CLINICAL TRIAL

Amoxicillin for Pneumonia

Recruiting · < 65 · All Sexes · Montreal, Canada

Twice Daily Treatment With Amoxicillin for Non-severe Community Acquired Pneumonia.

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About the trial for Pneumonia

Eligible Conditions
Pneumonia · Community-acquired Pneumonia

Treatment Groups

This trial involves 2 different treatments. Amoxicillin is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are in Phase 2 & 3 and have had some early promising results.

Main TreatmentA portion of participants receive this new treatment to see if it outperforms the control.
Amoxicillin
DRUG
Control TreatmentAnother portion of participants receive the standard treatment to act as a baseline.
Amoxicillin
DRUG

About The Treatment

Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Amoxicillin
FDA approved

Side Effect Profile for Benzyl Penicillin

Benzyl Penicillin
Show all side effects
0%
Respiratory failure
0%
Congestive heart failure
0%
Hypovolemic shock
0%
Renal failure
Respiratory failure
0%
Congestive heart failure
0%
Hypovolemic shock
0%
Renal failure
0%
This histogram enumerates side effects from a completed 2013 Phase 3 trial (NCT01399723) in the Benzyl Penicillin ARM group. Side effects include: Respiratory failure with 0%, Congestive heart failure with 0%, Hypovolemic shock with 0%, Renal failure with 0%.

Eligibility

This trial is for patients born any sex aged 65 and younger. There are 4 eligibility criteria to participate in this trial as listed below.

Inclusion & Exclusion Checklist
Mark “yes” if the following statements are true for you:
Presence of respiratory symptoms (cough and/or dyspnea)
Presence of signs of pneumonia (tachypnea, abnormal breath sounds, crackles)
Presence of fever
Positive chest radiography as interpreted by the treating physician
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Odds of Eligibility
Unknown<50%
Be sure to apply to 2-3 other trials, as you have a low likelihood of qualifying for this one.Apply To This Trial
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Approximate Timelines

Please note that timelines for treatment and screening will vary by patient
Screening: ~3 weeks
Treatment: varies
Reporting: 1 month
Screening: ~3 weeks
Treatment: Varies
Reporting: 1 month
This trial has approximate timelines as follows: 3 weeks for initial screening, variable treatment timelines, and reporting: 1 month.
View detailed reporting requirements
Trial Expert
Connect with the researchersHop on a 15 minute call & ask questions about:
- What options you have available- The pros & cons of this trial
- Whether you're likely to qualify- What the enrollment process looks like

Measurement Requirements

This trial is evaluating whether Amoxicillin will improve 1 primary outcome and 6 secondary outcomes in patients with Pneumonia. Measurement will happen over the course of Day 10 (after enrolment).

Clinical failure within 10 days of enrolment
DAY 10 (AFTER ENROLMENT)
As a primary outcome, clinical failure will be defined by any of the following occurring within 10 days of enrolment: Death or hospitalisation A need for a change in antibiotic according to the treating physician. In our settings, common reasons to change antibiotic are: Persistence of fever at 72h Clinical deterioration: • Clinical deterioration will include the development of lower chest-wall indrawing, central cyanosis, stridor while calm, or danger signs as defined by: inability to drink or breastfeed, convulsions, persistent vomiting, lethargy, or unconsciousness at any time during a child's treatment. Development of a comorbid condition such as a meningitis, bacteriemia, osteomyelitis or septic arthritis Allergic reaction
DAY 10 (AFTER ENROLMENT)
Adverse events
10 DAYS
Any adverse event
10 DAYS
Patient's and parents satisfaction with the discharge instructions' provided and the ease of administration
10 DAYS
Measured on a likert scale through a telephone survey
10 DAYS
Emergency department revisit within 72 hours
72 HOURS
Return to the emergency department in the following 72 hours
72 HOURS
Clinical recurrence
1 MONTH
Another diagnosis of pneumonia
1 MONTH
Number of working days missed by caregivers or school/daycare days missed by patients
1 MONTH
Total number of days missed by caregivers or school/daycare days missed by the parents
1 MONTH
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Who is running the study

Principal Investigator
J. G.
Jocelyn Gravel, Principal investigator
St. Justine's Hospital

Patient Q & A Section

Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What are common treatments for pneumonia?

There is considerable variation in the management of pneumonia in community settings. Appropriate management of pneumonia depends on the site and severity of the infection and involves treatment with antibiotics where evidence of infection is present, supportive care such as oxygen supplementation or IV antibiotics where evidence is present, and discharge.

Anonymous Patient Answer

What are the signs of pneumonia?

Signs of pneumonia include malaise, dry cough, tachypnea and low level of oxygen. Abnormal chest radiographs and elevated levels of C-reactive protein are common among people admitted to hospital with a diagnosis. If the diagnosis is unknown, chest radiography is required to demonstrate pneumonia.

Anonymous Patient Answer

How many people get pneumonia a year in the United States?

Around 16 million US adults are diagnosed with pneumonia a year. The most common type of pneumonia is bacterial and viral pneumonia. The prevalence increases with age. It is a major cause of death in older adults. It is more prevalent in male than in female patients. The most common cause is is due to an unknown agent.

Anonymous Patient Answer

What causes pneumonia?

The exact cause of pneumonia is not clearly understood. A number of factors, including genetics, environment, inflammation, and infection by bacteria or viruses are thought to play a role. Inappropriate treatment may also make it harder to expel the infection from the lungs. The risk of complications is also increased for very young children and people who are immunocompromised. It is a common cause among people of all ages. It is most common in children between the ages of 0 and 9. It occurs most often in male children. People who are very young are more likely to be afflicted with pneumonic plague. Overall, pneumonia has the highest number of deaths of any human illness.

Anonymous Patient Answer

What is pneumonia?

Pneumonia is a common and dangerous lung infection that can cause high fever, chills, dizziness, and shortness of breath. It is the most common cause of death in the community. Its cause and cure have been unclear since ancient times. Pneumonia can be divided into four types. Each has its own character and treatment. Lung infection can be caused by a number of infectious agents including viruses, bacterium, and fungi. Pneumonia is also a frequent complication of chronic lung disease and a major health issue affecting a large minority of patients hospitalized with acute exacerbation of chronic bronchitis. It is the most common cause of death in ICU.

Anonymous Patient Answer

Can pneumonia be cured?

Pneumonia is always a danger of dying. Treatments can improve outcomes of those who have a chronic illness. For every 1-decrease in mortality associated with pneumonia, 12-increase in life expectancy is observed.

Anonymous Patient Answer

What is amoxicillin?

In clinical practice, amoxicillin is frequently used, but it is not always as effective as first-generation drugs in the treatment of community-acquired pneumonia. It can be administered as an alternative to first-generation drugs in cases of resistance; the most commonly reported mutations are in the 'Q' penicillin-binding proteins. Further studies with adequate treatment lengths are needed before it can become a therapeutic option alone.

Anonymous Patient Answer

Does amoxicillin improve quality of life for those with pneumonia?

In this population with moderate or advanced pneumonias, no improvement in HRQoL was observed with amoxicillin versus placebo. The fact that most people in this study were frail, the small number of patients in each trial and the heterogeneity of treatment allocation ratios in previous trials make these findings inconclusive. However, this study demonstrates that the absence of any negative impact on HRQoL following treatment failure in this frail and heterogeneous population may be important, and suggests that the use of amoxicillin should be considered in this group.

Anonymous Patient Answer

What are the latest developments in amoxicillin for therapeutic use?

While the newer amoxicillin formulations have their share of advantages over older formulations, there is no major advantage of using new formulations; in general, newer formulations offer the same (or slightly better) clinical effect as amoxicillin and at lower cost. Thus, the choice between different formulations should not be based on potential advantages of using newer formulations.

Anonymous Patient Answer

What is the latest research for pneumonia?

The current research for pneumonia is primarily directed to the treatment of pneumonia, the diagnosis and management of pneumonia, and the prevention of pneumonia in immunocompromised people.

Anonymous Patient Answer

Have there been other clinical trials involving amoxicillin?

In the last 7 yr, there were many small trials. Almost all were published by non-American authors. Most trials were based in North America or Europe. There was no information regarding the publication of trials involving amoxicillin and treatment of acute respiratory infections. There is a strong need for a review to describe the current status of the use of amoxicillin in acute respiratory infections.

Anonymous Patient Answer
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