Food selection and effect of home preparation procedure for antibiotic food mixtures on homogeneity, stability, and dissolution.

Amoxicillin, doxycycline, and clindamycin are among the commonly used antibiotics to treat bacterial infections. However, dosage forms of antibiotics for pediatric patients may not be as readily available as the formulations for adult patients. As such, it is anticipated that during a public health emergency, special instruction may need to be provided on home preparation and administration procedures to dose pediatric patients using available stockpiles of oral tablet and capsule dosage forms. Mixing crushed tablets or capsule contents with soft- or liquid- foods is one of the most common home preparation procedures. To gain knowledge for safe and effective use of prepared drug product instead of the intended intact dosage form, the impact of manipulation of the dosage form was studied. Capsule opening, capsule content assay and uniformity, dissolution, homogeneity, and stability studies of drug mixed with various liquid and soft foods were carried out using intact capsules of amoxicillin, doxycycline, and clindamycin. Higher recovery of capsule contents was achieved when using hands or knives to open capsules compared to using scissors. The capsules of all three antibiotic products contained the labeled amount of active pharmaceutical ingredients (API). The peanut butter-drug mixtures failed both United States Pharmacopeia (USP) assay and dissolution criteria because the peanut butter significantly affected the solubility of the drugs, and hence it was omitted from further study. All drug-food mixtures of the three antibiotic products and 15 selected foods exhibited fast dissolution (e.g., >80 % in 60 min) in the tested medium, except for the amoxicillin-chocolate pudding mixture. Three household containers (cups, plates, and bowls) and four mixing times (0.5 min, 1 min, 2 min, and 5 min) were found to be suitable for preparation of homogeneous mixtures of the antibiotics and foods. For practical purposes, 1 to 2 min mixing time is sufficient to produce homogeneous mixtures. The results of this study provided product quality data on the interactions between the antibiotics and the foods and can potentially support future development of home preparation instructions of antibiotics for pediatric patients or patients with swallowing difficulties.

Central Nervous System Antimicrobial Exposure and Proposed Dosing for Anthrax Meningitis.

BACKGROUND: The high mortality of systemic anthrax is likely a consequence of the severe central nervous system (CNS) inflammation that occurs in anthrax meningitis. Effective treatment of such infections requires, at a minimum, adequate cerebrospinal fluid (CSF) antimicrobial concentrations. METHODS: We reviewed English medical literature and regulatory documents to extract information on serum and CSF exposures for antimicrobials with in vitro activity against Bacillus anthracis. Using CSF pharmacokinetic exposures and in vitro B. anthracis susceptibility data, we employed population pharmacokinetic modeling and Monte Carlo simulations to predict whether a specific antimicrobial dosage would likely achieve effective CSF antimicrobial activity in patients with normal to inflamed meninges (i.e., an intact to markedly disrupted blood brain barrier). RESULTS: Probability of microbiologic success at achievable antimicrobial dosages was high (≥95%) for ciprofloxacin, levofloxacin (500 mg q12 h), meropenem, imipenem/cilastatin, penicillin G, ampicillin, ampicillin/sulbactam, doxycycline, and minocycline; acceptable (90-95%) for piperacillin/tazobactam and levofloxacin (750 mg q24 h); and low (<90%) for vancomycin, amikacin, clindamycin, and linezolid. CONCLUSION: Prompt empiric antimicrobial therapy of patients with suspected or confirmed anthrax meningitis may reduce the high morbidity and mortality. Our data support using several ß-lactam-, fluoroquinolone-, and tetracycline-class antimicrobials as first-line and alternative agents for treatment of patients with anthrax meningitis; all should achieve effective microbiologic exposures. Our data also suggest antimicrobials that should not be relied upon to treat suspected or documented anthrax meningitis. Furthermore, the protein synthesis inhibitors clindamycin and linezolid can decrease toxin production and may be useful components of combination therapy.

Safety of Antimicrobials for Postexposure Prophylaxis and Treatment of Anthrax: A Review.

BACKGROUND: Bacillus anthracis, the causative agent for anthrax, poses a potential bioterrorism threat and is capable of causing mass morbidity and mortality. Antimicrobials are the mainstay of postexposure prophylaxis (PEP) and treatment of anthrax. We conducted this safety review of 24 select antimicrobials to identify any new or emerging serious or severe adverse events (AEs) to help inform their risk-benefit evaluation for anthrax. METHODS: Twenty-four antimicrobials were included in this review. Tertiary data sources (e.g. Lactmed, Micromedex, REPROTOX) were reviewed for safety information and summarized to evaluate the known risks of these antimicrobials. PubMed was also searched for published safety information on serious or severe AEs with these antimicrobials; AEs that met inclusion criteria were abstracted and reviewed. RESULTS: A total of 1316 articles were reviewed. No consistent observations or patterns were observed among the abstracted AEs for a given antimicrobial; therefore, the literature review did not reveal evidence of new or emerging AEs that would add to the risk-benefit profiles already known from tertiary data sources. CONCLUSIONS: The reviewed antimicrobials have known and/or potential serious or severe risks that may influence selection when recommending an antimicrobial for PEP or treatment of anthrax. Given the high fatality rate of anthrax, the risk-benefit evaluation favors use of these antimicrobials for anthrax. The potential risks of antimicrobials should not preclude these reviewed antimicrobials from clinical consideration for anthrax but rather guide appropriate antimicrobial selection and prioritization across different patient populations with risk mitigation measures as warranted.

Orthopoxvirus Testing Challenges for Persons in Populations at Low Risk or Without Known Epidemiologic Link to Monkeypox - United States, 2022.

Since May 2022, approximately 20,000 cases of monkeypox have been identified in the United States, part of a global outbreak occurring in approximately 90 countries and currently affecting primarily gay, bisexual, and other men who have sex with men (MSM) (1). Monkeypox virus (MPXV) spreads from person to person through close, prolonged contact; a small number of cases have occurred in populations who are not MSM (e.g., women and children), and testing is recommended for persons who meet the suspected case definition* (1). CDC previously developed five real-time polymerase chain reaction (PCR) assays for detection of orthopoxviruses from lesion specimens (2,3). CDC was granted 510(k) clearance for the nonvariola-orthopoxvirus (NVO)-specific PCR assay by the Food and Drug Administration. This assay was implemented within the Laboratory Response Network (LRN) in the early 2000s and became critical for early detection of MPXV and implementation of public health action in previous travel-associated cases as well as during the current outbreak (4-7). PCR assays (NVO and other Orthopoxvirus laboratory developed tests [LDT]) represent the primary tool for monkeypox diagnosis. These tests are highly sensitive, and cross-contamination from other MPXV specimens being processed, tested, or both alongside negative specimens can occasionally lead to false-positive results. This report describes three patients who had atypical rashes and no epidemiologic link to a monkeypox case or known risk factors; these persons received diagnoses of monkeypox based on late cycle threshold (Ct) values ≥34, which were false-positive test results. The initial diagnoses were followed by administration of antiviral treatment (i.e., tecovirimat) and JYNNEOS vaccine postexposure prophylaxis (PEP) to patients' close contacts. After receiving subsequent testing, none of the three patients was confirmed to have monkeypox. Knowledge gained from these and other cases resulted in changes to CDC guidance. When testing for monkeypox in specimens from patients without an epidemiologic link or risk factors or who do not meet clinical criteria (or where these are unknown), laboratory scientists should reextract and retest specimens with late Ct values (based on this report, Ct ≥34 is recommended) (8). CDC can be consulted for complex cases including those that appear atypical or questionable cases and can perform additional viral species- and clade-specific PCR testing and antiorthopoxvirus serologic testing.

Antimicrobial Treatment and Prophylaxis of Plague: Recommendations for Naturally Acquired Infections and Bioterrorism Response.

This report provides CDC recommendations to U.S. health care providers regarding treatment, pre-exposure prophylaxis, and postexposure prophylaxis of plague. Yersinia pestis, the bacterium that causes plague, leads to naturally occurring disease in the United States and other regions worldwide and is recognized as a potential bioterrorism weapon. A bioweapon attack with Y. pestis could potentially infect thousands, requiring rapid and informed decision making by clinicians and public health agencies. The U.S. government stockpiles a variety of medical countermeasures to mitigate the effects of a bioterrorism attack (e.g., antimicrobials, antitoxins, and vaccines) for which the 21st Century Cures Act mandates the development of evidence-based guidelines on appropriate use. Guidelines for treatment and postexposure prophylaxis of plague were published in 2000 by a nongovernmental work group; since then, new human clinical data, animal study data, and U.S. Food and Drug Administration approvals of additional countermeasures have become available. To develop a comprehensive set of updated guidelines, CDC conducted a series of systematic literature reviews on human treatment of plague and other relevant topics to collect a broad evidence base for the recommendations in this report. Evidence from CDC reviews and additional sources were presented to subject matter experts during a series of forums. CDC considered individual expert input while developing these guidelines, which provide recommended best practices for treatment and prophylaxis of human plague for both naturally occurring disease and following a bioterrorism attack. The guidelines do not include information on diagnostic testing, triage decisions, or logistics involved in dispensing medical countermeasures. Clinicians and public health officials can use these guidelines to prepare their organizations, hospitals, and communities to respond to a plague mass-casualty event and as a guide for treating patients affected by plague.

Safety of Antimicrobials During Pregnancy: A Systematic Review of Antimicrobials Considered for Treatment and Postexposure Prophylaxis of Plague.

BACKGROUND: The safety profile of antimicrobials used during pregnancy is one important consideration in the decision on how to treat and provide postexposure prophylaxis (PEP) for plague during pregnancy. METHODS: We searched 5 scientific literature databases for primary sources on the safety of 9 antimicrobials considered for plague during pregnancy (amikacin, gentamicin, plazomicin, streptomycin, tobramycin, chloramphenicol, doxycycline, sulfadiazine, and trimethoprim-sulfamethoxazole [TMP-SMX]) and abstracted data on maternal, pregnancy, and fetal/neonatal outcomes. RESULTS: Of 13 052 articles identified, 66 studies (case-control, case series, cohort, and randomized studies) and 96 case reports were included, totaling 27 751 prenatal exposures to amikacin (n = 9), gentamicin (n = 345), plazomicin (n = 0), streptomycin (n = 285), tobramycin (n = 43), chloramphenicol (n = 246), doxycycline (n = 2351), sulfadiazine (n = 870), and TMP-SMX (n = 23 602). Hearing or vestibular deficits were reported in 18/121 (15%) children and 17/109 (16%) pregnant women following prenatal streptomycin exposure. First trimester chloramphenicol exposure was associated with an elevated risk of an undescended testis (odds ratio [OR] 5.9, 95% confidence interval [CI] 1.2-28.7). Doxycycline was associated with cardiovascular malformations (OR 2.4, 95% CI 1.2-4.7) in 1 study and spontaneous abortion (OR 2.8, 95% CI 1.9-4.1) in a separate study. First trimester exposure to TMP-SMX was associated with increased risk of neural tube defects (pooled OR 2.5, 95% CI 1.4-4.3), spontaneous abortion (OR 3.5, 95% CI 2.3-5.6), preterm birth (OR 1.5, 95% CI 1.1-2.1), and small for gestational age (OR 1.6, 95% CI 1.2-2.2). No other statistically significant associations were reported. CONCLUSIONS: For most antimicrobials reviewed, adverse maternal/fetal/neonatal outcomes were not observed consistently. Prenatal exposure to streptomycin and TMP-SMX was associated with select birth defects in some studies. Based on limited data, chloramphenicol and doxycycline may be associated with adverse pregnancy or neonatal outcomes; however, more data are needed to confirm these associations. Antimicrobials should be used for treatment and PEP of plague during pregnancy; the choice of antimicrobials may be influenced by these data as well as information about the risks of plague during pregnancy.

Novel Treatment of a Vaccinia Virus Infection from an Occupational Needlestick - San Diego, California, 2019.

Vaccinia virus (VACV) is an orthopoxvirus used in smallpox vaccines, as a vector for novel cancer treatments, and for experimental vaccine research (1). The Advisory Committee on Immunization Practices (ACIP) recommends smallpox vaccination for laboratory workers who handle replication-competent VACV (1). For bioterrorism preparedness, the U.S. government stockpiles tecovirimat, the first Food and Drug Administration-approved antiviral for treatment of smallpox (caused by variola virus and globally eradicated in 1980*,†) (2). Tecovirimat has activity against other orthopoxviruses and can be administered under a CDC investigational new drug protocol. CDC was notified about an unvaccinated laboratory worker with a needlestick exposure to VACV, who developed a lesion on her left index finger. CDC and partners performed laboratory confirmation, contacted the study sponsor to identify the VACV strain, and provided oversight for the first case of laboratory-acquired VACV treated with tecovirimat plus intravenous vaccinia immunoglobulin (VIGIV). This investigation highlights 1) the misconception among laboratory workers about the virulence of VACV strains; 2) the importance of providing laboratorians with pathogen information and postexposure procedures; and 3) that although tecovirimat can be used to treat VACV infections, its therapeutic benefit remains unclear.

Preemptive Tecovirimat Use in an Active Duty Service Member Who Presented With Acute Myeloid Leukemia After Smallpox Vaccination.

Smallpox vaccine is contraindicated in immunosuppression due to increased risk for adverse reactions (eg, progressive vaccinia). We describe the first-ever use of tecovirimat as a preemptive vaccinia virus treatment strategy during induction chemotherapy in an active duty service member who presented with acute leukemia and inadvertent autoinoculation after smallpox vaccination.

Planning Considerations for State, Local, Tribal, and Territorial Partners to Receive Medical Countermeasures From CDC's Strategic National Stockpile During a Public Health Emergency.

The Centers for Disease Control and Prevention's Strategic National Stockpile is a national repository of potentially life-saving medical countermeasures including pharmaceuticals and medical supplies for use in a public health emergency severe enough to cause local, regional, and state supplies to run out. Several planning considerations can assist state, local, tribal, and territorial jurisdictions in preparing to receive, distribute, dispense, and administer medical countermeasures from the Strategic National Stockpile. These considerations include, but are not limited to, issues surrounding regulatory requirements, controlled substances, cold chain management, and ancillary supply needs. Multiple aspects to consider for each of these functions are discussed here to assist partners in their planning efforts.

Safety and Improved Clinical Outcomes in Patients Treated With New Equine-Derived Heptavalent Botulinum Antitoxin.

Background: Botulism is a rare, life-threatening paralytic illness. Equine-derived heptavalent botulinum antitoxin (HBAT), the only currently available treatment for noninfant botulism in the United States, was licensed in 2013. No reports have systematically examined safety and clinical benefit of HBAT among botulism patients. Methods: From March 2010 through March 2013, we collected data prospectively and through medical record reviews of patients with confirmed or suspected botulism who were treated with HBAT under an expanded-access Investigational New Drug program. Results: Among 249 HBAT-treated patients, 1 (<1%) child experienced an HBAT-related serious adverse event (hemodynamic instability characterized by bradycardia, tachycardia, and asystole); 22 (9%) patients experienced 38 nonserious adverse events reported by physicians to be HBAT related. Twelve (5%) deaths occurred; all were determined to be likely unrelated to HBAT. Among 104 (42%) patients with confirmed botulism, those treated early (≤2 days) spent fewer days in the hospital (median, 15 vs 25 days; P < .01) and intensive care (10 vs 17 days; P = .04) than those treated later. Improvements in any botulism sign/symptom were detected a median of 2.4 days and in muscle strength a median of 4.8 days after HBAT. Conclusions: HBAT was safe and provided clinical benefit in treated patients. HBAT administration within 2 days of symptom onset was associated with shorter hospital and intensive care stays. These results highlight the importance of maintaining clinical suspicion for botulism among patients presenting with paralytic illness to facilitate early HBAT treatment before laboratory confirmation might be available. Clinical consultation and, if indicated, HBAT release, are available to clinicians 24/7 through their state health department in conjunction with CDC.

Peramivir use for treatment of hospitalized patients with influenza A(H1N1)pdm09 under emergency use authorization, October 2009-June 2010.

BACKGROUND: In response to the influenza A(H1N1)pdm09 (pH1N1) pandemic, peramivir, an investigational intravenous neuraminidase inhibitor, was made available for treatment of hospitalized patients with pH1N1 in the United States under an Emergency Use Authorization (EUA). The Centers for Disease Control and Prevention (CDC) implemented a program to manage peramivir distribution to requesting clinicians under EUA. We describe results of the CDC's peramivir program and 3 related surveys. METHODS: We analyzed data on peramivir requests made by clinicians to the CDC through an electronic request system. Three surveys were administered to enhance clinician compliance with adverse event reporting, to conduct product accountability, and to collect data on peramivir-treated patients. Descriptive analyses were performed, and 2-source capture-recapture analysis based on the 3 surveys was used to estimate the number of patients who received peramivir through the EUA. RESULTS: From 23 October 2009 to 23 June 2010, CDC received 1371 clinician requests for peramivir and delivered 2129 five-day adult treatment course equivalents of peramivir to 563 hospitals. Based on survey responses, at least 1274 patients (median age, 43 years; range, 0-92 years; 49% male) received ≥1 doses of peramivir (median duration, 6 days). Capture-recapture analysis yielded estimates for the potential total number of peramivir recipients ranging from 1185 (95% confidence interval [CI], 1076-1293) to 1490 (95% CI, 1321-1659). CONCLUSIONS: Approximately 1274 hospitalized patients received peramivir through EUA program during the pH1N1 pandemic. Further analyses are needed to assess the clinical effectiveness of peramivir treatment of hospitalized patients with pH1N1.

First report worldwide of an infant botulism case due to Clostridium botulinum type E.

Clostridium botulinum type E has been associated with botulism in adults but never in infants. Infant botulism type E cases have been associated with neurotoxigenic strains of C. butyricum. We report the first infant botulism case due to C. botulinum type E worldwide.

Multistate outbreak of Salmonella Typhimurium and Saintpaul infections associated with unpasteurized orange juice--United States, 2005.

BACKGROUND: Infection due to Salmonella species causes an estimated 1.4 million illnesses and 400 deaths annually in the United States. Orange juice is a known vehicle of salmonellosis, for which regulatory controls have recently been implemented. We investigated a nationwide outbreak of Salmonella infection to determine the magnitude of the outbreak and to identify risk factors for infection. METHODS: We identified cases through national laboratory-based surveillance. In a case-control study, we defined a case as infection with Salmonella serotype Typhimurium that demonstrated the outbreak pulsed-field gel electrophoresis pattern in a person with illness onset from 1 May through 31 July 2005; control subjects were identified through random digit dialing. RESULTS: We identified 152 cases in 23 states. Detailed information was available for 95 cases. The median age of patients was 23 years; 46 (48%) of the 95 patients were female. For 38 patients and 53 age-group matched control subjects in 5 states, illness was associated with consuming orange juice (90% vs. 43%; odds ratio, 22.2; 95% confidence interval, 3.5-927.5). In a conditional logistic regression model, illness was associated with consuming unpasteurized orange juice from company X (53% vs. 0%; odds ratio, 38.0; 95% confidence interval, 6.5-infinity). The US Food and Drug Administration found that company X was noncompliant with the juice Hazard Analysis and Critical Control Point regulation and isolated Salmonella serotype Saintpaul from company X's orange juice. CONCLUSIONS: Unpasteurized orange juice from company X was the vehicle of a widespread outbreak of salmonellosis. Although the route of contamination is unknown, noncompliance with the juice Hazard Analysis and Critical Control Point regulation likely contributed to this outbreak. Pasteurization or other reliable treatment of orange juice could prevent similar outbreaks.

Surveillance for waterborne disease and outbreaks associated with recreational water use and other aquatic facility-associated health events--United States, 2005-2006.

PROBLEM/CONDITION: Since 1971, CDC, the U.S. Environmental Protection Agency, and the Council of State and Territorial Epidemiologists have collaboratively maintained the Waterborne Disease and Outbreak Surveillance System for collecting and reporting data related to waterborne-disease outbreaks (WBDOs) associated with drinking water. In 1978, WBDOs associated with recreational water (natural and treated water) were added. This system is the primary source of data regarding the scope and effects of disease associated with recreational water in the United States. In addition, data are collected on individual cases of recreational water-associated illnesses and infections and health events occurring at aquatic facilities but not directly related to water exposure. REPORTING PERIOD: Data presented summarize WBDOs and case reports associated with recreational water use that occurred during January 2005--December 2006 and previously unreported disease reports and outbreaks during 1978--2004. DESCRIPTION OF THE SYSTEM: Public health departments in the states, territories, localities, and the Freely Associated States (i.e., the Republic of the Marshall Islands, the Federated States of Micronesia, and the Republic of Palau, formerly parts of the U.S.-administered Trust Territory of the Pacific Islands) have primary responsibility for detecting, investigating, and voluntarily reporting WBDOs to CDC. Although the surveillance system includes data for WBDOs and cases associated with drinking water, recreational water, and water not intended for drinking, only cases and outbreaks associated with recreational water and health events at aquatic facilities are summarized in this report. RESULTS: During 2005--2006, a total of 78 WBDOs associated with recreational water were reported by 31 states. Illness occurred in 4,412 persons, resulting in 116 hospitalizations and five deaths. The median outbreak size was 13 persons (range: 2--2,307 persons). Of the 78 WBDOs, 48 (61.5%) were outbreaks of gastroenteritis that resulted from infectious agents or chemicals; 11 (14.1%) were outbreaks of acute respiratory illness; and 11 (14.1%) were outbreaks of dermatitis or other skin conditions. The remaining eight were outbreaks of leptospirosis (n = two), primary amebic meningoencephalitis (n = one), and mixed or other illnesses (n = five). WBDOs associated with gastroenteritis resulted in 4,015 (91.0%) of 4,412 illnesses. Fifty-eight (74.4%) WBDOs occurred at treated water venues, resulting in 4,167 (94.4%) cases of illness. The etiologic agent was confirmed in 62 (79.5%) of the 78 WBDOs, suspected in 12 (15.4%), and unidentified in four (5.1%). Thirty-four (43.6%) WBDOs had a parasitic etiology; 22 (28.2%), bacterial; four (5.1%), viral; and two (2.6%), chemical or toxin. Among the 48 gastroenteritis outbreaks, Cryptosporidium was confirmed as the causal agent in 31 (64.6%), and all except two of these outbreaks occurred in treated water venues where Cryptosporidium caused 82.9% (29/35) of the gastroenteritis outbreaks. Case reports associated with recreational water exposure that were discussed and analyzed separately from outbreaks include three fatal Naegleria cases and 189 Vibrio illnesses reported to the Cholera and Other Vibrio Illness Surveillance System. For Vibrio reporting, the most commonly reported species were Vibrio vulnificus, V. alginolyticus, and V. parahaemolyticus. V. vulnificus illnesses associated with recreational water exposure had the highest Vibrio illness hospitalization (77.6%) and mortality (22.4%) rates. In addition, 32 aquatic facility-related health events not associated with recreational water use (e.g., pool chemical mixing accidents) that occurred during 1983--2006 were received from New York. These events, which caused illness in 364 persons, are included in this report but analyzed separately. INTERPRETATIONS: The number of WBDOs summarized in this report and the trends in recreational water-associated disease and outbreaks demonstrate a substantial increase in number of reports from previous years. Outbreaks, especially the largest ones, occurred more frequently in the summer at treated water venues and caused gastrointestinal illness. Deficiencies leading to WBDOs included problems with water-quality, venue design, usage, and maintenance. Case reports of illness associated with recreational water use expand our understanding of the scope of waterborne illness by further underscoring the contribution of less well-recognized swimming venues (e.g., oceans) and illness (e.g., nongastrointestinal illness). Aquatic facilities are also a focus for injuries involving chemicals or equipment used routinely in the operation of swimming venues, thus illustrating the lack of training of some aquatics staff. PUBLIC HEALTH ACTIONS: CDC uses WBDO surveillance data to 1) identify the etiologic agents, types of aquatic venues, water-treatment systems, and deficiencies associated with outbreaks and case reports; 2) evaluate the adequacy of efforts (i.e., regulations and public awareness activities) to provide safe recreational water; 3) expand the scope of understanding about waterborne disease and health events associated with swimming and aquatics facilities; and 4) establish public health prevention priorities, data, and messaging that might lead to improved regulations, guidelines, and prevention measures at the local, state, and federal levels.

Nonfoodborne Vibrio infections: an important cause of morbidity and mortality in the United States, 1997-2006.

BACKGROUND: Infections due to Vibrio species cause an estimated 8000 illnesses annually, often through consumption of undercooked seafood. Like foodborne Vibrio infections, nonfoodborne Vibrio infections (NFVI) also result in serious illness, but awareness of these infections is limited. METHODS: We analyzed illnesses occuring during the period 1997-2006 that were reported to the Centers for Disease Control and Prevention's Cholera and Other Vibrio Illness Surveillance system. The diagnosis of NFVI required isolation of Vibrio species from a patient with contact with seawater. RESULTS: Of 4754 Vibrio infections reported, 1210 (25%) were NFVIs. Vibrio vulnificus infections were the most common (accounting for 35% of NFVIs), with 72% of V. vulnificus infections reported from residents of Gulf Coast states. Infections due to V. vulnificus resulted in fever (72% of cases), cellulitis (85%), amputation (10%), and death (17%). V. vulnificus caused 62 NFVI-associated deaths (78%). Recreational activities accounted for 70% of exposures for patients with NFVIs associated with all species. Patients with liver disease were significantly more likely to die as a result of infection (odds ratio, 7.8; 95% confidence interval, 2.8-21.9). Regardless of pre-existing conditions, patients were more likely to die when hospitalization occurred >2 days after symptom onset (odds ratio, 2.9; 95% confidence interval, 1.8-4.8). CONCLUSION: NFVIs, especially those due to V. vulnificus, demonstrate high morbidity and mortality. Persons with liver disease should be advised of the risks associated with seawater exposure if a wound is already present or is likely to occur. Clinicians should consider Vibrio species as an etiologic agent in infections occurring in persons with recent seawater exposure, even if the individual was only exposed during recreational marine activities. Immediate antibiotic treatment with aggressive monitoring is advised in suspected cases.

Surveillance for waterborne disease and outbreaks associated with recreational water--United States, 2003-2004.

PROBLEM/CONDITION: Since 1971, CDC, the U.S. Environmental Protection Agency, and the Council of State and Territorial Epidemiologists have collaboratively maintained the Waterborne Disease and Outbreak Surveillance System for collecting and reporting waterborne disease and outbreak (WBDO)-related data. In 1978, WBDOs associated with recreational water (natural and treated water) were added. This system is the primary source of data regarding the scope and effects of WBDOs in the United States. REPORTING PERIOD: Data presented summarize WBDOs associated with recreational water that occurred during January 2003-December 2004 and one previously unreported outbreak from 2002. DESCRIPTION OF THE SYSTEM: Public health departments in the states, territories, localities, and the Freely Associated States (i.e., the Republic of the Marshall Islands, the Federated States of Micronesia, and the Republic of Palau, formerly parts of the U.S.-administered Trust Territory of the Pacific Islands) have primary responsibility for detecting, investigating, and voluntarily reporting WBDOs to CDC. Although the surveillance system includes data for WBDOs associated with drinking water, recreational water, and water not intended for drinking, only cases and outbreaks associated with recreational water are summarized in this report. RESULTS: During 2003-2004, a total 62 WBDOs associated with recreational water were reported by 26 states and Guam. Illness occurred in 2,698 persons, resulting in 58 hospitalizations and one death. The median outbreak size was 14 persons (range: 1-617 persons). Of the 62 WBDOs, 30 (48.4%) were outbreaks of gastroenteritis that resulted from infectious agents, chemicals, or toxins; 13 (21.0%) were outbreaks of dermatitis; and seven (11.3%) were outbreaks of acute respiratory illness (ARI). The remaining 12 WBDOs resulted in primary amebic meningoencephalitis (n = one), meningitis (n = one), leptospirosis (n = one), otitis externa (n = one), and mixed illnesses (n = eight). WBDOs associated with gastroenteritis resulted in 1,945 (72.1%) of 2,698 illnesses. Forty-three (69.4%) WBDOs occurred at treated water venues, resulting in 2,446 (90.7%) cases of illness. The etiologic agent was confirmed in 44 (71.0%) of the 62 WBDOs, suspected in 15 (24.2%), and unidentified in three (4.8%). Twenty (32.3%) WBDOs had a bacterial etiology; 15 (24.2%), parasitic; six (9.7%), viral; and three (4.8%), chemical or toxin. Among the 30 gastroenteritis outbreaks, Cryptosporidium was confirmed as the causal agent in 11 (36.7%), and all except one of these outbreaks occurred in treated water venues where Cryptosporidium caused 55.6% (10/18) of the gastroenteritis outbreaks. In this report, 142 Vibrio illnesses (reported to the Cholera and Other Vibrio Illness Surveillance System) that were associated with recreational water exposure were analyzed separately. The most commonly reported species were Vibrio vulnificus, V. alginolyticus, and V. parahaemolyticus. V. vulnificus illnesses associated with recreational water exposure had the highest Vibrio illness hospitalization (87.2%) and mortality (12.8%) rates. INTERPRETATION: The number of WBDOs summarized in this report and the trends in recreational water-associated disease and outbreaks are consistent with previous years. Outbreaks, especially the largest ones, are most likely to be associated with summer months, treated water venues, and gastrointestinal illness. Approximately 60% of illnesses reported for 2003-2004 were associated with the seven largest outbreaks (>100 cases). Deficiencies leading to WBDOs included problems with water quality, venue design, usage, and maintenance. PUBLIC HEALTH ACTIONS: CDC uses WBDO surveillance data to 1) identify the etiologic agents, types of aquatic venues, water-treatment systems, and deficiencies associated with outbreaks; 2) evaluate the adequacy of efforts (i.e., regulations and public awareness activities) to provide safe recreational water; and 3) establish public health prevention priorities that might lead to improved regulations and prevention measures at the local, state, and federal levels.