NCT02758821

Brief Summary

PRIMARY OBJECTIVE To assess the impact of C-reactive protein (CRP) Point-of-care (POC) testing on health care worker prescribing behaviour in patients presenting to primary healthcare centres with an acute fever or recent history of fever. SECONDARY OBJECTIVES To assess the impact of CRP testing on clinical outcomes within the 14 days of follow-up. To assess the correlation between CRP results and clinical outcomes on the day 5 of the enrolment. To estimate the impact of CRP testing on antibiotic consumption after first consultation. To explore the attitudes of health centre staff towards the POC CRP test. To identify the prevalence of key pathogens in febrile patients in these settings. To validate the ability of CRP to discriminate between viral and bacterial pathogens in a subset of patients with a microbiologically confirmed diagnosis.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2,410

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jun 2016

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 10, 2016

Completed
2 months until next milestone

First Posted

Study publicly available on registry

May 3, 2016

Completed
1 month until next milestone

Study Start

First participant enrolled

June 8, 2016

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2017

Completed
Last Updated

August 15, 2018

Status Verified

August 1, 2018

Enrollment Period

1.3 years

First QC Date

March 10, 2016

Last Update Submit

August 14, 2018

Conditions

Fever

Keywords

C-reactive proteinantibiotic

Outcome Measures

Primary Outcomes (1)

  • The proportion of recruited patients prescribed an antibiotic

    The proportion of recruited patients prescribed an antibiotic at the health centre on or between their enrolment and the first follow-up visit (on day 5 +/- 1 day).

    6 Days

Secondary Outcomes (14)

  • Duration of symptoms

    14 Days

  • Severity of symptoms

    14 Days

  • Frequency of severe clinical outcomes

    14 Days

  • Proportion of patients that needed their clinical management changed within the 14 days of follow-up.

    14 Days

  • Frequency of unplanned re-consultation

    14 Days

  • +9 more secondary outcomes

Study Arms (3)

CRP-Control

OTHER

The health care provider will manage the patient using standard guidelines. No CRP will be measured onsite

Other: No CRP will be measured onsite

CRP-A

OTHER

CRP will be measured by a study nurse onsite and the result will be communicated to the health care provider.

Other: CRP cut-off of 20mg/L.

CRP-B

OTHER

CRP will be measured by a study nurse onsite and the result will be communicated to the health care provider.

Other: CRP cut-off of 40mg/L.

Interventions

No CRP will be measured onsiteOTHER

No CRP will be measured onsite

CRP-Control
CRP cut-off of 20mg/L.OTHER

Health care worker will be given an advice to prescribe antibiotic to patient who has CRP lever \< 20mg/L.

CRP-A
CRP cut-off of 40mg/L.OTHER

Health care worker will be given an advice to prescribe antibiotic to patient who has CRP lever \< 40mg/L.

CRP-B

Eligibility Criteria

Age1 Year+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Patients aged ≥1 year presenting to selected primary healthcare centres
  • Tympanic temperature \>37.5°c or history of fever ≤ 14 days.

You may not qualify if:

  • Patients that in view of the study nurse are in need of emergency referral to a higher-level facility, as indicated by either 1) impaired consciousness or 2) inability to take oral medication.
  • In sites that routinely test for malaria, patients with a positive malaria rapid diagnostic test or microscopy will be excluded
  • The main complaint is a trauma and/or injury
  • Suspicion of tuberculosis (any medical history and/or physical examination suggesting tuberculosis)
  • Suspicion of Urinary Tract Infections (any medical history and/or physical examination suggesting urinary tract infections)
  • Suspicion of local skin/dental abscess (any medical history and/or physical examination suggesting a local skin/dental abscess
  • Any presenting symptom present for more than 14 days
  • Bleeding, including otorrhagia, haematemesis, haemoptysis, haemorrhagic petechiae, haematuria, bloody diarrhoea.
  • Not able to comply with the follow-up at Day 5 (+ / - 1 day).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chiangrai Clinical research Unit

Chiangrai, Chiangrai, 50007, Thailand

Location

Related Publications (3)

  • Althaus T, Thaipadungpanit J, Greer RC, Swe MMM, Dittrich S, Peerawaranun P, Smit PW, Wangrangsimakul T, Blacksell S, Winchell JM, Diaz MH, Day NPJ, Smithuis F, Turner P, Lubell Y. Causes of fever in primary care in Southeast Asia and the performance of C-reactive protein in discriminating bacterial from viral pathogens. Int J Infect Dis. 2020 Jul;96:334-342. doi: 10.1016/j.ijid.2020.05.016. Epub 2020 May 11.

    PMID: 32437937DERIVED

  • Haenssgen MJ, Charoenboon N, Do NTT, Althaus T, Khine Zaw Y, Wertheim HFL, Lubell Y. How context can impact clinical trials: a multi-country qualitative case study comparison of diagnostic biomarker test interventions. Trials. 2019 Feb 8;20(1):111. doi: 10.1186/s13063-019-3215-9.

    PMID: 30736818DERIVED

  • Althaus T, Greer RC, Swe MMM, Cohen J, Tun NN, Heaton J, Nedsuwan S, Intralawan D, Sumpradit N, Dittrich S, Doran Z, Waithira N, Thu HM, Win H, Thaipadungpanit J, Srilohasin P, Mukaka M, Smit PW, Charoenboon EN, Haenssgen MJ, Wangrangsimakul T, Blacksell S, Limmathurotsakul D, Day N, Smithuis F, Lubell Y. Effect of point-of-care C-reactive protein testing on antibiotic prescription in febrile patients attending primary care in Thailand and Myanmar: an open-label, randomised, controlled trial. Lancet Glob Health. 2019 Jan;7(1):e119-e131. doi: 10.1016/S2214-109X(18)30444-3.

    PMID: 30554748DERIVED

MeSH Terms

Conditions

Fever

Condition Hierarchy (Ancestors)

Body Temperature ChangesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Yoel Lubell, MD

    Mahidol Oxford Tropical Medicine Research Unit

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 10, 2016

First Posted

May 3, 2016

Study Start

June 8, 2016

Primary Completion

September 30, 2017

Study Completion

September 30, 2017

Last Updated

August 15, 2018

Record last verified: 2018-08

Data Sharing

IPD Sharing
Will not share

Locations

TH(1)