CRP for Respiratory Diagnosis in Kyrgyz Pediatric Practice

Summary

Rationale:

Overuse of antibiotics globally is leading to increasing rates of antibiotic resistance and may lead to a 'post-antibiotic' era. Case fatality rates for pneumonia in children remain high in Central Asia and there is a lack of knowledge of which viruses and bacteria cause the disease. Antibiotic resistance patterns of common bacteria remain largely unknown in Central Asia which makes it challenging for clinicians to choose the right antibiotic to treat children with suspected bacterial pneumonia and sometimes healthcare workers overuse an antibacterial therapy even when the child does not need it.

Randomised trials of using CRP point of care test (POCT) to guide antibiotic prescription for respiratory tract infections has been successful in lowering unnecessary antibiotic prescriptions in adults in high income countries but left a small concern for safety in the form of possibly slightly increased risk of hospitalisation in the CRP group.

Objective:

This study seeks to gain evidence on whether use of C-reactive protein point-of-care test can safely decrease prescription of antibiotics for children under 12 with acute respiratory symptoms in primary level healthcare centres in Kyrgyzstan.

Study design:

Multicentre, open-label, individual randomised controlled clinical trial with 14 days blinded follow-up in rural Chui and Naryn regions of Kyrgyz Republic. Healthcare workers from ten selected healthcare centres will be trained in the CRP POCT and in interpreting the results in the field.

Study population:

Children aged from 6 month to 12 years attending the primary level healthcare centres during normal business hours with acute respiratory symptoms.

Main study parameters:

The proportion of patients in the two groups prescribed an antibiotic within 14 days of index consultation; length of disease, antibiotics given at index consultation, admissions and vital status.

Nature and extent of the burden and risks associated with participation, benefit and group relatedness:

Risks, inconvenience and burden associated with participating in this observational study are low. As part of the inclusion children in the CRP cluster group will have a finger-prick test performed. This may be unpleasant and course transient discomfort but poses no risks to the child. Follow-up will be three short phone calls day 3, 7 and 14 after inclusion. Risks includes possible undertreatment of serious disease, however previous studies have not found safety issues with CRP testing in children. There is no direct benefit to participants, but side effects and non-necessary medications are likely minimised.

Conditions

• Antibiotic Resistance
• Respiratory Tract Infections
• Pediatric Infectious Disease
• CRP

Interventions

DIAGNOSTIC_TEST

CRP POCT (C-reactive protein point of care test)

CRP POCT equipment will be supplied at healthcare centers, along with a short training in use and interpretation supporting the clinical evaluation of the child. It will be communicated that CRP levels less than 10 indicate that the disease is not severe, and antibiotics is most likely not needed, if between 10 and 50, that antibiotics might be needed, and if more than 50 that it is likely that they are needed. With CRP between 10-50 the HCW are instructed to take the clinical picture into account together with the value of the test. The training will also include knowledge of CRP pharmacodynamics and cases where a low CRP might need to be interpreted cautiously, e.g. a history of fever lasting less than 24 hrs. HCWs will be instructed to use CRP POCT for all patients in the intervention group and use the information to guide diagnosis and treatment choice. We will use Aidian (Copenhagen, Denmark) QuickRead go CRP POCT set-up.

Sponsors & Collaborators

• National Center of Maternity and Childhood Care

  collaborator UNKNOWN

• National Center of Cardiology and Internal Medicine named after academician M.Mirrakhimov

  collaborator OTHER_GOV

• The Research Unit for General Practice

  collaborator UNKNOWN

• Copenhagen School of Global Health

  collaborator UNKNOWN

• Unit of Global Health, The Juliane Marie Center, Rigshospitalet

  collaborator UNKNOWN

• Kyrgyz Thoracic Society

  collaborator UNKNOWN

• Rigshospitalet, Denmark

  lead OTHER

Principal Investigators

• Jesper Kjærgaard, MD, PhD · Copenhagen University Hospital Rigshospitalet, Copenhagen, Denmark

• Elvira Isaeva, Dr. · National Center of Maternity and Childhood Care, Bishkek, Kyrgyzstan

• Talant Sooronbaev, MD, Professor · Republican Research Centre of Pulmonology and Rehabilitation the Ministry of Health of the Kyrgyz Republic

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

6 Months

Max Age

12 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2022-11-01

Primary Completion

2023-04-06

Completion

2023-04-06

Countries

• Kyrgyzstan

Study Locations