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Steroids for pneumonia in adults in Kenya (SONIA Trial).

A Pragmatic Randomized Controlled Trial of Standard Care versus Steroids plus Standard Care for Treatment of Pneumonia in Adults Admitted to Kenyan Hospitals

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
PACTR
Registry ID
PACTR202111481740832
Enrollment
2180
Registered
2021-11-02
Start date
2021-11-15
Completion date
Unknown
Last updated
2026-08-03

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

Conditions

Community acquired pneumonia Respiratory

Interventions

Steroid plus standard pneumonia treatment
standard treatment for pneumonia

Sponsors

University of Oxford
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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, dyspnoea, haemoptysis, chest pain or crackles on chest examination. 3.Admitted to hospital within the previous 48 hours 4.Provides written informed consent

Exclusion criteria

Exclusion criteria: 1.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 2.Patients who in the opinion of the attending clinician, require to be treated with steroids. 3.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). 4.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. 5.Pregnancy or breast feeding 6.Any contraindication to steroid administration 7.Diagnosis of COVID-19 confirmed via PCR of NP/OP swabs (this only applies if test result known at the point of enrollment)

Design outcomes

Primary

MeasureTime frame
The primary outcome for the trial will be mortality at 30 days after randomization

Secondary

MeasureTime frame
1.Mortality at 7,14 and 21 days following randomization 2.In-hospital mortality 3.Mortality after discharge from hospital (up to 30 days post randomization) 4.Duration of hospital stay 5.Admission to ICU/referral to higher level hospital

Countries

Kenya

Contacts

Public ContactStella Mwakio

Project coordinator

smwakio@kemri-wellcome.org254724832853

Outcome results

None listed

Source: PACTR (via WHO ICTRP) · Data processed: Aug 9, 2026