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PACE Trial

- This study evaluated the use of point-of-care CRP testing to guide antibiotic prescribing for acute exacerbations of COPD in primary care. - Over 650 patients with COPD exacerbations were randomly assigned to either CRP testing plus usual care or usual care alone. - The CRP-guided group had significantly lower rates of antibiotic use (57% vs 77%) and improved COPD health status scores at 2 weeks compared to the usual care group. - Point-of-care CRP testing may help reduce unnecessary antibiotic use for COPD exacerbations without harming patients.

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Appu Elias
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54 views

PACE Trial

- This study evaluated the use of point-of-care CRP testing to guide antibiotic prescribing for acute exacerbations of COPD in primary care. - Over 650 patients with COPD exacerbations were randomly assigned to either CRP testing plus usual care or usual care alone. - The CRP-guided group had significantly lower rates of antibiotic use (57% vs 77%) and improved COPD health status scores at 2 weeks compared to the usual care group. - Point-of-care CRP testing may help reduce unnecessary antibiotic use for COPD exacerbations without harming patients.

Uploaded by

Appu Elias
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
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Download as PPTX, PDF, TXT or read online on Scribd
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Medicine 4

Background
• AECOPD – over 2 million antibiotic prescriptions each year in the UK.

• Over 70 % of patients – primary care.

• 70 % - triggered by infection; > 50 % viral.

Llor C, Bjerrum L, Munck A, Hansen MP, Cordoba GC, Stranderg EL, st al. Predictors for antibiotic prescribing in patients with exacerbations of COPD in General Practice. Ther Adv Respir Dis. 2013.

Celli BR, Barnes PJ. Exacerbations of chronic obstructive pulmonary disease. 2007.

Rohde G, Wiethege A, Borg I, Kauth M, Bauer TT, Gillissen A, et al. Respiratory viruses in exacerbations of chronic obstructive pulmonary disease requiring hospitalisation: a case – control study. 2003.
• Current prescribing recommendations – Anthonisen criteria
( symptoms alone ) – insufficient diagnostic accuracy to predict who
can be safely managed without antibiotics.

• Many patients with AECOPD do not benefit from antibiotics.

• Antibiotic resistance – Public health threat.

• Increases risk for subsequent exacerbations and disease progression.

Miravitlles M, Moragas A, Hernandez S, Bayona C, Llor C. Is it possible to identify exacerbations of mild to moderate COPD that do not require antibiotic treatment ? Chest. 2013.

Soler N, Ewig S, Torres A, Filella X, Gonzalez J, Zaubet A. Airway inflammation and bronchial microbial patterns in patients with stable chronic obstructive pulmonary disease. Eur Respir J.
1999;14(5):1015-22.
• An RCT – AECOPD in primary care practice showed little difference in
the rate of clinical cure with either antibiotics or placebo among those
who had a CRP level of less than 40 mg/L.

Point-of-care testing of CRP - reduce unnecessary use of antibiotics


without harming patients – AECOPD.

Llor C, Moragas A, Hernández S, Bayona C, Miravitlles M. Efficacy of antibiotic therapy for acute exacerbations of mild to moderate chronic obstructive pulmonary disease. Am J Respir Crit Care Med
2012; 186: 716-23.
• Population : COPD in clinical record; 40 years or older; presenting
with an AECOPD.

• Intervention : CRP point of care testing + Usual care.

• Control : Usual care alone.

• Outcomes : Patient reported antibiotic use of AECOPD within 4 weeks


of randomisation; COPD health status – Clinical COPD questionnaire at
2 weeks after randomisation.

• Time Period : January 2015 – September 2017.


Design
• Multicentre.
• Open label.
• Two arms (1:1).
• RCT.
Inclusion Criteria
• Current Acute exacerbation for atleast 24 hrs and not longer than 21
days .
( presenting with least one of : Increased dyspnea, Increased sputum
volume, Increased sputum purulence )

• Diagnosis of COPD in clinical register.


• Age – 40 or more.
• Patient should be able to provide primary outcome data at 2 weeks
and 4 weeks within the expected windows.
Exclusion Criteria
• Responsible clinician feels urgent referral to hospital is necessary.
• Severe Illness ( suspected pneumonia, tachypnoea > 30 breaths /min,
Respiratory failure ).
• Concurrent infection at another site ( UTI/Cellulitis ).
• Past history of respiratory failure or mechanical ventilation.
• Currently on antibiotics or received antibiotics for current
exacerbation.
• Active Inflammatory condition.

• Cystic Fibrosis / current tracheostomy / bronchiectasis.

• Immunocompromised ( AIDS / systemic immunosuppressive therapy /


chemo or radiotherapy )

• Pregnancy.

• Previously recruited into PACE study.


Methods
• Potentially eligible candidates identified – COPD register.

• Sent mails – informing about study – Flagged.

• Informed consent – when patient presented for consultation.


Randomisation
• Online computerised randomisation system with telephone backup.
Eligible COPDS

Acute Exacerbation

CRP POTC

Usual Care

CRP based antibiotic


prescription
Intervention
• CRP PCOT.

• 1.5 microliter of blood – finger prick ( capillary blood ).


• < 4mins

• Alere Afinion CRP PCOT.


Outcomes
• Antibiotic consumption at any point during 4 weeks post
randomisation – measured using telephone interviews at 1 week and
2 weeks and face to face interview at 4 weeks.

• COPD health status – Clinical COPD questionnaire via telephone


interview at 2 weeks.
Secondary Outcomes
• COPD health status over time.
• Prevalence of potentially pathogenic bacteria cultures from sputum at
4 weeks and proportion of bacteria that are resistant.
• Total antibiotic consumption.
• Antibiotic prescribing at index visit.
• Adverse effects secondary to antibiotics.
• Incidence of pneumonia.
• Use of other COPD treatments – steroids.
Statistical Methods
• Sufficient power to detect a 15% reduction from a current estimated
antibiotic consumption rate for AECOPD from 70% - 55%.
• Current estimates – approximately 70% prescribed antibiotics.
5% significance with 90% power – 650 participants,( accounting for lost
to follow up of 20% )
• Modified Intention to treat analysis – all patients who had undergone
randomisation and had available data ( clinical effectiveness ).
• Primary outcomes – intention to treat
Was the assignment of patients to
treatments randomised ?
• Yes

• Online computerised randomisation system with telephone backup

• 1:1
Were the groups similar at start of the trial
?
• Yes
Aside from the allocated treatment, were
the groups treated equally ?
• Yes
Were all patients who entered the trial accounted for ? And
were they analysed in the groups to which they were
randomised ?
• Yes.
Were measures objective, or were the patients and clinicians
kept blind to which treatment was being received ?
• No.
Results
• 317/325 in CRP arm got CRP
• 76 % had CRP less than 20 mg/L
• 12 % - CRP more than 40 mg/L

• 150/263 (57%) and 212/274 (77.4%) reported antibiotic use


• Adjusted odds ratio – 0.31
• 95% CI 0.20 – 0.47
Antibiotic use
• CRP arm – 150/263
• Usual arm – 212/274

• Relative risk – 0.74


• Absolute risk reduction – 20%
• Relative risk reduction – 0.26
• Number needed to treat – 5
• The adjusted mean difference in the total score on the Clinical COPD
Questionnaire at 2 weeks was −0.19 points (two-sided 90% CI, −0.33
to −0.05) in favour of the CRP-guided group.

• Mean – 2.7

• The Clinical COPD Questionnaire is a 10-item scale with a score


ranging from 0 (very good) to 6 (extremely poor). The minimal
clinically important difference is 0.4.

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