Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR202111481740832 Date of Approval: 02/11/2021
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Steroids for pneumonia in adults in Kenya (SONIA Trial).
Official scientific title A Pragmatic Randomized Controlled Trial of Standard Care versus Steroids plus Standard Care for Treatment of Pneumonia in Adults Admitted to Kenyan Hospitals
Brief summary describing the background and objectives of the trial We don’t know whether the addition of steroids (a class of medications that reduce the body’s reaction to injury or infection) to standard treatment in patients with pneumonia in Kenya is beneficial or not. Trials in patients with COVID-19 have shown that the addition of steroids reduces mortality. However, in Kenya most patients with pneumonia will not be tested for COVID-19 due to lack of resources. It is likely that clinicians in Kenya will treat all patients with pneumonia using steroids, in the belief that this strategy may be beneficial, based on data from preceding trials. This trial aims to determine whether such a strategy is beneficial to patients who are either negative for COVID-19 or their COVID-19 status is not known.
Type of trial RCT
Acronym (If the trial has an acronym then please provide) SONIA
Disease(s) or condition(s) being studied Infections and Infestations,Respiratory
Sub-Disease(s) or condition(s) being studied Community acquired pneumonia
Purpose of the trial Treatment: Drugs
Anticipated trial start date 15/11/2021
Actual trial start date 18/04/2022
Anticipated date of last follow up 15/10/2022
Actual Last follow-up date 01/11/2022
Anticipated target sample size (number of participants) 2180
Actual target sample size (number of participants)
Recruitment status Not yet recruiting
Publication URL Https://wellcome.ac.uk/grant-funding/guidance/data software-material-management-and-sharing-policy
Secondary Ids Issuing authority/Trial register
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Parallel: different groups receive different interventions at same time during study Randomised Simple randomization using a randomization table created by a computer software program Sealed opaque envelopes Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Steroid plus standard pneumonia treatment Steroid - Once daily dose. Either of the Steroids listed below will be used based on availability. Betamethasone 5mg Dexamethasone 6mg Hydrocortisone 160mg Methylprednisolone 30mg Prednisolone 50mg Prednisone 50mg 10 days Patients who are randomized to the intervention arm will receive the standard of care treatment for CAP and steroids for a period of 10 days: 1090
Control Group standard treatment for pneumonia a beta lactam antibiotic and a macrolide according to WHO and local guidelines for 7-14 days. Patients randomized to standard of care will receive treatment according to local guidelines for CAP which currently recommend a beta lactam antibiotic and a macrolide for 7-14 days. In order to minimize variability in the standard treatment offered at the different hospitals, the study team will provide hard copies of the treatment guidelines 1090 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
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 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) 80 and over: 80+ Year,Adolescent: 13 Year-18 Year,Adult: 19 Year-44 Year,Aged: 65+ Year(s),Middle Aged: 45 Year(s)-64 Year(s) 18 Year(s) 80 Year(s) Both
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 26/10/2021 SERU
Ethics Committee Address
Street address City Postal code Country
54840 KENYA 00200 Kenya
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome The primary outcome for the trial will be mortality at 30 days after randomization 30 days post randomization
Secondary Outcome 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 at day 30
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
KEMRI 230 Kilifi 80108 Kenya
FUNDING SOURCES
Name of source Street address City Postal code Country
WELLCOME TRUST 215 Euston road London United Kingdom
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor University of Oxford Wellington square Oxford United Kingdom Funding Agency
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Anthony Etyang aetyang@kemri-wellcome.org +254709983000 Nairobi
City Postal code Country Position/Affiliation
Nairobi Kenya Chief investigator
Role Name Email Phone Street address
Scientific Enquiries Ruth Lucinde rlucinde@kemri-wellcome.org 0702929295 Nairobi
City Postal code Country Position/Affiliation
Nairobi Kenya Investigator
Role Name Email Phone Street address
Public Enquiries Stella Mwakio smwakio@kemri-wellcome.org 254724832853 kilifi
City Postal code Country Position/Affiliation
Kilifi Kenya Project coordinator
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes After the trial ends, a clean final database(s) of anonymized, de-identified individual-level clinical, laboratory and safety data will be produced by KEMRI-CGMR-Coast. This will be shared with the trial statistician and trial team in order for the final analyses to take place as per the statistical analysis plan. A clean de-identified database will be provided as publicly available (‘open access’) or upon reasonable request, after the final study publication is published, as per the relevant medical journal regulations Study Protocol After the primary analyses of the trial, as specified, are published. Available immediately following the last publication, no end date Data access will be granted upon reasonable request. Reasonable request is defined as: The requestor has a disclosed hypothesis and research question that can be answered using the trial data and is affiliated with a reputable research organization, which has capacity to store and analyze the data according to good clinical practice /good data management practice In the short-term, each request will be evaluated by 3 or more current/former project team members with an understanding of the data (an external expert may also be invited to join where appropriate). This group can decide to approve access, request further information, or deny access. In the unlikely event that these people are no longer available, (e.g. they've moved onto other roles),responsibility for evaluation would transferred to Research Governance Committee
URL Results Available Results Summary Result Posting Date First Journal Publication Date
Https://wellcome.ac.uk/grant-funding/guidance/data software-material-management-and-sharing-policy No
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information