Pulse therapy with corticosteroids leads to better results in pulmonary leptospirosis, reducing pulmonary infiltrate, occurrence of pulmonary haemorrhage, number of days in mechanical ventilation, incidence of acute respiratory failure, occurrence of secondary respiratory infection and mortality.
Ethical Committee of Research, Health Science Department, Federal University of Pernambuco (Comitê de Ética em Pesquisa, Centro de Ciências da Saúde, Universidade Federal de Pernambuco) Date of approval: 22/02/2008 (ref: CEP/CCS/UFPE Nº 416/07)
Randomised, double-blind, controlled trial.
Primary study design
Secondary study design
Randomised controlled trial
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Patients will be randomised to either methylprednisolone or placebo in blocks of four according to a random number generator. The randomisation ratio was 2 (methylprednisolone) to 1 (placebo). The participants and the medical staff were blinded throughout the study.
Intervention group: 1 g methylprednisolone per day intravenously for three consecutive days
Control group: Placebo intravenously for three consecutive days
Primary outcome measures
Mortality, recorded during the whole hospitalisation period.
Secondary outcome measures
1. Outcome of pulmonary leptospirosis after corticosteroids administration, assessed during the first seven days and then on the 14th and 28th day, by clinical and radiological assessment, and PaO2/FiO2 and haemoglobin/haematocrit evaluation.
2. Number of days in mechanical ventilation
3. Number of days in hospital
4. Number of days in UCI
5. Respiratory infection, monitored during the first seven days and then on the 14th and 28th day, by clinical and radiological assessment, and PaO2/FiO2 and leukocyte evaluation.
6. Other respiratory complications, monitored during the first seven days and then on the 14th and 28th day, by clinical and radiological assessment, and the PaO2/FiO2 evaluation.
7. Other infectious complications, monitored during the first seven days and then on the 14th and 28th day
8. Adverse events associated with corticosteroid administration, monitored during the first seven days and then on the 14th and 28th day
Overall trial start date
Overall trial end date
Participant inclusion criteria
1. Both males and females
2. Diagnosis of leptospirosis: Abrupt fever and myalgia, jaundice, normal number of leucocytes or increased number of leucocytes, thrombocytopenia, high levels of muscle enzymes and lack of hyperkalemia
3. Diagnosis of pulmonary leptospirosis: Interstitial pulmonary infiltrate or alveolo interstitial bilateral, associated with at least one of the following:
1. Changes in respiratory
4. Decrease of haemoglobin
6. Hypoxemia (PO2/FiO2 <300)
Target number of participants
Participant exclusion criteria
1. Age under 15 years old
2. History of hypersensitivity to corticosteroids
4. History of active tuberculosis or fungal infection
5. Recent history of head trauma
7. Peptic ulcer disorder
8. Enrolled in another trial
Recruitment start date
Recruitment end date
Countries of recruitment
Trial participating centre
Rua Professor Augusto Lins e Silva
Federal University of Pernambuco (Universidade Federal de Pernambuco [UFPE]) (Brazil)
Av. Prof. Moraes Rego
Federal University of Pernambuco (Universidade Federal de Pernambuco [UFPE]), Clinical Hospital (Brazil)
Funding Body Type
Funding Body Subtype
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting