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

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN74625030

Enrollment

266

Registered

2008-05-16

Start date

2008-04-01

Completion date

Unknown

Last updated

2020-11-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Leptospirosis Infections and Infestations Leptospirosis

Interventions

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 par

Eligibility

Sex/Gender

All

Inclusion criteria

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)

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
Mortality, recorded during the whole hospitalisation period.	—

Secondary

Measure	Time frame
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	—

Measure

Time frame

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

—

Countries

Brazil

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026