Ridinilazole for Communicable Diseases

Phase-Based Estimates
2
Effectiveness
3
Safety
Hospital Universitario La Paz, Madrid, Spain
Communicable Diseases+3 More
Ridinilazole - Drug
Eligibility
< 18
All Sexes
Eligible conditions
Communicable Diseases

Study Summary

This study is evaluating whether ridinilazole is safe for adolescents and how ridinilazole is metabolized.

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Eligible Conditions

  • Communicable Diseases
  • Infections
  • Clostridium Infections
  • Clostridioides Difficile Infection

Treatment Effectiveness

Effectiveness Estimate

2 of 3
This is better than 85% of similar trials

Study Objectives

This trial is evaluating whether Ridinilazole will improve 4 primary outcomes, 7 secondary outcomes, and 3 other outcomes in patients with Communicable Diseases. Measurement will happen over the course of Day 1 through Study completion.

30 days post EOT
SCR based on clinical response - defined as clinical response with no recurrence assessed through 30 days post-EOT
Sustained clinical response (SCR) over 30 days post end of treatment (EOT)
Sustained clinical response (SCR) over 30 days post end of treatment (EOT) - defined as clinical cure at the assessment of cure (AOC) visit and no recurrence of CDI within 30 days post EOT
60 days post EOT
Sustained clinical response (SCR) over 60 days post end of treatment (EOT)
Sustained clinical response over 60 days post EOT
90 days post EOT
Sustained clinical response (SCR) over 90 days post end of treatment (EOT)
Sustained clinical response over 90 days post EOT
Day 100
Incidence and severity of treatment emergent adverse events
Medical resource utilization and health economics endpoints
Day 1
Incidence and severity of treatment-emergent adverse events (TEAEs)
Day 12
Clinical cure at the assessment of cure (AOC) visit
Clinical response at the AOC visit
Day 5
Fecal concentration of ridinilazole
Plasma concentration of ridinilazole

Trial Safety

Safety Estimate

3 of 3
This is better than 85% of similar trials

Trial Design

2 Treatment Groups

Vancomycin
Ridinilazole

This trial requires 40 total participants across 2 different treatment groups

This trial involves 2 different treatments. Ridinilazole 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 3 and have had some early promising results.

Ridinilazole
Drug
Ridinilazole dosed BID and a comparator placebo dosed QID, to maintain blind, for 40 doses over 10 days.
Vancomycin
Drug
Vancomycin dosed QID and a Ridinilazole placebo dosed BID, to maintain blind, for 40 doses over 10 days.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Ridinilazole
Not yet FDA approved

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: day 1 through study completion, an average of 100 days
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly day 1 through study completion, an average of 100 days for reporting.

Closest Location

Children's Hospital of Michigan - Detroit, MI

Eligibility Criteria

This trial is for patients born any sex aged 18 and younger. There are 2 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
Is between 12 and 18 years old. show original
The subject has diarrhea, and the investigator believes that the subject needs antimicrobial therapy for CDI show original

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 the signs of communicable diseases?

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Communicable diseases could be identified by a rapid febrile illness but also by a nonspecific signs and symptoms. The diagnosis of an individual communicable disease usually requires the presence of certain symptoms or signs. We are not sure how many cases were missed, and some of these cases would be easily manageable if patients are admitted to hospital early enough. To detect them effectively, guidelines for the hospital care of patients with infections were discussed, and some new guidelines for the care of people with mild symptoms were suggested.

Unverified Answer

How many people get communicable diseases a year in the United States?

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About 25 million Americans are infected annually with cholera, tuberculosis, anthrax, syphilis, and tetanus, for which prevention programs are funded by the Centers for Disease Control and Prevention and state Public Health Officers' Advisory Committee on Immunization Practices.

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What causes communicable diseases?

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communicable diseases can result from multiple causes. In many cases, the pathogenesis is poorly understood; therefore, preventive efforts are rarely possible. However, in some cases, effective interventions can lower burden of disease and increase public health.

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What are common treatments for communicable diseases?

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The health-care providers and patients typically choose from several options, and thus the choice of available treatments typically varies widely. These options serve specific purposes, but they may also be combined to serve a particular function. The available evidence suggests that, in terms of health benefits, some combinations offer a clear advantage. The quality of available evidence on the treatments for some diseases and conditions is far inadequate and it will be necessary to refine this through further research and clinical trials of more refined design.

Unverified Answer

What is communicable diseases?

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The WHO is committed for the eradication of the diseases and to improving the health condition for the global population. Communicable diseases such as AIDS, Tuberculosis and Malaria are public health problem all over the world.\n• Epidemiology of malaria in Bangladesh (2017): The number of malaria cases in Bangladesh increased from 393 in 2010 to 4897 in 2017/2017. The number of deaths due to malaria in Bangladesh also decreased from 27/100,000 to 22/100,000 in 2017/2017. The trend of deaths due to malaria was increasing in this span of time.

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Can communicable diseases be cured?

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Infectious diseases of public health significance can be controlled but cannot be cured, as such control and eradication efforts are beyond the capability of state and federal health services. This limitation may be of limited public health significance, but the lack of a strategy for elimination of public health priority communicable diseases, while they are still in existence, suggests that the elimination of some diseases could be possible.

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Does communicable diseases run in families?

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Infectious diseases and cancer may increase in family members who are first-degree relatives of individuals with such diseases, but not in relatives who are second-degree relatives.

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How serious can communicable diseases be?

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The number of deaths in an epidemiological study can be misleading. The most important factor in interpreting the results is an accurate calculation of the case fatality ratio. Deaths in the study must then be confirmed as being unrelated to the exposure to be reliable.

Unverified Answer

Who should consider clinical trials for communicable diseases?

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Physicians participating in a clinical trial for a infectious disease may underestimate both the cost benefits of treatment of their patients and the burden of their illness. Physicians and public health officials must be educated about the potential risks of conducting trials for communicable diseases.

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Has ridinilazole proven to be more effective than a placebo?

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In a recent study, findings shows the value of randomized controlled studies for evaluating the efficacy of new therapeutic interventions for patients with infectious diseases, which are difficult to treat with conventional strategies.

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What does ridinilazole usually treat?

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Ridinilazole usually treats the following disease: bronchopulmonary obstruction caused mainly by aspergillus or by Pseudallescheria. It is usually ineffective in the following diseases: asthma, pneumonia, and other causes of respiratory tract infection. Ridinilazole can treat sepsis and bacteremia caused mainly by Pseudallescheria or A. fumigatus. It is usually ineffective in the following diseases: atypical pneumonia and other pneumonias, cellulitis, wound infection, and urinary tract infection. Ridinilazole can also treat skin disease caused mainly by yeasts, such as tinea versicolor.

Unverified Answer

Is ridinilazole typically used in combination with any other treatments?

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Using a combination of ridinilazole with other antibiotics was found to be uncommon. Ridaforolimus and mycophenolic acid have been used extensively in an immunosuppressive setting. Although not tested in the United Kingdom, the results are similar to reports from USA and Germany.

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