Dexamethasone for Pneumonia

Recruiting at 1 trial location

Overseen By Yewande Odeyemi, M.B.B.S.

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Mayo Clinic

Disqualifiers: Adrenal insufficiency, Septic shock, Autoimmune pulmonary, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 4 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 5 days or until hospital discharge

24 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new method of using the steroid dexamethasone to treat pneumonia. The researchers aim to determine if adjusting steroid doses based on a blood test for inflammation, known as C-reactive protein (CRP), can reduce side effects and enhance treatment effectiveness. One group will receive usual care, while another will have their steroid dose adjusted according to CRP levels. This trial suits adults hospitalized with pneumonia not caused by autoimmune issues, who have no history of certain serious conditions and are open to steroid treatment. As a Phase 2 trial, the research focuses on evaluating the treatment's effectiveness in an initial, smaller group, offering participants a chance to contribute to significant medical advancements.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

Is there any evidence suggesting that this treatment is likely to be safe for humans?

A previous study found that corticosteroids like dexamethasone did not increase the risk of side effects such as stomach bleeding or infections. Another study showed these steroids could reduce the chance of death in severe cases. However, caution is advised. Some research has indicated a higher risk of hospital-acquired pneumonia for those using corticosteroids. Overall, while dexamethasone offers benefits, some risks require consideration. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Unlike the standard of care for pneumonia, which often involves a fixed dosing of corticosteroids, this trial uses an individualized dosing strategy with dexamethasone. The unique feature here is the use of biomarker-guided treatment, where daily CRP (C-reactive protein) levels are monitored to tailor the dosing. Researchers are excited about this approach because it has the potential to optimize treatment effectiveness while minimizing side effects by ensuring patients receive just the right amount of medication based on their daily needs.

What evidence suggests that dexamethasone might be an effective treatment for pneumonia?

Research has shown that dexamethasone can reduce the risk of death in people with serious breathing problems. One study on COVID-19 found that dexamethasone lowered the death rate within 28 days for patients who had been sick for more than a week. Although this study did not focus specifically on pneumonia, it suggests that dexamethasone might help with severe lung issues. In this trial, participants may receive dexamethasone as part of an individualized dosing strategy guided by biomarkers. The treatment reduces swelling, a major problem in many lung diseases. The aim of using dexamethasone for pneumonia is to control this swelling while minimizing side effects. ^{1 5 6 7 8}

Who Is on the Research Team?

Yewande Odeyemi, MBBS

Principal Investigator

Mayo Clinic

Are You a Good Fit for This Trial?

This trial is for adults hospitalized with community-acquired pneumonia. It's not suitable for those with adrenal insufficiency, septic shock, or conditions requiring steroids; pregnant women; and patients unwilling to use corticosteroids or on comfort care.

Inclusion Criteria

I have pneumonia that I caught outside of a hospital.

I am an adult patient currently in the hospital.

Exclusion Criteria

I might have lung inflammation caused by an autoimmune condition.

You are pregnant according to a pregnancy test.

I have a condition that requires me to use steroids.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1 week

Treatment

Participants receive either usual care or an individualized steroid dosing strategy based on CRP levels

5 days or until hospital discharge

Follow-up

Participants are monitored for safety and effectiveness after treatment

28 days

What Are the Treatments Tested in This Trial?

Interventions

• Dexamethasone

Trial Overview

The study tests an individualized dosing strategy of Dexamethasone based on CRP levels in the blood against usual care. The aim is to optimize steroid use by giving the right amount at the best time to reduce side effects and improve outcomes.

How Is the Trial Designed?

Group I: Individualized dosing strategy Experimental Treatment 1 Intervention

Biomarker guided corticosteroid use. Initiation of corticosteroid will be recommended based on the an individual treatment rule (ITR) and subsequent dosing of corticosteroid will be recommended based on daily CRP values till CRP \<50 mg/L.

Group II: Usual Care Group Active Control 1 Intervention

Usual care as determined by the patient's primary team. Initiation and daily dosing of corticosteroid treatment will be based on clinicians' preference and clinicians.

Dexamethasone is already approved in European Union, United States, Canada, Japan for the following indications:

Approved in European Union as Dexamethasone for:

• Inflammation
• Allergic reactions
• Respiratory diseases
• Skin conditions
• Eye diseases
• Immune system disorders

Approved in United States as Dexamethasone for:

• Inflammatory conditions
• Allergic states
• Respiratory diseases
• Blood disorders
• Neoplastic diseases
• Nervous system disorders

Approved in Canada as Dexamethasone for:

• Inflammation
• Allergic reactions
• Respiratory diseases
• Skin conditions
• Eye diseases

Approved in Japan as Dexamethasone for:

• Inflammatory conditions
• Allergic states
• Respiratory diseases
• Blood disorders

Who Is Running the Clinical Trial?

Mayo Clinic

Lead Sponsor

Trials

3,427

Recruited

3,221,000+

Published Research Related to This Trial

Dexamethasone (DEX) pretreatment significantly mitigated the negative effects of lipopolysaccharide (LPS) on neonatal type II alveolar epithelial cells, reducing cell apoptosis and enhancing growth, particularly at a concentration of 1.0 μmol/l.

DEX pretreatment also increased the expression of insulin-like growth factor-1 (IGF-1) mRNA, which is important for cell growth, while it positively influenced the expression of surfactant protein C, suggesting a protective role against endotoxin-induced lung injury.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Protective role of glucocorticosteroid prior to endotoxin exposure in cultured neonatal type II alveolar epithelial cells. He, L., Dong, Y., Wu, W., et al.[2019]

In a study of 1161 children aged 4 to 17 hospitalized for asthma exacerbations, dexamethasone was compared to prednisone, showing a slightly higher return utilization rate of 3.9% versus 2.2%, respectively.

However, the analysis indicated that the choice of steroid (dexamethasone vs. prednisone) did not significantly impact the likelihood of unplanned readmissions or emergency department visits within 30 days after discharge.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dexamethasone Versus Prednisone in Children Hospitalized With Asthma Exacerbation. Hoefgen, ER., Huang, B., Schuler, CL., et al.[2022]

In a pilot study involving 80 adults with pneumonia-related pleural effusion, treatment with intravenous dexamethasone showed no significant benefits in improving vital signs or reducing inflammation compared to placebo.

The study also found that while dexamethasone was associated with a higher rate of transient hyperglycemia, the overall rates of serious adverse events were similar between the dexamethasone and placebo groups.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Steroid Therapy and Outcome of Parapneumonic Pleural Effusions (STOPPE): A Pilot Randomized Clinical Trial. Fitzgerald, DB., Waterer, GW., Budgeon, C., et al.[2023]

Late postnatal dexamethasone treatment in preterm infants significantly reduced neonatal mortality and the incidence of bronchopulmonary dysplasia (BPD), based on a review of 19 randomized controlled trials involving 1,345 participants.

Despite its benefits, late dexamethasone treatment was associated with short-term complications like hyperglycemia and hypertension, and potential long-term risks such as increased rates of cerebral palsy, suggesting that its use should be limited to specific cases where infants cannot be weaned from mechanical ventilation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dexamethasone treatment after the first week of life for bronchopulmonary dysplasia in preterm infants: a systematic review. Doyle, LW., Ehrenkranz, RA., Halliday, HL.[2018]

In a study involving 30 adults (15 with unstable asthma and 15 healthy controls), high doses of inhaled steroids (beclomethasone dipropionate and budesonide) significantly improved lung function, with FEV1 increasing from 88% to 96% after one month, and nocturnal asthma symptoms disappearing within two weeks.

Both treatments led to a significant initial decrease in insulin resistance and improvement in glucose tolerance, suggesting that high-dose inhaled steroids may have beneficial effects on carbohydrate metabolism in patients with uncontrolled asthma.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of eight months of inhaled beclomethasone dipropionate and budesonide on carbohydrate metabolism in adults with asthma. Kiviranta, K., Turpeinen, M.[2019]

A systematic review of 8 trials with 3469 patients showed that high-dose dexamethasone (12-24 mg daily) does not reduce mortality compared to low-dose dexamethasone (6-8 mg daily) in adults with acute COVID-19 pneumonia.

High-dose dexamethasone was linked to a higher risk of hyperglycaemia (23.6% vs. 17.2%), indicating potential safety concerns, while there was no significant difference in the risk of secondary infections.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of dexamethasone dose on outcomes in acute COVID-19 disease: A systematic review and meta-analysis. Snow, TAC., Arulkumaran, N., Singer, M., et al.[2023]

Dexamethasone treatment in preterm infants is linked to worse long-term pulmonary outcomes, including lower lung function scores in childhood and adolescence, based on a systematic review of 18 studies involving 1,609 patients.

The use of dexamethasone is also associated with lower IQ scores in children compared to preterm and term controls, indicating potential cognitive deficits as a long-term effect of this medication.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Systematic review of the long-term effects of postnatal corticosteroids. Jenkinson, AC., Kaltsogianni, O., Dassios, T., et al.[2023]

In a study of 36 preterm infants, a 42-day course of dexamethasone significantly improved the speed of weaning from mechanical ventilation and supplemental oxygen compared to a placebo, indicating its efficacy in reducing morbidity associated with bronchopulmonary dysplasia.

Follow-up assessments at 6 and 15 months showed better neurodevelopmental outcomes in infants who received the 42-day dexamethasone treatment, with 7 out of 9 showing normal development, compared to only 2 out of 9 in the 18-day group and 2 out of 5 in the placebo group.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A controlled trial of dexamethasone in preterm infants at high risk for bronchopulmonary dysplasia. Cummings, JJ., D'Eugenio, DB., Gross, SJ.[2013]

In a study investigating the effects of dexamethasone on pneumococcal antibody formation in patients with community-acquired pneumonia (CAP), no significant differences were observed between those receiving dexamethasone and those receiving a placebo.

The findings suggest that adding dexamethasone to the treatment of CAP does not enhance the immune response or antibody levels against pneumococcal infections.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dexamethasone treatment has no effect on the formation of pneumococcal antibodies during community-acquired pneumonia. van Mens, SP., Meijvis, SC., Grutters, JC., et al.[2021]

In a study comparing dexamethasone (Dex) and hydrocortisone (HC) in newborn rats, Dex was found to negatively impact brain and body weight gain, while HC did not have these adverse effects.

Dex increased neurotoxicity markers and impaired learning and memory in juvenile rats, whereas HC, even at high doses, did not affect cognitive behavior, suggesting that HC may be a safer alternative for treating premature infants.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dexamethasone but not the equivalent doses of hydrocortisone induces neurotoxicity in neonatal rat brain. Feng, Y., Kumar, P., Wang, J., et al.[2017]

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[57] reported that patients receiving corticosteroids had more than 200% higher risk of developing hospital-acquired pneumonia, even after adjusting for ...

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ccjm.org

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Do patients with severe community-acquired bacterial ...

A meta-analysis by Siemieniuk et al published in 2015 showed conflicting evidence regarding the use of systemic corticosteroids in CAP but ...