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Objectives: To evaluate in a retrospective analysis the efficacy and safety of a 6 day course of liposomal amphotericin B (L-AmB) in infantile cases of Mediterranean visceral leishmaniasis (VL) diagnosed over a 10 year period in Italy., Patients and Methods: Patients included were diagnosed as having VL consecutively admitted from December 1992 to December 2001 at four main referral children's hospitals in Italy and treated with six intravenous doses of 3 mg/kg L-AmB given on days 1-5 and 10 (a total dose of 18 mg/kg). Demographic data, nutritional status, underlying diseases, clinical and laboratory findings, and therapy outcome were considered., Results: A total of 164 HIV-negative children (median age 1.6 years; range 4 months to 14 years) were enrolled. All patients were initially cured by the given treatment, and did not present adverse events related to drug infusion. Seven patients (4.3%) had a clinical and parasitological relapse 3-15 months after therapy. All relapses were successfully retreated with 3 mg/kg L-AmB for 10 consecutive days (a total dose of 30 mg/kg)., Conclusions: This study highlights the efficacy (>95%) and safety of the six dose L-AmB regimen and validates it as a first-line treatment for Mediterranean VL in children.

In the first half of the 20th century, visceral leishmaniasis (VL) was a common infantile syndrome in coastal territories of the Campania region of Italy. After World War II, the incidence dropped to a few cases/year for three decades; in late 1980s the disease reemerged among both children and adults. To face the VL recrudescence, a Paediatric Reference Centre was established at the Santobono-Pausilipon hospital in Naples, for the clinical diagnosis, care and drug treatment of all infantile VL cases occurred in the Campania region. Rapid laboratory diagnosis was secured by a Diagnostic Reference Centre established at the Istituto Superiore di Sanità. Here, we report on the epidemiological and parasitological features of all cases referred to the Centre in the past 15 years. From 1990 to March 2004, a total of 255 cases were diagnosed and treated at the Centre. The Figure shows the yearly trend of patients (min. 3 cases in 1990 and 1991, max. 30 cases in 2000). There were 135 males (52.9%); the age ranged 4 months-14 years, but 189 patients (74.1%) were < or = 3 years old. The majority of the patients (189, 74.1%) were from the Naples province, with a cluster of 102 cases (40% of total patients) from the towns and districts surrounding Vesuvius. Twenty-seven cases (10.6%) were from the town of Maddaloni, Caserta province, whereas 15 cases (5.9%) were from coastal villages of the Salerno province. Only 1 and 2 cases were from Benevento and Avellino provinces, respectively. All patients but seven, who have been treated with antimonial drugs in the 1990-1993 period, were successfully treated with a liposomal amphotericin B regimen. From bone-marrow aspirate samples, 138 Leishmania cultures were obtained in EMTM and Sloppy Evans' media, of which 134 have been typed by the electrophoretic analysis of 13 isoenzymes. Two zymodemes (Z) of L. infantum were routinely identified over the study period, ZMON-1 (the commonest zymodeme in the Mediterranean area) and ZMON-72, variant from MON-1 in PGM mobility and detected only in our region. The latter, identified in 61 patients (45.5%), was found exclusively distributed in towns of the Vesuvius area and in Maddaloni until 1996, but in recent years it appears to have spread to other areas of the Naples (including the island of Ischia) and Caserta provinces, but not to Salerno province. In conclusion, the VL macrofocus of the Naples-Caserta area is probably responsible for the highest number of infantile cases among any VL macrofoci described in southern Europe. Considering the limited efforts paid to control the canine reservoir, rapid diagnosis and appropriate treatment of patients still remain the first-line control measures aimed at reducing the health impact of the disease.

We used liposomal amphotericin B as first-choice treatment of visceral leishmaniasis in 106 immunocompetent children who acquired the infection in a temperate region of southern Europe (Italy) where Leishmania infantum visceral leishmaniasis is endemic. The aim of the study was to identify the minimum total dose of liposomal amphotericin B needed to cure the infection in children and reduce the period of hospitalization. We conclude that the optimal regimen in immunocompetent children with L. infantum visceral leishmaniasis to be a total dose of 18 mg/kg of liposomal amphotericin B (3 mg/kg per day for 5 days, followed by 3 mg/kg administered as an outpatient regimen on day 10).

We evaluated liposomal amphotericin B (AmBisome; Vestar, San Dimas, CA) administered to 88 immunocompetent patients (56 children) with visceral leishmaniasis (VL) caused by Leishmania infantum. Thirteen patients received 4 mg/kg on days 1-5 and 10 (total dose, 24 mg/kg), and all were cured; 42 received 3 mg/kg on days 1-5 and 10 (18 mg/kg), and 41 were cured; 32 received 3 mg/kg on days 1-4 and 10 (15 mg/kg), and 29 were cured (amastigotes were not cleared from 1 child, and 2 relapsed). One adult was cured with a total dose of 12mg/kg. The four children who were not cured received 3 mg/kg for 10 days; none had further relapses. There were no significant adverse events. For VL due to L. infantum, we recommended a total dose of AmBisome of > or = 20 mg/kg, given in > or = 5 doses of 3-4 mg/kg over > or = 10 days.

The rapidity and efficacy of a short course of liposomal amphotericin B was evaluated in 29 children affected by visceral leishmaniasis (Leishmania infantum). Their overall health status was assessed using the prognostic inflammatory and nutritional index (PINI), and their haematological status by the reticulocyte count and haemoglobin blood levels. All these quantities were measured on day 0, and 3 and 10 d after starting therapy. A significant decrease of inflammatory signs, associated with an improved reticulocyte count, was recorded after 3 d of therapy. A significant increase of haemoglobin levels was also observed 10 d after the start of treatment. The early reduction of inflammatory signs and the improvement of bone marrow function in most patients confirmed the validity of amphotericin B therapy. The PINI score is helpful in assessing the severity of visceral leishmaniasis and the follow-up of its treatment.

Visceral leishmaniasis (VL) is a public health problem in most countries bordering the Mediterranean sea. The disease has been found in central and southern Italy, Sicily, Sardinia; some pockets are present in Liguria. Dogs are the reservoirs and the vectors are some species of sandfly (Phlebotomus species). The incubation period is usually between 2 and 8 months; children and adults may become infected; lethality may be high and depends upon a correct diagnosis and treatment. The diagnosis should be suspected on the basis of the epidemiological data and clinical picture and confirmed by the detection of specific antibodies by appropriate techniques. Leishmaniasis can be detected in splenic or bone marrow aspirates. Patients with HIV infection and VL may lack specific antibodies; parasitological diagnosis is mandatory for these patients. Antimonials are the classic therapeutic agents for VL. Recently liposomal amphotericin B (Ambisome) has been successfully used, with negligible toxicity.

Thirty-one patients with visceral leishmaniasis (VL) caused by Leishmania infantum received liposomal amphotericin B (AmBisome) in a multi-centre study. Ten immunocompetent patients (six children) received 1-1.38 mg/kg/day for 21 days, and ten (nine children) received 3 mg/kg/day for 10 days. All were cured without significant adverse events and without relapse during 12-24 months of follow-up. Eleven immunocompromised adults, including seven co-infected with HIV (four with AIDS) received 100 mg (1.38-1.85 mg/kg) daily for 21 days. All were initially considered cured, but eight relapsed clinically and parasitologically at 3-22 months. Liposomal amphotericin B is a new, safe and effective drug for the treatment of VL.

Although human visceral leishmaniasis (VL) is a notifiable disease in Italy, there is evidence that the actual number of cases is far higher than that notified. A programme for active surveillance of VL in the 14 Italian endemic regions was launched by the Istituto Superiore di Sanità. We report data collected during a 3-year period of active surveillance in Campania, a south Tyrrhenian region covering 4.5% of the Italian territory. Out of 120 clinically suspected cases referred to medical and diagnostic references centres, there were 52 confirmed VL cases (17.3/year), i.e. 10-fold more than previously notified. Most of the infection sites were in rural areas or peripheral districts of towns in hilly parts of Naples province. An epidemic cluster of 10 cases was identified in a microfocus of Caserta province. The biochemical analysis of 23 Leishmania stocks showed a zymodeme composition indicating Campania as an old and well-established focus of VL. The data obtained emphasize that the present notification system for VL in Italy is inadequate.

The Authors describe a case report of a girl of 7 years affected by visceral leishmaniasis (VL) complicated by herpes zoster (Hz). Hz infection is unusual in paediatric age, but it may complicate immunodeficiency states. VL causes, as well known, T cell immunity depression: Hz infection could be facilitated by this situation.