Frequently Asked Questions Testing for Gonorrhea Q1: What test should be completed for accurately diagnosing gonorrhea? A1: Testing is done with either a culture or a NAAT (nucleic acid amplification test). Regardless of symptoms, it is important to test all sites that may have been exposed, including rectum or pharynx. Over the past several years, gonorrhea has become harder to treat because drug-resistant strains of gonorrhea are increasing in many parts of the world and Canada. In order to monitor drug-resistant gonorrhea in Saskatchewan and to better guide treatment, testing should be conducted as outlined in the algorithm in Question #4. Successful culturing of N. gonorrhea is dependent on several factors associated with specimen collection, transportation and storage. For example: collection method, transport (loss of viability due to transport or storage temperature or duration of transport,) overgrowth of N. gonorrhea by competing organisms in the sample collected, and dilution of the organism in collection medium. The result of any of these factors may lead false negative culture results (Association of Public Health Laboratories, 2014). NAAT is an appropriate alternative to cultures when the above criteria cannot be met. Q2: What are the signs and symptoms consistent with gonorrhea infection? A2: Individuals with gonorrhea may have mucopurulent discharge of the urethra or cervix. Symptoms of rectal infection may include discharge, anal itching, soreness, bleeding or painful bowel movements. Individuals with a history of oral sex may have pharyngeal infection, however these infections are usually asymptomatic. Q3: What are the risk factors for gonorrhea? A3: Individuals are at increased risk for gonorrhea if one or more of the following apply: Sexual contact with a person with a confirmed or suspected gonococcal infection; Unprotected sex with a resident of an area with high gonorrhea burden or high risk of antimicrobial resistance; History of previous gonococcal infection; History of other STIs, including HIV; Sex workers and their sexual partners; Sexually active youth < 25 years of age; Street-involved youth and other homeless populations; Men who have unprotected sex with men; and Sex with multiple partners. September 2014 Page 1
Q4: What testing should be completed for patients? A4: The following algorithm outlines the most appropriate testing based on client risk factors and clinical presentation. Obtain cultures (cervix or urethra) prior to NAAT specimens from symptomatic individuals with risk factors. Screen asymptomatic individuals for infection by NAAT on genital tract specimens (urine or cervix). Obtain cultures and NAATs from rectal or pharyngeal sites from individuals who have unprotected sexual exposure at these sites. NOTE: Chlamydia should be tested at the same time as gonorrhea in all cases. Gonorrhea Screening Recommendations Does the Patient Have Risk Factors (see Q#3)? If yes, proceed in the chart: Symptoms No Symptoms Is there Rectal or Pharyngeal Exposures*? Males Females Males and Females Culture AND Endocervial culture Urethral Culture (1st) and Urine NAAT and Endocrevical, vaginal or urine NAAT Urine NAAT (and cervical swab if doing pelvic exam) NAAT * For all symptomatic individuals and asymptomatic men who have sex with men and women with a history of performing oral sex. Source: Public Health Agency of Canada (2013) Adapted from Public Health Ontario (2013) Q5: What are the specimen collection and transport requirements? A5: Refer to the Saskatchewan Disease Control Laboratory (SDCL) Compendium of Tests (http://www.health.gov.sk.ca/compendium) Bacteriology: Gonococcal Culture for details and contact your regional lab to obtain appropriate materials that are not supplied by SDCL. September 2014 Page 2
Treatment Recommendations Q6: What is the recommended treatment for uncomplicated gonorrhea (ano-genital or pharyngeal gonorrhea) in Saskatchewan? A6: Until further notice, first-line treatment for persons above nine years of age (including pregnant women and nursing mothers) with confirmed or suspected uncomplicated urogenital gonorrhea (cervix, vagina, pharynx or rectum) and their sex partners is Ceftriaxone 250 mg intramuscularly plus azithromycin 1g orally. Q7: Why are two antimicrobials recommended to treat gonorrhea? A7: Treatment of gonorrhea with two antimicrobials is recommended nationally to improve the efficacy of treatment and delay the emergence and spread of resistance in N. gonorrhoeae. Cephalosporin-azithromycin combination therapy has also been found to be more effective in treating pharyngeal infections, which are usually asymptomatic. Q8: Is azithromycin being used to treat chlamydia or gonorrhea? A8: Both. Individuals with gonorrhea are commonly co-infected with chlamydia. Azithromycin treats chlamydia and also acts synergistically with cephalosporin to treat gonorrhea. Q9: When should treatment be provided? A9: In general, do not provide treatment for gonorrhea until there is laboratory evidence of gonorrhea infection. However, provide empiric treatment prior to receiving confirmatory lab results in the following circumstances: Patient presents with urethra/cervical mucopurulent discharge: If the partner is infected with gonorrhea, ceftriaxone and azithromycin should be provided; OR If follow-up is not assured, ceftriaxone and azithromycin should be provided; OR Provide azithromycin to treat chlamydia and if local prevalence of gonorrhea is high (contact your medical health officer if you require details of local epidemiology), consider treating with ceftriaxone. Patient presents without urethral/cervical mucopurulent discharge: If the individual is at high risk for infection and follow-up is not assured, provide ceftriaxone and azithromycin; OR If the sexual partner is infected with gonorrhea, provide ceftriaxone and azithromycin. Q10: What is the recommendation for second line treatment for gonorrhea? A10: Because cefixime is currently not available, second line options are Spectinomycin 2 g intramuscular plus Azithromycin 1 g orally OR Azithromycin 2 g orally (SEE BOX BELOW: Cautions regarding Azitthromycin). Note: Spectinomycin is only available through Health Canada s Special Access Programme using Form A http://www.hc-sc.gc.ca/dhp-mps/alt_formats/hpfbdgpsa/pdf/acces/sapf1_pasf1-eng.pdf September 2014 Page 3
Cautions regarding Azithromycin Azithromycin 2 g PO in a single dose should only be considered as an alternate treatment option if there is a history of severe allergy to cephalosporins. There are also significant gastrointestinal side effects associated with high dose azithromycin (Public Health Agency of Canada, 2013). Azithromycin is not recommended as monotherapy because of concern over the emergence of resistance. Instead, a 1 g dose of azithromycin is recommended as a component of dual therapy for gonorrhea, in conjunction with a cephalosporin (i.e., 250 mg of ceftriaxone) (CDC, 2011). An azithromycin-resistant variant of gonorrhea that developed in just 12 days was detected with genotyping highlighting the rapid emergence of clinical gonococcal resistance (Hill, 2012). Azithromycin can cause potentially life-threatening arrhythmias, especially in individuals taking a multi-day course of the medication. Individuals most at risk of this are those who have prolonged QT interval, other cardiac conditions (bradycardia, heart failure) or are elderly (Public Health Agency of Canada, 2013). Q11: What do I do if my patient has an allergy to penicillin? A11: Patients with a history of a severe reaction to penicillin, or any allergic reaction to the cephalosporins should be prescribed a non-cephalosporin based regimen for any suspected or confirmed gonorrhea infection and referred to a drug allergy clinic if available. Therapies to consider in this context include Spectinomycin 2 g intramuscular plus azithromycin 1g orally, or azithromycin 2 g orally (note cautions around using azithromycin as monotherapy noted above). Both of these treatments require a test of cure. Only a small number of patients that are told that they have a penicillin allergy will have any reaction if they take a cephalosporin. The estimated rates of severe reactions to the administration of a cephalosporin to an individual with a history of a penicillin allergy are between 0.0001 and 0.1%. Q12: What do I do if my patient has an allergy to azithromycin? A12: Allergies to azithromycin are extremely rare. In the instance of allergy to azithromycin, doxycycline 100 mg PO BID x 7 days is recommended in addition to ceftriaxone 250 mg IM. This treatment requires a test of cure. Doxycycline is contraindicated in pregnant and breastfeeding women. Q13: What do I do if my patient did not receive first line therapy (ceftriaxone and azithromycin)? A13: A test of cure is recommended to ensure the infection has been cleared. If infection is cleared, no additional treatment is necessary. If gonorrhea infection is still present, treatment with both ceftriaxone and azithromycin is recommended. Chlamydia testing should also be ruled out as a possible co-infection for all individuals who have been identified with gonorrhea. If chlamydia infection is identified, treatment is suggested as per the Saskatchewan Communicable Disease Control Manual http://www.health.gov.sk.ca/communicable-diseasecontrol-manual. September 2014 Page 4
Q14: What is a Test of Cure? A14: A Test of Cure is laboratory tests conducted at a defined timeframe following the completion of treatment to ensure the infection has resolved. Q15: How do I do a Test of Cure? A15: For Test of Cure, regardless of presence or absence of symptoms, the preferred testing method is culture. Test of Cure using culture should be performed four to five days after completion of therapy. If culture is not locally available, NAAT testing is a second-line option, but should be performed four weeks post-treatment at the earliest. Q16: When should I do a Test of Cure? A16: Test of Cure by culture should be completed whenever ceftriaxone AND azithromycin has not been provided. In addition to the above, Test of Cure by culture (4-5 days post treatment) if the client has: pharyngeal infection; persistent post-treatment symptoms; and been linked to drug resistance or treatment failure. Test of Cure by culture (4-5 days post treatment) or PCR (urine NAAT) (4 weeks post treatment) if the client: Is 16 years of age or under; Is pregnant; Has concomitant infections; Is concerned about re-infection; Is a man who has sex with men; Is a prepubertal child; Is diagnosed with pelvic inflammatory disease (PID); and Experienced treatment failure previously. Q17: How long do cases have to abstain from sex following this new treatment? A17: Advise patients and contacts to abstain from unprotected intercourse until 7 days after completion of treatment. Q18: What information should be provided to my patients about treatment? A18: Patient information sheets on gonorrhea and the medications are available. Inform your patients about contraindications, side effects, drug interactions and the length of time that they should abstain from unprotected intercourse (i.e. for seven days following completion of treatment). Q19: When should treated cases of gonorrhea be re-screened for STI? A19: Individuals diagnosed with gonorrhea are at high risk of reinfection. Rescreen patients who are diagnosed with gonorrhea six months after initial diagnosis, or when they next seek medical care within the next 12 months (Public Health Agency of Canada, 2013). September 2014 Page 5
Management of Contacts Q20: Who is a contact? A20: All partners who have had sexual contact with the case (including oral, anal and vaginal) within 60 days prior to symptom onset or when the specimen was collected if the case was asymptomatic. If your patient indicates having no partners in the past 60 days, the most recent partner should be notified (Public Health Agency of Canada, 2013). Q21: How do I manage a contact? A21: All contacts should be assessed, tested, treated empirically and counseled. Q22: What is required as part of an assessment? A22: In addition to the physical assessment, a risk assessment should be completed to determine if the contact has more risks than the known exposure. See Attachment Risk Assessment Questionnaire in the Saskatchewan Communicable Disease Control Manual: http://www.health.gov.sk.ca/cdc-section5 Q23: What testing is required for contacts? A23: Testing (culture versus NAAT) should be conducted based on symptoms. See Questions #1 and #4 for Gonorrhea Testing Recommendations (Symptomatic or Asymptomatic Patients). In addition to completing gonorrhea tests, test contacts for chlamydia, syphilis and HIV due to the increased risk of co-infection with other STIs. Additional tests should be completed based on the risk assessment. Q24: How do I treat a contact? A24: Give empiric treatment with ceftriaxone 250 mg intramuscularly plus azithromycin 1 g orally as soon as possible to all sexual contacts of cases regardless of clinical findings and without waiting for test results (Public Health Agency of Canada, 2013). Empiric treatment is recommended to reduce the risk of further transmission and the potential of re-infecting their treated partner. Q25: What counseling should be provided to contacts? A25: Patient information sheets on gonorrhea and the medications are available. Provide contacts information about contraindications, side effects, drug interactions and the length of time that they should abstain from unprotected intercourse (i.e. for 7 days following completion of treatment). Recommend STI testing every six months for at-risk individuals. September 2014 Page 6
Administration and Access to STI medications Q26: Who is eligible to access publicly-funded STI medications in Saskatchewan? A26: In Saskatchewan, STI medications are publicly funded to facilitate effective treatment in a timely manner for individuals who have laboratory confirmed STI or who are eligible for empiric treatment (See Question #9). To order publicly-funded STI medications, please contact your local public health unit. To find the public health unit nearest you, please visit: http://www.health.gov.sk.ca/health-region-list Publicly funded medications are available for treatment of notifiable sexually transmitted infections. As such, for each dose of medication provided, an accompanying notification form must be completed indicating if the disease that is suspected or confirmed. See attached. Q27: Should health care practitioners keep a limited stock of STI medications in the clinic? A27: Yes. To facilitate timely treatment of patients and reduced transmission of STIs, it is recommended that health care practitioners keep a limited stock of STI medications in their clinic to provide treatment of clients with a STI (i.e., laboratory confirmed case or those requiring empiric treatment) at their clinic. Consult with your local public health unit http://www.health.gov.sk.ca/health-region-list Q28: How should ceftriaxone for IM injection be stored? A28: Ceftriaxone for injection sterile powder should be stored at 15-30 C (room temperature) and protected from light. Solutions should be reconstituted immediately before use. If storage is required (after reconstitution), these solutions may be stored under refrigeration and should be used within 48 hours. See product monograph: http://www.sterimaxinc.com/media/djcatalog/20110503_105815_iiiiaa000.02%20ceftriaxone_pi_ all%20strengths_rev2.pdf: Q29: What diluents should be used for reconstitution of ceftriaxone for IM injection? A29: The preferred diluent for reconstituting ceftriaxone is lidocaine (1%) and is publicly funded when used for this purpose. The following solutions may also be used for reconstitution for intramuscular injection in the event of a contraindication to lidocaine, but these solutions are not publicly funded. Sterile Water for Injection 0.9% Sodium Chloride Injection 5% Dextrose Injection Bacteriostatic Water for Injection For detailed information about the agent used as a diluent for the specific product received from your local health unit please refer to the product monographs at http://www.sterimaxinc.com/media/djcatalog/20110503_105815_iiiiaa000.02%20ceftriaxone_pi _all%20strengths_rev2.pdf and http://www.alvedapharma.com/pdf/lidocaineenglish.pdf September 2014 Page 7
Q30: Should ceftriaxone 250 mg IM be administered with safety engineered needles? A30: As per Section 474.1(3) of the Saskatchewan Occupational Health and Safety regulations 1, the use of safety engineered needles are required by workers or self-employed persons. Q31: How do I prepare the injection? A31: Refer to the product monographs for ceftriaxone for full details and other diluent options: http://www.sterimaxinc.com/media/djcatalog/20110503_105815_iiiiaa000.02%20ceftriaxone_pi_ all%20strengths_rev2.pdf. Q32: How should ceftriaxone be administered? A32: The medication should be administered IM into the intragluteal region. Aspirate following needle placement to avoid injecting intravenously. See below for description and images of appropriate land marking 2. Dorsogluteal site Draw an imaginary line from the posterior superior iliac spine to the greater trochanter. Insert the needle at a 90-degree angle above and outside the drawn line. You can administer a Z-track injection through this site. After drawing up the drug, change the needle, displace the skin lateral to the injection site, withdraw the needle, and then release the skin. Ventrogluteal site With the palm of your hand, locate the greater trochanter of the femur. Spread your index and middle fingers posteriorly from the anterior superior iliac spine to the furthest area possible. This is the correct injection site. Remove your fingers and insert the needle at a 90-degree angle. 1 http://www.qp.gov.sk.ca/documents/english/regulations/regulations/o1-1r1.pdf 2 Source: http://books.mcgrawhill.com/medical/nursesdrughandbook/safe_drug_admin/identifying_injection_sites/identifyinginjectionsites.php September 2014 Page 8
Follow-Up of Individuals Q33: What is the definition of Gonorrhea Treatment Failure? A33: Gonorrhea Treatment Failures are defined as treated individuals with confirmed gonorrhea and a positive test of cure (NAAT or culture) in the absence of risk of reinfection (i.e., patient denies potential sexual re-exposure) (Public Health Agency of Canada, 2014). False positive results may occur if a culture was taken less than 4 days after treatment or the NAAT was taken less than 4 weeks after treatment. Q34: What do I do if I am concerned that my patient has had treatment failure? A34: If first-line treatment was not used initially, use the first-line treatment, if no contraindications. Perform a test of cure using culture four to five days post re-treatment. Report any suspected or confirmed gonorrhea treatment failures to your local public health unit. Once notified of a suspected or confirmed case of gonorrhea treatment failure, the public health unit will work with the responsible health care practitioner to provide notification to Saskatchewan Ministry of Health and to discuss any further public health action that may be required. Q35: Why do I need to disclose treatment failures to my local Medical Health Officer? A35: Disclosure is required in order to monitor resistance patterns of multi-drug resistant N. gonorrhoeae, to ensure individuals are being treated effectively for gonorrhea, and to limit ongoing transmission. In order to do this, health care practitioners, local public health units and the Saskatchewan Ministry of Health must work together to make sure each is aware of treatment failures. Resources Q36: Where can I go to get more information? A36: There are several resources to turn to for more information regarding multi-drug resistant gonorrhea, and the assessment and management of gonorrhea and sexually transmitted infections in general. Your local public health office or medical health officer can answer questions you may have. You can also access the Saskatchewan Communicable Disease Control Manual online at http://www.health.gov.sk.ca/communicable-disease-control-manual Also see The Canadian Guidelines on Sexually Transmitted Infections (Public Health Agency of Canada): http://www.phac-aspc.gc.ca/std-mts/sti-its/cgsti-ldcits/index-eng.php September 2014 Page 9
References Guidelines for Testing and Treatment of Gonorrhea in Saskatchewan, 2014 Association of Public Health Laboratories (2014) http://www.aphl.org/aboutaphl/publications/documents/id_2014mar_transportation-of- Specimens-for-Neisseria-gonorrhoeae-Culture.pdf British Columbia Centers for Disease Control - http://www.bccdc.ca/dis-cond/az/_g/gonorrhea/default.htm Public Health Agency of Canada - http://www.phac-aspc.gc.ca/std-mts/sti-its/cgsti-ldcits/indexeng.php and http://www.phac-aspc.gc.ca/std-mts/sti-its/cgsti-ldcits/section-5-6-eng.php Public Health Ontario (2013) - http://www.publichealthontario.ca/en/erepository/guidelines_gonorrhea_ontario_2013.pdf Saskatchewan Communicable Disease Control Manual - http://www.health.gov.sk.ca/communicable-disease-control-manual US Centers for Disease Prevention and Control - http://www.cdc.gov/std/gonorrhea/ Hill (2012) Gonorrhea Develops Rapid Resistance to Azithromycin. Medscape. Mar 15, 2012. http://www.medscape.com/viewarticle/760301_print Centers for Disease Control and Prevention (2011) Neisseria gonorrhoeae with Reduced Susceptibility to Azithromycin, Morbidity and Mortality Weekly Report. 2011;60(18):579-581 September 2014 Page 10