CRP and Patient Information Leaflets to Optimise Antibiotic Treatments for Adults With Respiratory Tract Infections in Primary Care in Kyrgyzstan
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Rigshospitalet, Denmark
- Enrollment
- 1,050
- Locations
- 2
- Primary Endpoint
- The primary outcome (mainly relevant relative to the PIL intervention)
Study Overview
Brief Summary
This study aims to determine how CRP levels and Patient Information Leaflets (PILs) affect antibiotic prescribing in adults with acute respiratory symptoms in Kyrgyz primary care. It will evaluate the effectiveness of PILs in reducing antibiotic use and ensuring safety and assess the effectiveness and safety of three CRP thresholds (20, 40, 60 mg/L) for adults with acute respiratory tract infections. Conducted as a multicentre, open label, individually randomized controlled clinical trial with 21 days of blinded follow-up, the study will compare PIL to no PIL in a 1:1 ratio and assess antibiotic use and safety across the three CRP cut-offs in a 1:1:1 ratio, resulting in six groups. The trial will take place in 14 district primary healthcare centres in rural Kyrgyzstan and one urban primary healthcare centre in Bishkek.
Detailed Description
BACKGROUND Antimicrobial resistance (AMR) poses a significant global health threat, particularly in Kyrgyzstan, where overuse and misuse of antibiotics have fueled the crisis. The easy over-the-counter availability of antibiotics has led to widespread misuse, escalating resistance among common pathogens. This undermines effective treatment for infections, increasing healthcare costs and mortality rates. Although Kyrgyzstan is part of the Central Asian and European Surveillance of Antimicrobial Resistance (CAESAR) network, it faces challenges such as inadequate data reporting, limited resources, and insufficient training in rational antibiotic use. Efforts are underway, including a national action plan and a CIS-wide joint initiative to address AMR, focusing on public education, vaccination, and healthcare training. Improved diagnostic tools like C-reactive protein (CRP) testing have shown promise in reducing unnecessary antibiotic prescriptions by distinguishing between bacterial and viral infections.
The COORDINATE trial in Kyrgyzstan demonstrated that CRP point-of-care testing (POCT) effectively reduces antibiotic use for respiratory tract infections (RTIs) without compromising patient safety. The study's findings prompted the Ministry of Health to plan nationwide implementation of CRP POCT in primary healthcare. However, further research is needed to establish appropriate CRP thresholds for adults. Complementary strategies such as antibiotic-free patient information leaflets (PILs) can educate the public on appropriate antibiotic use, promoting alternative symptom management and reducing patient demand for unnecessary prescriptions. Together, these measures can improve antibiotic stewardship, mitigate AMR, and enhance public health outcomes.
The research team will address these challenges in the 2CARE study:
- an adequate understanding of the AMR context may work together with the use of CRP POCT to additionally lower antibiotic use. Hence, this understanding needs to be instilled in the patient. To aid in this, the use of written materials (PILs) in the consultation is evaluated in the present study.
- What CRP-threshold to choose: a low threshold may not lower antibiotic use much, while a high threshold could significantly reduce antibiotic use, but possibly at the expense of a higher rate of adverse events (hospitalisations, longer recovery times) due to the risk of undertreatment of bacterial pneumonia. In order to identify relevant thresholds, guidelines are reviewed to assess which CRP values are applied in adult patients who present with acute respiratory infection.
AIM The study aims to determine how CRP levels and PILs affects antibiotic prescribing in adults presenting with acute respiratory symptoms in Kyrgyz primary care.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Factorial
- Primary Purpose
- Diagnostic
- Masking
- Single (Outcomes Assessor)
Masking Description
Following the baseline consultation, follow-up calls will be made to the telephone number provided by the participants on days 3, 7, 14 and 21 (Figure 1) by a blinded researcher from the Bishkek office.
Eligibility Criteria
- Ages
- 18 Years to 70 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Adults aged 18 to 70 years with ARTI according to the attending HCW;
- •Having at least one of the following respiratory symptoms lasting for less than 2 weeks (with or without a fever):
- •shortness of breath;
- •sore throat;
- •stuffy nose;
- •wheezing.
- •Able and willing to comply with all study requirements.
- •Able and willing to give informed consent.
Exclusion Criteria
- •Severely ill and in need of urgent referral where measurement of POCT CRP is not relevant or would delay the process;
- •Terminally ill patients;
- •Patients with known immunosuppression or severe chronic disease (HIV, liver failure, kidney failure, history of neoplastic disease, long term systemic steroid use or similar conditions as assessed by the health worker or research team);
- •Patients who are not able to participate in follow-up procedures (lack of telephone etc.);
- •Have taken antibiotics within 24 hours before the index consultation;
- •Pregnant women;
- •Unable or unwilling to provide informed consent.
Arms & Interventions
Group AX
This arm will receive the CRP POCT intervention plus patient information leaflet. The threshold values of CRP for this group are 20 mg/l.
Intervention: The C-reactive protein point-of-care test (CRP-POCT) (Diagnostic Test)
Group AX
This arm will receive the CRP POCT intervention plus patient information leaflet. The threshold values of CRP for this group are 20 mg/l.
Intervention: Patient information leaflets (Behavioral)
Group AY
This arm will receive the CRP POCT intervention plus patient information leaflet. The threshold values of CRP for this group are 40 mg/l.
Intervention: The C-reactive protein point-of-care test (CRP-POCT) (Diagnostic Test)
Group AY
This arm will receive the CRP POCT intervention plus patient information leaflet. The threshold values of CRP for this group are 40 mg/l.
Intervention: Patient information leaflets (Behavioral)
Group AZ
This arm will receive the CRP POCT intervention plus patient information leaflet. The threshold values of CRP for this group are 60 mg/l.
Intervention: The C-reactive protein point-of-care test (CRP-POCT) (Diagnostic Test)
Group AZ
This arm will receive the CRP POCT intervention plus patient information leaflet. The threshold values of CRP for this group are 60 mg/l.
Intervention: Patient information leaflets (Behavioral)
Group BX
This arm will receive only the CRP POCT intervention. The threshold values of CRP for this group are 20 mg/l.
Intervention: The C-reactive protein point-of-care test (CRP-POCT) (Diagnostic Test)
Group BY
This arm will receive only the CRP POCT intervention. The threshold values of CRP for this group are 40 mg/l.
Intervention: The C-reactive protein point-of-care test (CRP-POCT) (Diagnostic Test)
Group BZ
This arm will receive only the CRP POCT intervention. The threshold values of CRP for this group are 60 mg/l.
Intervention: The C-reactive protein point-of-care test (CRP-POCT) (Diagnostic Test)
Outcomes
Primary Outcomes
The primary outcome (mainly relevant relative to the PIL intervention)
Time Frame: Over 21 days.
The rate of total antibiotic prescriptions (prescribed as well as non-prescribed (e.g. purchased over the counter or taken from home storage).
The second primary outcome (mainly relevant relative to the CRP threshold intervention)
Time Frame: Over 21 days.
The safety measured as a rate of hospital admissions.
Secondary Outcomes
- Secondary study outcomes(At baseline assessment (Day 0) and over 21 days.)
Investigators
Jesper Kjærgaard
Head of the unit for children and adolescents with infections or organ-disease
Rigshospitalet, Denmark