Stakeholder Opinions: Nosocomial Infections - The need for new gram-negative drugs

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Publication Date: 2007-03-22

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In the US and Europe, an estimated 510% of patients are expected to develop an infection during their hospital stay. The four main types of infections that occur within the hospital setting are urinary tract infections, hospital acquired pneumonia, surgical site infections and blood-stream infections, accounting for approximately 35%, 15%, 14% and 10% respectively.

Scope

Overview of the epidemiological trends of the four main types of nosocomial infections.

An analysis of the incidence and antimicrobial susceptibilities of etiologic agents

An estimation of the current antibiotic treatment costs and market size by infection site

An assessment of key unmet needs and new product development

Report Highlights
Over the past decades, there has been a notable rise in the number of hospital infections caused by gram-positive bacteria such as Staphylococcus aureus and enterococci. However, the most important observation has been that of the rising numbers of gram positive bacteria resistant to several of the currently available antibiotics.

Although gram-positive organisms account for the majority of nosocomial infections, there has been a big increase in multi-drug resistant gram-negative bacteria such as extended-spectrum beta-lactamase (ESBL) producing E. coli and K. pneumoniae and strains of P. aeruginosa and A. baumannii resistant to all currently available antimicrobials.

The majority of newly introduced products and products in late stage development target gram-positive bacteria such as MRSA. Although these agents have been welcomed by the infectious disease community, Datamonitor believes there is a significant opportunity for new antibacterials which can treat multi-drug resistant gram-negative organisms.

Reasons to Purchase

Identify the key factors that determine treatment choice in nosocomial infections

Examine the remaining and emerging unmet needs in the nosocomial infections market and identify opportunities for new product development

Gain an overview of market size and treatment cost of the four most common infections in terms of value and patient numbers

ABOUT DATAMONITOR HEALTHCARE - page 2
- About the Infectious Diseases and Respiratory (ID&R) pharmaceutical analysis team - page 2
CHAPTER 1 EXECUTIVE SUMMARY - page 3
- Scope of the analysis - page 3
- Datamonitor insight into the nosocomial infections market - page 4
CHAPTER 2 DISEASE BACKGROUND - page 12
- Disease definition - page 12
- Epidemiology - page 13
- Modes of acquisition - page 17
  - Surgical site infections - page 20
    - Causative pathogens - page 22
    - General incidence - page 23
    - Pathogenesis - page 27
  - Bloodstream infections - page 28
    - Causative pathogens - page 29
    - General incidence - page 32
    - Intravascular catheter-related infections account for the majority of BSIs - page 34
    - Pathogenesis - page 35
  - Urinary tract infections - page 35
    - Causative pathogens - page 36
    - General Incidence - page 36
    - The majority of hospital acquired UTIs are associated with contaminated urinary catheters - page 37
    - Pathogenesis - page 38
  - Pneumonia - page 39
    - Causative pathogens - page 39
    - General incidence - page 40
    - Mechanical ventilation increases the risk of HAP - page 42
    - Pathogenesis - page 43
CHAPTER 3 ETIOLOGIC AGENTS - page 44
- Bacterial pathogens - page 44
  - Bacterial resistance - page 49
  - Gram-positive bacteria - page 54
    - Staphylococcus aureus - page 54
    - Enterococci - page 60
    - Clostridium difficile - page 66
  - Gram-negative bacteria - page 70
    - Escherichia coli - page 70
    - Klebsiella pneumoniae - page 74
    - Pseudomonas aeruginosa - page 76
    - Acinetobacter baumannii - page 79
- Viral pathogens - page 83
- Fungal pathogens - page 84
CHAPTER 4 TREATMENT OPTIONS - page 86
- Hospital antibacterial market - page 86
  - The overall value in terms of patient numbers - page 86
  - Size of the market in terms of sales - page 87
  - Classes of antibacterials - page 90
    - Cephalosporins - page 91
    - Penicillins - page 92
    - Fluoroquinolones - page 93
    - Carbapenems - page 93
    - Macrolides and ketolides - page 94
    - Glycopeptides - page 94
  - Empiric management of nosocomial infections - page 95
  - Cost of therapy by site of infection - page 95
  - Surgical site infections - page 98
    - Antibiotic prophylaxis prior to surgical operations - page 98
    - Post-operative treatment - page 99
  - Bloodstream infections - page 101
  - Urinary tract infections - page 103
  - Hospital acquired pneumonia - page 105
- Pathogen specific therapy - page 111
  - Gram-positive pathogens - page 112
    - Staphylococcus aureus (including MRSA) - page 112
    - Enterococci - page 113
    - Clostridium difficile - page 115
  - Gram-negative pathogens - page 117
    - Klebsiella pneumoniae - page 117
    - Pseudomonas aeruginosa - page 118
    - Acinetobacter baumannii - page 119
- Factors influencing physician decision-making - page 120
CHAPTER 5 FUTURE TRENDS AND IMPROVING TREATMENT OUTCOMES - page 126
- New product development - page 126
  - Effective gram-negative drugs is the greatest unmet need - page 128
    - The financial burden of multidrug-resistant gram-negative organisms - page 129
  - Majority of newly introduced compounds and compounds in late-stage development target gram-positive pathogens - page 129
    - Tigecycline - page 132
    - Daptomycin - page 133
    - Dalbavancin - page 134
    - Telavancin - page 135
    - Doripenem - page 136
    - Ceftobiprole - page 136
- Preventative strategies to help combat spread of infections in hospitals - page 137
  - Surveillance - page 141
  - Combating bacterial resistance - page 143
  - Financial burden of nosocomial infections - page 145
BIBLIOGRAPHY - page 148
- Books - page 160
- Press releases - page 160
- Websites - page 160
- Datamonitor reports - page 161
- Contributing experts - page 162
  - Disclaimer - page 163

List of Tables
Table 1: Most common pathogens isolated from hospital acquired bloodstream infections, US - page 30
Table 2: Incidence rates and distribution of pathogens most commonly isolated from monomicrobial bloodstream infections and associated crude mortality rates for all patients, patients in intensive care units (ICUs) and patients in non-ICU wards - page 31
Table 3: Staphylococcus aureus-related discharge diagnoses in the US by patient age and infection site, 1999-2000 - page 56
Table 4: The number of invasive S. aureus (SAU) isolates and the proportion resistant to methicillin in the five major EU markets, 2005 - page 58
Table 5: Prolonged stay and mortality rate from Acinetobacter infections in the US - page 82
Table 6: Overall cost of therapy in the US by site of infection - page 97
Table 7: Overview of recently launched antibacterials and antibacterials in late stage development, 2007 - page 130

List of Figures
Figure 1: The four major types of nosocomial infections - page 15
Figure 2: Percentage of four main types of nosocomial infections of all nosocomial infections - page 16
Figure 3: Endogenous and exogenous routes of acquisition - page 19
Figure 4: Infections associated with invasive devices and procedures - page 20
Figure 5: Types of Surgical Site Infections (SSI) - page 21
Figure 6: Diagrammatic representation of types of SSI - page 22
Figure 7: Incidence density (/1000 patient days) of registered SSI by surgical procedure (overall) and 95% confidence intervals - page 24
Figure 8: Incidence density (overall) mean of registered surgical site infection by NNIS risk index and by surgical procedure - page 25
Figure 9: Cumulative incidence of SSI in hospitals in England and Wales, 1997-2005 - page 26
Figure 10: Adjusted SSI rates,1997-2005 - page 27
Figure 11: Definition of Bloodstream infection (BSI) - page 29
Figure 12: Incidence rates and distribution of pathogens most commonly isolated from monomicrobial bloodstream infections and associated crude mortality rates for all patients, patients in intensive care units (ICUs) and patients in non-ICU wards - page 32
Figure 13: Estimated number of deaths caused by nosocomial BSIs each year in the US, 2001 - page 33
Figure 14: Mean rates of BSI across ICUs in NNIS hospitals, 2004 - page 34
Figure 15: The urinary tract - page 35
Figure 16: Mean rate of UTI per 1000 urinary catheter days in NNIS hospitals, 2004 - page 37
Figure 17: Classification of Urinary Tract Infections (UTI) - page 38
Figure 18: Classification of Hospital-acquired pneumonia - page 39
Figure 19: Mean rate of VAP per 1000 ventilator-days in NNIS hospitals, 2004 - page 41
Figure 20: Endotracheal intubation - page 42
Figure 21: Distribution of outbreaks of hospital infections by pathogen, 1997-2002 - page 44
Figure 22: Gram-negative and gram-positive bacteria - page 46
Figure 23: Distribution of type of bacteria in hospital infections - page 48
Figure 24: Percentages of gram-negative and gram-positive organisms by site of infection from 1986-2003 - page 49
Figure 25: Selected antimicrobial-resistant pathogens associated with nosocomial infections in ICU hospitals, comparison of resistance rates from January-December 2003 with rates for 1998-2002 - page 52
Figure 26: Methicillin (oxacillin)-resistant Staphylococcus aureus (MRSA) among ICU patients, 1995-2004 - page 57
Figure 27: Staphylococcus aureus: proportion of invasive isolates resistant to oxacillin (MRSA) in Europe, 2005 - page 59
Figure 28: Staphylococcus aureus: trends of methicillin-resistance in the 5 major European markets, 1999-2005 - page 60
Figure 29: Vancomycin-resistant Enterococci among ICU patients in the US, 1995-2004 - page 63
Figure 30: Proportion of invasive Enterococcus faecalis isolates resistant to aminoglycosides in Europe, 2005 - page 64
Figure 31: Proportion of invasive Enterococcus faecium isolates resistant to vancomycin in Europe, 2005 - page 65
Figure 32: National estimates of US short-stay hospital discharges with Clostridium difficile listed as primary or as any diagnosis, 1996-2003 - page 67
Figure 33: C. difficile reports from patients aged 65 years and over, received under the mandatory reporting scheme in England during 2004 and 2005 - page 68
Figure 34: US states with the NAP1 strain C. difficile confirmed by the CDC as of September 2006 - page 70
Figure 35: Escherichia coli: trends of amino-penicillin resistance in the five major Euripean markets 1999-2005 - page 73
Figure 36: Escherichia coli: trends of fluoroquinolone resistance in the five major Euripean markets 1999-2005 - page 73
Figure 37: Third generation cephalosporin-resistant Klebsiella pneumoniae among ICU patients in NNIS participating hospitals in the US,1995-2004 - page 75
Figure 38: Proportion of invasive Klebsiella pneumoniae isolates resistant to 3rd generation cephalosporins, carbapenems, fluoroquinolones and aminoglycosides in Europe, 2005 - page 76
Figure 39: Fluoroquinolone-resistant Pseudomonas aeruginosa among ICU patients in the US, 1995-2004 - page 77
Figure 40: Proportion of invasive Pseudomonas aeruginosa isolates resistant to carbapenems, ceftazidime, fluoroquinolones and aminoglycosides in Europe, 2005 - page 79
Figure 41: Total number of patients developing nosocomial infections in an average year in the US - page 87
Figure 42: Antibacterial sales across the seven major markets by sales and volume, 2001-05 - page 88
Figure 43: Sales and volume use in the hospital versus the community market, excluding Japan, 2001-05 - page 89
Figure 44: Sales of hospital antibacterials in the six major markets, excluding Japan, 2005 - page 90
Figure 45: Percentage share of overall hospital antibacterial sales by class in the six major markets, excluding Japan, 2005 - page 90
Figure 46: Cost of antibiotic therapy per patient by site of infection (US average wholesale prices) - page 96
Figure 47: Share of each type of infection of overall expenditure on antibacterials to treat nosocomial infections, US - page 97
Figure 48: Summary of management strategies for patients with suspected HAP, VAP and HCAP - page 106
Figure 49: Empiric management of HAP, HCAP, VAP - page 108
Figure 50: Initial antibiotic therapy for patients with no known risk factors for multidrug resistant pathogens, early onset and any disease severity - page 109
Figure 51: Initial therapy for hospital-acquired pneumonia in patients with late-onset disease or risk factors for multidrug resistant pathogens and all disease severity - page 109
Figure 52: Initial intravenous adult doses of antibiotics for empiric therapy of HAP, HCAP and VAP in patients with late-onset disease or risk factors for multidrug-resistant pathogens - page 110
Figure 53: Treatment options for CDAD - page 117
Figure 54: Summary of the factors influencing prescription choice from KOL research - page 121
Figure 55: Patient stratification by risk factors - page 139
Figure 56: Prevention strategies by risk factor - page 139
Figure 57: Antibiotic resistance: a vicious cycle - page 143
Figure 58: A schematic representation of the costs associated with HAI - page 146

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Stakeholder Opinions: Nosocomial Infections - The need for new gram-negative drugs

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