Donovanosis (granuloma inguinale)

The incubation period is unknown, probably 1-16 weeks. The period of communicability is also unknown, probably for the duration of open lesions on the skin or mucous membranes. Contact infectivity is low.

The lesions develop over one to four weeks or longer. They begin as a single nodule or multiple subcutaneous nodules, usually on the genitalia. These nodules enlarge and erode through the skin to produce beefy red granulations or ulcers that are typically painless, and have thick, rolled edges. Occasionally the organism may spread to extra-genital sites through auto-inoculation or systemic spread.

STI Atlas (external site)

Special considerations

• Make sure it is clear to laboratories that the specimens are for examination for donovanosis.
• The anorectal region should be checked for donovanosis lesions in all patients.
• Donovanosis can be mistaken for malignancy, warts or condylomata lata of secondary syphilis. 
• Pelvic examination in women may not initially be possible because of extensive vulval disease, and may have to be postponed.
• Untreated donovanosis can lead to serious complications such as local tissue lymphatic destruction with subsequent pseudo-elephantiasis of genitalia, malignant transformation to squamous cell carcenoma, contagious spread (e.g. from cervix to pelvic organs), and haematogenous spread to distant sites (e.g. long bones, psoas muscle). 

Specimen collection and handling

It is essential that a serological test for syphilis be done whenever the diagnosis of donovanosis is suspected.

A NAAT based method has been developed for the detection of the organisms in lesions. This is a simple and acceptable test which appears to have high sensitivity and specificity. It is recommended that another test be done to confirm the diagnosis of donovanosis. Other tests are an impression smear (press slide), crush smear or punch biopsy.

The diagnosis of donovanosis relies on detecting the organism through NAAT or finding characteristic intracytoplasmic Donovan bodies in the infected tissue. Notification of donovanosis can be either 'confirmed' with laboratory and clinical findings or 'probable' with clinical and epidemiological evidence. See case definitions (external site).

NAAT

• Using a dry swab firmly swab at or beneath the leading edge of the ulcer.
• Following collection, handle swabs according to the instructions from your testing laboratory.
• It is recommended that the pathology request is for 'Genital Ulcer Disease (GUD) NAAT', which will test for donovanosis, syphilis and herpes.

Alternative confirmatory tests include:

• Gently clean the lesion of blood, slough or debris with a gauze swab and saline.
• Gently squeeze the lesion to bring the exudate to the surface.

• if the lesions are internal, swab the ulcer vigorously and make a smear.
• Allow to air-dry.
• Clearly label the specimen 'For donovan bodies' so it can be stained with the appropriate stain.

A crush smear can be done if granulation tissue can be easily removed. The removed tissue can be placed in saline and sent to the laboratory under cool conditions. This is preferred if the operator is not experienced in making impression smears.

A punch biopsy may be taken if the smear is negative. An experienced operator should perform this procedure. It is preferable that a separate sample in saline is sent for NAAT but if that is unavailable, a portion of the formalin fixed specimen can be used. Biopsies should be taken whenever there is a reasonable suspicion that the lesion may be malignant either at primary presentation or on review. Failure to respond to adequate treatment and/or a negative NAAT should prompt early review and biopsying of the lesion.

Treatment is usually commenced on clinical diagnosis after specimens are collected. Treatment should be directly observed (DOT). Weekly treatment should be provided initially for four weeks. Review the ulcer each week if possible. If no response to treatment at four weeks, consider a biopsy to investigate other causes, i.e. malignancy.

Standard

• Azithromycin 1 g orally (DOT), weekly for 4 weeks or until healing occurs (whichever is longer) (preferred treatment because of much greater compliance)

        or

• azithromycin 500 mg orally (DOT), daily for 7 days only

        If allergic to macrolides give either:

• doxycycline 200 mg orally, daily (or 100mg 12-hourly) for 4 weeks or until healing occurs (whichever is longer)

        or

• ceftriaxone 1 g intramuscularly or intravenously, daily for 14 days. Check for recurrences which may occur with this treatment.

Pregnancy

• Azithromycin 1 g orally, each week for 4 weeks or until healing occurs (whichever is longer) (preferred treatment) (category B1)
• Australian categorisation system for prescribing medicines in pregnancy (external site).

        or

• ceftriaxone 1 g intramuscularly or intravenously, daily for 14 days (category B1).

The appropriate response to treatment should be resolution of lesions with progressive healing after seven days.

Neonate

A baby born to a mother with active donovanosis lesions should receive prophylactic treatment. Expert advice is mandatory in this situation.

Special considerations

Tetracycline antibiotics, including doxycycline, should never be used in:

• women who are pregnant or possibly pregnant, or breastfeeding

Counselling is important in managing STIs/HIV and should be considered at every contact with the patient. As a minimum, consider counselling at the first presentation and subsequently during treatment and follow-up.

• Counselling is an opportunity to educate and support the patient in prevention strategies. This should be done in a confidential setting.
• The key points are:
  • communicating the confidentiality of the diagnosis
  • communicating the reasons for testing and contact tracing
  • formulating expectations from treatment
  • promoting awareness of risk behaviours.
• Counselling should also include discussion of the implications of STI testing (ie that testing does not prevent transmission). Emotional reactions can accompany a positive STI/HIV diagnosis with delayed reactions sometimes occurring several days after the consultation.
• Patients should be advised no sexual contact for 7 days after completion of treatment and to avoid sexual contact with partners form the last 6 months until 7 days after they have been tested and treated.

It is the responsibility of all health care providers, including doctors, to begin tracing sex partners so that they can be assessed and treated.

This involves counselling to ensure that the patient understands the implications of transmission of the infection.

Managing sex partners may require referral to another practitioner.

Donovanosis is not highly contagious, but reasonable efforts should be made to examine sex partners.

Partners should be advised no sexual contact for 7 days after completion of treatment and to avoid sexual contact with any partners from the last 6 months until 7 days after they have been tested and treated.

Follow up

Review the ulcer each week if possible. It is essential that the lesion be re-examined at four weeks after commencement of treatment.

• If there is no response to treatment at four weeks, consider a biopsy to investigate other causes, i.e. malignancy.
• If the lesion has healed, no further treatment is required.
• If the lesion has improved but not yet healed a further two weeks of treatment should be given (weeks five and six). However, if the lesion has not healed by week six, a biopsy should be considered.

Follow-up at three and six months after the lesion has healed is recommended to ensure that relapse does not occur.

If the patient has had a poor response, consider another diagnosis (e.g. carcinoma or immunosuppression).

To ensure continuity of care, record follow-up instructions in the patient's medical record.

As part of follow-up of patients with donovanosis, it is essential to:

• assess healing of ulcers and compliance with therapy
• consider hospital admission if response to therapy as an outpatient is inadequate.

Special considerations

This also provides an opportunity to repeat blood tests for syphilis, HIV and HBV.

Contact tracing is important to prevent further transmission and reinfection. Screen and treat for coexisting STIs (particularly ulcerative diseases such as herpes and syphilis) and especially HIV. A person with an ulcerative condition has a tenfold risk of acquiring HIV.

For further information, see genital ulceration. If a child is diagnosed with donovanosis, issues of sexual abuse and/or sexual assault should be considered.

This is a notifiable infection. Medical practitioners must complete the appropriate notification forms for all patients diagnosed with a notifiable STI/HIV, as soon as possible after confirmed diagnosis.