About this trial
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 criteria
Qualifiers
Adults aged 18 to 70 years with ARTI according to the attending HCW;
cough;
shortness of breath;
sore throat;
Disqualifiers
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.);
Trial design
Treatments tested in this trial
- The C-reactive protein point-of-care test (CRP-POCT)
- Patient information leaflets
Treatment groups
6
Treatment groupsSee each treatment group below.
Locations
2Map coordinates are unavailable for these locations. Locations are shown below instead.
Sponsors and collaborators
Rigshospitalet, Denmark
Lead sponsor
International Centre for Antimicrobial Resistance Solutions (ICARS)
Collaborator
University of Copenhagen
Collaborator