NCT07261969 CRP and Patient Information Leaflets to Optimise Antibiotic Treatments for Adults With Respiratory Tract Infections in Primary Care in Kyrgyzstan
| NCT ID | NCT07261969 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Rigshospitalet, Denmark |
| Condition | Respiratory Tract Infection Bacterial |
| Study Type | INTERVENTIONAL |
| Enrollment | 1,050 participants |
| Start Date | 2024-12-18 |
| Primary Completion | 2026-03-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 1,050 participants in total. It began in 2024-12-18 with a primary completion date of 2026-03-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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): * 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 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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07261969 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 70 Years, studying Respiratory Tract Infection Bacterial. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07261969 currently recruiting?
Yes, NCT07261969 is actively recruiting participants. Contact the research team at azamatti@yahoo.com for enrollment information.
Where is the NCT07261969 trial being conducted?
This trial is being conducted at Sokuluk Village, Kyrgyzstan, At-Bashy Village, Kyrgyzstan.
Who is sponsoring the NCT07261969 clinical trial?
NCT07261969 is sponsored by Rigshospitalet, Denmark. The trial plans to enroll 1,050 participants.