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The Impact of C-reactive Protein Testing

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ClinicalTrials.gov Identifier: NCT02758821
Recruitment Status : Recruiting
First Posted : May 3, 2016
Last Update Posted : May 9, 2017
Sponsor:
Collaborator:
Department of Medical Research, Lower Myanmar
Information provided by (Responsible Party):
University of Oxford

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.


Condition or disease Intervention/treatment
Fever Other: No CRP will be measured onsite Other: CRP cut-off of 20mg/L. Other: CRP cut-off of 40mg/L.

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 2400 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Other
Official Title: The Impact of C-reactive Protein Testing on Antibiotic Prescription in Febrile Patients Attending Primary Care in Low-resource Settings
Actual Study Start Date : May 2016
Estimated Primary Completion Date : June 2017
Estimated Study Completion Date : June 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Antibiotics Fever
U.S. FDA Resources

Arm Intervention/treatment
CRP-Control
The health care provider will manage the patient using standard guidelines. No CRP will be measured onsite
Other: No CRP will be measured onsite
No CRP will be measured onsite
CRP-A
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.
Health care worker will be given an advice to prescribe antibiotic to patient who has CRP lever < 20mg/L.
CRP-B
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.
Health care worker will be given an advice to prescribe antibiotic to patient who has CRP lever < 40mg/L.



Primary Outcome Measures :
  1. The proportion of recruited patients prescribed an antibiotic [ Time Frame: 6 Days ]
    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).


Secondary Outcome Measures :
  1. Duration of symptoms [ Time Frame: 14 Days ]
    Symptoms as defined by fever, any other symptom

  2. Severity of symptoms [ Time Frame: 14 Days ]
    Severity will be assessed by the nurse using a rating scale graded from 1 to 4 (#Grading 1=mild, 2=moderate, 3=severe, 4=potentially life-threatening), according to the patients' description of their symptoms, and the findings of the physical examination.

  3. Frequency of severe clinical outcomes [ Time Frame: 14 Days ]
    as defined by admission to hospital or death within the 14 days of follow up

  4. Proportion of patients that needed their clinical management changed within the 14 days of follow-up. [ Time Frame: 14 Days ]
  5. Frequency of unplanned re-consultation [ Time Frame: 14 Days ]
  6. Clinical outcome on Day 5 compare to CRP level [ Time Frame: 5 Days ]
  7. Proportion of patients with an immediate versus subsequent prescription within 2 weeks. [ Time Frame: 14 Days ]
  8. Proportion of urine samples that tested positive for presence of antibiotics [ Time Frame: 14 Days ]
  9. Interview of health centre staff for attitudes and satisfaction [ Time Frame: 6 months ]
    Attitudes and satisfaction of health centre staff towards the CRP POC test

  10. The proportion of a population who have key pathogens [ Time Frame: 6 months ]
    Key pathogens are Flavivirus, Alphavirus, Influenza A & B, Rickettsia including typhus group and spotted fever group, Leptospirosis, PCR 16s for the detection of any bacteria and malaria

  11. Percentage of subjects who are correctly identified as having bacterial infections by using CRP testing [ Time Frame: 6 months ]
    Sensitivity is defined as the proportion of patients with high CRP, out of all PCR confirmed bacterial infections.

  12. Percentage of subjects who are correctly identified as having viral infections by using CRP testing [ Time Frame: 6 months ]
    Specificity is defined as the proportion of patients with low CRP, out of all PCR confirmed viral infections.

  13. The likelihood ratio (LR) of correctly identifying a bacterial infection by using CRP-testing. [ Time Frame: 6 months ]
    The positive likelihood ratio is the fraction of sensitivity over (1 - Specificity) , and the negative likelihood ratio is the fraction of (1 - Sensitivity) over Specificity.

  14. The receiver operating characteristic (ROC) for evaluating the accuracy of CRP-testing in identifying bacterial infections. [ Time Frame: 6 months ]
    We will use the ROC, or ROC curve, as a graphical plot, in order to illustrate the performance of the CRP-testing to classify bacterial and non-bacterial infections as its discrimination threshold is varied.



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Ages Eligible for Study:   1 Year and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • 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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02758821


Contacts
Contact: Yoel Lubell, PhD +6622036333 yoel@tropmedres.ac
Contact: Thomas Althaus, MD +6622036333 Thomas.A@tropmedres.ac

Locations
Thailand
Chiangrai Clinical research Unit Recruiting
Chiangrai, Thailand, 50007
Contact: Tri Wangrangsimakul, Doctor    +(66) 0830745931    tri@tropmedres.ac   
Contact: Pratakpong Wongkiti, study nurse    +(66) 052029842      
Sponsors and Collaborators
University of Oxford
Department of Medical Research, Lower Myanmar
Investigators
Principal Investigator: Yoel Lubell, MD Mahidol Oxford Tropical Medicine Research Unit

Responsible Party: University of Oxford
ClinicalTrials.gov Identifier: NCT02758821     History of Changes
Other Study ID Numbers: CRP POC
First Posted: May 3, 2016    Key Record Dates
Last Update Posted: May 9, 2017
Last Verified: May 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by University of Oxford:
C-reactive protein
antibiotic

Additional relevant MeSH terms:
Anti-Bacterial Agents
Antibiotics, Antitubercular
Anti-Infective Agents
Antitubercular Agents