinical Research Unit of Nanoro (CRUN)
Nanoro, Burkina Faso, BP 218
2
Shai-Osudoku District Hospital
Accra, Dodowa, Ghana
3
Jan Swathya Sahyog
Ganiyari, Chhattisgarh, India, 495112
4
National Institute of Cholera & Enteric Diseases
Beliaghata, Kolkata, India, 700010