AzTrials
AzTrials

Respiratory Tract InfectionsPhase 3NCT06472219

PREDICATE Trial For Respiratory Tract Infections

A Phase 3 study testing Prednisolone 30 mg in people with Respiratory Tract Infections, run by The University of Hong Kong at 1 site in Hong Kong.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

Background The goal of this clinical trial is to learn if prednisolone works to treat moderate to severe respiratory tract infections in adults admitted to hospital. It will also learn about the safety of prednisolone in this context. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Respiratory Tract Infections
What is being tested?
Prednisolone 30 mg
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
1,300 participants
Where
1 siteHong Kong
Study dates
23 Dec 2024to 8 Dec 2028
Phase
Phase 3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patients will be eligible for the study if ALL the following are present:
  • Adults ≥18 years of age; AND
  • scARI; AND
  • Intended hospitalisation; AND
  • No medical history that might, in the opinion of the attending clinician, put the patient at significant risk if he/she were to participate in the trial

Who cannot join

  • Patients will be excluded if the treating clinician considers that the patient is not suitable for the trial.
  • Patients may be excluded if any ONE of the following are present:
  • Vulnerable subjects (pregnancy; cognitively impaired; prisoners; students; umemployee; minorities);
  • Cardiac arrest or post-cardiac arrest ROSC;
  • Not expected to survive 3 days due to pre-existing chronic disease;
  • Palliative (comfort) care
Show all 19Show fewer
  • Undergoing active cancer therapy;
  • Neutropenia due to chemotherapy/malignancy (but not due to sepsis)
  • Immunocompromised or being treated with immunotherapy
  • Organ transplantation
  • HIV and on HIV drugs (indinavir, atazanavir, nelfinavir, saquinavir, ritonavir)
  • Recent Surgery (within one month)
  • Dialysis (including CAPD)
  • Diabetic ketoacidosis
  • Acute asthma
  • Recurrent chest infection,
  • Cushing's or Addisonian's disease,
  • Long term systemic steroid
  • Long-term antibiotics

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Timothy H Rainer, MD contact

39176846

thrainer@hku.hk

Hong Kong1 site, 1 recruiting

  • Queen Mary Hospital

    Hong Kong

    Miffy Hudson Lam, Bachelor, +852-55063028, lly201@hku.hk

    Carrie Ip, Bachelor, +852-97360869, ipcarrie@hku.hk

    Recruiting

Other trials in Hong Kong

About this study

Official title: Early Prednisolone for Suspected Community-acquired Acute Respiratory Tract Infection (PREDICATE): A Double-blind, Randomised, Multi-centre, Adaptive Platform, Controlled Trial

Background

The goal of this clinical trial is to learn if prednisolone works to treat moderate to severe respiratory tract infections in adults admitted to hospital. It will also learn about the safety of prednisolone in this context. The main questions it aims to answer are:

Read more

Does prednisolone lower the number of participants who develop sepsis or who survive? What medical problems do participants have when taking prednisolone? Researchers will compare prednisolone to a placebo (a look-alike substance that contains no drug) to see if prednisolone works to treat respiratory tract infections in adults.

Participants will:

Take prednisolone 30mg or a placebo every day for 5 days. Complete a daily diary of symptoms for 30 days and have telephone follow up. Investigators propose to recruit 1300 patients, 650 in each group. The Trial will be conducted in the Emergency Departments and wards of hospitals in Hong Kong.

Investigators expect the proportion of patients admitted to the hospital who develop sepsis or who die within 30 days to be reduced from 25% to 18% after taking active treatment. Secondly, investigators expect any difference in the proportion of patients with Serious adverse events(SAEs) not to exceed 5% between active treatment group and control.

Benefits to Hong Kong and Worldwide: Active treatments (e.g. prednisolone are cheap, HK$0.2 per 5mg tablet) are widely available across the world. Any reduction of progression to sepsis and death if applied worldwide would improve the lives of millions of patients and save millions of dollars of healthcare costs.

Read the detailed description

Introduction Acute Respiratory Infections (ARIs) are the fourth leading cause of death worldwide, third in China and second in Hong Kong. They are usually caused by bacteria or viruses and are associated with an early hyperinflammatory response. Evidence for the early detection of the disease and pathogen, risk-stratification and management are high priorities for the World Health Organisation (WHO).

The pathogens most likely to cause annual epidemics and pandemics are respiratory viruses although bacteria may cause up to 50% of ARI in hospitalised patients. Despite individual variation, the clinical course of ARIs generally involves an incubation period that lasts hours to days; and an early inflammatory prodrome which lasts days to a week and is characterised by symptoms such as a cough, fever, lethargy, headache (stage I). Whilst most patients recover, some progress to Stage II respiratory deterioration in the subsequent week; and Stage III severe respiratory failure may occur over subsequent weeks. The kinetics of bacterial and viral replication can last up to and even longer than 21 days. This prolonged and relatively slow progression provides several windows of opportunity in which early anti-inflammatory and immunomodulatory therapies could influence the course of the disease, reduce early hyperinflammation, facilitate recovery and well-being, and reduce hospital stay, disease progression, need for intensive care and mortality.

Usual care (UC) for patients with ARI presenting to EDs in Hong Kong is like other primary care settings in the world. For example, in Europe, early treatments are highly variable and consist of paracetamol, non-steroidal anti-inflammatory drugs, low-dose corticosteroids, over-the-counter medicines, fluids, rest, time off school/work, and antibiotics or antivirals. Rapid diagnostic tests (RDTs) are rarely available in the emergency department (ED) and even after admission a pathogen may not be identified in up to 70% of cases. Thus, treatment is usually begun and continued without an identifiable bacterial and/or viral pathogen. As many ARIs follow generic hyperinflammatory pathways, evaluating and repurposing existing anti-inflammatory drugs (e.g. prednisolone, 12) is a common and reasonable strategy which could have relevance not only for Hong Kong but worldwide.

Adaptive Platform Design and Response Adaptive Randomisation An adaptive platform trial (APT) is a trial in which multiple treatments for the same disease are tested simultaneously. New interventions can be added or replace existing ones during the course of the trial in accordance with pre-specified criteria. APTs offer innovations that could reshape clinical trials, and several APTs are now funded in various disease areas. APTs enhance research efficiency, shorten the duration of futile studies, and optimise sample size and study duration based on emerging data. The platform design allows for subsequent levels of randomisation if further treatments require evaluation.

The initial randomisation ratio is fixed 1:1 for a comparison between two trial arms, but the trial has the capability for these proportions to be altered according to participants' responses to interventions. Pre-specified decision criteria allow for dropping a treatment for futility, declaring a treatment superior, or adding a new treatment to be tested. If at any point a treatment is deemed superior to the usual care arm, the superior treatment may replace the usual care arm as the new standard of care.

Unmet Clinical Need Acute Respiratory Infections (ARIs) are a leading cause of death worldwide and in Hong Kong. There is relatively little evidence for early pathology- or pathogen-specific treatments for suspected community-acquired ARI (scARI). Every year, winter crises and epidemics are such that hospital wards, and particularly intensive care facilities, are frequently overstretched. Even treatments with moderate impact on survival or on hospital resources could be worthwhile.

One important area where evidence is scant is the role for steroids in scARI requiring hospitalisation. Although many trials report benefits of using steroids that outweigh adverse events(AEs) in severe COVID and community-acquired pneumonia(CAP), the value in hospitalised patients with less severe disease, in scARI and early treatment (e.g. started in EDs) is unclear. Specifically, evidence for a safe role for early, low dose, short-course prednisolone to safely reduce excessive inflammation, progression to sepsis and mortality in adult patients with scARI is needed.

All patients will receive UC in the participating hospitals. Initially randomisation will be between two treatment arms:

Control Arm: Placebo Active Treatment Arm I: Prednisolone 30mg tablets administered once a day for five days.

Being tested
Prednisolone 30 mg, Placebo
Keywords
Emergency Care, Inflammation, Mortality, Pneumonia, Prednisolone, Randomised Controlled Trial, Respiratory Tract Infections, Safety, Sepsis, Steroids
Medical subject headings
Respiratory Tract Infections, Inflammation, Pneumonia, Sepsis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Prednisolone 30 mgDrug

    Also called Prednisolone

    This is a glucocorticoid like cortisol used for its anti-inflammatory, immunosuppressive, anti-neoplastic and vasoconstrictive effects. It binds to the glucocorticoid receptor, inhibiting pro-inflammatory signals and promoting anti-inflammatory signals. It has a short duration of action as the half-life is 2.1-3.5 hours and 98% is eliminated in urine. On 21 June 1955 it was granted FDA approval.

  • PlaceboDrug

    Also called Prednis

    This a tablet identical to prednisolone.

Study groups in NCT06472219
Study groupRoleWhat they receive
Placebo + usual carePlacebo comparatorPlacebo tablets administered once a day for five days.
Receives: Drug: Placebo
Active Treatment I + usual careActive comparatorPrednisolone 30mg tablets administered once a day for five days.
Receives: Drug: Prednisolone 30 mg

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 30-day all-cause sepsis or all-cause mortality

    The proportion of patients with all-cause sepsis or all-cause mortality

    Measured: Up to 30-days

  2. 30-day Severe Adverse Events

    The proportion of patients with an SAE

    Measured: Up to 30-days

Secondary outcomes (6)

  1. Maximal WHO Clinical Progression Scale(WHO-CPS)

    Differentiation of median maximal WHO-CPS hospitalised patients with scARI. [0 - not infected] Ambulatory mild disease

    1. Not hospitalised, asymptomatic, no limitation on activities, virus detected;
    2. Not hospitalised, symptomatic, independent
    3. Not hospitalised, limitation on activities, assistance required; Hospitalised moderate disease
    4. Hospitalised, not requiring supplemental oxygen;
    5. Hospitalised, requiring supplemental oxygen; Hospitalised severe disease
    6. Hospitalised, on oxygen by Non-invasive ventilation(NIV) or high flow;
    7. Hospitalised, intubation and mechanical ventilation
    8. Hospitalised, mechanical ventilation or vasopressors
    9. Hospitalised, mechanical ventilation, vasopressors, dialysis or Extracorporeal membrane oxygenation(ECMO);
    10. Death.

    Measured: Up to 30-days

  2. Mortality

    The proportion of patients with mortality

    Measured: Up to 30-days

  3. Sepsis

    The proportion of patients with sepsis

    Measured: Up to 30-days

  4. Length of Hospital Stay

    Differentiation of median length of stay

    Measured: Up to 30-days

  5. Patient Satisfaction

    Differentiation of median patient satisfaction score [Score:0 - 10]

    Measured: Up to 30-days

  6. Cost-effectiveness analysis

    Cost-effectiveness comparison between the two groups. • Cost-effectiveness analysis measure is the total cost difference between treatment group and placebo group divided by total Quality-adjusted life year(QALY) difference between treatment group and placebo group;

    • Total cost difference between treatment group and placebo group divided by difference in primary and secondary outcomes between treatment group and placebo group

    Measured: 30-days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Jun 2024
  2. Study start23 Dec 2024
  3. Primary completion8 Dec 2027 (estimated)
  4. Study completion8 Dec 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
1,300 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06472219
Sponsor's protocol ID
PREDICATE
Status last verified
Jan 2025
First submitted
14 Jun 2024
Last updated
15 Jan 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Wang M, Huang Y, Song Y, Chen J, Liu X. Study on Environmental and Lifestyle Factors for the North-South Differential of Cardiovascular Disease in China. Front Public Health. 2021 Jul 16;9:615152. doi: 10.3389/fpubh.2021.615152. eCollection 2021.

    PubMed 34336751

  • Healthy Hong Kong, Hong Kong Government. Leading cause of all deaths. https://www.healthyhk.gov.hk/phisweb/en/chart_detail/22/ accessed 13th February 2022

  • WHO Fact Sheet. The Top 10 causes of death. https://www.who.int/news-room/fact- sheets/detail/the-top-10-causes-of-death accessed 13th February 2022

  • WHO The Global Impact of Respiratory Disease 2nd Edition. https://www.who.int/gard/publications/The_Global_Impact_of_Respiratory_Disease.pdf accessed 13th February 2022

  • Southeast Asia Infectious Disease Clinical Research Network. Causes and outcomes of sepsis in southeast Asia: a multinational multicentre cross-sectional study. Lancet Glob Health. 2017 Feb;5(2):e157-e167. doi: 10.1016/S2214-109X(17)30007-4.

    PubMed 28104185

  • Gu X, Zhou F, Wang Y, Fan G, Cao B. Respiratory viral sepsis: epidemiology, pathophysiology, diagnosis and treatment. Eur Respir Rev. 2020 Jul 21;29(157):200038. doi: 10.1183/16000617.0038-2020. Print 2020 Sep 30.

    PubMed 32699026

  • Hung IFN, To KKW, Chan JFW, Cheng VCC, Liu KSH, Tam A, Chan TC, Zhang AJ, Li P, Wong TL, Zhang R, Cheung MKS, Leung W, Lau JYN, Fok M, Chen H, Chan KH, Yuen KY. Efficacy of Clarithromycin-Naproxen-Oseltamivir Combination in the Treatment of Patients Hospitalized for Influenza A(H3N2) Infection: An Open-label Randomized, Controlled, Phase IIb/III Trial. Chest. 2017 May;151(5):1069-1080. doi: 10.1016/j.chest.2016.11.012. Epub 2016 Nov 22.

    PubMed 27884765

  • RECOVERY Collaborative Group; Horby P, Lim WS, Emberson JR, Mafham M, Bell JL, Linsell L, Staplin N, Brightling C, Ustianowski A, Elmahi E, Prudon B, Green C, Felton T, Chadwick D, Rege K, Fegan C, Chappell LC, Faust SN, Jaki T, Jeffery K, Montgomery A, Rowan K, Juszczak E, Baillie JK, Haynes R, Landray MJ. Dexamethasone in Hospitalized Patients with Covid-19. N Engl J Med. 2021 Feb 25;384(8):693-704. doi: 10.1056/NEJMoa2021436. Epub 2020 Jul 17.

    PubMed 32678530

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Montgomery S, Mouncey P, Murthy S, Nichol A, Parke R, Rowan K, Seymour C, Turner A, van de Veerdonk F, Webb S, Zarychanski R, Campbell L, Forbes A, Gattas D, Heritier S, Higgins L, Kruger P, Peake S, Presneill J, Seppelt I, Trapani T, Young P, Bagshaw S, Daneman N, Ferguson N, Misak C, Santos M, Hullegie S, Pletz M, Rohde G, Rowan K, Alexander B, Basile K, Girard T, Horvat C, Huang D, Linstrum K, Vates J, Beasley R, Fowler R, McGloughlin S, Morpeth S, Paterson D, Venkatesh B, Uyeki T, Baillie K, Duffy E, Fowler R, Hills T, Orr K, Patanwala A, Tong S, Netea M, Bihari S, Carrier M, Fergusson D, Goligher E, Haidar G, Hunt B, Kumar A, Laffan M, Lawless P, Lother S, McCallum P, Middeldopr S, McQuilten Z, Neal M, Pasi J, Schutgens R, Stanworth S, Turgeon A, Weissman A, Adhikari N, Anstey M, Brant E, de Man A, Lamonagne F, Masse MH, Udy A, Arnold D, Begin P, Charlewood R, Chasse M, Coyne M, Cooper J, Daly J, Gosbell I, Harvala-Simmonds H, Hills T, MacLennan S, Menon D, McDyer J, Pridee N, 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K, Moore L, Day C, Gibson C, Gordon E, Zitter L, Keenan S, Baker E, Cherian S, Cutler S, Roynon-Reed A, Harrington K, Raithatha A, Bauchmuller K, Ahmad N, Grecu I, Trodd D, Martin J, Wrey Brown C, Arias AM, Craven T, Hope D, Singleton J, Clark S, Rae N, Welters I, Hamilton DO, Williams K, Waugh V, Shaw D, Puthucheary Z, Martin T, Santos F, Uddin R, Somerville A, Tatham KC, Jhanji S, Black E, Dela Rosa A, Howle R, Tully R, Drummond A, Dearden J, Philbin J, Munt S, Vuylsteke A, Chan C, Victor S, Matsa R, Gellamucho M, Creagh-Brown B, Tooley J, Montague L, De Beaux F, Bullman L, Kersiake I, Demetriou C, Mitchard S, Ramos L, White K, Donnison P, Johns M, Casey R, Mattocks L, Salisbury S, Dark P, Claxton A, McLachlan D, Slevin K, Lee S, Hulme J, Joseph S, Kinney F, Senya HJ, Oborska A, Kayani A, Hadebe B, Orath Prabakaran R, Nichols L, Thomas M, Worner R, Faulkner B, Gendall E, Hayes K, Hamilton-Davies C, Chan C, Mfuko C, Abbass H, Mandadapu V, Leaver S, Forton D, Patel K, Paramasivam E, 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Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Prednisolone 30 mg in people with Respiratory Tract Infections, run by The University of Hong Kong at 1 site in Hong Kong.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 15 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Timothy H Rainer, MD (39176846, thrainer@hku.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

30-day all-cause sepsis or all-cause mortality (time frame: Up to 30-days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06472219, which also lists 25 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jan 2025.

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