A Randomized, Controlled, Noninferiority, Multicenter Trial of Systemic vs Intralesional Treatment With Meglumine Antimoniate for Cutaneous Leishmaniasis in Brazil.

BACKGROUND: Meglumine antimoniate (MA) remains the main treatment for cutaneous leishmaniasis (CL). Uncontrolled studies suggest that intralesional MA (IL-MA) may be noninferior and safer than systemic MA (S-MA). METHODS: Multicenter, randomized, controlled, open-label, phase 3 clinical trial to evaluate the efficacy and toxicity of IL-MA in 3 infiltrations at 14-day intervals compared with S-MA (10-20 mg Sb5+/kg/day, 20 days) for CL, with noninferiority margin of 20%. Primary and secondary outcomes were definitive cure at day 180 and epithelialization rate at day 90 of treatment, respectively. A 2-year follow-up was performed to assess relapses and emergence of mucosal lesions. Adverse events (AEs) were monitored according to the Division of AIDS AE grading system. RESULTS: We evaluated 135 patients. The cure rates (95% confidence interval) for IL-MA and S-MA treatment were, respectively, 82.8% (70.5-91.4) and 67.8% (53.3-78.3) per protocol (PP) and 70.6% (58.3-81.0) and 59.7% (47.0-71.5) per intention to treat (ITT). The epithelialization rates of the IL-MA and S-MA treatment were, respectively, 79.3% (66.6-88 + 8) and 71.2% (57.9-82.2) PP and 69.1% (55.2-78.5) and 64.2% (50.0-74.2) ITT. AEs in the IL-MA and S-MA groups were, respectively, clinical, 45.6% and 80.6%; laboratory, 26.5% and 73.1%; and electrocardiogram, 8.8% and 25.4%. Ten participants in the S-MA group and 1 in the IL-MA group were discontinued due to severe or persistent AEs. CONCLUSIONS: IL-MA provides a similar cure rate and results in less toxicity compared with S-MA and may be used as first-line therapy for CL patients. CLINICAL TRIALS REGISTRATION: REBEC: RBR-6mk5n4.

Risk Factors for Death from Visceral Leishmaniasis in an Urban Area of Brazil.

BACKGROUND: Over the last three decades, the epidemiological profile of visceral leishmaniasis (VL) has changed with epidemics occurring in large urban centers of Brazil, an increase in HIV/AIDS co-infection, and a significant increase in mortality. The objective of this study was to identify the risk factors associated with death among adult patients with VL from an urban endemic area of Brazil. METHODOLOGY: A prospective cohort study included 134 adult patients with VL admitted to the University Hospital of the Federal University of Mato Grosso do Sul between August 2011 and August 2013. PRINCIPAL FINDINGS: Patients ranged from 18 to 93 years old, with a mean age of 43.6 (±15.7%). Of these patients, 36.6% were co-infected with HIV/AIDS, and the mortality rate was 21.6%. In a multivariate analysis, the risk factors associated with death were secondary bacterial infection (42.86, 5.05-363.85), relapse (12.17, 2.06-71.99), edema (7.74, 1.33-45.05) and HIV/AIDS co-infection (7.33, 1.22-43.98). CONCLUSIONS/SIGNIFICANCE: VL has a high mortality rate in adults from endemic urban areas, especially when coinciding with high rates of HIV/AIDS co-infection.

Unifocal bone paracoccidioidomycosis, Brazil.

We report a 47 year-old man from the State of Mato Grosso do Sul, Brazil, with unifocal tibial paracoccidioidomycosis. A radiograph showed an osteolytic lesion on the tibial middle third diaphysis. The diagnosis was confirmed by histopathologic analysis, and treatment with sulfamethoxazole and trimethoprim was started. After three months, the patient showed significant clinical improvement. Ten months after treatment, the patient showed lesion bone healing. This case describes the rare occurrence of an osteolytic lesion caused by endemic Paracoccidioides brasiliensis in Latin America.

Obstetric, clinical, and perinatal implications of H1N1 viral infection during pregnancy.

OBJECTIVE: To determine perinatal outcome and epidemiologic, clinical, and obstetric characteristics among pregnant women infected with the H1N1 virus admitted to a Brazilian university hospital. METHODS: A cross-sectional study was conducted of pregnant women infected with H1N1 who were admitted to the University Hospital at the School of Medicine, Federal University of Mato Grosso do Sul, Campo Grande, Brazil, during the 2009 pandemic. Data were obtained via a questionnaire, which was administered during the hospital evaluation of patients' medical records. RESULTS: Thirty-one patients were included in the study. Antiviral therapy was initiated within 48 hours of the onset of symptoms in 64.5% of cases. Infection with the H1N1 virus was associated with severe clinical complications in 22.6% of patients and adverse perinatal outcomes in 41.9% of cases. The rate of maternal and perinatal mortality was 9.7%. There was a statistically significant association between late treatment with oseltamivir and increase in systemic complications in pregnancy (odds ratio 22.80 [95% confidence interval, 2.20-235.65]; P=0.007). CONCLUSION: Early treatment with oseltamivir may prevent serious complications associated with H1N1 infection in pregnant women but it does not affect perinatal outcome.