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Access to diagnostic innovation essential for prevention of antimicrobial resistance

Impact of improved diagnostic tools, practices,training and communication on acute fever case management and antibiotic prescriptions for children and adolescents presenting at outpatient facilities in the Community Clinics of ICMR-NICED, India - FIND

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2020/04/024681
Enrollment
1760
Registered
2020-04-16
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

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

Conditions

Health Condition 1: R509- Fever, unspecified

Interventions

Intervention1: 1. Point of care diagnostic tests 2. Behavioural Intervention: Trial Intervention is defined as (i) any diagnostic Point of care test (see below), (ii) diagnostic and clinical algorithm

Sponsors

Foundation for Innovative New Diagnostics FIND
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: A. Patients with fever with no focus / RTI: a. Children (6 months to 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

Exclusion criteria

Exclusion criteria: Participants are excluded using the following 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). o Patients with acute febrile illness outside the allowed age range. o Severely ill patients requiring hospital admission or referral as assessed by the study clinicians. o Anyone 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).

Design outcomes

Primary

MeasureTime frame
1. Measure and compare proportion of outpatient cases of acute febrile illness with favourable outcome (defined as being alive and asymptomatic). 2. Measure and compare rates of antibiotic prescriptions for acute febrile illness in the clinic Timepoint: After 12 months of recruitment

Secondary

MeasureTime frame
1. Adherence to new algorithm by health care workers. 2. Adherence to prescription by patients/caregivers. 3. Rates of adverse events Timepoint: After 12 months of recruitment

Countries

India

Contacts

Public ContactDr Shanta Dutta

ICMR-NICED

drshantadutta@gmail.com913323633373

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026