dr_sabiha_essack
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http://www.cddep.org/sites/cddep.org/files/dr_sabiha_essack.pdfTRANSCRIPT
Surveillance-‐Based Treatment Guidelines for Infec7ons
The South African Experience
Professor Sabiha Essack
B. Pharm., M. Pharm., PhD Dean – Faculty of Health Sciences, UKZN Chair – South African Chapter of APUA
Overview o Mul$-‐centre passive surveillance study
n An$bio$c use and resistance
o Disease-‐based ac$ve surveillance study n Nosocomial infec$ons
o Surveillance-‐based clinical prac$ce, infec$on control & policy development
STGs and the EDL
o Na$onal DoH implemented STGs and the EDL for common health problems at primary care and hospital level as part of the health policy.1
o STGs were formulated by expert commiGees. o PK and PD, drug interac$ons, adverse effects, routes of
administra$on, concentra$ons at anatomical sites and cost are considered in the development of STGs and the EDL. 2
o An$microbial resistance nullifies these factors in the development of STGs for infec$ons.2
Mul7centre Surveillance Study Sample Sites and Size
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kilometres
40 80
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MozambiqueMozambiqueMozambiqueMozambiqueMozambiqueMozambiqueMozambiqueMozambiqueMozambiqueSwazilandSwazilandSwazilandSwazilandSwazilandSwazilandSwazilandSwazilandSwaziland
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E a s t e r n C a p eE a s t e r n C a p eE a s t e r n C a p eE a s t e r n C a p eE a s t e r n C a p eE a s t e r n C a p eE a s t e r n C a p eE a s t e r n C a p eE a s t e r n C a p e
M p u m a l a n g aM p u m a l a n g aM p u m a l a n g aM p u m a l a n g aM p u m a l a n g aM p u m a l a n g aM p u m a l a n g aM p u m a l a n g aM p u m a l a n g a
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Hospitals by TypeHospitals by TypeHospitals by TypeHospitals by TypeHospitals by TypeHospitals by TypeHospitals by TypeHospitals by TypeHospitals by Type
16 hospitals at 3 progressive levels of health care (district, regional, ter$ary)
100 consecu$ve, non-‐repe$$ve isolates submiGed, iden$fied and subjected to suscep$bility tes$ng
Mul7centre Surveillance Study Methodology
• Iden$fica$on using the API system • An$bio$c suscep$bility determina$on using the Kirby Bauer disc diffusion method with MICs extrapolated on an automated reading system3.
• Isolates grouped according to their natural resistance profiles. • Mean %suscep$bility and SD to each an$bio$c stra$fied within and across hospital levels.
• An$bio$c use data was calculated as daily defined dose DDD/1000 pa$ent days.
Mul7centre Surveillance Study Results
22
3 2
24
2
10 3
13
9
4 6
% Species Isolated
Staphylococcus aureus
Streptococcus spp.
Enterococcus spp.
Escherichia coli
Citrobacter spp.
Klebsiella spp.
Enterobacter spp.
Proteus spp.
Pseudomonas spp.
Acinetobacter spp.
Mul7centre Surveillance Study Results (2)
0 10 20 30 40 50 60 70 80 90 100
%
% Suscep7bility of Klebsiella spp., C. diversus & Proteus spp. (excl P. mirabilis)
District
Regional
Ter$ary
64+19 53+15
72+29
57+31 50+31
88+13 84+25 95+10 96+9 99+2
• 3% (40/1270) sensi$ve to all an$bio$cs. • 6% (79/1270) resistant to a single agent. • Remaining 91% were mul$-‐resistant • SD ranged from 3-‐55%
Mul7centre Surveillance Study Results (3)
17
1
22
28
3
33
23
9
34
0
5
10
15
20
25
30
35
40
MRSA ESBL producing organisms
AmpC producing organisms
%
% MRSA, ESBL+ & AmpC Producers Isolated
District Regional Tertiary
Ceftazidime Use and Resistance in Klebsiella spp., C. diversus ....
R2 = 0.6433
0
20
40
60
80
100
120
0 0.01 0.02 0.03 0.04 0.05 0.06 0.07 0.08 0.09
DDD/1000 patient days
%Se
nsiti
vity
Ac7ve, Disease-‐Based Surveillance Study Sites, Sampling and Methodology o 3 hospitals – 1 district, 1 regional & 1 ter$ary o 100 each of each pathogen implicated in infec$ons of the:
n respiratory tract, viz., Streptococcus pyogenes, Streptococcus pneumoniae, Heamophilis influenzae and Moraxella catarrhalis,
n gastro-‐intes$nal tract, viz., Salmonella spp., Salmonella typhi and Shigella spp.,
n uro-‐genital tract, viz., Escherichia coli and Proteus spp, n skin, viz., Staphylococcus aureus and Streptococcus pyogenes, and n nosocomial infec$ons, viz., Klebsiella spp., Citrobacter spp.,
Enterobacter spp, Serra@a spp, Acinetobacter spp., Pseudomonas spp. and , Enterococcus spp.
o Methodology -‐ as for mul$centre surveillance study
0102030405060708090
100
piperacillin tazobactam cefepime meropenem
%
% Sensitivity of K. pneumoniae, Acinetebacter spp. & P. aeruginosa
K. pneumoniaeP. aeruginosaAcinetobacter spp.
50+29
36+21
54+40
• Implicated in hospital-acquired pneumonia, ventilator associated pneumonia • Empiric therapy: • Either piperacillin-tazobactam, cefepime, carbapenem4
p<0,001 across all antibiotics p<0,001 for K. pneumoniae, 0.003 for P aeruginosa
Ac7ve Disease-‐Based Surveillance Study Results – Nosocomial Infec7ons
Conclusions and Recommenda7ons o STGs and EDL for infec$ons were compiled by expert
commiGees without the availability of surveillance data. o Microbial ae$ology of the disease, an$bio$c use and an$bio$c
resistance impact on treatment guidelines.1 o Resistance profiles amongst bacteria vary too much to allow a
na$onal an$bio$c policy as proposed in the STGs and EDL.
o Treatment guidelines, treatment algorithms and an7bio7c policies should be formulated by evalua7ng the suscep7bility pa[erns of common causa7ve organisms obtained from large scale, representa7ve, quality-‐assured, ac7ve disease-‐based surveillance studies.
Uses of Surveillance Surveillance: o Improves the quality of empirical an$microbial treatment o Guides the formula$on of an$microbial policies & use o Educates all an$microbial users, including the public o Prospec$vely monitors the efficacy of an$microbials o Informs hospital infec$on control in preven$ng the
dissemina$on of resistant organisms o Iden$fies resistance problems and recommends solu$ons o Guides the development of new an$microbial agents by the
pharmaceu$cal industry o Monitors the evolu$on of resistance locally & interna$onally
to allow early interven$on.5
Uses of Surveillance (2) Surveillance: o Assists pa$ent diagnosis o Guides treatment of individual pa$ents o Informs local & na$onal drug policies & guidelines o Focuses local infec$on control in hospitals & communi$es o Enables infec$on control to be regional, na$onal & global o Can improve tes$ng in pa$ent care laboratories o Supports sen$nel laboratories in areas with minimal
resources o Enhances safety of pa$ents in par$cipa$ng centres6
Surveillance in Global Ini7a7ves to Contain An7bio7c Resistance
o The WHO Global Strategy for the Containment of An$bio$c Resistance o US -‐ “Public Heath Ac$on Plan to Combat An$microbial Resistance” o UK -‐ “Resistance to An$bio$cs” by the House of Lords Select CommiGee on
Science and Technology o EU -‐ “Copenhagen Recommenda$ons Report on the EU Conference on the
Microbial Threat”. o India – “Na$onal Policy for Containment of An$microbial Resistance” o Kenya – Na$onal Policy on Infec$on Control published by Ministry of Health
GARP-‐Kenya and CDDEP convened a policy development workshop in March 2011.
o South Africa –Medicines Control Council Conference 2003, with the theme “An$microbial Resistance-‐Facing the Reality” and the mission cited as “appropriate an$microbial policies for public health”.
o Vietnam – member of ReACT SEA, a regional plamorm for policy & programmes Cri7cal to all these ini7a7ves is surveillance which provides evidence for empirical treatment decisions and provides epidemiological data to inform
containment strategies.7 .
o
Acknowledgements
o Medical Research Council
o Na$onal Research Founda$on
o Ms Cathy Connolly, Department of Biosta$cs, MRC, Durban
References 1. The Na$onal Department of Health. (1998). Standard treatment guidelines and
essen$al drugs list. The Na$onal Department of Health. South Africa. 2. Blondeau JM, Tillotson GS. (1999). Formula to help select ra$onal
an$microbial therapy (FRST): its applica$on to community-‐ and hospital-‐acquired urinary tract infec$ons. Interna@onal Journal of An@microbial Agents 12, 145-‐150.
3. Clinical and Laboratory Standards Ins$tute. 2005. Methods for dilu$on an$microbial suscep$bility tests for bacteria that grow aerobically. 6th edi$on. Approved standard. M7-‐A6, Wayne, P.A., USA.
4. The Na$onal Department of Health. (2006). Standard treatment guidelines and essen$al drugs list. The Na$onal Department of Health. South Africa.
5. Masterton, R., Craven, D., Rello, J., Streulens, M. et al. 2007. Hospital-‐acquired pneumoniae guidelines in Europe: a review of their status and future development. Journal of An@microbial Chemotherapy 60, 206-‐213.
6. Masterson, R.G. 2000. Surveillance studies: how they can help the management of infec$on. Journal of An@microbial Chemotherapy 46 Topic T2, 53-‐58.
7. O’Brien, T.F. & Stelling, J. 2011. Integrated Mul$level Surveillance of the World’s Infec$ng Microbes & their Resistance to An$microbial Agents. Clinical Microbiology Reviews 24, 281-‐295