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Enterobacter sakazakii Case Reports and Outbreaks Involving Infants as Reported in the Peer-Reviewed English Medical LiteratureKarl C. KlontzEpidemiology TeamCenter for Food Safety and Applied NutritionFood and Drug Administration,Case Definition- E. sakazakii infection,An infant meeting at least one of the following criteria:E. sakazakii recovered from 1 of the following normally sterile sites: Blood Cerebrospinal fluid Brain tissue UrineOutbreak of necrotizing enterocolitis and E. sakazakii recovered from blood, stool, or stomach aspirate of 1 infantBloody diarrhea, E. sakazakii recovered from stool in pure culture,Number Reports E. sakazakii Infection English-Language Peer-Reviewed Literature,Age group No. references No. cases (%)Infants20 48 (83) Children (1 yr), adults 7 10 (17) Age group No. cases Percent0 1 month37 641 12 months1017 1 4 years 4 7 4 years 6 10 (median age = 74 yr) Not stated 1 2 (infant, but ? age) Total 58 100,Initial Reports of E. sakazakii infection: Chronology,Urmenyi (1961)Jker (1965)Monroe (1979)Kleiman (1981) Adamson (1981)Muytjens (1982) Jimnez (1982)*Muytjens (1983) Case series (1st study to propose possible link to powdered formula),Case reports,E. sakazakii Infections in Infants: Selected Clinical Features Peer-Reviewed Literature (N=48),Gender: 52% female Syndromes: Meningitis (58%), Sepsis/bacteremia (17%); Necrotizing enterocolitis (29%) Overall case-fatality: 33% (15/46 for whom info available)Birth weight (g)NumberNo. Died (%) 2500 10 3 (30),Muytjens et al. (1983): Analysis of 8 cases of neonatal meningitis and sepsis due to E. sakazakii,Reanalyzed 20 Enterobacter strains isolated from CSF (going back 6 yrs) and 25 strains from blood (2 yrs) in the NetherlandsHypothesis: E. sakazakii may not have been identified originally because organism produces minimal pigment at 36 CUsing various biochemical and growth parameter systems (25 C), 8 strains identified as E. sakazakiiAll 8 strains confirmed by CDC as E. sakazakii Clinical data for E. sakazakii cases obtained retrospectively,Muytjens et al. (1983): Clinical features of 8 cases of neonatal meningitis and sepsis due to E. sakazakii,3/8 cases delivered by C-sectionProgress in first few days of life was normal First signs of illness occurred between days 4-8 of life 2/8 cases had necrotizing enterocolitis + meningitis75% case-fatality rate; 2 survivors “retarded”Death occurred within hours several days“Hemorrhagic encephalitis”,Muytjens et al. (1983): Epidemiologic features of 8 cases of neonatal meningitis and sepsis due to E. sakazakii,6/8 cases birth weights 2,500 grams (lowest: 850 g)5/8 cases premature (gestation 36 wk)5/8 cases occurred at same general hospitalOther 3 cases born in 3 other hospitalsTemporal clustering: 3/5 cases in general hospital became ill within 3 months; 2/3 cases in other hospitals within 2 months,Muytjens et al. (1983): Environmental Sampling Results,Environmental sampling at pediatric ward of general hospital E. sakazakii recovered from prepared formula, dish brush, and stirring spoon, but not from powdered formula and waterPlasmid profiles: “3 or 4 of 5 isolates from patients at the general hospital were probably the same strain”Plasmid profiles differed between cases vs. prepared formula(1990 note: “No cases observed at general hospital since powder formula replaced by liquid formula 8 years ago.”),E. sakazakii and Powdered Infant Formula: Developments From 1961-1988,1980 (Farmer): 1/57 isolates came from “can of dried milk”1983 (Muytjens) E. sakazakii recovered from prepared formula Recommended sampling of “milk” as part of investigations1988 (Muytjens) 141 powdered infant formula products obtained from 35 countries tested for presence of Enterobacteriaceae 52% samples + 20 powders (14%) from 13 countries yielded E. sakazakii Concentration of Enterobacteriaceae uniformly 1 CFU/g,Three Cases of Neonatal Meningitis Caused by E. sakazakii in Powdered Formula (Biering 1989-Iceland),Illnesses in 1986, 1987 (2 within one month)2 infants normal at birth (36- and 38-wk gestation); 1 DownsAll 3 did well until day 5 when they became ill1 died, 2 recovered with severe neurologic sequelaeAll 3 fed powdered infant formula1st study to show, in illness setting, E. sakazakii recovery (low numbers) from freshly prepared formula from previously unopened cansNo recovery from environment (milk kitchen, utensils, ward),Three Cases of Neonatal Meningitis Caused by E. sakazakii in Powdered Formula (Biering 1989-Iceland),In addition to 3 ill cases, 1 colonization4 E. sakazakii strains isolated from neonates had same plasmid profile as 22 formula strainsAnecdotal evidence that formula bottles occasionally kept at 35-37 C for extended periods in bottle heatersBut in 1 instance, recovery (direct plating) from bottle that had been refrigerated“milk powder can be the mode of transmission for E. sakazakii meningitis or sepsis in neonates”,Outbreaks of E. sakazakii infections linked to powdered infant formula: Historical cohort studies,Simmons et al. (1989): Enterobacter sakazakii Infections in Neonates Associated with Intrinsic Contamination of a Powdered Infant Formula (Infect Control Hosp Epidemiol)Van Acker et al. (2001): Outbreak of Necrotizing Enterocolitis Associated with Enterobacter sakazakii in Powdered Milk Formula (J Clin Microbiol)CDC. Enterobacter sakazakii Infections Associated with the Use of Powdered Infant Formula-Tennessee, 2001. MMWR 2002;51:297-300,E. sakazakii Infections in Neonates Associated with Intrinsic Contamination of Powdered Infant Formula (Simmons-1989),Feb-Mar 1988: bacteremia (2 infants), UTI (1), bloody diarrhea (1)E. sakazakii recovered from stool of all 4 infantsInvestigation revealed all 4 had been fed same powdered formulaFormula prepared in blender; rinsed with tap water between usesBlender yielded heavy growth of E. sakazakiiNo further clinical isolates once blender sterilized Historical cohort study in NICU assessed risk factors for infection and colonization (2/7-3/13),E. sakazakii Infections in Neonates Associated with Intrinsic Contamination of Powdered Infant Formula (Simmons-1989),Infected/Colonized Yes No Yes 4 1 5Formula No 0 40 40 Relative risk = undefined; p = 0.0006,E. sakazakii Infections in Neonates Associated with Intrinsic Contamination of Powdered Infant Formula (Simmons-1989),Implicated elemental formula given 1 to most premature infants Samples obtained from opened, yet unmixed, can powdered formulaPowder cultured using method of Muytjens et al.E. sakazakii ( 8 CFU/100 g), E. cloacae (48 CFU/100 g) recoveredSame plasmid, multilocus enzyme profile (formula and patients),van Acker et al. (2001): Necrotizing enterocolitis associated with E. sakazakii in powdered formula,12 cases NEC diagnosed June-July, 1998 in Belgium NICU50 neonates admitted to NICU during this periodAll 12 had birth weights 2,000 g, fed powdered infant formula 6/12 neonates had + cultures blood, anal swab, or stomach aspirate for E. sakazakii vs. 0/38 without NEC (p0.001)10/12 neonates with NEC had been fed the same powdered formula: Alfar (semi-elemental formula with low osmolarity),van Acker et al. (2001): Necrotizing enterocolitis associated with E. sakazakii in powdered formula,E. sakazakii + (NEC) Yes No Yes 6 8 14Formula No 0 36 36 Relative risk = undefined; p = 0.0002,van Acker et al. (2001): Necrotizing enterocolitis associated with E. sakazakii in powdered formula,E. sakazakii recovered from prepared formula, unopened cans Molecular typing (AP-PCR) confirmed partial strain similarity between powdered formula, patient is