II. Diagnosis: GC Can Be Diagnosed by a Positive Gram Stain, Culture Or NAAT Result

GONORRHEA (8/11/2011 Final Revision)

I. Background

A. G:\StrategicArea\STD_HIV_Prev_Control\STD Standing Orders\Background B. http://www.cdc.gov/std/gonorrhea/default.htm C. http://www.cdc.gov/std/treatment/2010/STD-Treatment-2010-RR5912.pdf

The following protocol has been revised according to evidenced-based practice specific to Denver Metro Health Clinic utilizing the CDC 2010 Treatment guidelines. The following should not be considered all inclusive as other testing and treatment options may be available.

II. Diagnosis: GC can be diagnosed by a positive Gram stain, culture or NAAT result

A. History: 1. Often asymptomatic, or c/o following signs/symptoms: a. Men may c/o penile discharge or dysuria; men might also have edema and erythema of the meatus. Infection spreading to the epididymis may cause testicular pain and swelling. b. Women may c/o abnormal vaginal discharge, dysuria, intermenstrual uterine bleeding, and/or menorrhagia that may range in intensity from minimal to severe; if the infection spreads from the cervix to the fallopian tubes, she may c/o various combinations of lower abdominal pain, lower back pain, fever, nausea, pain with intercourse, or abnormal menses. c. Men or women who have receptive anal intercourse may acquire gonorrhea infection in the rectum, which can cause rectal pain, discharge, or bleeding. d. Men or women can also have pharyngeal infection if having oral sex with an infected partner and may c/o of sore throat; however, is often asymptomatic. 2. GC may cause complications, in which may be diagnosed and treated empirically (see epididymitis, and PID protocols)

B. Examination: 1. Oropharyngeal: often asymptomatic 2. Men: a. Inspection of penis: including retraction of foreskin, inspection of meatus, and “milking” of urethra for discharge, which is often mucoid or mucopurulent (yellow or green). b. Palpation of scrotal contents: possible unilateral scrotal pain, swelling, or tenderness 3. Women: a. Palpation of the lower abdomen b. Speculum examination of the vagina and cervix: often mucopurulent cervical discharge and cervical hypertrophic ectopy (edematous and bleeds easily) c. Bimanual pelvic exam 4. Anal: often asymptomatic; or possible bleeding and/or mucopurulent discharge

GC C. Laboratory: NAAT testing will be performed on all clients receiving testing. Gram stain and cultures as outlined below.

1. NAAT (Nucleic Acid Amplification Test/Aptima) - positive urine, vaginal, urethral or endocervical test should be considered diagnostic of GC

a. Collect urine specimens on all males i. If patient is unable to produce urine, urethral NAAT tests are available upon request. b. Collect vaginal specimens on all females i. Self-collected vaginal swab if asymptomatic or declines exam – clinicians instruct patients according to the manufacturer recommendations ii. Urine NAAT testing also available if declines exam or self-collection, or has had hysterectomy iii. See “Screening for Rectal or Pharyngeal Gonorrhea and Chlamydia”

2. Gram stain – smear showing polymorphonuclear leukocytes (PMNs) with Gram negative intracellular diplococci (GNID) of typical morphology is diagnostic of GC

a. Urethra: Obtain on all symptomatic males b. Pharynx: Gram stain is unreliable and should not be performed c. Rectum: Gram stain is unreliable and should not be performed d. Endocervix : Gram stain is unreliable and should not be performed

3. Culture - positive GC culture from urethra, pharynx, rectum or endocervix is diagnostic of GC

a. Urethra: culture if Gram Stain consistent with GNID (up to the first 25 specimens every month), or in the case of suspected treatment failure b. Pharynx: culture in the case of suspected treatment failure c. Rectum: culture in the case of suspected treatment failure d. Endocervix: culture in the case of suspected treatment failure

III. Treatment

A. Recommended (use if no history of cephalosporin or severe [hives, anaphylaxis, respiratory compromise] PCN allergy): 1. Ceftriaxone 250 mg IM once 2. And i. Doxycycline 100 mg orally twice a day for 7 days I) only in a non-pregnant patient ii. or Azithromycin 1 gram orally once

B. Alternative (use if severe allergy to cephalosporin/PCN or if patient categorically refuses IM treatment): 1. Ofloxacin 400 mg orally once and Azithromycin 2 grams orally once a. No additional Chlamydia therapy is needed as azithromycin is being given already

GC C. Pregnancy 1. Recommended: a. Ceftriaxone 250 mg IM once b. And i. Azithromycin 1 gram orally once ii. or (if unable to take azithromycin) amoxicillin 500 mg orally 3 times a day for 7 days 2. Alternative (use if severe allergy to cephalosporin/PCN or if patient categorically refuses IM treatment): a. Azithromycin 2 grams orally once i. No additional Chlamydia therapy is needed as azithromycin is being given already 3. Contraindicated: doxycycline is Pregnancy Category D and should not be used in a pregnant woman

D. Lactation: 1. Recommended: a. Ceftriaxone 250 mg IM once b. And i. Azithromycin 1 gram orally once ii. or (if unable to take azithromycin) amoxicillin 500 mg orally 3 times a day for 7 days 2. Alternative (use if severe allergy to cephalosporin/PCN or if patient categorically refuses IM treatment): a. Azithromycin 2 grams orally once i. No additional Chlamydia therapy is needed as azithromycin is being given already 3. Contraindicated: doxycycline should not be used in a lactating woman

IV. Other considerations

A. Test-of-cure: recommended for patients receiving the alternative treatment listed above. If ceftriaxone was given, the patient does not need to return to clinic unless symptoms are persistent or recurrent 1. Culture depends on finding live organisms; it can be performed as soon as 3 days after treatment. 2. NAAT can be positive when only dead organisms are present; it should not be performed until at least 3 weeks after completion of treatment. a. Remember that single high-dose azithromycin acts for approximately a week, so completion of therapy is considered to be a week after administration of the dose.

B. Treatment failure should be suspected with lack of resolution of symptoms in a patient with symptomatic GC, though this may also reflect infection with an organism such a T. vaginalis which would not be covered by treatment for GC and CT. In the case of suspected treatment failures send GC cultures to be tested for antibiotic susceptibilities.

C. Disseminated gonococcal infection (DGI): occurs rarely but should be suspected in young, sexually active individuals with petechial or pustular acral (i.e. at wrists/ankles) skin lesions, asymmetrical arthralgias, tenosynovitis or septic arthritis. Suspected cases

GC should be seen by the clinic physician and if DGI is thought to be present the patient must be referred for hospitalization.

D. Medication issues: 1. Azithromycin: a. Nausea or vomiting i. Patient instructions: usually eating with the dose makes it tolerable I) If patient vomits at least 45 minutes after the dose was taken, likely it had already passed into the duodenum and another dose does not need to be given II) If intact pills appear to be present in the vomitus, re-treatment is needed b. 2 gram dose may be separated but should be taken within the same day.

2. Doxycycline: a. Nausea: i. Patient instructions: usually eating with the dose makes it tolerable b. Photosensitivity: i. The drug is a photosensitizer, meaning that skin will be more susceptible to the effects of UV rays, including sunburn ii. This occurs in all skin types, with the degree of effect likely to be worst with lighter skin types iii. Patient instructions: avoid the sun while taking medication in order to avoid sunburn, or wear protective outer covering or sunscreen c. Calcium binding: i. Doxycycline may be bound by minerals including calcium, which prevents absorption of the drug into the body from the intestine ii. Patient instructions: avoid taking medication 2 hours before or after calcium containing foods or supplements d. Contraindicated in pregnancy: i. All tetracyclines are Pregnancy Category D because of effects on developing fetal bone and tooth structures e. Contraindicated with lactation: i. Doxycycline has adverse effects on teeth and bone in an infant, and should not be used in a lactating woman

3. Ceftriaxone: a. Possible PCN allergy: i. Do not use ceftriaxone if the patient reports hives, anaphylaxis, tongue swelling or difficulty breathing as a reaction to PCN in the past. ii. Simple, non-hives-type rashes to PCN are not a contraindication to use of a cephalosporin antibiotic

4. Ofloxacin: a. Contraindicated in pregnancy: i. All fluoroquinolones are Pregnancy Category C because of hypothesized effects on developing fetal joint structures b. Contraindicated with lactation: i. Enters breast milk/not recommended (but AAP rates “compatible”)

GC V. Counseling

A. Abstaining from sexual contact: Advise abstention from all sexual contact until completion of treatment and symptoms have resolved if present. If azithromycin is used, advise the patient to abstain for 7 days.

B. Early detection of re-infection: Because of the high rate of re-infection, all persons with GC infections, especially those younger than 25 years old, should be advised to be re-evaluated for STDs 3-4 months after treatment, regardless of whether the patient believes that his or her sex partner(s) were treated.

C. Prevention: Consistent condom use does lower the risk of acquiring an infection

D. HIV risk: Because of the association of GC and HIV infection, MSM with GC should be counseled regarding risk reduction and advised to have a follow-up HIV test in 3 months.

VI. Follow-up

A. Persistent or recurrent symptoms 1. Men: a. Gram stain for urethral discharge i. If the Gram stain is negative for GC but urethritis is still present, follow the NGU protocol b. Culture - if at least 3 days out from therapy (with no reported sexual activity) i. If GC found on repeat culture, the culture will be sent for resistance testing 2. Women: a. Wet prep for T. vaginalis if vaginal or endocervical discharge is present b. Culture – if at least 3 days out from therapy (with no reported sexual activity) i. If GC found on repeat culture, the culture will be sent for resistance testing

VII. Management of contacts

A. Evaluation and presumptive treatment should be performed for all contacts within the preceding 60 days regardless of symptoms. 1. If the most recent contact occurred > 60 days ago, that contact should still be evaluated and presumptively treated.

B. Clients should be given contact cards for all recent sexual contacts, to increase the likelihood that partners will be treated.

C. Treatment of contacts to GC: 1. Contacts presenting to the clinic: a. Follow the treatment recommendations given above (section III) 2. Contacts for whom EPT is taken: a. Follow the treatment recommendations in the EPT protocol