Granuloma Inguinale (Donovanosis)

Granuloma inguinale is a genital ulcerative disease caused by the intracellular gram-negative bacterium Klebsiella granulomatis (formerly known as Calymmatobacterium granulomatis). The disease occurs rarely in the United States, although it is endemic in some tropical and developing areas, including India; Papua, New Guinea; the Caribbean; central Australia; and southern Africa (383-385). Clinically, the disease is commonly characterized as painless, slowly progressive ulcerative lesions on the genitals or perineum without regional lymphadenopathy; subcutaneous granulomas (pseudobuboes) also might occur. The lesions are highly vascular (i.e., beefy red appearance) and bleed. Extragenital infection can occur with extension of infection to the pelvis, or it can disseminate to intra-abdominal organs, bones, or the mouth. The lesions also can develop secondary bacterial infection and can coexist with other sexually transmitted pathogens.

Diagnostic Considerations

The causative organism of granuloma inguinale is difficult to culture, and diagnosis requires visualization of dark-staining Donovan bodies on tissue crush preparation or biopsy. No FDA-cleared molecular tests for the detection of K. granulomatis DNA exist, but such an assay might be useful when undertaken by laboratories that have conducted a CLIA verification study.

Treatment

Several antimicrobial regimens have been effective, but only a limited number of controlled trials have been published (383). Treatment has been shown to halt progression of lesions, and healing typically proceeds inward from the ulcer margins; prolonged therapy is usually required to permit granulation and re-epithelialization of the ulcers. Relapse can occur 6–18 months after apparently effective therapy.

Recommended Regimen

  • Azithromycin 1 g orally once per week or 500 mg daily for at least 3 weeks and until all lesions have completely healed

Alternative Regimens

  • Doxycycline 100 mg orally twice a day for at least 3 weeks and until all lesions have completely healed
    OR
  • Ciprofloxacin 750 mg orally twice a day for at least 3 weeks and until all lesions have completely healed
    OR
  • Erythromycin base 500 mg orally four times a day for at least 3 weeks and until all lesions have completely healed
    OR
  • Trimethoprim-sulfamethoxazole one double-strength (160 mg/800 mg) tablet orally twice a day for at least 3 weeks and until all lesions have completely healed

The addition of another antibiotic to these regimens can be considered if improvement is not evident within the first few days of therapy. Addition of an aminoglycoside to these regimens is an option (gentamicin 1 mg/kg IV every 8 hours).

Other Management Considerations

Persons should be followed clinically until signs and symptoms have resolved. All persons who receive a diagnosis of granuloma inguinale should be tested for HIV.

Follow-up

Patients should be followed clinically until signs and symptoms resolve.

Management of Sex Partners

Persons who have had sexual contact with a patient who has granuloma inguinale within the 60 days before onset of the patient’s symptoms should be examined and offered therapy. However, the value of empiric therapy in the absence of clinical signs and symptoms has not been established.

Special Considerations

Pregnancy

Doxycycline should be avoided in the second and third trimester of pregnancy because of the risk for discoloration of teeth and bones, but is compatible with breastfeeding (317). Data suggest that ciprofloxacin presents a low risk to the fetus during pregnancy (317). Sulfonamides are associated with rare but serious kernicterus in those with G6PD deficiency and should be avoided in third trimester and during breastfeeding (317). For these reasons, pregnant and lactating women should be treated with a macrolide regimen (erythromycin or azithromycin). The addition of an aminoglycoside (gentamicin 1 mg/kg IV every 8 hours) can be considered if improvement is not evident within the first few days of therapy.

HIV Infection

Persons with both granuloma inguinale and HIV infection should receive the same regimens as those who do not have HIV infection. The addition of an aminoglycoside (gentamicin 1 mg/kg IV every 8 hours) can be considered if improvement is not evident within the first few days of therapy.

 

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