Use of corticosteroids in pulmonary leptospirosis: a randomised double-blind clinical trial

ISRCTN	ISRCTN74625030
DOI	https://doi.org/10.1186/ISRCTN74625030
Protocol serial number	FR-167386
Sponsor	Federal University of Pernambuco (Universidade Federal de Pernambuco [UFPE]) (Brazil)
Funder	Federal University of Pernambuco (Universidade Federal de Pernambuco [UFPE]), Clinical Hospital (Brazil)

Submission date: 25/03/2008
Registration date: 16/05/2008
Last edited: 23/10/2020

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Infections and Infestations

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Ana Flávia Azevedo
Scientific

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

Study information

Primary study design	Interventional
Study design	Randomised, double-blind, controlled trial.
Secondary study design	Randomised controlled trial
Study type	Participant information sheet
Scientific title	Use of corticosteroids in pulmonary leptospirosis: a randomised double-blind clinical trial
Study acronym	ARDS
Study objectives	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(s)	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)
Health condition(s) or problem(s) studied	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 / device / biological / vaccine name(s)	Methylprednisolone
Primary outcome measure(s)	Mortality, recorded during the whole hospitalisation period.
Key secondary outcome measure(s)	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
Completion date	31/12/2009

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	All
Target sample size at registration	266
Key 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)
Key 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
Date of first enrolment	01/04/2008
Date of final enrolment	31/12/2009

Locations

Countries of recruitment

Brazil

Study participating centre

Rua Professor Augusto Lins e Silva

Recife
81030-030
Brazil

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Protocol article	protocol	30/06/2011	23/10/2020	Yes	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes

Editorial Notes

23/10/2020: Publication reference added.