dr_sabiha_essack

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

[email protected]

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

F r e eF r e eF r e eF r e eF r e eF r e eF r e eF r e eF r e eS t a t eS t a t eS t a t eS t a t eS t a t eS t a t eS t a t eS t a t eS t a t e

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

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