Levels of evidence (I-IV) and grades of recommendation (A-C) are defined at the end of the "Major Recommendations" field.
The main method of diagnosis is the demonstration of Donovan bodies in either:
- Cellular material taken by scraping/impression; smear/swab/crushing of pinched off tissue fragment on to glass slide
- Tissue sample collected by biopsy
Smears can be stained with Giemsa, Wright's stain, or Leishman stain. Biopsies are best stained with silver stains (for example, Warthin-Starry) or Giemsa. Donovan bodies are characterised by:
- Location within large (20-90 µm) histiocytes
- Pleomorphic appearance 1-2 x 0.5-0.7 µm
- Bipolar densities and a capsule often visible
- Stain Gram-negative
Expert opinion has estimated that in endemic areas identification of Donovan bodies is achievable in 60% to 80% of patients considered to have donovanosis on clinical grounds.
Successful culture of the causative organism, Klebsiella granulomatis, has recently been reported in human peripheral blood monocytes and in HEp-2 cells. Both polymerase chain reaction (PCR) methods and serological tests for donovanosis have been described but are not yet routinely available.
All patients with active lesions shown to contain Donovan bodies should receive antimicrobial treatment. Patients from areas endemic for donovanosis with a clinical diagnosis of the disease should be given presumptive treatment.
Treatment options are presented in the table below, which lists drugs shown to be effective in the treatment of donovanosis in prospective studies. Drugs have been selected on the basis of current availability, lack of major toxicity, and convenient dosage regimens. Older drugs known to be effective but not included are trivalent antimonials, streptomycin, chloramphenicol, thiamphenicol, chlortetracycline, and oxytetracycline. Ampicillin has been omitted because of conflicting data on efficacy. Recent experience with azithromycin in Australia has been so encouraging in all categories of patient that a proposal to eradicate donovanosis by the year 2003 in Australia has been formally adopted.
Table: Drugs Shown to be Effective in the Treatment of Donovanosis
||Grading of Recommendation
||Level of Evidence
||1 g weekly or 500 mg daily
||1 g daily
||Intramuscular (IM)/Intravenous (IV)
||160/800 mg twice daily
||100 mg twice daily
||500 mg four times daily
||400 mg twice daily
||1 mg/kg every 8 hours
*Currently recommended by the U.S. Centers for Disease Control and Prevention (CDC).
Notes on the Table
- Azithromycin is recommended for donovanosis in the Australian Antibiotic Guidelines.
- The CDC recommends ciprofloxacin which has better bioavailability than norfloxacin.
- Gentamicin is recommended by the CDC as an adjunct to therapy in patients whose lesions do not respond in the first few days to other agents.
- Doxycycline has not been individually assessed prospectively and recommendations are based on trials carried out with older tetracyclines (oxytetracycline, chlortetracycline, etc.) which are assumed to be equivalent to doxycycline, which is chosen for more convenient twice daily dosing.
- Duration of treatment should be until lesions have healed. Healing times vary greatly between patients. The CDC recommends a minimum of 3 weeks' treatment.
Treatment for Pregnant or Lactating Mothers
Gentamicin, doxycycline, co-trimoxazole, and norfloxacin are not recommended for pregnant or lactating women. Erythromycin has been used successfully in pregnant women with donovanosis. Children born to mothers with untreated genital lesions of donovanosis are at risk of infection and a course of prophylactic antibiotics should be considered.
Any person with a history of unprotected sexual contact with a patient with active donovanosis or within 40 days before the onset of lesions should be assessed clinically for evidence of infection and offered treatment. This recommendation is based on best estimates of the incubation period reported by one researcher who studied 60 patients and found an incubation period of between 3 and 40 days in 92% of patients.
Patients should be followed until symptoms have resolved.
Levels of Evidence
||Type of Evidence
||Evidence obtained from meta-analysis of randomised controlled trials
||Evidence obtained from at least one randomised controlled trial
||Evidence obtained from at least one well-designed controlled study without randomisation
||Evidence obtained from at least one type of well-designed quasi-experimental study
||Evidence obtained from well-designed, non-experimental descriptive studies, such as comparative studies, correlation studies and case control studies
||Evidence obtained from expert committee reports or opinions and/or clinical experience of respected authorities
Grades of Recommendation
|A (Evidence levels Ia, Ib)
||Requires at least one randomised controlled trial as part of the body of literature of overall good quality and consistency addressing the specific recommendation
|B (Evidence levels IIa, IIb, III)
||Requires availability of well-conducted clinical studies but no randomised clinical trials on the topic of recommendation
|C (Evidence level IV)
||Requires evidence from expert committee reports or opinions and/or clinical experience of respected authorities. Indicates absence of directly applicable studies of good quality