CRP and Patient Information Leaflets to Optimise Antibiotic Treatments for Adults With Respiratory Tract Infections in Primary Care in Kyrgyzstan
Rigshospitalet, Denmark
1,050 participants
Dec 18, 2024
INTERVENTIONAL
Conditions
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.
Eligibility
Inclusion Criteria9
- 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):
- cough;
- 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 Criteria7
- 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.
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Interventions
The 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.
The 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).
Locations(2)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT07261969