Condition category
Infections and Infestations
Date applied
25/03/2008
Date assigned
16/05/2008
Last edited
19/05/2008
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Ana Flávia Azevedo

ORCID ID

Contact details

Rua Professor Augusto Lins e Silva
228/901
Boa Viagem
Recife
81030-030
Brazil

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

http://www.ufpe.br

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

Publication citations

Additional files

Editorial Notes