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

NCT05292508 | Unknown DMC

• 1 other identifier: 1-2022
• Study Type: interventional
• Target: 924
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

C-Reactive Protein; Acute Febrile Illness; Viral Infection; Bacterial Infection; Antimicrobial Drug; CRP Rapid Test

Outcome Measures

Primary Outcomes (1)

• Use of antimicrobial

  The investigators will record if the patient was prescribed antimicrobial at the time of presenting to the health post during the current acute febrile illness. This outcome will be recorded as Yes/No

  On the 1 day of recruitment to the study

Secondary Outcomes (3)

• Complicated Illness

  One month from recuitment

• Referral to hospital

  One month from recruitment

• Admission to hospital

  One month from recuitment

Study Arms (2)

CRP Tests in addition to Usual Standard of Care

EXPERIMENTAL

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.

Diagnostic Test: C-reactive Protein Rapid Diagnostic Test

Usual Standard of Care Alone

NO INTERVENTION

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.

Interventions

C-reactive Protein Rapid Diagnostic Test 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.

CRP Tests in addition to Usual Standard of Care

Eligibility Criteria

• Age: 1 Year+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Child younger than 1 year
• Main complaint being trauma or injury
• Symptoms requiring hospital referral
• Impaired consciousness
• Inability to take oral medication
• Convulsions
• Confirmed malaria
• Confirmed urinary tract infection
• Local skin infection
• Dental abscess or infection
• Suspicion of tuberculosis
• Any symptom other than fever present for more than 14 days
• Any bleeding such as from skin, nose and gums.

Sponsors & Collaborators

• Patan Academy of Health Sciences: lead
• Gulmidarbar Rural Municipality: collaborator
• Dhurkot Rural Municipality: collaborator
• Resunga Municipality: collaborator

Study Sites (1)

Paralmi Health Post

Resunga Nagarpalika, Lumbini, Nepal

RECRUITING

MeSH Terms

Conditions

Virus Diseases; Bacterial Infections

Condition Hierarchy (Ancestors)

Infections; Bacterial Infections and Mycoses

Study Officials

• Amit Arjyal, MBBS, DPhil

  Patan Academy of Health Sciences

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Amit Arjyal, MBBS, DPhil

CONTACT

+9779864478329; amitarjyal@pahs.edu.np

Uttam Pachya, MBBS, MD

CONTACT

+9779851188826; uttampachya@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: A study investigator will make the assessment of outcome for each patient after reviewing the patients electronic clinical records. This electronic record will not have information about the health post where the trial recruitment took place. The allocation arm will also not be disclosed in this record.
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: We will conduct a Cluster Randomized Controlled Trial (cRCT) at eight Health Posts of Gulmi District. Eight Health Posts will be randomly allocated to the intervention arm (use of rapid diagnostic test for C-reactive protein) and the other will be allocated to the control arm. Thus, there will be four Health Posts each in the intervention and control arms.

Study Record Dates

• First Submitted: February 23, 2022
• First Posted: March 23, 2022
• Study Start: February 26, 2023
• Primary Completion: December 1, 2023
• Study Completion: December 1, 2023
• Last Updated: June 23, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will not share

Locations

NE (1)