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
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.
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.
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.
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|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||1204 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||Individually randomized clinical trial|
|Masking:||None (Open Label)|
|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|
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
- 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).
- 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).
- Antibiotics prescribed at the index consultation [ Time Frame: Up to 1 year ]Number of children who were prescribed antibiotics at the index consultation
- Antiviral treatment at follow up [ Time Frame: Up to 1 year ]Number of children who were prescribed antiviral treatment at the follow up
- Reconsultation within 14 days from index consultation [ Time Frame: Up to 1 year ]Number of reconsultations within 14 days from index consultation
- Hospital referral at index consultation [ Time Frame: Up to 1 year ]Number of hospitalisations at index consultation
- Hospital admission at follow up [ Time Frame: Up to 1 year ]Number of hospital admissions at follow up
- Mortality [ Time Frame: Up to 1 year ]Number of children who died from the index consultation till the follow-up
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
|Contact: Rune M. Aabenhus, Assistant Prof.||+45 35 33 73 email@example.com|
|Contact: Jesper Kjærgaard, MD, PhD||+45 firstname.lastname@example.org|
|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|