Rapid Diagnostic Testing for C-reactive Protein to Differentiate Bacterial and Viral Infection in Febrile Patients to Reduce Antimicrobial Use in Remote Health Care Centers of Gulmi District of Nepal: a Cluster Randomized Controlled Trial

Status: Not yet recruiting
Intervention Type: Diagnostic Test
Study Type: Interventional
Study Phase: Not Applicable

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.

Participation Requirements
Sex: All
Minimum Age: 1
Healthy Volunteers: No

• History of reported fever or fever greater than 100.4◦F (38◦C) with duration of illness up to 7 days

• Duration of fever less than or equal to 7 days

• Can connect with mobile phone for follow up

Contact Information
Amit Arjyal, MBBS, DPhil
Uttam Pachya, MBBS, MD
Time Frame
Start Date: October 2022
Estimated Completion Date: July 2023
Target number of participants: 924
Experimental: CRP Tests in addition to Usual Standard of Care
For the clusters (health posts) in this arm, the health worker will prick the finger of the eligible patient using a lancet device following aseptic precautions. A very small drop (10 microliters) of whole blood will be obtained which will be added to specimen dilution buffer and the dipstick will be placed into the diluted sample. It will be removed after the liquid rises and the timer will be started and result will be interpreted in 5 minutes. Interpretation of CRP levels: Only red color line (No blue line): <10 mg/L One blue line: 10-40 mg/L Two blue lines: 40-80 mg/L Three blue lines: >80 mg/L. CRP levels of 40 mg/L or above will be considered as increased CRP levels. The decision on antimicrobial use and other treatments will be made with the help of CRP results in addition to information obtained from the history and physical examination.
No Intervention: Usual Standard of Care Alone
For the clusters (health posts) in this control arm, Usual Standard of Care Alone will be provided. This usual standard of care is given to patients with febrile illness at health posts. Commonly, this involves taking a brief history and conducting a simple physical examination followed by symptomatic treatment such as paracetamol, cough medication or analgesics such as NSAIDs. Often antimicrobial treatment is also prescribed based on clinical suspicion of bacterial infection.
Related Therapeutic Areas
Collaborators: Resunga Municipality, Gulmidarbar Rural Municipality, Dhurkot Rural Municipality
Leads: Patan Academy of Health Sciences

This content was sourced from clinicaltrials.gov

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