Steroids for pneumonia in adults in Kenya

Phase 4

• Conditions: Treatment of community acquired pneumonia in adults; Respiratory

• Registration Number: ISRCTN36138594
• Lead Sponsor: niversity of Oxford

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2022-11-25
• Last Update Posted: 18 March 2024
• Study Completion: 2024-09-30

Recruitment & Eligibility

• Status: Ongoing
• Sex: All
• Target Recruitment: 2180

Inclusion Criteria

1. Adults aged 18 years or over
2. Admitted to hospital with a diagnosis of community-acquired pneumonia. Pneumonia will be based on a clinical definition as follows: the presence of at least 2 of the following signs and symptoms for less than 14 days: cough, fever, dyspnea, hemoptysis, chest pain or crackles on chest examination
3. Admitted to hospital within the previous 48 hours in this current illness
4. Provides written informed consent

Exclusion Criteria

1. Diagnosis of COVID-19 confirmed via polymerase chain reaction (PCR) of nasopharyngeal/oropharyngeal (NP/OP) swabs or antigen rapid diagnostic tests (RDTs) done at the hospital. This criterion only applies if the test result is known at the point of enrollment
2. Hospital acquired pneumonia- defined as pneumonia in a patient who has been in hospital for >48 hours who did not have the symptoms at admission
3. Patients who in the opinion of the attending clinician, require to be treated with steroids.
4. Known or suspected condition which in the opinion of attending clinician requires treatment with steroids, including but not limited to chronic obstructive pulmonary disease, asthma, adrenal insufficiency, Pneumocystis Jirovecii pneumonia (PCP)
5. If the clinician strongly suspects COVID-19 and wants to provide steroids to the patient because of this suspicion, then the patient will be excluded from the trial
6. Pregnancy or breast feeding
7. Any contraindication to steroid administration

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Mortality recorded as ‘dead or alive’ at 30 days after randomization measured using patient records

Secondary Outcome Measures

Name	Time	Method
Measured using patient records:<br>1. Mortality recorded as ‘dead or alive’ at 7,14- and 21-days following randomization<br>2. In-hospital mortality compared to mortality after discharge from hospital (up to 30 days post randomization) <br>3. Time to death measured in days following randomization<br>4. Correlation of pre-existing and treatment induced changes in the participants’ immune and metabolic profiles with study outcomes at baseline, 24 hours, 48 hours and 72 hours