Use of corticosteroids in pulmonary leptospirosis: a randomised double-blind clinical trial
| ISRCTN | ISRCTN74625030 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN74625030 |
| Secondary identifying numbers | FR-167386 |
- 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
Scientific
Rua Professor Augusto Lins e Silva
228/901
Boa Viagem
Recife
81030-030
Brazil
Study information
| Study design | Randomised, double-blind, controlled trial. |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient 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 |
| Pharmaceutical study type(s) | |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Methylprednisolone |
| Primary outcome measure | 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 study start date | 01/04/2008 |
| Completion date | 31/12/2009 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 266 patients |
| 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
81030-030
Brazil
Sponsor information
Federal University of Pernambuco (Universidade Federal de Pernambuco [UFPE]) (Brazil)
University/education
University/education
Av. Prof. Moraes Rego
1235
Cidade Universitária
Recife
50670-901
Brazil
| Website | http://www.ufpe.br |
|---|---|
"ROR" |
https://ror.org/047908t24 |
Funders
Funder type
University/education
Federal University of Pernambuco (Universidade Federal de Pernambuco [UFPE]), Clinical Hospital (Brazil)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | 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 |
Editorial Notes
23/10/2020: Publication reference added.
