Comparison of Rates of Antimicrobial Use in Febrile Patients With or Without the Use of C-reactive Protein Blood Test

Summary

In Health Posts of rural areas operated by the Government of Nepal, there are limitations of tests to differentiate between bacterial and viral infections. Due to this, health workers are obliged to prescribe antimicrobials (antibacterials) just on the basis of clinical features. This can lead to irrational use of antimicrobials, consequently contributing to antimicrobial resistance. C-reactive protein is the marker of inflammation which rises during bacterial infection but rarely rises during viral infection. The investigators wish to compare the effect on antimicrobial usage of using CRP(C-Reactive Protein) test, a rapid diagnostic test used to differentiate bacterial and viral infection, with usual standard of care, by carrying out a cluster-randomized controlled trial. The investigators plan to carry out this study in eight Health Posts of Resunga, Dhurkot and Gulmi-Durbar Municipalities of Gulmi District. The investigators will randomly allocate four Health Posts (clusters) to the intervention arm- CRP TESTS in addition to Usual Standard of Care, and four Health Posts (clusters) to the control arm- Usual Standard of Care Alone. The investigators plan to study all patients above one year of age presenting with fever or a history of reported fever with a duration of up to 7 days in Health Posts. Primarily, the investigators will assess the rates of antimicrobial use per patient who presents with febrile illness. Secondarily, the investigators will also assess the outcome of illness of the patient such as need for subsequent hospital admission or severe or complicated illness. This testing method will supplement the existing methods to differentiate bacterial and viral infections based on history and clinical examination by health professionals as a part of usual standard of care in the Health Posts included in this study.

Conditions

• Acute Febrile Illness
• Use of Antimicrobial Agents
• C-reactive Protein Level

Interventions

DIAGNOSTIC_TEST

C-reactive Protein Rapid Diagnostic Test

In the intervention arm in addition to Usual Standard of Care, CRP Testing will be performed. In this test, health worker at health post will prick the finger of the patient using a lancet device following aseptic precautions. A very small drop (10 microliters) of whole blood will be obtained. This will be added to specimen dilution buffer. Then the sample will be mixed by inverting the tube upside down 10-15 times. Then the yellow dip area of the dipstick will be placed into the diluted sample. It will be held there until the liquid rises to the result area by capillary action. The the dipstick is removed from the solution and placed in a horizontal position. The timer will be started and result will be interpreted in 5 minutes. Treatment decision making regarding the use of antimicrobials will be conducted with the help of CRP test results and other clinical features.

Sponsors & Collaborators

• Gulmidarbar Rural Municipality

  collaborator UNKNOWN

• Dhurkot Rural Municipality

  collaborator UNKNOWN

• Resunga Municipality

  collaborator UNKNOWN

• Patan Academy of Health Sciences

  lead OTHER

Principal Investigators

• Amit Arjyal, MBBS, DPhil · Patan Academy of Health Sciences

Study Design

Allocation

RANDOMIZED

Purpose

DIAGNOSTIC

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

1 Year

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2023-02-26

Primary Completion

2023-12-31

Completion

2023-12-31

Countries

• Nepal