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

NCT07261969 | Recruiting DMC

• 1 other identifier: INSTALL WP1
• Study Type: interventional
• Target: 1,050
• Locations: 1 country
• Sites: 2

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.

Conditions

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

Keywords

CRP POCT; Primary care; ARVI; ARTI; Adults; PIL; RCT

Outcome Measures

Primary Outcomes (2)

• The primary outcome (mainly relevant relative to the PIL intervention)

  The rate of total antibiotic prescriptions (prescribed as well as non-prescribed (e.g. purchased over the counter or taken from home storage).

  Over 21 days.

• The second primary outcome (mainly relevant relative to the CRP threshold intervention)

  The safety measured as a rate of hospital admissions.

  Over 21 days.

Secondary Outcomes (1)

• Secondary study outcomes

  At baseline assessment (Day 0) and over 21 days.

Study Arms (6)

Group AX

ACTIVE COMPARATOR

This arm will receive the CRP POCT intervention plus patient information leaflet. The threshold values of CRP for this group are 20 mg/l.

Diagnostic Test: The C-reactive protein point-of-care test (CRP-POCT); Behavioral: Patient information leaflets

Group AY

ACTIVE COMPARATOR

This arm will receive the CRP POCT intervention plus patient information leaflet. The threshold values of CRP for this group are 40 mg/l.

Diagnostic Test: The C-reactive protein point-of-care test (CRP-POCT); Behavioral: Patient information leaflets

Group AZ

ACTIVE COMPARATOR

This arm will receive the CRP POCT intervention plus patient information leaflet. The threshold values of CRP for this group are 60 mg/l.

Diagnostic Test: The C-reactive protein point-of-care test (CRP-POCT); Behavioral: Patient information leaflets

Group BX

ACTIVE COMPARATOR

This arm will receive only the CRP POCT intervention. The threshold values of CRP for this group are 20 mg/l.

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

Group BY

ACTIVE COMPARATOR

This arm will receive only the CRP POCT intervention. The threshold values of CRP for this group are 40 mg/l.

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

Group BZ

ACTIVE COMPARATOR

This arm will receive only the CRP POCT intervention. The threshold values of CRP for this group are 60 mg/l.

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

Interventions

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

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.

Also known as: Aidian QuickRead go (Espoo, Finland)

Group AX; Group AY; Group AZ; Group BX; Group BY; Group BZ

Patient information leaflets BEHAVIORAL

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).

Also known as: Antiobiotic-free prescription produced by WHO

Group AX; Group AY; Group AZ

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Rigshospitalet, Denmark: lead
• International Centre for Antimicrobial Resistance Solutions (ICARS): collaborator
• University of Copenhagen: collaborator

Study Sites (2)

Sokuluk Family Medicine Center

Sokuluk Village, Chui Region, 724800, Kyrgyzstan

RECRUITING

Azim Azhybek uulu

At-Bashy Village, Naryn Region, 722600, Kyrgyzstan

RECRUITING

Related Publications (13)

• Antimicrobial Resistance Collaborators. Global burden of bacterial antimicrobial resistance in 2019: a systematic analysis. Lancet. 2022 Feb 12;399(10325):629-655. doi: 10.1016/S0140-6736(21)02724-0. Epub 2022 Jan 19.

  PMID: 35065702 BACKGROUND

• Holmes AH, Moore LS, Sundsfjord A, Steinbakk M, Regmi S, Karkey A, Guerin PJ, Piddock LJ. Understanding the mechanisms and drivers of antimicrobial resistance. Lancet. 2016 Jan 9;387(10014):176-87. doi: 10.1016/S0140-6736(15)00473-0. Epub 2015 Nov 18.

  PMID: 26603922 BACKGROUND

• Munita JM, Arias CA. Mechanisms of Antibiotic Resistance. Microbiol Spectr. 2016 Apr;4(2):10.1128/microbiolspec.VMBF-0016-2015. doi: 10.1128/microbiolspec.VMBF-0016-2015.

  PMID: 27227291 BACKGROUND

• Baktygul K, Marat B, Ashirali Z, Harun-Or-rashid M, Sakamoto J. An assessment of antibiotics prescribed at the secondary health-care level in the Kyrgyz Republic. Nagoya J Med Sci. 2011 Aug;73(3-4):157-68.

  PMID: 21928697 BACKGROUND

• Do NTT, Vu TVD, Greer RC, Dittrich S, Vandendorpe M, Pham NT, Ta DN, Cao HT, Khuong TV, Le TBT, Duong TH, Nguyen TH, Cai NTH, Nguyen TQT, Trinh ST, van Doorn HR, Lubell Y, Lewycka S. Implementation of point-of-care testing of C-reactive protein concentrations to improve antibiotic targeting in respiratory illness in Vietnamese primary care: a pragmatic cluster-randomised controlled trial. Lancet Infect Dis. 2023 Sep;23(9):1085-1094. doi: 10.1016/S1473-3099(23)00125-1. Epub 2023 May 22.

  PMID: 37230105 BACKGROUND

• Smedemark SA, Aabenhus R, Llor C, Fournaise A, Olsen O, Jorgensen KJ. Biomarkers as point-of-care tests to guide prescription of antibiotics in people with acute respiratory infections in primary care. Cochrane Database Syst Rev. 2022 Oct 17;10(10):CD010130. doi: 10.1002/14651858.CD010130.pub3.

  PMID: 36250577 BACKGROUND

• Isaeva E, Bloch J, Poulsen A, Kurtzhals J, Reventlow S, Siersma V, Akylbekov A, Sooronbaev T, Munck Aabenhus R, Kjaergaard J. C reactive protein-guided prescription of antibiotics for children under 12 years with respiratory symptoms in Kyrgyzstan: protocol for a randomised controlled clinical trial with 14 days follow-up. BMJ Open. 2023 Apr 11;13(4):e066806. doi: 10.1136/bmjopen-2022-066806.

  PMID: 37041063 BACKGROUND

• Ngwengi Y, Ngaba GP, Nida M, Enyama D. Evaluation of CRP as a marker for bacterial infection and malaria in febrile children at the Douala Gyneco-Obstetric and Pediatric Hospital. PLoS One. 2023 Jul 21;18(7):e0289012. doi: 10.1371/journal.pone.0289012. eCollection 2023.

  PMID: 37478118 BACKGROUND

• Escadafal C, Incardona S, Fernandez-Carballo BL, Dittrich S. The good and the bad: using C reactive protein to distinguish bacterial from non-bacterial infection among febrile patients in low-resource settings. BMJ Glob Health. 2020 May;5(5):e002396. doi: 10.1136/bmjgh-2020-002396.

  PMID: 32467355 BACKGROUND

• Sustersic M, Gauchet A, Foote A, Bosson JL. How best to use and evaluate Patient Information Leaflets given during a consultation: a systematic review of literature reviews. Health Expect. 2017 Aug;20(4):531-542. doi: 10.1111/hex.12487. Epub 2016 Sep 26.

  PMID: 27669682 BACKGROUND

• de Bont EG, Alink M, Falkenberg FC, Dinant GJ, Cals JW. Patient information leaflets to reduce antibiotic use and reconsultation rates in general practice: a systematic review. BMJ Open. 2015 Jun 3;5(6):e007612. doi: 10.1136/bmjopen-2015-007612.

  PMID: 26041493 BACKGROUND

• Wyczalkowska-Tomasik A, Czarkowska-Paczek B, Zielenkiewicz M, Paczek L. Inflammatory Markers Change with Age, but do not Fall Beyond Reported Normal Ranges. Arch Immunol Ther Exp (Warsz). 2016 Jun;64(3):249-54. doi: 10.1007/s00005-015-0357-7. Epub 2015 Aug 18.

  PMID: 26283530 BACKGROUND

• Williamson SF, Grayling MJ, Mander AP, Noor NM, Savage JS, Yap C, Wason JMS. Subgroup analyses in randomized controlled trials frequently categorized continuous subgroup information. J Clin Epidemiol. 2022 Oct;150:72-79. doi: 10.1016/j.jclinepi.2022.06.017. Epub 2022 Jul 2.

  PMID: 35788399 BACKGROUND

Related Links

• O'Neill J. Tackling drug-resistant infections globally: Final report and recommendations. Review on Antimicrobial Resistance. 2016.
• Central Asian and European Surveillance of Antimicrobial Resistance Annual Report 2020.
• Global antimicrobial resistance and use surveillance system (GLASS) report: 2022
• Influenza and ARVI in Kyrgyzstan
• Life expectancy at birth, total (years) - Kyrgyz Republic
• QuikRead go Instrument

MeSH Terms

Conditions

Inflammation

Interventions

World Health Organization

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

United Nations; International Agencies; Organizations; Health Care Economics and Organizations

Central Study Contacts

Azamat Akylbekov, MD

CONTACT

+996700351748; azamatti@yahoo.com

Jesper Kjærgaard, MD, PhD

CONTACT

+4521918714; jesper.kjaergaard@regionh.dk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Following the baseline consultation, follow-up calls will be made to the telephone number provided by the participants on days 3, 7, 14 and 21 (Figure 1) by a blinded researcher from the Bishkek office.
• Purpose: DIAGNOSTIC
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of the unit for children and adolescents with infections or organ-disease

Model Details: A multicentre, open-label, individually randomised controlled clinical trial with 21 days blinded follow-up comparing PIL to no PIL in a 1:1 ratio on antibiotic use and safety. Additionally, antibiotic use and safety will be assessed across three CRP cut-offs (20-40-60 mg/L) in a 1:1:1 ratio to determine the optimal CRP cut-offs in these cohorts. Thus, in total, six groups will be randomly formed and compared. The trial will be conducted in 14 selected district primary-level Healthcare Centres (HCs) in rural Kyrgyzstan and one urban primary-level HC in Bishkek.

Study Record Dates

• First Submitted: December 18, 2024
• First Posted: December 3, 2025
• Study Start: December 18, 2024
• Primary Completion: March 30, 2026
• Study Completion (Estimated): April 30, 2027
• Last Updated: December 3, 2025

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

KY (2)