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Sandyford Protocols SYPHILIS Significant changes in this guideline: A confirmatory sample should be taken when an initial sample indicates a diagnosis of syphilis. If clinical suspicion confirms this test result treatment should not be delayed until the result of this second sample. History Taking: In the last few years major outbreaks of syphilis (mostly in men who have sex with men) have been reported in London, Manchester, Brighton and Dublin as well as Glasgow and Edinburgh. Ask about sex in scene venues (saunas, back rooms) and record geographical location of sex partners. Please document clearly where applicable: Possible symptoms of primary or secondary syphilis Previous treatment (when, where, what with, VDRL on discharge) Obstetric history and blood donation history Clinical and Laboratory Assessment: The primary screen for syphilis in GGC is an automated EIA (Architect): Specialist Virology Laboratory, Gartnavel for Glasgow sites and Inverclyde Royal for all Clyde sites. A single specimen is all that is needed for HIV, syphilis and Hep B testing. Positive screens at IRH are sent immediately to Gartnavel. The serological screening test used routinely is a Treponemal EIA combined IgG/IgM test. If this is found to be positive VDRL, TPPA, Inno-LIA blot and specific IgM will be performed. IgM is positive from around second week, IgG from fourth week after infection. (see testing algorithm) If syphilis is suspected clinically, indicate this clearly on the request form, asking for ‘Full syphilis testing’ and the lab will do IgM, VDRL and TPPA as well as screening EIA. However, do NOT request full serology on NaSH patient order as all syphilis tests are reported and managed under the NaSH test “Syphilis EIA”. Positive results are usually phoned back within 48 hours. Do NOT request full serological tests for no good reason as we end up with likely false +ve IgMs etc. A confirmatory sample should be taken at the time the patient presents for treatment after initial sample is positive. Treatment should not be delayed waiting for this result if clinical suspicion from the history or examination supports the diagnosis. Arrange repeat serology a week later and ideally at 6 weeks and 3 months if initial serology is inconclusive or clinical suspicion. Always do dark ground testing on all suspicious lesions and take a Genital Ulcer PCR (which will get a T pallidum PCR and HSV PCR test) (applies throughout all services including Clyde) In a Sandyford HUB patients with suspicious lesions should be sent to Sandyford Central for dark ground microscopy if possible and they are willing to travel. Full clinical examination, with particular emphasis on the skin, genitals, lymph nodes and mucosal surfaces (anogenital and mouth) is essential in all patients found to have positive syphilis serology. Cardiovascular and neurological examination is required in secondary syphilis and apparent latent syphilis. Syphilis cannot be considered latent until end-organ damage is excluded. SYPHILIS CEG DEC 2015 Page 1 of 9 Sandyford Protocols HIV testing should be recommended to all patients diagnosed with syphilis. Testing Algorithm 1. Initial sample Screening test Reactive VDRL+ TPPA+ VDRL – TPPA+ IgM testing Non reactive VDRL – TPPA- IgM testing IgM testing Referred for immunoblot All samples will be authorised unless waiting for an immunoblot result when an interim report marked with “further results to follow” will be authorised. SYPHILIS CEG DEC 2015 Page 2 of 9 Sandyford Protocols 2. Follow up sample Screening EIA Reactive VDRL IgM and TPPA only if requested Follow up samples are tested in the screening test too as this ensures no samples are missed in the laboratory and ensure that all positive samples are “flagged” to the Sandyford (if GGC sample). Surveillance: A national surveillance scheme exists for all early infectious syphilis utilising laboratory data and clinician-initiated reports. This is coordinated locally by Dr Andy Winter. Separate HPS notification forms need completion – this is done by Sexual Health Advisers. HIV Infection: Limited case review data suggests higher risk of neurosyphilis in HIV+ if VDRL >=1:32. In known HIV+ with new syphilis be alert for increased risk of neurological involvement, unusual neurological manifestations rapid progression to gummatous syphilis. False negative or low titre serological tests HIV infected patients also commonly have neurological abnormalities which may be difficult to differentiate from neurosyphilis. If in doubt seek senior help and arrange admission to Brownlee for imaging and LP. SYPHILIS CEG DEC 2015 Page 3 of 9 Sandyford Protocols Incubating Syphilis / Epidemiological Treatment If patients report exposure to contacts with infectious syphilis, discuss option of immediate treatment versus waiting with repeat serology at monthly intervals for three months. In outbreak situations we believe epidemiologic treatment should be given especially if there is a chance the patient will not return. However injections are painful Benzathine penicillin 2.4MU IM ??stat (see appendix) (if no penicillin allergy) Or Doxycycline 100mg BD po x 14 days Note: there have been some reports of azithromycin resistance for syphilis – so it should not be used! Epidemiologically treated patients still require serological follow-up. Diagnosis Primary syphilis: Dark ground microscopy of serous exudate from any visible ulcers (slide to be prepared in a clinical room room adjacent to the laboratory to reduce time to microscope and reduce transit of potentially highly infectious material around the clinic)) (NB: No value in intra-anal or oral lesions). Only take a dark ground if you know how!! Get help if you don’t. PCR testing is now routine on all HSV samples in Sandyford services In a Sandyford Hub refer the patient to Sandyford Central for dark ground microscopy, the patient should be fast tracked and the consultant or senior doctor on clinic notified to expect the patient. Serological tests May be negative in primary stage ALWAYS request full range of serological tests if suspicious of primary syphilis and tell the lab for each blood test. The lab can provide a 48 hr turn-round if notified. Avoid use of antibiotics if possible at this stage if diagnosis remains uncertain and the patient reports no exposure to syphilis as treatment may prevent any serological response. If pyogenic component then use trimethoprim 400mg po bd for 7 days (or cotrimoxazole 960 mg bd for 7days if no sulphur allergy) If a suspicious lesion is dark ground negative, bring the patient back for up to two more dark grounds and repeat serology one week later. Secondary Syphilis: Dark-ground microscopy: from mucous patches or condylomata lata. Serological tests: invariably all positive. Other tests: Full blood count, liver and renal function tests Rapid tests: We have a small supply of Abbott Determine TP fingerprick tests. These are especially useful for confirming clinical suspicion of secondary syphilis. See separate leaflet for how to use them. They are insufficiently sensitive to exclude syphilis completely and should not replace formal serological testing. SYPHILIS CEG DEC 2015 Page 4 of 9 Sandyford Protocols Early Latent syphilis: Serological tests: positive (on two separate occasions) and (i) known to have been negative within the last two years or (ii) positive specific IgM with likelihood of infection in the last two years. And: Patient asymptomatic, with no clinical evidence of disease after thorough examination. If in doubt the patient should be managed as if LATE infection but notified as a possible early case, this is especially important with the move to a single dose regimen. Management: Treatment must be initiated as soon as a diagnosis is reasonably established to limit infectivity. Please do not defer therapy because someone is uncertain about HIV testing or to bring patients back for further confirmatory tests. If you are happy with the clinical picture and the dark ground is positive or typical symptoms in an exposed individual then start treatment immediately.. Penicillin non-allergic: Benzathine penicillin G 2.4 MU IM?? single dose (see appendix) Preparation Instructions for Benzathine penicillin G 2.4MU 1. Take one vial of Benzathine penicillin G 2.4MU aqueous suspension, shake, then perforate the stopper with a needle 2. Aspirate 6ml-8ml (depending on form of benzathine being used) 1% lidocaine for injection into a syringe and add to the vial. 3. Remove the syringe from the needle and leaving both needles in place shake the bottle to create a homogenous suspension 4. Carefully aspirate the suspension 5. Inject I/M, half into the upper outer quadrant of each buttock OR (if Penicillin allergic and not pregnant, or declines parenteral treatment) Doxycycline 100 mg PO BD for 14 days There is little good clinical evidence to support this regimen and parenteral penicillin is the preferred treatment. Discuss desensitisation with consultant. Complications of Treatment (i) Jarisch Herxheimer reaction occurs at approximately 8 hours. Warn patients (document in notes), advise bed rest, paracetamol or aspirin. (ii) Procaine reaction (if procaine penicillin used as in neurosyphilis regime – see later section) SYPHILIS CEG DEC 2015 Page 5 of 9 Sandyford Protocols Partner Notification All patients diagnosed with primary syphilis should see a sexual health adviser at diagnosis and at each follow up visit, until partner notification and any local surveillance is documented as complete. Follow-up Sexual Health Advisers will plan follow-up. Assess clinically and serologically at the end of treatment. Repeat serology at 1, 2 and 3 months then three monthly for a year irrespective of results. If VDRL was positive at presentation expect a four-fold drop in titre by six months. If VDRL titre does not fall, or at any stage shows a >2-fold rise, discuss with senior doctor. There is a robust system of consultant review of all positive results and recall and all positive results should be interpreted by a senior doctor annotating the case record. Discharge if serofast at 12 months. Ask permission to write to GP to confirm treatment complete and/or give patient a written summary of treatment (there are proforma letters). Late Latent Syphilis Diagnosis Serological tests positive and not known to have been negative within the last two years. Patient asymptomatic, with no evidence of disease. Examination All patients need careful clinical cardiovascular, abdominal, skin, fundoscopic and neurological examination recorded in NaSH under the examination form (‘Examination for syphilis at foot of form’) Investigations All patients should be offered full STI screen and HIV test Patients with clinical evidence of aortic valve disease should be referred for an echocardiogram (via Radiology) to chase pathway for cardiac ECHO If this suggests syphilitic aortic disease, referral to a cardiologist is mandatory. Lumbar puncture after imaging should be performed in patients with neurological or ophthalmic signs or symptoms and considered in treatment failure. Treatment There much less urgency in treating late syphilis and it is better to plan treatment so that it can be reliably completed than start treatment and find someone defaults. SYPHILIS CEG DEC 2015 Page 6 of 9 Sandyford Protocols Benzathine penicillin G 2.4 MU IM at day 1 & 8 & 15 (see appendix) *For administration, see instructions for primary syphilis* Partner Notification All patients to see sexual health adviser. Follow-up 3 weeks - to check compliance and partner notification. 3 months - to repeat serology ± HIV test If VDRL titre was raised prior to treatment, repeat at three monthly intervals until VDRL negative or serologically stable on two occasions. Ask permission to write to GP to confirm treatment complete or give patient a written summary of treatment. Maternal syphilis Transplacental infection is commoner with early stage syphilis and high titre VDRL. Refer women at greater than 26 weeks gestation to obstetric unit for monitoring at initiation of treatment (risk of pre-term delivery) and fetal ultrasound. In early syphilis (primary, secondary, early latent), national guidelines suggest it is safe to use a single dose of benzathine up to 24 weeks gestation. However the implications of failed treatment in pregnancy are so profound, with risk to the fetus and risk of the infant requiring parenteral penicillin, it is better to give 2 doses - (local clinician preference Dr Andy Winter, Dr Anthony Rea). All infants require examination and paediatric assessment. Discuss all maternal cases with a GUM consultant. Discuss penicillin allergic patients with a GUM consultant. Benzathine penicillin G 2.4 MU IM?? at day 1 & 8 *For administration, see instructions for primary syphilis* If pregnant and penicillin allergic Erythromycin 500mg QID for 21 days, but may not adequately treat foetus, therefore baby will require treatment once delivered. Discuss desensitisation with consultant. Neurosyphilis Meningovascular: may be associated with early (secondary stage) or late syphilis. Parenchymatous: GPI and/or tabes dorsalis. CSF tests should include: SYPHILIS CEG DEC 2015 Cell count Total protein Oligoclonal bands CSF albumin and CSF IgG are ideally needed but not obtainable locally to calculate the TPHA index Page 7 of 9 Sandyford Protocols CSF FTA has lower specificity for a diagnosis of neurosyphilis than VDRL/RPR, but may be more sensitive. A negative FTA in CSF would usually exclude neurosyphilis. Treatment for Neurosyphilis Procaine penicillin 1.8 megaunits IM daily for 17 days (As TUBEX 1ml + TUBEX 2ml) PLUS Probenecid 500 mg PO QDS for 17 days PLUS Prednisolone 20 mg PO to be given as a single dose on the day prior to antibiotic therapy and for the following three days. Cardiovascular Syphilis Asymptomatic: diagnosed on clinical, radiological and echocardiographic changes. Symptomatic: usually from aortic valve disease, aneurysmal changes of the aorta or coronary ostial occlusion. Requires cardiological assessment. Discuss with senior doctor before referring. Treatment For Cardiovascular Syphilis As for neurosyphilis PLUS Prednisolone 20 mg to be given as a single dose on the day prior to antibiotic therapy and for the following three days. OR Oral therapies as for late latent syphilis PLUS Prednisolone as above. For ENT or optic atrophy complicating syphilis infection, include longer prednisolone course. Start with 60 mg/day (divided doses). Consultant to assess. Refer ENT/Ophthalmology opinion. Partner notification and follow-up as for late latent syphilis but also will need to see relevant specialist for life. Appendix This protocol is to be used for the reconstitution of Benzathine penicillin for the treatment of syphilis with lidocaine 1% Medicine: Benzathine penicillin as a 2.4 Mega unit dose presented as a powder solution for injection. Contraindications: Allergy to penicillin or lidocaine. Concomitant anticoagulant therapy Bleeding diathesis (e.g. Haemophilia) Patient declines IM therapy SYPHILIS CEG DEC 2015 Page 8 of 9 Sandyford Protocols Administration To reduce the pain experienced by patients receiving this injection, 1% lidocaine (lignocaine) can be prescribed as the diluent. This may be outside the licence of some brands of Benzathine but is supported practice within Sandyford Services. Reconstitute the vial of Benzathine penicillin with 6-8ml of 1% Lidocaine Hydrochloride BP solution (depending on type of benzathine being used – Sandyford currently has three forms made by different companies) Split the resultant solution into two equal volumes. The solution should be administered by intramuscular injection at two different sites (left and right upper outer quadrant of each buttock or ventro-gluteal site). Use 19G (1.10) needle owing to recognised needle-clogging with a concentrated formulation References Amir. J.,Ginat.S., et. al. (1998). Lidocaine as a diluent for administration of benzathine penicillin G. The Pediatric Infectious Disease Journal. 17. 890-3. Kingston. M., French. P. et. al. (2008). UK National Guidelines on the Management of Syphilis 2008. Appendix 1. International Journal of STD & AIDS. 19. 729-740. SYPHILIS CEG DEC 2015 Page 9 of 9