title: Randomized controlled trial of pulse methyl prednisolone × placebo in treatment of pulmonary involvement associated with severe leptospirosis. [ISRCTN74625030].
abstract: BACKGROUND
  The lungs are involved in up to 70% of cases of leptospirosis. In the more severe forms-bleeding from the lungs and acute respiratory distress syndrome-the lethality is high. The treatment proposed for leptospirotic pneumonitis includes just care for patients in critical condition. Clinical and experimental studies point to the involvement of immunological mechanisms in the physiopathology of lung damage caused by leptospirosis. The aim of this study is to evaluate pulse treatment with methylprednisolone × placebo for leptospirotic pneumonitis.
  
  
  METHODS
  This is a randomized double-blind clinical trial to test the efficacy of pulse treatment with methylprednisolone in patients with leptospirotic pneumonitis, compared with a placebo. The patients are recruited from three hospitals in the city of Recife, in the Brazilian State of Pernambuco. The exclusion criteria include patients aged under 15 years, a history of hypersensitivity to the use of corticosteroids, the presence of active infection of fungal, tuberculous or bacterial origin apart from the infection by leptospira itself, the presence of hemoconcentration or atypical lymphocyte count on admission to hospital, the presence of co-morbidities that could be responsible for the radiological and gasometric alterations used to diagnose leptospirotic pneumonitis, evidence of recent cranial trauma, neurosurgery, peptic ulcer, and participation in another clinical trial. The patients are followed until they are discharged from hospital or die. The intervention consists of endovenous pulse treatment with 1 g methylprednisolone for three consecutive days in the study group and a placebo in the control group. The primary end-point is mortality from leptospirotic pneumonitis. The secondary end-points are: evolution of lung disease; the occurrence of nosocomial respiratory infection; duration of mechanical ventilation; duration of intensive care unit (ICU) stay; duration of hospital stay; occurrence of other infection-related complications; other respiratory complications; and adverse effects of methylprednisolone. The study is designed to recruit 266 patients and has a statistical "power" of 80% to detect a 50% reduction in mortality.
  
  
  CONCLUSIONS
  Lung involvement in leptospirosis is a serious manifestation, with a high and variable mortality rate. There is still no specific clearly-established treatment. Well-designed studies are needed to pave the way towards development of such a treatment.
authors: Department of Tropical Medicine, Federal University of Pernambuco, Recife, Brazil. afcga@hotmail.com
authors: Ana Flávia C
authors: AF
authors: Azevedo
authors: Demócrito de B
authors: Dde B
authors: Miranda-Filho
authors: Gustavo T
authors: GT
authors: Henriques-Filho
authors: Alfredo
authors: A
authors: Leite
authors: Ricardo A A
authors: RA
authors: Ximenes
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000893:Anti-Inflammatory Agents / Q000008:administration & dosage*; D001938:Brazil; D005260:Female; D006801:Humans; D007922:Leptospirosis / Q000150:complications* / Q000188:drug therapy* / Q000401:mortality; D008297:Male; D008875:Middle Aged; D010919:Placebos / Q000008:administration & dosage; D011014:Pneumonia / Q000150:complications* / Q000188:drug therapy* / Q000401:mortality; D011239:Prednisolone / Q000008:administration & dosage / Q000031:analogs & derivatives*; D012128:Respiratory Distress Syndrome / Q000188:drug therapy* / Q000401:mortality; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D000893:Anti-Inflammatory Agents; D010919:Placebos; C025429:methyl prednisolonate; D011239:Prednisolone