Oral Vancomycin for Relapse

Phase-Based Progress Estimates
3
Effectiveness
3
Safety
Infectious Disease Associates of Tampa Bay, Tampa, FL
Relapse+6 More
Oral Vancomycin - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This study is evaluating whether a common antibiotic may help prevent a common infection.

See full description

Eligible Conditions

  • Relapse
  • Clostridium Difficile Infection (CDI)
  • Clostridium Difficile Infection Recurrence

Treatment Effectiveness

Effectiveness Progress

3 of 3
This is further along than 93% of similar trials

Other trials for Relapse

Study Objectives

This trial is evaluating whether Oral Vancomycin will improve 1 primary outcome and 1 secondary outcome in patients with Relapse. Measurement will happen over the course of Day 0 - data will be collection upon enrollment.

90 days
Recurrence Rate
Day 0
Risk factors associated clostridium difficile infection recurrences

Trial Safety

Safety Progress

3 of 3
This is further along than 85% of similar trials

Other trials for Relapse

Side Effects for

Oral Vancomycin
Abdominal pain
25%
Syncope, altered mental status
13%
Volume overload
13%
Hypoxemia
13%
Headache, vertigo, nausea/vomiting
0%
C. difficile EIA positive stool sample
0%
This histogram enumerates side effects from a completed 2021 Phase 4 trial (NCT03388268) in the Oral Vancomycin ARM group. Side effects include: Abdominal pain with 25%, Syncope, altered mental status with 13%, Volume overload with 13%, Hypoxemia with 13%, Headache, vertigo, nausea/vomiting with 0%.

Trial Design

2 Treatment Groups

Study drug
1 of 2
Placebo
1 of 2
Experimental Treatment
Non-Treatment Group

This trial requires 130 total participants across 2 different treatment groups

This trial involves 2 different treatments. Oral Vancomycin is the primary treatment being studied. Participants will all receive the same treatment. Some patients will receive a placebo treatment. The treatments being tested are in Phase 4 and have been shown to be safe and effective in humans.

Study drug
Drug
Oral vancomycin 125mg twice a day prescribed for the duration of antibiotics
Placebo
Other
Matched placebo twice a day prescribed for the duration of antibiotics
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Vancomycin
FDA approved

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 90 days
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly 90 days for reporting.

Closest Location

Infectious Disease Associates of Tampa Bay - Tampa, FL

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. You must have received 1 prior treatment for Relapse or one of the other 6 conditions listed above. There are 5 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
Patients admitted to Tampa General Hospital or outpatients at Infectious Disease Associates of Tampa Bay clinics who are receiving systemic antibiotics and have a history of at least one episode of CDI.
Participants must at least 18 years of age to participate.
Participants must be able to understand and sign a written informed consent form prior to initiation of study procedures.
Expected to receive at least 3 days of systemic antibiotics.
Life expectancy greater than 6 months.

Patient Q&A Section

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

"The National Health Survey (NHES) estimates that around one fifth of all individuals with a history of cannabis use experience recurrent use, with as few as 3.8% of those experiencing more severe consequences. Data from a recent study suggest that the lifetime use may be considerably higher than reported from surveys. As such, the numbers may underestimate relapse rates, and highlight the need for improved surveillance and improved communication of relapse rates among service providers and their patients." - Anonymous Online Contributor

Unverified Answer

What are the signs of relapse?

"The symptoms of relapse in bipolar disorder have been discussed with a range of phenomenological descriptions. The evidence in the present study is consistent with the thesis that the manifestation of symptoms in bipolar disorder requires the coexistence of a psychotic episode during the depressive and manic phases. The authors also discuss the possibility that the experience of rebound manic symptoms, which feature prominently in some accounts, may have been influenced by the presence of cognitive biases. This article has been reproduced anonymously in accordance with its publication guidelines." - Anonymous Online Contributor

Unverified Answer

What is relapse?

"There are different ways that remission can be defined. There are no hard and fast rules and the individualized definition of the end point of treatment is important. In conclusion, to define a cure requires many variables of study, all of which must be taken into account to make a logical decision on treatment. A definitive "cure" does not exist and treatments are never fully perfect." - Anonymous Online Contributor

Unverified Answer

What causes relapse?

"The risk of relapse in patients with lung cancer is dependent on two factors, the initial tumor size and grade, and type of tumor (pTNM stage). Patients with surgically resected N2 NSCLC have a higher risk for relapse compared to patients with stage I NSCLC." - Anonymous Online Contributor

Unverified Answer

What are common treatments for relapse?

"Relapse is common in those who experience relapse after remission from their original depressive episode. Antidepressants may reduce this risk by about 36% in those with the most severe depressive disorder (MDD)." - Anonymous Online Contributor

Unverified Answer

Can relapse be cured?

"Despite initial success, relapse is a common occurrence. Relapse after ablation occurs in up to half of cases. Patients who are relapsing are usually receiving a new biologic agent. A more detailed definition of ablation of recurrence is required in this subgroup of patients to permit appropriate treatment." - Anonymous Online Contributor

Unverified Answer

What is the primary cause of relapse?

"The primary cause of relapses is unknown (as yet); however, some factors are hypothesized to play a role: 1) loss of treatment benefit 2) loss of treatment efficacy 3) loss of target engagement. If patients have more than one relapse, different causes should be considered for each relapse." - Anonymous Online Contributor

Unverified Answer

What is oral vancomycin?

"The usual definition of CVC is difficult to apply to these patients, given that they generally do not have any obvious sign of endocarditis on the initial clinical assessment. This issue may be overcome by defining oral vancomycin therapy as the first step in the treatment of endocarditis and then evaluating the requirement for its continuation or discontinuation on the basis of the presence or absence of clinical evidence of relapse." - Anonymous Online Contributor

Unverified Answer

Is oral vancomycin safe for people?

"Oral vancomycin is efficacious at the usual dosages for the treatment of bloodstream infections in pediatric patients, and is generally well tolerated. It may be used safely to treat localized infections." - Anonymous Online Contributor

Unverified Answer

Is oral vancomycin typically used in combination with any other treatments?

"In our study, the majority of subjects that were given oral vancomycin were also given at least one other treatments. Oral vancomycin has a clear therapeutic benefit and a better safety-effect profile when used as a monotherapy compared to when used in combination with other antibiotics." - Anonymous Online Contributor

Unverified Answer

What is the latest research for relapse?

"Currently, many patients experience remission of the cancer before the diagnosis of CLL. One of the main goals is to reduce the number of patients who experience a relapse and hopefully cure CLL. It is also a common sense that doctors aim to avoid treatment and medications that trigger severe side effects when the diagnosis of CLL is already made as early as possible." - Anonymous Online Contributor

Unverified Answer

What are the common side effects of oral vancomycin?

"Oral vancomycin is generally well tolerated and generally well tolerated by patients. In clinical practice, these side effects usually go into remission when vancomycin is stopped and patients are monitored regularly after this. There are no clear recommendations about when this should happen but it may be prudent to review and make changes to the vancomycin protocol if patients are unhappy or have problems with adherence or have experienced the side effects above." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
See if you qualify for this trial
Get access to this novel treatment for Relapse by sharing your contact details with the study coordinator.