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

NCT07261969 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 1050

Last updated 2025-12-03

No results posted yet for this study

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.

Conditions

  • Respiratory Tract Infection Bacterial
  • Respiratory Tract Infection Viral
  • AMR
  • CRP
  • Inflammation

Interventions

DIAGNOSTIC_TEST

The C-reactive protein point-of-care test (CRP-POCT)

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.

BEHAVIORAL

Patient information leaflets

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).

Sponsors & Collaborators

  • International Centre for Antimicrobial Resistance Solutions (ICARS)

    collaborator UNKNOWN
  • University of Copenhagen

    collaborator OTHER
  • Rigshospitalet, Denmark

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
SINGLE
Model
FACTORIAL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-12-18
Primary Completion
2026-03-30
Completion
2027-04-30

Countries

  • Kyrgyzstan

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07261969 on ClinicalTrials.gov