STBBI MUCOPURULENT CERVICITIS PELVIC INFLAMMATORY DISEASE (PID) URETHRITIS EPIDIDYMITIS/EPIDIDYMO ORCHITIS

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1 JANUARY 2012 PHARMACOLOGICAL TREATMENT STBBI This optimal usage guide is provided for information purposes only and should not replace the judgment of a professional. The recommendations included in this guide apply to adolescents aged 14 and over and to adults. This guide has been adapted primarily from the Canadian Guidelines on Sexually Transmitted Infections and takes into account the deliberations of an experts committee. GENERAL CONSIDERATIONS The recommendations in this optimal usage guide apply exclusively to the management of clinical syndromes potentially associated with STIs prior to obtaining laboratory analysis results (syndromic approach). The guide therefore follows an empiric treatment approach. Appropriate laboratory analyses must be completed. For the treatment of pregnant or nursing women, consult an experienced colleague. CLINICAL MANIFESTATIONS SYNDROME POSSIBLE CLINICAL MANIFESTATIONS 1 Mucopurulent Cervicitis Pelvic Inflammatory Disease (PID) Urethritis Epididymitis/ Epididymoorchitis 2, 3 Purulent or mucopurulent endocervical exudate visible in the endocervical canal or on an endocervical swab specimen Intermenstrual or post coital vaginal bleeding Abnormal vaginal discharge Endocervical bleeding induced by passage of a swab through the cervix Lower abdominal, cervical motion or adnexal tenderness Oral temperature above 38 C A recent C. trachomatis or N. gonorrhoeae infection in a female patient or her partners supports a diagnosis of PID Intermittent or persistent urethral discharge (mucoid, mucopurulent or purulent) Intermittent or persistent burning sensation during urination Urethral discomfort Usually, absence of: urinary frequency, hematuria, urinary urgency, vesical tenesmus Typically unilateral testicular pain (generally develops progressively) Testicular tenderness upon palpation Palpable swelling of the epididymis Urethral discharge Hydrocele Erythema or swelling of the scrotum on the affected side Fever 1. Syndromes do not always present all of the possible clinical manifestations listed in the table. 2. Epididymo orchitis primarily means an inflammation of the epididymis and the testicle. 3. In all cases of acute testicular pain, possible torsion of the testicle (most common in men under 20 years of age) should be considered. It constitutes a surgical emergency. CRITERIA FOR HOSPITALIZATION OR REFERRAL TO A COLLEAGUE WITH EXPERIENCE IN PELVIC INFLAMMATORY DISEASE Inability to rule out surgical emergencies (e.g. appendicitis or ectopic pregnancy) Pregnancy Absence of clinical response (after 3 days) or intolerance to ambulatory antibiotic therapy Anticipated problem complying with ambulatory antibiotic therapy Severe impairment of general condition, nausea, vomiting or high fever Suspected abscess in the pelvic region Moderate or severe immunosuppression PHARMACOLOGICAL TREATMENT STBBI

2 ADULTS ADOLESCENTS AGED 14 OVER, EXCLUDING PREGNANT NURSING WOMEN Most frequently caused by: C. trachomatis and N. gonorrhoeae Azithromycin 3, 4 (Zithromax TM ) 1 g, orally, Doxycycline mg, orally, twice a day for 7 days Cefixime (Suprax TM ) 800 mg, orally, Cefixime (Suprax TM ) 800 mg, orally, If allergic to cephalosporins or allergic to penicillin (type I allergy): Azithromycin 3,4,6 (Zithromax TM ) 2 g, orally, A test of cure should be conducted in the following cases: pregnancy, persistent signs or symptoms, reinfection during or after treatment is possible, treatment compliance problems are anticipated, there is demonstrated resistance to the antibiotics used, for the partner of a patient with demonstrated resistance to the antibiotics used, previous treatment failure, treatment regimen other than those recommended is being used and gonococcal pharyngeal infection. The preferred test of cure is a culture test 1-2 weeks after the completion of treatment for N. gonorrhoeae infections in adults and adolescents aged 14 and over. The preferred test of cure is an NAAT (e.g. PCR) 4-6 weeks after the completion of treatment for gonococcal infections for which it is impossible to get a sample for a N. gonorrhoeae culture and for C. trachomatis infections. In some cases, including in the presence of persistent signs or symptoms, it may be necessary to perform a clinical assessment before the test of cure. For mucopurulent cervicitis: Conduct further testing and consult an experienced colleague as required if symptoms persist or reappear following the end of treatment or if there are visible lesions on the cervix. For urethritis: It may take up to 7 days following the end of treatment for symptoms to disappear. A re-evaluation is necessary if symptoms persist or reappear after treatment (a week after the beginning of the treatment). Symptoms alone, without laboratory evidence or clinical signs, are not a sufficient basis for retreatment. 3. If the patient begins to vomit within an hour of administering azithromycin, administer another dose with antiemetic prophylaxis. 4. For people weighing less than 45 kg, single doses of mg/kg and mg/kg are recommended in place of the respective 1 g and 2 g single doses. 5. Doxycycline is contraindicated for pregnant and nursing women. 6. This dosage of azithromycin is effective for the treatment of C. trachomatis infection N. gonorrhoeae infection.

3 ADULTS ADOLESCENTS AGED 14 OVER, EXCLUDING PREGNANT NURSING WOMEN Early diagnosis and treatment are essential to avoid complications (ectopic pregnancy, chronic pelvic pain, infertility). The possibility of a pregnancy must be ruled out. Treatment regimens must cover a broad spectrum of likely pathogens, in addition to accounting for the polymicrobial nature of PIDs. Evaluate the probability of the type of infection likely at the root of the PID: a sexually transmitted infection (STI) OR an infection contracted through gynaecological procedures. In case of doubt, always treat as an STI. To treat infections contracted through gynaecological procedures, refer the person to an experienced colleague. Antibiotic therapy may be administered orally or parenterally. In this guide, only ambulatory treatment is addressed. Consult the Canadian Guidelines on Sexually Transmitted Infections for inpatient treatment. If antibiotic therapy is initiated on an inpatient basis, outpatient therapy should continue until completion of at least 14 days of therapy. Intrauterine devices (IUDs): Evidence is insufficient to recommend the removal of IUDs. Close clinical follow-up is required, however, if an IUD is left in place. STI-TYPE PID (VERY LIKELY CAUSED BY C. TRACHOMATIS OR N. GONORRHOEAE) 7, 8, 9 Ceftriaxone (Rocephin TM ) Doxycycline 5, 8 WITH OR WITHOUT Metronidazole 10 (Flagyl TM ) 250 mg, IM, 100 mg, orally, twice a day 500 mg, orally, twice a day If the patient is allergic to penicillin (type I allergy) or to cephalosporins, consult an experienced colleague. Treatment with a quinolone may be considered, as long as a sample for an N. gonorrhoeae culture is obtained to ascertain the sensitivity of the isolated pathogen (if applicable) to the quinolone being used. Should susceptibility testing be unavailable, a test of cure must be performed. All patients receiving ambulatory treatment must be closely monitored and be re-examined 2-3 days after initiation of treatment. PID-related pain should begin to subside 2 3 days after the beginning of antibiotic therapy. If no clinical improvement is observed after 3 days, consult an experienced colleague and evaluate the need for hospitalization. 5. Doxycycline is contraindicated for pregnant and nursing women. 7. The preferred diluent for ceftriaxone is 1% lidocaine without epinephrine (0.9 ml/250 mg) to reduce discomfort. 8. This product is recommended in the Canadian Guidelines on Sexually Transmitted Infections, although it has not received approval from Health Canada for this purpose. 9. In place of ceftriaxone, cefoxitin 2 g, IM,, with probenecid 1 g, taken orally, may be used. 10. The use of metronidazole for the treatment of PID covers anaerobic bacteria. Patients should not consume alcohol during metronidazole treatment.

4 EPIDIDYMITIS/EPIDIDYMO-ORCHITIS ADULTS ADOLESCENTS AGED 14 OVER, EXCLUDING PREGNANT NURSING WOMEN Two types of infections with different etiologies are possible: STIs (very likely caused by C. trachomatis or N. gonorrhoeae), often associated with STI risk factors, OR Infection in the absence of STI risk factors or acquired, for example, through urological procedures (most probably caused by Gram-negative rods sometimes involved in urinary tract infections) Assess the likelihood of each type of infection before initiating treatment, which should be chosen in line with the most plausible cause of the infection. When in doubt, always treat as an STI. Ceftriaxone 7, 8 (Rocephin TM ) Doxycycline 8 WITH STI RISK FACTORS (VERY LIKELY CAUSED BY C. TRACHOMATIS OR N. GONORRHOEAE) 250 mg, IM, 100 mg, orally, twice a day for days If the patient is allergic to penicillin (type 1 allergy) or to cephalosporins, consult an experienced colleague who will propose a procedure similar to that in the second-choice treatment column for STI-TYPE PID. IN THE ABSENCE OF STI RISK FACTORS OR ACQUIRED, FOR EXAMPLE, THROUGH UROLOGICAL PROCEDURES (VERY LIKELY CAUSED BY GRAM-NEGATIVE RODS) Ofloxacine 8,11 (Floxin TM ) 200 mg, orally, twice a day 11, 12 Levofloxacine (Levaquin TM ) 500 mg, orally, daily for 10 days Signs and symptoms that do not improve within 2 3 days after initiation of treatment require re-evaluation of diagnosis and treatment. The patient should be re-examined around 1 month after treatment to ensure that there are no other testicular abnormalities and that the testicle is back to its normal shape. 7. The preferred diluent for ceftriaxone is 1% lidocaine without epinephrine (0.9 ml/250 mg) to reduce discomfort. 8. This product is recommended in the Canadian Guidelines on Sexually Transmitted Infections, although it has not received approval from Health Canada for this purpose. 11. A warning has been issued about the use of quinolones in patients aged 17 and under. 12. This product is recommended in the american guidelines. It has not received approval from Health Canada for this purpose. Antibiotic resistance in cases of N. gonorrhoeae infection is a serious concern. There are currently N. gonorrhoeae strains in Québec with reduced susceptibility to cephalosporins. These strains are identified as sensitive in sensitivity analysis reports, but their minimum inhibitory concentrations (MIC) are close to resistance thresholds. These cases can be treated using recommended treatment regimens, but call for a more careful follow-up of the response to treatment. Recommended treatments may be modified according to the evolution of sensitivities. Vigilance on the clinician s part is important.

5 PRISE EN CHARGE Free access to prescribed medication For people who have a valid health insurance card If the code K (for the infected patient) or L (for partners) is written on the prescription Intervention with the infected patient Management must include adequate treatment and follow-up for the infected patient as well as a procedure for the notification and treatment of sexual partners. Recommend abstinence from sexual relations for 7 days following the completion of a single-dose treatment or until the end of multi-dose therapy until symptoms are resolved. In cases where abstinence is uncertain, strongly recommend using condoms for all types of sexual relations (vaginal, anal or orogenital). Interventions with sexual partners Recommend clinical intervention for the following sexual partners: Partners who have had sexual contact with the infected patient in the 60 days preceding the patient s onset of symptoms or diagnosis; The patient s most recent sexual partner if a patient s last sexual relation was more than 60 days before onset of symptoms or diagnosis; Partners who had sexual relations with the infected patient prior to the completion of therapy or in the 7 days following a single-dose treatment or before his symptoms are resolved. Clinical intervention with each partner should include: Assessment of risk factors; Screening with laboratory analyses; Treatment, even if the results of laboratory analyses are inconclusive or negative; A procedure to notify this person s sexual partners if the screening results are positive. The regional public health department may provide clinicians with information about the support available for notifying partners and referring them to competent resources for clinical evaluation, laboratory analysis, treatment and health education. Mandatory reporting Confirmed cases of C. trachomatis and N. gonorrhoeae infections are notifiable diseases. They must be reported to the regional public health department. Cervicitis, urethritis, pelvic inflammatory disease and epididymitis are not considered notifiable diseases when laboratory results do not confirm the presence of these bacteria. When a person consults a clinician, for instance about STBBIs, contraception or during a periodic examination, the clinician should: ASSESS RISK FACTORS for STBBIs and SCREEN according to indications, since many persons are asymptomatic and unaware that they are infected; INFORM the person of safer sexual practices and encourage consistent use; VACCINATE against hepatitis and the human papillomavirus as indicated in the Protocole d immunisation du Québec (chapter 10.4). Family physicians can use procedure code no for STBBI-related preventive interventions. A variety of STBBI-related tools directed at health professionals are available and can be consulted at in the Documentation section under Professionnels/outils. REFERENCES Public Health Agency of Canada (PHAC). Canadian Guidelines on Sexually Transmitted Infections. Ottawa, ON: PHAC; Centers for Disease Control and Prevention (CDC). Sexually Transmitted Diseases Treatment Guidelines, Atlanta, GA: CDC, U.S. Department of Health and Human Services; Ministère de la Santé et des Services sociaux (MSSS). Guide québécois de dépistage des infections transmissibles sexuellement et par le sang. Québec, QC: MSSS; Ministère de la Santé et des Services sociaux (MSSS). Intervention préventive auprès des personnes atteintes d une infection transmissible sexuellement et auprès de leurs partenaires. Aide-mémoire à l intention des professionnels de la santé. Québec, QC : MSSS ; This guide was prepared in collaboration with the Institut national de santé publique du Québec, the ministère de la Santé et des Services sociaux and various experts in the field. It has the support of the professional orders (CMQ, OPQ, OIIQ), the federations (FMOQ, FMSQ), and various associations of Québec physicians and pharmacists. Any reproduction of this document in whole or in part for non-commercial use is permitted on condition that the source is mentioned.