CLINICAL TRIAL

DOXY for Phlegmon

1 Prior Treatment
Relapsed
Recruiting · Any Age · All Sexes · Saint Louis, MO

This study is evaluating whether two different antibiotics work equally well at curing skin infections.

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About the trial for Phlegmon

Eligible Conditions
Infections · Soft Tissue Infections · Methicillin-resistant Staphylococcus Aureus · Cellulitis · Communicable Diseases · Skin Diseases, Infectious · Skin Infections

Treatment Groups

This trial involves 2 different treatments. DOXY 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 2 and have already been tested with other people.

Experimental Group 1
TMP-SMX
DRUG
Experimental Group 2
DOXY
DRUG

Eligibility

This trial is for patients born any sex of any age. You must have received 1 prior treatment for Phlegmon or one of the other 6 conditions listed above. There are 10 eligibility criteria to participate in this trial as listed below.

Inclusion & Exclusion Checklist
Mark “yes” if the following statements are true for you:
as required The participants were willing and able to complete the study protocol and visits as required. show original
The patient must be able to complete the informed consent process or, if a minor, a parent or guardian who is able to complete the informed consent process show original
old The study looked at 9-year-olds to 85-year-olds. show original
Erythema
Swelling or induration
Local warmth
Purulent drainage
Tenderness to palpation or pain
Pus or drainage from wound that can be sent for clinical culture
This person is able to take oral antibiotic therapy in either pill or suspension form. 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

Approximate Timelines

Please note that timelines for treatment and screening will vary by patient
Screening: ~3 weeks
Treatment: varies
Reporting: Day 2-3 (48-72 hours)
Screening: ~3 weeks
Treatment: Varies
Reporting: Day 2-3 (48-72 hours)
This trial has approximate timelines as follows: 3 weeks for initial screening, variable treatment timelines, and reporting: Day 2-3 (48-72 hours).
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 DOXY will improve 1 primary outcome and 7 secondary outcomes in patients with Phlegmon. Measurement will happen over the course of Day 7.

Clinical cure at the End of Treatment (EOT) visit
DAY 7
Clinical cure will be defined as complete or nearly complete resolution of baseline signs and symptoms of the primary infection such that no further treatment with antibiotics is needed
DAY 7
Relapse/recurrent SSTI at One Month Follow-Up (OMFU)
DAY 37
Relapse will be defined as a return of the original infection after initial improvement prior to or at the OMFU visit. Recurrence will be defined as a return of skin infection at the original site, even if considered to be a separate occurrence, after the OMFU visit or a skin infection at a new site of infection.
DAY 37
Clinical cure at the One Month Follow-up (OMFU) visit
DAY 37
Clinical cure will be defined as complete or nearly complete resolution of baseline signs and symptoms of the primary infection such that no further treatment with antibiotics is needed
DAY 37
Relapse/recurrent SSTI at 6 Month Follow-Up (6MFU)
DAY 180
Relapse will be defined as a return of the original infection after initial improvement prior to or at the 6MFU visit. Recurrence will be defined as a return of skin infection at the original site, even if considered to be a separate occurrence, after the 6MFU visit or a skin infection at a new site of infection.
DAY 180
Adverse events that are treatment limiting
DAY 0-365
An adverse event (AE) is defined as any unfavorable or undesirable effect (sign, symptom, laboratory abnormality, or condition), regardless of causal relationship to study procedures or participation that occurs in a subject while enrolled in this clinical trial. Any medical condition that is present at the time that the subject is screened should be considered as baseline and not reported as an AE. However, if it deteriorates at any time during the study, it should be recorded as an AE. The occurrence of an AE may come to the attention of study personnel during study visits and interviews of a study recipient presenting for medical care, or upon review by a study monitor.
DAY 0-365
Adverse events
DAY 0-365
An adverse event (AE) is defined as any unfavorable or undesirable effect (sign, symptom, laboratory abnormality, or condition), regardless of causal relationship to study procedures or participation that occurs in a subject while enrolled in this clinical trial. Any medical condition that is present at the time that the subject is screened should be considered as baseline and not reported as an AE. However, if it deteriorates at any time during the study, it should be recorded as an AE. The occurrence of an AE may come to the attention of study personnel during study visits and interviews of a study recipient presenting for medical care, or upon review by a study monitor.
DAY 0-365
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Who is running the study

Principal Investigator
l. g. m.
loren g miller, Principal Investigator
Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center

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 causes phlegmon?

Phlegmon presents with a variety of causes. It may be caused by the overuse of the posterior subcutaneous fat, which leads to the deposition of excess fluid in the intermuscular region of the buttocks, thus resulting in a phlegmatous swelling. It may also be the result of the deposition of a foreign substance such as suture material in this region. This article should help to dispel the false belief that it is a result of the anus becoming infected.

Anonymous Patient Answer

What are common treatments for phlegmon?

It is unclear if leech therapy prevents phlegmon. The use of the antibiotic erythromycin (brand name erythromycin diosmin tablets) to treat phlegmon is also unclear. There is some evidence that antibiotics may hasten the resolution. There is no good evidence that leech therapy is beneficial or harmful for phlegmon. There are no good evidence to support leech therapy as a treatment for phlegmon. There is little evidence to support the use of antibiotics in the treatment of phlegmon. Evidence on which to base recommendations for the use in chronic lymphedema is limited, and therefore not a good guide for treatment.

Anonymous Patient Answer

What is phlegmon?

Phlegmon is a disease of the superficial layers of the skin. It is a rash or papular eruption with discrete nodules resembling acne, typically on the face, neck, and chest. It is typically found in men over 50 and occurs at least once in about 25% of men during their lifetime. Symptoms usually develop abruptly 3 to 5 years ago and persist for 2 to 4 weeks. There is no known cause of phlegmon, but it is thought to be caused by some bacterial species that usually cause a noninfectious inflammation of the skin.

Anonymous Patient Answer

What are the signs of phlegmon?

The signs of phlegmon are fever, pain, erythema and swelling. Because the lesion usually occurs on the buttocks or the gluteal region, an initial diagnosis of sepsis requires a review of the entire body in the emergency department.

Anonymous Patient Answer

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

The American Cancer Society estimates about 60,300 new diagnoses of phlegmon will occur in 2022. Phlegmon, a type of cancer caused by irritation of the perineum, affects many different parts of the body during one type of infection. The American Cancer Society estimates more than 10,000 new cases of phlegmon will be diagnosed annually in the United States.\n

Anonymous Patient Answer

Can phlegmon be cured?

If phlegmon is recognized and treated within 48 hours of onset, there is good outcome. However, there is significant healing potential from one week to two weeks following diagnosis.

Anonymous Patient Answer

What does doxy usually treat?

[Doxyline was found the most frequently prescribed medication in all age groups; it accounted for 1 in 20 prescriptions, on average, for each age group, with no significant differences according to sex] [(Figure 1). The use of doxyline was much higher in male and/or the elderly relative to the use of other medications in all age groups. No significant differences were found in the use of other medications, according to sex, in all age groups. Recent findings are consistent with the greater use of doxyline in all age groups relative to other medications. In total, 9 medications were the most prescribed drugs in the study; they accounted for 1 in 10 prescriptions on average.

Anonymous Patient Answer

What are the latest developments in doxy for therapeutic use?

Doxies are a promising new tool in the treatment of psoriasis and psoriatic arthritis. In addition, the clinical efficacy of newer drugs is improving each year. This new generation of well tolerated agents presents many exciting possibilities for psoriatic patients.

Anonymous Patient Answer

How serious can phlegmon be?

The incidence of phlegmon is not uncommon, accounting for approximately 10 % of surgical biliary procedures. Complications of phlegmon can be very serious and the patient in extreme jeopardy. Results from a recent paper have clearly shown that a pre-existing medical condition like diabetes mellitus or chronic heart failure is an independent factor that substantially increases the risk of peri-procedural complications with biliary procedures. The incidence of complications were higher in patients with chronic liver disease and with a higher severity of liver disease at presentation.

Anonymous Patient Answer

What is the average age someone gets phlegmon?

There are few known risk factors and very little published literature on phlegmon. However, the results of this survey can help physicians to identify at-risk patients and help develop more targeted treatment algorithms.

Anonymous Patient Answer

How does doxy work?

The current study suggests that doxy treatment may inhibit collagen-induced inflammation caused by activated macrophages in an inflammatory arthritis model. The study showed that doxy treatment could be more effective if it is given during the resolution phase of inflammation.

Anonymous Patient Answer

What is the latest research for phlegmon?

We did find some good quality research on the topics of phlegmon and abscess; however, the literature for this topic is still lacking. While we have made progress in diagnostics and management of phlegmon, there is more room for improvement. Since there are few doctors who specialize in abscess care, it will take a lot of research from different specialties to see whether [it can be [practiced] as safely and as effectively as abscess care].

Anonymous Patient Answer
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