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CRP for Respiratory Diagnosis in Kyrgyz Pediatric Practice (COORDINATE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05195866
Recruitment Status : Not yet recruiting
First Posted : January 19, 2022
Last Update Posted : April 27, 2022
Sponsor:
Collaborators:
National Center of Maternity and Childhood Care
National Center of Cardiology and Internal Medicine named after academician M.Mirrakhimov
The Research Unit for General Practice
Copenhagen School of Global Health
Unit of Global Health, The Juliane Marie Center, Rigshospitalet
Kyrgyz Thoracic Society
Information provided by (Responsible Party):
Jesper Kjærgaard, Rigshospitalet, Denmark

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.


Condition or disease Intervention/treatment Phase
Antibiotic Resistance Respiratory Tract Infections Pediatric Infectious Disease CRP Diagnostic Test: CRP POCT (C-reactive protein point of care test) Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1204 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Individually randomized clinical trial
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Using the CRP Test in Children Under 12 Years With Respiratory Symptoms in Kyrgyz Republic
Estimated Study Start Date : August 1, 2022
Estimated Primary Completion Date : April 30, 2023
Estimated Study Completion Date : May 31, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Antibiotics

Arm Intervention/treatment
Active Comparator: Group A - CRP POCT
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)

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.


No Intervention: Group B - Usual care
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



Primary Outcome Measures :
  1. Proportion of children receiving antibiotics [ Time Frame: Up to 1 year ]
    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).

  2. Patient safety [ Time Frame: Up to 1 year ]
    The second primary study outcome is patient safety measured as the number of days until recovery (non-inferiority analysis).


Secondary Outcome Measures :
  1. Antibiotics prescribed at the index consultation [ Time Frame: Up to 1 year ]
    Number of children who were prescribed antibiotics at the index consultation

  2. Antiviral treatment at follow up [ Time Frame: Up to 1 year ]
    Number of children who were prescribed antiviral treatment at the follow up

  3. Reconsultation within 14 days from index consultation [ Time Frame: Up to 1 year ]
    Number of reconsultations within 14 days from index consultation

  4. Hospital referral at index consultation [ Time Frame: Up to 1 year ]
    Number of hospitalisations at index consultation

  5. Hospital admission at follow up [ Time Frame: Up to 1 year ]
    Number of hospital admissions at follow up

  6. Mortality [ Time Frame: Up to 1 year ]
    Number of children who died from the index consultation till the follow-up



Information from the National Library of Medicine

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Ages Eligible for Study:   6 Months to 12 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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)

Exclusion Criteria:

  • 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);
  • Positive rapid diagnostic test for SARS-CoV-2;
  • Haven taken antibiotics within 24 hours before the index consultation

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05195866


Contacts
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Contact: Rune M. Aabenhus, Assistant Prof. +45 35 33 73 02 runa@sund.ku.dk
Contact: Jesper Kjærgaard, MD, PhD +45 35456797 jesper.kjaergaard@regionh.dk

Sponsors and Collaborators
Rigshospitalet, Denmark
National Center of Maternity and Childhood Care
National Center of Cardiology and Internal Medicine named after academician M.Mirrakhimov
The Research Unit for General Practice
Copenhagen School of Global Health
Unit of Global Health, The Juliane Marie Center, Rigshospitalet
Kyrgyz Thoracic Society
Investigators
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Study Chair: Jesper Kjærgaard, MD, PhD Copenhagen University Hospital Rigshospitalet, Copenhagen, Denmark
Principal Investigator: Elvira Isaeva, Dr. National Center of Maternity and Childhood Care, Bishkek, Kyrgyzstan
Study Director: Talant Sooronbaev, MD, Professor Republican Research Centre of Pulmonology and Rehabilitation the Ministry of Health of the Kyrgyz Republic
  Study Documents (Full-Text)

Documents provided by Jesper Kjærgaard, Rigshospitalet, Denmark:
Informed Consent Form  [PDF] February 11, 2022

Additional Information:
Publications:
Hug L, Sharrow D, You D. Levels & Trends in Child Mortality. New York, 2017 http://www.childmortality.org/files_v21/download/IGME report 2017 child mortality final.pdf.
WHO. Integrated Management of Childhood Illness Chart Booklet. 2014.
WHO. ANTIMICROBIAL RESISTANCE Global Report on Surveillance. Geneva, 2014 http://apps.who.int/iris/bitstream/10665/112642/1/9789241564748_eng.pdf?ua=1.
O'Neill J. Tackling Drug-Resistant Infections Globally: Final Report and Recommendations. 2016 https://amr-review.org/sites/default/files/160525_Final paper_with cover.pdf.

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Responsible Party: Jesper Kjærgaard, Coordinator, Global Health Unit, Department of Paediatrics and Adolescent Health, Principal Investigator, MD, PhD, Rigshospitalet, Denmark
ClinicalTrials.gov Identifier: NCT05195866    
Other Study ID Numbers: CRPKG
First Posted: January 19, 2022    Key Record Dates
Last Update Posted: April 27, 2022
Last Verified: April 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Jesper Kjærgaard, Rigshospitalet, Denmark:
antibiotic resistance
respiratory tract infections
crp
respiratory symptoms
acute respiratory tract infections
CRP POCT
Pediatrics
Additional relevant MeSH terms:
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Infections
Communicable Diseases
Respiratory Tract Infections
Disease Attributes
Pathologic Processes
Respiratory Tract Diseases