CLINICAL TRIAL

Omadacycline Injection [Nuzyra] for Bacterial Infections

Recruiting · < 18 · All Sexes · Little Rock, AR

Study to Evaluate the PK of IV and PO Omadacycline in Children and Adolescents With Suspected or Confirmed Bacterial Infections

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About the trial for Bacterial Infections

Eligible Conditions
Bacterial Infections · Infections · Communicable Diseases

Treatment Groups

This trial involves 2 different treatments. Omadacycline Injection [Nuzyra] is the primary treatment being studied. Participants will be divided into 2 treatment groups. There is no placebo group. The treatments being tested are in Phase 1 and are in the first stage of evaluation with people.

Experimental Group 1
Omadacycline Injection [Nuzyra]
DRUG
+
Omadacycline Oral Tablet
DRUG
Experimental Group 2
Omadacycline Injection [Nuzyra]
DRUG
+
Omadacycline Oral Tablet
DRUG

Eligibility

This trial is for patients born any sex aged 18 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:
Male or female subjects, age 8 to < 18 (inclusive) who have written and signed parental/legal authorized representative (LAR) informed consent and pediatric assent.
Currently hospitalized with a suspected or confirmed bacterial infection and receiving or planned to receive systemic antibiotic therapy other than omadacycline.
Weight within the 5th and 95th percentile for age and sex.
Subjects must not be pregnant or nursing at the time of enrollment, and must agree to use a highly effective birth control method during the study. show original
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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: Pre-dose, and 0.5, 1, 2, 8, and 24 hours post-dose
This trial has approximate timelines as follows: 3 weeks for initial screening, variable treatment timelines, and reporting: Pre-dose, and 0.5, 1, 2, 8, and 24 hours post-dose.
View detailed reporting requirements
Trial Expert
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- 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 Omadacycline Injection [Nuzyra] will improve 2 primary outcomes and 4 secondary outcomes in patients with Bacterial Infections. Measurement will happen over the course of From the time of signing the informed consent form up to study completion visit (up to 9 days).

Vital signs
FROM THE TIME OF SIGNING THE INFORMED CONSENT FORM UP TO STUDY COMPLETION VISIT (UP TO 9 DAYS)
Number of participants with clinically significant changes from baseline in vital signs
Adverse events and serious adverse events
FROM THE TIME OF SIGNING THE INFORMED CONSENT FORM UP TO STUDY COMPLETION VISIT (UP TO 9 DAYS)
Incidence, severity, and type of adverse events and serious adverse events
Clinical laboratory tests
FROM THE TIME OF SIGNING THE INFORMED CONSENT FORM UP TO STUDY COMPLETION VISIT (UP TO 9 DAYS)
Number of participants with abnormal clinical laboratory tests
Physical examination
FROM THE TIME OF SIGNING THE INFORMED CONSENT FORM UP TO STUDY COMPLETION VISIT (UP TO 9 DAYS)
Number of participants with clinically significant abnormal physical examination findings
Characterize the PK of a single PO dose of omadacycline in children and adolescents 8 to < 18 years of age with suspected or confirmed bacterial infections
PRE-DOSE, AND 1, 2, 3, 8, AND 24 HOURS POST-DOSE
Plasma concentrations of omadacycline for PK analysis from Day 1 to Day 2
Characterize the PK of a single IV dose of omadacycline in children and adolescents 8 to < 18 years of age with suspected or confirmed bacterial infections
PRE-DOSE, AND 0.5, 1, 2, 8, AND 24 HOURS POST-DOSE
Plasma concentrations of omadacycline for PK analysis from Day 1 to Day 2

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 bacterial infections?

Most patients with bacterial infections receive antibiotics. While some patients will not benefit from antibiotics, other patients may benefit from antibiotic treatment. More importantly, the data suggest that patient populations and patient preferences might affect antibiotic use and outcomes. With this knowledge, physicians, health policy makers, and patients may use this information when implementing effective treatment guidelines and guidelines for preventive strategies.

Anonymous Patient Answer

What is bacterial infections?

Bacterial infections may be the cause of most diseases and death in the world. Infectious diseases can be acquired by living in an area where one can be exposed to and get infected by a pathogen. There are many diseases, which can be prevented in the future if we use our skills and knowledge properly. Preventive measures include proper hygiene and cleanliness, using the latest equipment and tools, regular physical check-ups for example for a regular blood test. Vaccines also prolong the average life of an animal or human. If the illness is not already present, the treatment is usually to eliminate the pathogen. Preventive measures can be used in the future to help solve the problems associated with bacterial infections.

Anonymous Patient Answer

Can bacterial infections be cured?

Bacterial infections are uncommon in normal human populations. Bacterial infections in immunocompromised hosts are sometimes due to treatment of opportunistic bacterial infections. Antibiotic therapy can sometimes be highly effective in reducing or eliminating bacterial infections.

Anonymous Patient Answer

What causes bacterial infections?

The risk of developing bacterial infections is increased in those with diabetes, age > 85, a history of neutropenia, CVC, prolonged hospitalization, chronic renal disease, chronic lung disease, malignancy, SIRS, major surgeries, malignancy, liver dysfunction, and older age (> 65 yrs). It is important to keep your health by taking your medication correctly, not eating foods high in saturated fat or red meats, and drinking plenty of water every day. In addition, you should not smoke, as smoking slows down recovery from disease.

Anonymous Patient Answer

How many people get bacterial infections a year in the United States?

Around 1 million people were hospitalized for bacterial infections in 2008. Each year, approximately 20,000 people are hospitalized from an acute bacterial infections. About 609,600 infections per year are suspected to be acquired in the community by health-care-related sources. Infectious causes of hospitalization (i.e. pneumonia, urinary tract infections, and sepsis) represented 22.7 percent of all hospitalizations in 2008. Inpatient care accounted for 79.8% of hospitalizations in 2008 resulting in 23.6% of hospitalizations being hospital-acquired. The most frequent hospital-acquired infection is pneumonia, responsible for 7,800 deaths.

Anonymous Patient Answer

What are the signs of bacterial infections?

The signs associated with bacterial infections may differ depending on the type of infection. Common symptoms that may arise would be fever and chills, muscle aches, weight loss, headache, feeling tired, difficulty sleeping, or nausea.

Anonymous Patient Answer

What does omadacycline injection [nuzyra] usually treat?

These studies are in development for omadacycline's potential treatment of a variety of infectious gastrointestinal diseases, including Clostridium difficile-associated diarrhea and other antibiotic-associated infectious diarrhea... One interesting possibility of omadacycline in treating infectious diarrhea is its ability to treat all causes of Clostridium difficile-associated diarrhea—other microbes can even be the initial cause of the illness. But we don’t know which route (by mouth or by injection) it will most effectively treat or treat best or how long it will be effective by injection.

Anonymous Patient Answer

Does bacterial infections run in families?

The present population-based survey suggests that children's healthcare use is strongly influenced by their parents' healthcare utilization. These associations differ depending on their mother's age: this finding may have important implications in deciding the timing of routine childhood immunizations.

Anonymous Patient Answer

How serious can bacterial infections be?

The majority of bacterial infections presented at the ED are minor; however, these diagnoses often require follow up because of their significant health effects. Patients suffering from an inducible bacterial infection might benefit from antibiotic therapy and intravenous fluids.

Anonymous Patient Answer

What is the average age someone gets bacterial infections?

Nearly 25 million cases of bacterial infections occur in the United States each year. Approximately one third of these cases result in hospitalization and one sixth of these instances lead to death. Nearly a quarter of these infections will be due to community-acquired infections such as [Clostridium difficile Infection (CDI)] which may be life-threatening. With the increase in [CDI] incidence across the United States is the incidence of hospital-acquired infections also increasing. The data collected here show not only that bacterial infections are becoming an increasing issue for patients in the U.S., but they are also becoming a larger health crisis internationally.

Anonymous Patient Answer

What are the common side effects of omadacycline injection [nuzyra]?

Side effects of omadacycline are similar to those of other second-generation tetracyclines and are generally mild. Most side effects are not severe and resolve fairly quickly. The infrequent, but not rare, side effects of omadacycline are: erythema multiforme, fever, erythema with increased skin pigmentation, urticaria, nausea, vomiting, constipation, and diarrhea. Mild, sometimes protracted diarrhea, which is a usual dose-related effect of all tetracycline antibiotics, may be experienced in some patients. Patients' baseline characteristics are the most important predictors of side effects.

Anonymous Patient Answer
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