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Diphtheria Investigation Guideline

CONTENT: Investigation Protocol: • Investigation Guideline Supporting Materials found in attachments: • Fact Sheets VERSION DATE: 02/2012 03/2009

Revision History: Date


Revised format. Added diphtheria worksheet. Replaced BSE with BEPHI. Added notification section. Removed references to KS-EDSS. Revised case definition with CDC 2010 version.

Released 03/2009 Current Version 02/2012

Comment: Cutaneous diphtheria should not be reported. or larynx. and/or piece of membrane. pharynx.Collect from several areas to increase sensitivity.Diptheria Disease Management and Investigative Guidelines CASE DEFINITION (CDC 2010) Case Classification: • Confirmed: An upper respiratory tract illness with an adherent membrane of the nose. pseudotuberculosis). • Collection kit: Use routine swab (either cotton or polyester-tipped) systems. and ο lack of epidemiologic linkage to a laboratory-confirmed case of diphtheria. throat. • Contact the KHEL to arrange for shipping. < 0. diphtheria and any other diphtheria toxin-producing Corynebacterium species (C. ο Obtain material for culture from the inflamed areas in the nasopharynx. • Specimen(s): Swab of nose. • Timing of specimens: As soon as possible before antibiotic treatment. • Shipment: Ship within 24 hours of collection. or ο epidemiologic linkage to a laboratory-confirmed case of diphtheria. tonsils. or larynx. tonsils. an upper respiratory tract illness with: ο an adherent membrane of the nose. For additional information concerning collection or sample transport: • Call (785) 296-1620 or refer to www. ο To screen contacts and/or to assure eradication of organism after antibiotic treatment. LABORATORY ANALYSIS Kansas Health and Environmental Laboratory (KHEL) is equipped to test for C. Page 1 .gov/labs/lab_ref_guide. If transport is expected to be more than 24 hours after collection. It does not confirm a case for surveillance as the test does not show toxin is being actively produced. Serology: Measurement of serum antibodies to diphtheria toxin before administration of antitoxin helps to assess the probability of diphtheria. swab beneath the membrane. • Probable: In the absence of a more likely diagnosis. use silica gel transport packages Testing of isolates: For C. or ο histopathologic diagnosis of diphtheria.If membrane can be removed. wounds.kdheks. CDC requests that all isolates of these types be sent to the CDC Diphtheria Laboratory. PCR can still be used to detect the toxin production gene (dtxR) and the toxin gene (tox). and any of the following: ο isolation of Corynebacterium diphtheriae from the nose or throat.) • <0. pharynx.01 IU/ml. ulcerans or C.09 IU/ml = presence of basic immunity PCR: If a patient has received antibiotics. . diphtheria using culture but must be contacted at 785-296-1634 before specimens are sent. swabs (for culture) are collected from both the nose and throat. . immunity is likely to be absent • >0.01 IU/ml.htm Kansas Disease Investigation Guidelines Version 02/2012 Diptheria. and ο absence of laboratory confirmation.1 IU/ml is considered protective and diphtheria is unlikely the cause • >0. (Very few laboratories have the capability to accurately test antibody levels. Isolates will then be sent to CDC for toxin testing.

Contributing factors included increased susceptibility among adults due to waning of vaccine-induced immunity. however. a grampositive bacillus. it can occur in immunized. are: gravis. and failure fully to immunize children because of unwarranted contraindications. and an adherent grayish membrane of the tonsil(s). upper respiratory tract illness characterized by sore throat. Effective antibiotic therapy can reduce communicability to < 4 days. B. and/or nose. Kansas Disease Investigation Guidelines Version 02/2012 Diphtheria. two-thirds of the affected people were 20 years of age or older. Carriers may shed organisms for ≥ 6 months. The 4 biotypes. a massive outbreak began in the Russia and spread to all countries of the former Soviet Union and Mongolia. In the U. an outbreak of about 200 cases occurred in 1993–94.S.EPIDEMIOLOGY A disease of colder months in temperate zones. E. In Ecuador. occasionally longer. and declining socioeconomic conditions. Reservoirs: Humans are the only reservoir of C. involving primarily nonimmunized children less than 15 years of age. Usually < 2 weeks and rarely > 1 month. Diphtheria epidemics can occur in susceptible populations. - F. and marked swelling and edema of neck ("bull neck"). Late effects of the toxin include cranial and peripheral motor and sensory nerve palsies. an average of <4 cases were reported annually. Mode(s) of Transmission: Person-to-person transmission by droplets or through direct contact with the nasopharyngeal secretions of an infected person. Cutaneous diphtheria usually appears as a localized ulcer. D. pharynx. diphtheriae. lowgrade fever. 2-5 days. for example. diphtheria. about 50% cases occurred in persons aged 15 years or older. mitis. In both epidemics. and nephropathy. intermedius. Fomites and raw milk may serve as a vehicle of transmission.. Incubation Period: Average. Agent: Diphtheria is caused by toxin-producing biotypes of C. Page 2 . the epidemic declined. In 1990. control was achieved through mass immunization campaigns. anti-vaccine movements. Clinical Description: A toxin mediated. myocarditis. partially immunized and unimmunized persons but is often less severe in those who are partially or fully immunized. Period of Communicability: Transmission may occur as long as virulent bacilli are present in discharges and lesions. in order of likelihood of producing toxin. and belfanti. from 1980 to 1992. Symptoms also include large tender cervical lymph nodes. After peaking in 1995. Upper airway obstructions may be caused by extensive membrane formation. DISEASE OVERVIEW A. C.

Kansas Disease Investigation Guidelines Version 02/2012 Diphtheria. an FDA-licensed diphtheria antitoxin product is no longer available commercially in the United States and is only available from CDC as an Investigational New Drug (IND). Treatment: ** Suspect cases of diphtheria should receive diphtheria antitoxin immediately after bacteriologic specimens are taken without waiting for lab results. Lifelong immunity is usually. CDC.–4:30 p. • KDHE-BEPHI will notify the CDC immediately by phone of all confirmed or suspected cases and will file electronic reports weekly with CDC. completing the form within 7 days of receiving a notification of a measles report. acquired after infection. protection is usually lost before the 6th month. Local health jurisdiction: report to KDHE . but not always. 2. Page 3 . Eastern time. Susceptibility and Resistance: Infants born of immune mothers are relatively immune. IMMEDIATE. followed by submission of an electronic case notification in next regularly scheduled electronic transmission.G.BEPHI Kansas Department of Health and Environment (KDHE) Bureau of Epidemiology and Public Health Response (BEPHI) Phone: 1-877-417-7317 Fax: 1-877-417-7318 Further responsibilities of state and local health departments to the CDC: As a nationally notifiable condition. • During office hours. Antibiotics are not a substitute for the antitoxin which is the primary treatment. NCIRD. all cases even before classification t require an IMMEDIATE. NOTIFICATION TO PUBLIC HEALTH AUTHORITIES Diphtheria shall be designated as infectious or contagious in their nature. Prolonged active immunity can be induced by toxoid. In addition. H.BEPHI 3. Laboratories: report to KDHE . 1. ** Suspected diphtheria cases should be reported promptly by telephone to CDC so that diphtheria antitoxin can be obtained for the patient. Local public health jurisdiction will report information requested on the supplemental form as soon as possible. EXTREMELY URGENT report to the Center of Disease Control and Prevention (CDC). and cases or suspect cases shall be reported within seven days**: 1. 8:00 a. Health care providers and hospitals: report to local health jurisdiction 2.m. at 404-639-3158 or • The DEOC at 404-639-7100 for diphtheria antitoxin at any time.m. appropriate antibiotic therapy with erythromycin or penicillin should be given in conjunction with antitoxin to eradicate the organism and reduce the period of communicability. URGENT reporting requires a KDHE epidemiologist to call the CDC EOC at 770-488-7100 within 24 hours of a case being reported. contact staff at the Meningitis and Vaccine-Preventable Diseases Branch.

biotype and toxigenicity test. with postmortem examination results and death certificate diagnoses 2) Through a credible immunization registry or medical record: obtain information on history of diphtheria vaccine: dates of vaccination. why. (e. daycare.g. • Under-immunized population within the community. − If not done. − If patient hospitalized. STANDARD CASE INVESTIGATION AND CONTROL METHODS Case Investigation 1) Contact the medical provider who reported or ordered testing of the case.INVESTIGATOR RESPONSIBILITIES 1) 2) 3) 4) 5) Report all confirmed. neck edema. phone number(s)) • Record hospitalizations: location and duration of stay • Record treatment. 8) As appropriate. including: − Date of administration and number of units of antitoxin − Antibiotics prescribed. 6) Initiate control and prevention measures to prevent spread of disease. throat. Use current case definition. obtain medical records. • Determine if further laboratory testing is needed. unless otherwise noted.. sex. coordinate testing for symptomatic. and discharge summary. • Culturing of contacts. manufacturer. prophylaxis. 7) Complete information requested in the state electronic surveillance system. contacts and other individuals or groups. • Collect case’s demographic data and contacting information (birth date. lab report(s). vaccinations. PCR. neuritis) • Examine the laboratory testing that was done. number of doses or if not vaccinated. and restrictions. (i. type. Focus on 1 week prior to illness onset. • Collect clinical data: − Date of illness onset. • Record outcomes: survived or date of death. date started and duration of therapy. examine: Kansas Disease Investigation Guidelines Version 02/2012 Diphtheria. county. larynx) − Signs and symptoms. to confirm diagnosis with the medical provider. risk factors and transmission settings. address. Conduct case investigation to identify potential source of infection. Identify whether the source of infection is major public health concern. (e. fever. race/ethnicity. probable and suspect cases to the KDHE. Page 4 . • Obtain information from the provider or medical chart.g. • Case involved in a high-risk occupation or if another special situation is involved. sore throat. highly suspected cases.. molecular typing. Conduct contact investigation to locate additional cases and/or contacts. use the notification letter(s) and the disease fact sheet to notify the case.g..e. 3) Interview the case to determine source. including admission notes. myocarditis. nose. stridor) − Complications. (e. progress notes. − Site of infection.. health care). especially: − Culture.

• If a symptomatic contact is laboratory confirmed – the primary case that was not laboratory confirmed is confirmed based on the epi-link. or eating/drinking utensils with the case. • For suspected outbreaks refer to Managing Special Situations section. include dates and location • Contact with immigrants or returning travelers from endemic-disease areas. • Obtain name. • Note any school or daycare attendance. Work and Daycare Restrictions. Contact Investigation Contacts are defined as those who sleep in the same house or who share food. include dates and locations. − If found. 4) Institute control measures for school or day-care contacts as indicated under Isolation. (The period can be shortened to 4 days after the completion of an antibiotic therapy if the therapy was considered effective. etc). • Obtain dates. activities and locations during the period from illness onset to 2 weeks after onset. record the previously reported record number in the record of the case you are investigating • Highly suspected cases. address. • Obtain name of school and grade of case (if applicable). 1) Consider case’s occupation and activities. co-workers. especially involvement in child or direct patient care or contact with infants or other high risk individuals. 5) Investigate epi-links among cases (clusters. • Obtain name.Local or international travel history during 2-week period before illness onset or date of presentation to provider. 5) Follow-up with household and close contacts (especially high risk contacts) as recommended under Contact Management. • Contact with possible symptomatic individuals • Source of milk supply. 4) Collect information from case for the Contact Investigation. household.) 2) Create a line listing of primary contacts. drink. determine if the other “cases” have been reported to the state: − Search the state electronic surveillance for the possible case.) • Note any high risk contacts. 3) Follow-up symptomatic contacts as suspect cases. Page 5 . and telephone of contacts • Collect primary contact’s immunization status and any diphtheria symptoms • Collect information on the contact’s occupation. that have not previously been reported should be investigated as a suspect case and reported to KDHE-BEPHI. (Include facility name and location. Kansas Disease Investigation Guidelines Version 02/2012 • Diphtheria. (See below). and telephone number of case. as well as healthcare workers in contact with the case’s oral or respiratory secretions • High risk contacts: at risk for developing severe disease or who may expose persons at high risk for severe disease or who are inadequately immunized. • A contact meeting the clinical case definition is considered a confirmed case if epi-linked to a laboratory confirmed case. address. • If the case had contact with person(s) who have/had diphtheria.

refer to the package insert. the individual is free of infection. 7) Conduct a follow-up interview to determine outcome of illness. as disease does not confer immunity. • With antimicrobial therapy. 8) As an additional reference. • Healthy carriers with diphtheria shall be treated. 6) Conduct a follow-up as needed to assure compliance with control measures.Isolation. the first specimens are taken at >24 hours from the completion of antimicrobial therapy. • The recommended dosage and route of administration depends on the extent and duration of disease. Work and Daycare Restrictions K. see Figure 1. • Patients should be tested for sensitivity to horse serum and. • Diphtheria antitoxin is currently available only through the CDC under an FDA-approved Investigational New Drug protocol. and control measures. 2) Antimicrobial therapy (penicillin or erythromycin) is not a substitute for antitoxin treatment but is administered to eradicate the organism. if necessary. collect the first specimens for culture immediately. − The local/state health departments will work with CDC to obtain antitoxin. diphtheriae. are culture negative for C. • If illness onset was >2 weeks prior and symptoms have resolved without antimicrobial therapy. collected >24 hours apart. • If both sets of cultures are negative. prevent further production of toxin and decrease chance of further transmission. as needed. desensitized before administration of the antitoxin. treatment. • Each household contact and all other close contacts shall have nose and throat specimens tested and be monitored for symptoms for seven days from the time of last exposure to the disease. 5) Provide active immunization with diphtheria toxoid during convalescence. − BEPHI staff can contact the CDC Division of Immunization (Phone: 404639-2888) to obtain antitoxin and make arrangements for transport. • Reference the Kansas Community Containment Toolbox for templates concerning voluntary isolation. an additional 10-day course of oral erythromycin is administered with follow-up cultures again repeated as described. • Each contact who is a food handler or works with children shall be excluded from that occupation until the nose and throat cultures are negative. Case Management 1) Prompt administration of diphtheria antitoxin is important. 4) If a repeat culture is positive. 3) Strict isolation for two weeks or until two consecutive sets of nose and throat swabs. important epidemiologic and clinical data are needed prior to its release.R 28-1-6 for Diphtheria: • Each infected person shall remain in isolation for 14 days or until two consecutive negative pairs of nose and throat cultures are obtained at least 24 hours apart and not less than 24 hours after discontinuation of antibiotic therapy. Page 6 .A. Kansas Disease Investigation Guidelines Version 02/2012 Diphtheria.

to 10. Respiratory Diphtheria: Recommendations for Case Management and Investigation of Close Contacts * Maintain isolation until elimination of the organism is demonstrated by negative cultures of two samples obtained at least 24 hours apart after the completion of antimicrobial therapy. ** Prophylaxis includes a single dose of benzathine penicillin G or a 7. caretakers. ‡‡ Persons who continue to harbor the organism after treatment with either penicillin or erythromycin should receive an additional 10-day course of oral erythromycin and should submit samples for follow-up cultures. and then oral erythromycin or oral penicillin V is used. †† Preventive measures may extend to close contacts of carriers but should be a lower priority than control measures for contacts of a case. § Antimicrobial therapy is not a substitute for antitoxin treatment in clinical diphtheria but may eliminate the organism. §§ Refer to published recommendations for the schedule for routine administration of course of oral erythromycin. † Both nasal and pharyngeal swabs should be obtained for culture. " Vaccination is required because clinical diphtheria does not necessarily confer immunity.Figure 1. Page 7 . ‡ Contact the state health department to make arrangements for antitoxin from the CDC. Procaine penicillin G or parenteral erythromycin is used until patient can swallow comfortably. or regular visitors to home) and medical staff exposed to oral or respiratory secretions of the case-patient.g. # Close contacts include household members and other persons with a history of direct contact with a case-patient (e. relatives. (Source: Appendix 2-6 of the CDC Manual for the Surveillance of Vaccine-Preventable Diseases) Kansas Disease Investigation Guidelines Version 02/2012 Diphtheria.

• Symptomatic contacts are treated as suspect cases. − If any culture is positive. are culture negative for C. • To assure eradication: > 24 hours after the completion of antimicrobial prophylaxis. • Close contacts of carriers should proceed with the preventive measures described for the close contacts of cases but: − Assign close contacts of persons with clinical diphtheria highest priority. − Single penicillin dose is used when the contact’s compliance in doubt.hhs. recommend a single dose of benzathine penicillin or a 7-10 day course of erythromycin. an additional 10-day course of oral erythromycin should be administered with the cultures then repeated. not cases. • Contacts that are food handlers or work with children shall be excluded until nose and throat cultures are negative. repeat cultures with two consecutive sets of nose and throat swabs. − Contacts of carriers should be given secondary priority. • Report any adverse event that occurs after the administration of a vaccine to Vaccine Adverse Events Reporting System at http://vaers. 2) Contacts should have cultures taken from the nose and throat and be under active surveillance for 10 days after last contact with an infectious case. • Non-immunized contacts (those with <3 doses or unknown histories) should begin and/or continue with a primary series according to published recommendations for routine immunizations. collected >24 hours apart. • Asymptomatic contacts that are culture-positive are carriers. collected >24 hours apart with the second set collected at a minimum of two weeks after the antibiotic 4) Screen contacts for signs and symptoms of diphtheria. and the disposition of the contact after 10 days of active surveillance. 6) Management of carriers: • Assure antimicrobial treatment is received to eradicate the organism. 3) Prophylaxis of contacts is initiated after specimens are collected for culture: • Regardless of the contact’s immunization status. prophylaxis recommended/completed (antibiotics and booster doses). • Previously immunized contacts should receive a booster dose of diphtheria toxoid if >5 years have elapsed since their last dose. • Instruct carriers to isolate themselves from situations that could result in close contact with inadequately vaccinated persons until after successful treatment is received eradicating the organism. Note: The risk of developing diphtheria is sevenfold higher after household exposure to clinical diphtheria case than after household exposure to a carrier. 5) Management of culture-positive secondary cases (symptomatic contacts): • Treat and manage as described in Case Management. including any missing or gone explanations (MOGE). culture results. Page 8 . including the strict isolation for two weeks or until two consecutive sets of nose and throat swabs. Kansas Disease Investigation Guidelines Version 02/2012 Diphtheria.Contact Management 1) Maintain a listing of all contacts log information on symptoms screenings. immunization histories. diphtheriae. 7) Active surveillance for suspect cases in the affected settings should take place for at least 2 incubation periods (10 days).

3) Active case finding will be an important part of any investigation. 4) Instruct cases and contacts to be aware of the high risk that infection poses to certain individuals. Environmental • Disinfect fomites and discharges from lesions. Treatment should be considered for persons with any of the signs or symptoms that are compatible with pertussis. 1-877-427-7317. Education 1) Provide education that includes basic information about the disease and its complications and ways to treat and prevent transmission of illness. medical care should be sought promptly and appropriate specimens taken. • Should symptoms develop. Page 9 . 2) Instruct cases on the necessary isolation. carriers and contacts should be instructed to pay strict attention to personal hygiene by: • Covering nose and mouth with tissue when coughing. especially when there is no history of international travel or contact with visitors who have been to a area endemic for diphtheria. • Washing hands with soap and water every time there is contact with respiratory secretions or infected wounds. Report data via the state electronic surveillance system. MANAGING SPECIAL SITUATIONS A.8) As an additional reference. • Use pasteurized milk. • Placing all contaminated tissues directly into garbage containers. Organize and collect data. please include the Record Number of the related case. especially unvaccinated or inadequately vaccinated persons such as infants under 2 months of age. see Figure 1 on page 7. (For epi-linked cases. 4) All epidemiologic data will be reported and managed through the Kansas outbreak module of the electronic surveillance system 5) Recommendations will be made based on the CDC’s Manual for the Surveillance of Vaccine-Preventable Diseases. • Especially data that collected during the investigation that helps to confirm or classify a case. Outbreak Investigation: 1) A single case of suspected diphtheria should be treated with urgency. 3) Cases. DATA MANAGEMENT AND REPORTING TO THE KDHE A. 5) Counsel contacts to watch for signs or symptoms for 10 days after exposure. B.) Kansas Disease Investigation Guidelines Version 02/2012 Diphtheria. 2) Notify KDHE immediately.

0. 2009. American Public Health Association.. H..cdc. Control of Communicable Diseases Manual.htm Kansas Disease Investigation Guidelines Version 02/2012 Diptheria. Epidemiology. 19th Edition.htm D. Available at: www. Manual for the Surveillance of Vaccine-Preventable Diseases: Available at: Additional Information (CDC): www. Quarantine and Isolation: Kansas Community Containment Isolation/ Quarantine Toolbox Section III. Illinois.htm F. Kansas Regulations/Statutes Related to Infectious Disease: www. Investigation and Control: Heymann. Page 10 .cdc. Available at: www. ed. DC. Washington.kdheks.html. 2009 Red Book: Report of the Committee on Infectious Disease. C.ADDITIONAL INFORMATION / REFERENCES A. Case Definitions: CDC Division of Public Health Surveillance and Informatics. 2009.cdc. B.pdf E.html Guidelines and Sample Legal Orders www. Pink Book: Epidemiology and Prevention of Vaccine-Preventable Diseases.0. Treatment / Differential Diagnosis: American Academy of Academy of Pediatrics. 28th Edition.

.Supporting Materials Supporting Materials are available under attachments: CLICK HERE TO VIEW ATTACHMENTS Then double click on the document to open. <Attachments> – OR – Click on the “Paper Clip” icon on the left. Other Options to view attachments: Go to <View>. <Navigation Pane>.