Respiratory Tract Infections Clinical Trial
— COORDINATEOfficial title:
Using the CRP Test in Children Under 12 Years With Respiratory Symptoms in Kyrgyz Republic
NCT number | NCT05195866 |
Other study ID # | CRPKG |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | November 1, 2022 |
Est. completion date | April 6, 2023 |
Verified date | April 2023 |
Source | Rigshospitalet, Denmark |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 1204 |
Est. completion date | April 6, 2023 |
Est. primary completion date | April 6, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 6 Months to 12 Years |
Eligibility | 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); - Haven taken antibiotics within 24 hours before the index consultation |
Country | Name | City | State |
---|---|---|---|
Kyrgyzstan | At-Bashy FMC | Naryn | Naryn Region |
Lead Sponsor | Collaborator |
---|---|
Rigshospitalet, Denmark | Copenhagen School of Global Health, Kyrgyz Thoracic Society, National Center of Cardiology and Internal Medicine named after academician M.Mirrakhimov, National Center of Maternity and Childhood Care, The Research Unit for General Practice, Unit of Global Health, The Juliane Marie Center, Rigshospitalet |
Kyrgyzstan,
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* Note: There are 18 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | |
Primary | 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 | Antibiotics prescribed at the index consultation | Number of children who were prescribed antibiotics at the index consultation | Up to 1 year | |
Secondary | Antiviral treatment at follow up | Number of children who were prescribed antiviral treatment at the follow up | Up to 1 year | |
Secondary | Reconsultation within 14 days from index consultation | Number of reconsultations within 14 days from index consultation | Up to 1 year | |
Secondary | Hospital referral at index consultation | Number of hospitalisations at index consultation | Up to 1 year | |
Secondary | Hospital admission at follow up | Number of hospital admissions at follow up | Up to 1 year | |
Secondary | Mortality | Number of children who died from the index consultation till the follow-up | Up to 1 year |
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