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.
Adults aged 18 to 70 years with ARTI according to the attending HCW;
cough;
shortness of breath;
sore throat;
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.);
Factorial
The C-reactive protein point-of-care test (CRP-POCT)
Diagnostic testThe intervention involves using the Aidian QuickRead go system, a portable, user-friendly device designed for point-of-care testing. This system provides rapid and reliable results for various tests, including C-reactive protein (CRP) levels, which help in diagnosing and managing infections. The device features an intuitive touch screen, minimal hands-on time, and secure data storage, making it an effective tool for guiding antibiotic use in primary healthcare settings.
Patient information leaflets
BehavioralThe WHO's antibiotic-free prescription intervention aims to reduce unnecessary antibiotic use by providing clear guidelines and educational materials to healthcare providers and patients. This intervention includes Patient Information Leaflet (PIL) that explain when antibiotics are not needed, such as for viral infections, and promote alternative symptom management strategies (symptomatic).
6
Treatment groupsSee each treatment group below.
The primary outcome (mainly relevant relative to the PIL intervention)
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)
The safety measured as a rate of hospital admissions.
Secondary study outcomes
The rate of antibiotic prescriptions at the baseline assessment; self-reported recovery (rate of responses from participants indicating their recovery; mortality (rate of deaths); rate of antibiotic use started outside of health care visits; rate of antiviral treatment prescriptions; rate of re-consultations; rate of hospital referral at the baseline consultation.
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KyrgyzstanKyrgyzstanClick on the lead sponsor to view all of their trials.
Rigshospitalet, Denmark
Lead sponsor
International Centre for Antimicrobial Resistance Solutions (ICARS)
Collaborator
University of Copenhagen
Collaborator