CRP and Patient Information Leaflets to Optimise Antibiotic Treatments for Adults With Respiratory Tract Infections in Primary Care in Kyrgyzstan

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-70
SponsorRigshospitalet, Denmark

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

1,050 Participants
are divided into 6 treatment groups

6

Treatment groups

See each treatment group below.

Locations

2

Map coordinates are unavailable for these locations. Locations are shown below instead.

Sokuluk Family Medicine CenterRecruiting724800, Sokuluk Village, Chui RegionKyrgyzstanKyrgyzstan
Azim Azhybek uuluRecruiting722600, At-Bashy Village, Naryn RegionKyrgyzstanKyrgyzstan

Sponsors and collaborators

Rigshospitalet, Denmark

Lead sponsor

International Centre for Antimicrobial Resistance Solutions (ICARS)

Collaborator

University of Copenhagen

Collaborator