CRP for Respiratory Diagnosis in Kyrgyz Pediatric Practice

NCT05195866 | Completed

• 1 other identifier: CRPKG
• Study Type: interventional
• Target: 1,204
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

antibiotic resistance; respiratory tract infections; crp; respiratory symptoms; acute respiratory tract infections; CRP POCT; Pediatrics

Outcome Measures

Primary Outcomes (2)

• Proportion of children receiving antibiotics

  The primary study outcome is the proportion of included children in each study arm that are prescribed an antibiotic within 14 days from the index consultation (superiority analysis).

  Up to 1 year

• Patient safety

  The second primary study outcome is patient safety measured as the number of days until recovery (non-inferiority analysis).

  Up to 1 year

Secondary Outcomes (6)

• Antibiotics prescribed at the index consultation

  Up to 1 year

• Antiviral treatment at follow up

  Up to 1 year

• Reconsultation within 14 days from index consultation

  Up to 1 year

• Hospital referral at index consultation

  Up to 1 year

• Hospital admission at follow up

  Up to 1 year

Study Arms (2)

Group A - CRP POCT

ACTIVE COMPARATOR

Participants assigned to Group A will take C-reactive protein (CRP) point of care test (POCT) during a check-up with their healthcare worker (HCW). The assistant investigator will attend the child's consultation with the local HCW and complete the case report form (CRF). Consequently, the CRP result will be recorded in the CRF, which will be the basis for choosing a treatment, depending on its result.

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

Group B - Usual care

NO INTERVENTION

HCWs will also consult children who have been randomised to Group B. The assistant investigator will complete the CRF for these children, but the CRP POCT will not test them. They will receive the treatment prescribed by the HCW as usual care

Interventions

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

Group A - CRP POCT

Eligibility Criteria

• Age: 6 Months - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Between 6 month and 12 years of age;
• Parents/caregivers of a child are able and willing to comply with all study requirements;
• Parents/caregivers of a child is able and willing to give Informed Consent;
• Having at least one of the following focal symptoms lasting for less than 2 weeks (cough; fast/difficult breathing; dore throat; shortness of breath; wheezing)

You may not qualify if:

• Severely ill and in need of urgent referral where measurement of CRP POCT would delay the process;
• Terminally ill patients;
• Patients with ear ache only;
• Patients with known immunosuppression or severe chronic disease (HIV, liver disease, history of neoplastic disease, long term systemic steroid use or similar conditions as assessed by the health worker or AI);
• Parents/caregivers who are not able to participate in follow-up procedures (lack of telephone etc);
• Haven taken antibiotics within 24 hours before the index consultation

Sponsors & Collaborators

• Rigshospitalet, Denmark: lead
• National Center of Maternity and Childhood Care: collaborator
• National Center of Cardiology and Internal Medicine named after academician M.Mirrakhimov: collaborator
• The Research Unit for General Practice: collaborator
• Copenhagen School of Global Health: collaborator
• Unit of Global Health, The Juliane Marie Center, Rigshospitalet: collaborator
• Kyrgyz Thoracic Society: collaborator

Study Sites (1)

At-Bashy FMC

Naryn, Naryn Region, Kyrgyzstan

Location

Related Publications (21)

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  BACKGROUND

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  PMID: 37041063 DERIVED

Related Links

• CRP POCT
• SealedEnvelope Randomisation Programme

MeSH Terms

Conditions

Respiratory Tract Infections; Signs and Symptoms, Respiratory

Condition Hierarchy (Ancestors)

Infections; Respiratory Tract Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Jesper Kjærgaard, MD, PhD

  Copenhagen University Hospital Rigshospitalet, Copenhagen, Denmark

  STUDY CHAIR

• Elvira Isaeva, Dr.

  National Center of Maternity and Childhood Care, Bishkek, Kyrgyzstan

  PRINCIPAL INVESTIGATOR

• Talant Sooronbaev, MD, Professor

  Republican Research Centre of Pulmonology and Rehabilitation the Ministry of Health of the Kyrgyz Republic

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Coordinator, Global Health Unit, Department of Paediatrics and Adolescent Health, Principal Investigator, MD, PhD

Model Details: Individually randomized clinical trial The children will be randomized into two groups. Randomization will be stratified by male/female as well as age \<5 years and \>5 years.

Study Record Dates

• First Submitted: November 24, 2021
• First Posted: January 19, 2022
• Study Start: November 1, 2022
• Primary Completion: April 6, 2023
• Study Completion: April 6, 2023
• Last Updated: April 12, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

KY (1)