Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
FR-167386
Study information
Scientific title
Acronym
ARDS
Study hypothesis
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.
Ethics approval
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)
Study design
Randomised, double-blind, controlled trial.
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Leptospirosis
Intervention
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
Intervention type
Drug
Phase
Not Specified
Drug names
Methylprednisolone
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
01/04/2008
Overall trial end date
31/12/2009
Reason abandoned
Eligibility
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
2. Cough
3. Dyspnea
4. Decrease of haemoglobin
5. Haemoptysis
6. Hypoxemia (PO2/FiO2 <300)
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
266 patients
Participant exclusion criteria
1. Age under 15 years old
2. History of hypersensitivity to corticosteroids
3. Pregnancy
4. History of active tuberculosis or fungal infection
5. Recent history of head trauma
6. Neurosurgery
7. Peptic ulcer disorder
8. Enrolled in another trial
Recruitment start date
01/04/2008
Recruitment end date
31/12/2009
Locations
Countries of recruitment
Brazil
Trial participating centre
Rua Professor Augusto Lins e Silva
Recife
81030-030
Brazil
Sponsor information
Organisation
Federal University of Pernambuco (Universidade Federal de Pernambuco [UFPE]) (Brazil)
Sponsor details
Av. Prof. Moraes Rego
1235
Cidade Universitária
Recife
50670-901
Brazil
Sponsor type
University/education
Website
Funders
Funder type
University/education
Funder name
Federal University of Pernambuco (Universidade Federal de Pernambuco [UFPE]), Clinical Hospital (Brazil)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
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
Publication summary