Post on 29-Jan-2022
Antimicrobial Resistance (AMR) Research & Innovation:
Addressing Africa’s Regional Priorities
Dr Francis J Ndowa• Specialist: Venereology/Dermatology• Chairperson, Harare Central Hospital Management Board• Member of the WHO Strategic and Technical Advisory
Group on Antimicrobial Resistance (WHO AMR-STAG)• Member of the Antimicrobial Resistance (AMR) Program Advisory
Committee of Zimbabwe• Executive Member of International Union against STI (IUSTI)• International consultant on STIs and gonococcal
antimicrobial resistance (GC AMR)
Cape Town 1 September 2016
Introduction to Break-Out Sessions
Group 1
Public Health AMR Priorities in Africa
• Surveillance
• Treatments
• Diagnostics
Group 2
Key elements of ensuring stewardship and sustainable access to new treatments
• To impede the rapid development of antimicrobial resistance
• To limit cross-resistance within the class(es) of antibiotics
• Practical policy issues and regulatory processes
Group 3
Clinical Research for Antibiotic Treatments in and for Africa: potential for regional collaboration and clinical trial networks
• What are the gaps
• Where are the gaps (in what areas of intervention?)
Introduction to Break-Out Sessions
Group 1 Surveillance
• Consider what to survey as priority and why
• Populations
• Location and Periodicity
Group 1 Treatments
• Standardisation
• Use of antimicrobial agents
• Availability
• Procurement
Group 1 Diagnostics
• Priority for which infections and why
• Interpretation and use of diagnostic tests – what are the issues?
Introduction to Break-Out Sessions
Group 2 Stewardship
• What does stewardship mean:o At the national level
o At the local (central or peripheral level of health care
• How to foster and sustain stewardship
• How to ensure access but promoting responsible use of:o Existing treatments
o New treatments
Group 3 Clinical Research for Antibiotic Treatments (Use)
• Morbidity and mortality data
• Knowledge and attitudes of health-care providers and clients towards use and importance of antimicrobial agents
• Collaboration between clinicians and laboratorianso What are the gaps?
• What lessons learned from regional collaborative clinical research networks for accelerating introduction of new treatments – how can collaboration help accelerate regulatory pathways where capacity differs among countries?
Countries reporting increased MIC of Cefixime and
Ceftriaxone in N. gonorrhoeae (2010)
Status of gonococcal antimicrobial resistance surveillance in 12
countries in the WHO African Region, July 2013
Country Centres with skills for
AMR susceptibility
testing?
Centres with -
70° or -20°
freezers
Culture media for
GC
Antimicrobial
susceptibility
testing used
Was β-lactamase
test done?
Cameroon Yes Yes Choc agar Agar diffusion
E-test
Yes
Côte
d'IvoireYes Yes TM medium Agar diffusion
E-test
Yes
Dem Rep of
CongoYes Yes Choc agar N/A No
Ethiopia Yes Yes Mod TM Disc diffusion YesGambia Yes Yes Choc agar,
TM, Blood agar
Disc diffusion No
Kenya Yes Yes TM medium N/A N/AMadagascar Blank Yes Blank E-test Yes
Rwanda Yes Yes N/A N/A N/ASeychelles Yes Yes Blood agar Antibiotic disc on
agar plates
No
Tanzania Yes Yes TM medium Agar diffusion
E-test
Yes
Zimbabwe Yes Yes Amies E-test Yes
Number of gonococcal isolates per country by year of
survey in selected African countries, 2004-2012
Country Year of survey Total N. gonorrhoeaeisolates tested by country
2004 2005 2006 2007 2008 2009 2010 2011 2012
Cameroon 79 22 26 18 17 24 186
Central Africa Republic
30 30
Côte d'Ivoire 10 12 9 31
Kenya 166 17 183
Madagascar 126 21 19 22 52 240
Malawi 106 106
Mozambique 55 55
Namibia 123 123
South Africa 259 389 219 682 522 121 175 146 2,513
Zimbabwe 69 69
Total number ofisolates per
year259 444 454 911 565 342 313 224 24 3,536
Use of laboratory results vs clinical status of patientThe case of Mr X Age 19 years
Mr X, age 19 years
Medical History:
• Sexual intercourse with girlfriend known for 1 month (April 2016)
• Genital discharge 1 week later (April 2016)
• Seen by GP: 1 July for “recurrent mucus-like urethral discharge and itchiness of glans penis and ?anal region
• Treated with an exhaustive list of antibiotics!
Laboratory tests1 July: RPR -ve, TPHA -ve, HIV test -ve, Urine microscopy: wbc (occasional), C & S no growth18 August: Persistent penile itchingLaboratory testsUrethral swab: wbc <1Gram stain: Gram +ve cocciCulture: E. coli (see antibiogram)
Use of laboratory results vs clinical status of patientThe case of Mr X Age 19 years
Use of laboratory results vs clinical status of patient: The case of Mr X Age 19 years
Use of laboratory results vs clinical status of patient: The case of Mr X Age 19 years
REQUEST FOR EXPERT OPINION ON RESTRICTION OF FLOROQUINOLONE USE TO TBby
The Medicines Control Authority of Zimbabwe, 3 August 2016
“Before the WHO recommendation for use of floroquinolones for TB treatment MCAZ had registered some products containing levofloxacin, moxifloxacin and ofloxacin for treatment of respiratory tract infections [other] than TB, urinary tract and soft tissue infections. After the WHO indication of levofloxacin, moxifloxacin and ofloxacinfor TB treatment MCAZ has restricted the indications of the new registered products to TB treatment only, with the intention [to] reclassify all previously registered products to be used for TB treatment only. Some applicants with existing open marketing authorisation and other applicants with new marketing authorisations have submitted representations against the proposed restriction of use [of] levofloxacin, moxifloxacin and ofloxacin to TB treatment only. They cite viability issues if the products would be restricted to TB treatment only. The Authority’s concern is possibility of development resistance by TB pathogens to floroquinolone medicines thereby limiting their efficacy in TB treatment”
AN EXAMPLE OF POLICY DECISION AT THE NATIONAL LEVEL TO PREVENT DEVELOPMENT OF ANTIMICROBIAL RESISTANCE IN A SPECIFIC INFECTION
The proposal for policy/guideline change by MCAZ
• i) MCAZ should restrict the use of all medicines containing levofloxacin, ofloxacin and moxifloxacin to the treatment of TB only
• ii) MCAZ should review the indications of already registered levofloxacin, ofloxacin and moxifloxacin products to exclude treatment of other bacterial infections than TB.
• iii) MCAZ should extend the restriction to other earlier generation floroquinolones such as ciprofloxacin in a bid to limit resistance to the fluoroquinolone class.
Enjoy the discussions and Report Back