Hiram Villanueva-Lozano1,2, Rogelio de J Treviño-Rangel1, Gloria M González1, Pedro A Hernández-Rodríguez2, Adrián Camacho-Ortiz2, Luis Castillo-Reyna3, Sandra G Galindo-Alvarado2, Michel F Martínez-Reséndez4. 1. Department of Microbiology, School of Medicine, Universidad Autónoma de Nuevo León, Monterrey, Nuevo Leon, Mexico. 2. Infectious Diseases Service, Department of Internal Medicine, University Hospital "Dr. José E. González", Universidad Autónoma de Nuevo León, Av. Francisco I. Madero and Dr. José E. González s/n. Mitras Centro, Monterrey, 64460, Nuevo Leon, Mexico. 3. Department of Preventive Medicine and Public Health, School of Medicine, Universidad Autónoma de Nuevo León, Monterrey, Nuevo Leon, Mexico. 4. Infectious Diseases Service, Department of Internal Medicine, University Hospital "Dr. José E. González", Universidad Autónoma de Nuevo León, Av. Francisco I. Madero and Dr. José E. González s/n. Mitras Centro, Monterrey, 64460, Nuevo Leon, Mexico. drmichelfernando@gmail.com.
Abstract
PURPOSE: Cryptococcal meningitis is a potentially fatal fungal infection associated with a significant attributable morbidity and mortality, especially among HIV/AIDS patients. The first-line therapy for the treatment of this clinical entity is the combinatory therapy of amphotericin B plus flucytosine. However, the high cost, toxic effects, and limited repertoire of effective antifungal drugs have led to the investigation of novel molecules. This is a prospective, double-blinded, and randomized study performed in a Mexican tertiary care center to evaluate the antifungal activity of sertraline in the treatment of cryptococcal meningitis in HIV patients. METHODS:During June 2015-December 2016, patients were recruited and included in one of two study groups: group A was given standard antifungal treatment plus sertraline 200 mg/day, while group B was given standard antifungal plus placebo. Lumbar punctures were performed on days 0, 7, and 14 of the study, and cryptococcal antigenemia and quantitative fungal culture in cerebrospinal fluid at each time point were evaluated to measure the rate of fungal clearance. RESULTS: The fungal loads and cryptococcal antigenemia titers showed a marked tendency to decrease by day 14 in both groups. Otherwise, group B exhibited a slightly higher nonstatistical rate of fungal clearance (-0.2868 ± 0.08275 log CFU/ml/day) than group A (-0.2496 ± 0.08340 log CFU/ml/day). CONCLUSIONS: A statistical difference between study groups was not found. This is the first study in Latin America that reports the experience of using sertraline as an adjuvant in the antifungal management of cryptococcal meningitis in HIV patients.
RCT Entities:
PURPOSE:Cryptococcal meningitis is a potentially fatal fungal infection associated with a significant attributable morbidity and mortality, especially among HIV/AIDSpatients. The first-line therapy for the treatment of this clinical entity is the combinatory therapy of amphotericin B plus flucytosine. However, the high cost, toxic effects, and limited repertoire of effective antifungal drugs have led to the investigation of novel molecules. This is a prospective, double-blinded, and randomized study performed in a Mexican tertiary care center to evaluate the antifungal activity of sertraline in the treatment of cryptococcal meningitis in HIVpatients. METHODS: During June 2015-December 2016, patients were recruited and included in one of two study groups: group A was given standard antifungal treatment plus sertraline 200 mg/day, while group B was given standard antifungal plus placebo. Lumbar punctures were performed on days 0, 7, and 14 of the study, and cryptococcal antigenemia and quantitative fungal culture in cerebrospinal fluid at each time point were evaluated to measure the rate of fungal clearance. RESULTS: The fungal loads and cryptococcal antigenemia titers showed a marked tendency to decrease by day 14 in both groups. Otherwise, group B exhibited a slightly higher nonstatistical rate of fungal clearance (-0.2868 ± 0.08275 log CFU/ml/day) than group A (-0.2496 ± 0.08340 log CFU/ml/day). CONCLUSIONS: A statistical difference between study groups was not found. This is the first study in Latin America that reports the experience of using sertraline as an adjuvant in the antifungal management of cryptococcal meningitis in HIVpatients.
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