Advancing access to diagnostic innovation essential foruniversal health coverage and anti-microbial resistance preventio

Not Applicable

Completed

• Conditions: Health Condition 1: R509- Fever, unspecified

• Registration Number: CTRI/2020/05/025193
• Lead Sponsor: Indian Council of Medical Research

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2022-08-30
• Last Update Posted: 9 January 2023

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 2816

Inclusion Criteria

Patients with fever with no focus /Respiratory Tract Infection:

Children (3months to <10years), adolescents (10years to <18years old) of both sexes and adults (more than 18-65 years)

Presenting with an acute febrile illness defined as temperature of >37.5°C or history of fever within the last 7days with no focus or suspected Respiratory Tract Infection

Parent/guardian/patients providing written informed consent for their children if <18 years.

Assent for adolescent between 12 and <18 years and consent from for adults.

Willing to provide blood samples and swabs 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.

Exclusion Criteria

Children, adolescents and adults with chronic febrile illness (fever lasting >7 days)

Patients with acute febrile illness outside the allowed age range.

Severely ill patients requiring hospital admission or referral as assessed by the study clinicians.

Anyone refusing consent to be part of the study or not available for follow-up (adults, the parents/guardians of children, 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 favorable outcome (defined as being alive and asymptomatic). <br/ ><br>2. Measure and compare antibiotic prescriptions for acute febrile illness in the clinic <br/ ><br>Timepoint: 1 year <br/ ><br>

Secondary Outcome Measures

Name	Time	Method
1. Proportion of patients treated for specific bacterial infection <br/ ><br>2. Proportion of patients with disease specific diagnosis identified by PoC tests <br/ ><br>3. Proportion of patients prescribed antibiotic at clinic who reported adherence to prescription on day 7 <br/ ><br>4. Proportion of patients who were not prescribed antibiotics at clinic who received antibiotics elsewhere between day 0 and day 7 <br/ ><br>5. Behaviour Change Intervention Recommendations <br/ ><br>6. Adherence to new algorithm by health care workersTimepoint: 1 year