Access to diagnostic innovation essential for prevention of antimicrobial resistance
- Conditions
- Health Condition 1: R509- Fever, unspecified
- Registration Number
- CTRI/2020/04/024681
- Lead Sponsor
- Foundation for Innovative New Diagnostics FIND
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
A.Patients with fever with no focus / RTI:
a.Children (6 months to <14years) and adolescents (14 years to less than 18 years old) of both sexes.
b.Presenting with an acute febrile illness defined as temperature of >37.5°C (oral) or history of fever within the last 7 days with no focus or suspected RTI.
c.Parent/guardian providing written informed consent for their children aged less than 18 years of age.
d.Obtain assent for adolescent between 12 and less than 18 years old
e.Willing to provide blood (as well as urine, NP or throat swab if required) samples and adhere to study procedures explained in the consent forms following the protocol.
f. Available and willing to return for follow-up visit at the health facility.
B.Training and communication (for those randomised to intervention arm):
a.Parent/guardian providing informed consent to participate in the training and communication component of the study. The same informed consent form will cover both populations adult caregivers and adolescents
b.Clinic staff who have provided written informed consent to participate in the training and communication as per randomisation protocol
Participants are excluded using the following exclusion criteria:
oChildren and adolescents from 6 months to less than 18 years old presenting with chronic febrile illness (fever lasting more than 7 days).
oPatients with acute febrile illness outside the allowed age range.
oSeverely ill patients requiring hospital admission or referral as assessed by the study clinicians.
oAnyone refusing consent to the study or not available for follow-up (adults, the children of parents/guardians, or adolescents who refuse or are missed when asking for consent).
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1.Measure and compare proportion of outpatient cases of acute febrile illness with favourable outcome (defined as being alive and asymptomatic). <br/ ><br>2.Measure and compare rates of antibiotic prescriptions for acute febrile illness in the clinic <br/ ><br>Timepoint: After 12 months of recruitment
- Secondary Outcome Measures
Name Time Method 1.Adherence to new algorithm by health care workers. <br/ ><br>2.Adherence to prescription by patients/caregivers. <br/ ><br>3.Rates of adverse events <br/ ><br>Timepoint: After 12 months of recruitment