Fungal Infections

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Fungal Infections

General Purpose:

Fungi prefer to live in moist areas, which make certain locations of the body – including the toes, genitals, and underneath the breasts – prone to a number of common infections. Although fungal skin infections can affect anyone, obese individuals and those who have diabetes are more susceptible than others.

Yeast infections are a common type of fungal infection and are caused by the fungus Candida. They can lead to rashes, itching, and scaling of the affected areas. Yeast infections are more likely to occur during hot and humid weather, while wearing tight, synthetic underwear, and among individuals with poor hygiene.

In addition, certain medications can also promote the growth of fungi that lead to yeast infections. In most cases, yeast infections can usually be successfully treated through the use of antifungal creams or oral antifungal medications; however, for individuals with weakened immune systems, yeast infections can become system-wide and life-threatening if not properly treated.

Ringworm (also known as tinea) is another common fungal skin infection, and is caused by a number of different fungi. Ringworm is usually classified according to its location on the body. Although Ringworm is often associated with the appearance of a ring-shaped rash, other symptoms include scaling and itching, and they frequently vary depending on the location of the infection.

Tinea pedis, commonly known as athlete’s foot, is associated with redness and itching, as well as cracking of the skin. If not treated properly, athlete’s foot can lead to bacterial infection, in particular among older individuals and those who have insufficient blood flow to their feet.

“Jock itch” (tinea cruris) and scalp ringworm (tinea capitis) are also related infections, the latter of which is highly contagious and common among children. Tinea versicolor refers to an infection with the fungus Malassezia furfur, which affects the top layer of the skin and results in scaly, discolored patches.

These patches are generally asymptomatic, but can grow larger over time. Although effective treatments are available to treat the underlying fungal infection, skin may not regain its normal color for a long period of time following treatment.

Research related to fungal skin infections is constantly seeking to develop more effective anti-fungal medications, as well as to evaluate methods of preventing infections and minimizing their complications among at-risk individuals.

What Will Fungal Skin Infection Clinical Trials Be Like?

The types of procedures used in fungal skin infection clinical trials will ultimately depend on the specific nature of the study, the type of fungi being studied, and the specific aspect(s) of the associated symptoms. Provided below is a list of common procedures, tests, and assessments that may be incorporated into fungal skin infection clinical trials:

  • Detailed physical examination
  • Skin or hair biopsy
  • Blood tests
  • You may also be asked to avoid wearing lotions, perfumes, colognes, or scented make-up on the day(s) of your appointment.
  • Use of lotions, creams, oral medications, or laser light therapy
  • Photography of the skin

Typical Fungal Skin Infection Clinical Trial Protocol:

Specific examples of clinical trials for fungal skin infections might include the following:

  • A clinical trial to determine if a topical anti-fungal cream, applied once a day for four weeks in between each toe of the affect foot/feet, is effective and safe at treating athlete’s foot in men and women.
  • A randomized clinical trial in which a standard oral antifungal therapy plus a new topical antifungal medication is collectively more effective at treating severe vaginal yeast infections when compared to standard oral antifungal therapy plus a placebo topical medication.
  • A study to determine if a personal hygiene educational intervention is effective at reducing the rate of athlete’s foot among high school athletes.
  • A long-term study conducted in newborn babies and infants to determine if repeated use of a standard topical anti-fungal cream to treat diaper rash causes the yeast to become resistant to the medication over a two year period.

A brief word about randomized trials and placebos:

Many clinical trials involve the comparison of an investigational treatment to a “standard” treatment. Some studies determine which therapy a patient receives through a process known as randomization, in which patients are randomly assigned to receive either the investigational treatment or the standard treatment.

On occasion, a trial will investigate the use of a standard treatment plus a new drug compared to standard treatment plus a placebo (such as the second clinical trial example provided above). Placebos are inactive or “sham” treatments that are identical in appearance to the active treatment but have no therapeutic value.

Placebos are necessary to help determine if adverse effects that occur during the clinical trial are the result of the investigational treatment or due to some other factor. They also allow researchers to measure the effects of the active treatment and observe what would have happened without it.

In rare instances where no standard therapy exists, or when a new drug or therapy is being investigated, the investigational treatment might be compared to a placebo alone. In these types of trials, those patients who are randomized to the placebo group do not receive an active treatment.

It is important to know that placebo-only trials are only conducted when scientifically necessary and when patients have been adequately informed that they may end up receiving the placebo rather than the active treatment. It is very important to note, however, that no one should ever participate in such a placebo trial when there is a widely available and highly effective standard treatment already in existence for their particular disease or condition.

Trial Eligibility and Medical Information Needed:

The type of clinical trial you may be eligible for often depends on many factors, including the type of fungal skin infection you have. Therefore, it is important to know as many details as possible with regard to your specific circumstances when searching for clinical trials.  Examples of information you may want to have on hand include the following:

  • The type of infection you have, and associated fungi (if known)
  • Your prior and current diagnoses of any other health conditions or diseases
  • Your current medications (including vitamins, minerals, and other dietary supplements)

Suggested Search Terms: 

Once you are ready to begin your search for clinical trials for fungal skin infections, it is advisable to search using your particular diagnosis (i.e., athlete’s foot, vaginal yeast infection, ringworm, etc.) followed by any of these terms: “treatment,” “prevention,” “children,” “pediatric,” “hygiene,” “diabetes,” “obesity,” “medication,” and “complications.”

Current Search Term:

“Fungal Infections”

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Association of Plasma Transfusions and Invasive Fungal Infection


Conditions:   Plasma Administration;   Invasive Fungal Infection;   Neonatal Infection
Interventions:   Drug: plasma transfusions;   Drug: non-plasma transfusions
Sponsor:   Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
Recruiting - verified May 2017


Safety, Pharmacokinetics, Bioavailability, Food Effect, Drug-Drug Interaction Study of APX001 Administered Orally


Condition:   Fungal Infection
Interventions:   Drug: APX001 single IV dose;   Drug: APX001 single oral dose 1;   Drug: APX001 single oral dose 2;   Drug: APX001 single oral dose 3;   Drug: APX001 single oral dose fasted;   Drug: APX001 single oral dose fed;   Drug: APX001 multiple oral doses 1;   Drug: APX001 multiple oral doses 2;   Drug: APX001 multiple oral doses 3;   Drug: Cytochrome P450 substrates;   Drug: Matching placebo control
Sponsor:   Amplyx Pharmaceuticals
Active, not recruiting - verified March 2017


Safety, Tolerability and Pharmacokinetics of APX001 Administered Intravenously


Condition:   Fungal Infection
Interventions:   Drug: APX001 single dose 1;   Drug: APX001 single dose 2;   Drug: APX001 single dose 3;   Drug: APX001 single dose 4;   Drug: APX001 single dose 5;   Drug: APX001 single dose 6;   Drug: APX001 multiple dose 1;   Drug: APX001 multiple dose 2;   Drug: APX001 multiple dose 3;   Drug: APX001 multiple dose 4;   Drug: Matching Placebo
Sponsor:   Amplyx Pharmaceuticals
Recruiting - verified November 2016


Safety and Effectiveness of A-dmDT390-bisFv(UCHT1) Fusion Protein in Subjects With Mycosis Fungoides


Condition:   Mycosis Fungoides
Interventions:   Biological: A-dmDT390-bisFv(UCHT1);   Drug: Vorinostat
Sponsors:   Angimmune LLC;   City of Hope National Medical Center;   Columbia University;   Dana-Farber Cancer Institute;   Feinberg School of Medicine, Northwestern University;   H. Lee Moffitt Cancer Center and Research Institute;   Ohio State University Comprehensive Cancer Center;   Rush University Medical Center;   Scott and White Hospital & Clinic;   Yale University;   Stanford University;   Thomas Jefferson University;   University of Arkansas;   University of Colorado Denver School of Medicine Barbara Davis Center;   University of Texas Southwestern Medical Center;   University of Washington;   Vanderbilt University School of Medicine;   Washington University School of Medicine
Not yet recruiting - verified October 2016


Study of the Level of a Protein Which Could Predict the Development of a Fungal Infection in Patients With Acute Leukemia


Conditions:   Acute Leukemia;   Invasive Fungal Infection
Intervention:   Biological: blood sample
Sponsor:   Centre Hospitalier Universitaire Dijon
Completed - verified June 2016


Vfend Special Investigation For Prophylaxis


Condition:   Fungal Infection
Intervention:  
Sponsor:   Pfizer
Active, not recruiting - verified May 2017


Clinical Study Assessing Outcomes, Adverse Events, Treatment Patterns, and Quality of Life in Patients Diagnosed With Mycosis Fungoides Cutaneous T-cell Lymphoma


Condition:   Mycosis Fungoides
Intervention:   Drug: Valchlor
Sponsor:   Actelion
Recruiting - verified November 2016


MT2013-37R: Voriconazole Monitoring in Pediatric Stem Cell Transplant Patients


Condition:   Fungal Infection
Intervention:   Drug: Voriconazole
Sponsor:   Masonic Cancer Center, University of Minnesota
Recruiting - verified November 2016


Pharmacokinetics and Safety of Posaconazole Tablet in Participants at High Risk for Invasive Fungal Infections (MK-5592-065/P05615)


Condition:   Fungal Infections
Interventions:   Drug: Posaconazole 200 mg;   Drug: Posaconazole 300 mg
Sponsor:   Merck Sharp & Dohme Corp.
Completed - verified March 2017


Fungiscope - A Global Emerging Fungal Infection Registry


Condition:   Invasive Fungal Disease
Intervention:  
Sponsors:   University of Cologne;   Astellas Pharma GmbH;   Gilead Sciences;   Merck Sharp & Dohme Corp.;   Pfizer;   Basilea Pharmaceutica
Recruiting - verified July 2016


A Study of the Safety, Tolerance, and Pharmacokinetics of Oral Posaconazole in Immunocompromised Children (P03579)


Condition:   Fungal Infections
Interventions:   Drug: Posaconazole 12 mg/kg/day BID;   Drug: Posaconazole 18 mg/kg/day BID;   Drug: Posaconazole 18 mg/kg/day TID;   Drug: Posaconazole 12 mg/kg/day TID
Sponsor:   Merck Sharp & Dohme Corp.
Terminated - verified March 2017


A Pharmacokinetic Analysis of Posaconazole in Lung Transplant Recipients (MK-5592-105)


Condition:   Fungal Infection
Interventions:   Drug: Posaconazole;   Drug: Calogen®
Sponsor:   Merck Sharp & Dohme Corp.
Terminated - verified March 2017


PUVA Maintenance Therapy in Mycosis Fungoides


Condition:   Patch/Plaque Stage Mycosis Fungoides
Intervention:   Drug: 8-methoxypsoralen
Sponsor:   Medical University of Graz
Active, not recruiting - verified January 2017


Caspofungin Acetate, Fluconazole, or Voriconazole in Preventing Fungal Infections in Patients Following Donor Stem Cell Transplant


Conditions:   Fungal Infection;   Hematopoietic/Lymphoid Cancer
Interventions:   Drug: caspofungin acetate;   Drug: fluconazole;   Drug: voriconazole;   Other: laboratory biomarker analysis
Sponsors:   Children's Oncology Group;   National Cancer Institute (NCI)
Active, not recruiting - verified January 2017


A Trial Comparing Efficacy and Safety of Voriconazole Administered With Therapeutic Drug Monitoring vs. Standard Dosing


Condition:   Fungal Infection
Intervention:   Drug: Prospective TDM Arm
Sponsors:   Johns Hopkins University;   Pfizer
Completed - verified July 2016


Assessment of the Fungal Infection Incidence Across Canada for High Risk Participants With Hematological Disease (P07501)


Conditions:   Mycoses;   Leukemia
Intervention:   Other: Standard Care
Sponsors:   Merck Sharp & Dohme Corp.;   McGill University Health Center
Completed - verified September 2016


Pharmacokinetics, Safety, and Tolerability of Intravenous Posaconazole Solution Followed by Oral Posaconazole Suspension in Subjects at High Risk for Invasive Fungal Infections (P05520)


Condition:   Fungal Infection
Interventions:   Drug: Posaconazole;   Drug: Dextrose 5% in water
Sponsor:   Merck Sharp & Dohme Corp.
Completed - verified March 2017


Posaconazole Treatment of Invasive Fungal Infection (IFI) (P05551)


Condition:   Fungal Infection
Intervention:   Drug: Posaconazole
Sponsor:   Merck Sharp & Dohme Corp.
Completed - verified March 2017


Single Patient Treatment of Posaconazole in Invasive Fungal Infections (Study P05113)(COMPLETED)


Condition:   Mycoses
Intervention:   Drug: Posaconazole
Sponsor:   Merck Sharp & Dohme Corp.
Completed - verified March 2017


A Study to Examine the Efficacy and Safety of Posaconazole When Introduced Early in the Treatment of Refractory Fungal Infections (P05090 AM2)


Condition:   Mycoses
Intervention:   Drug: Posaconazole
Sponsors:   Merck Sharp & Dohme Corp.;   JSS Medical Research Inc.
Completed - verified March 2017


Phase I/II Study of Intratumoral Injection of CPG 7909, a TLR9 Agonist, Combined With Local Radiation for Patients With Recurrent Mycosis Fungoides.


Condition:   Mycosis Fungoides
Intervention:   Drug: CPG 7909
Sponsors:   Stanford University;   National Institutes of Health (NIH)
Withdrawn - verified November 2016


Stem Cell Transplant Therapy With Campath-1H for Treating Advanced Mycosis Fungoides and Sezary Syndrome


Conditions:   Mycosis Fungoides;   Sezary Syndrome
Intervention:   Drug: Campath-1H
Sponsor:   National Heart, Lung, and Blood Institute (NHLBI)
Active, not recruiting - verified March 31, 2017


Study of Posaconazole in the Treatment of Invasive Fungal Infections (Study P02095)


Condition:   Mycoses
Intervention:   Drug: Posaconazole oral suspension
Sponsor:   Merck Sharp & Dohme Corp.
Completed - verified March 2017


Open Label Study of Posaconazole in the Treatment of Invasive Fungal Infections (Study P00041)


Condition:   Mycoses
Intervention:   Drug: Posaconazole
Sponsor:   Merck Sharp & Dohme Corp.
Completed - verified March 2017


Surveillance of Fungal Infections in Bone Marrow/Stem Cell and Organ Transplant Recipients


Condition:   Fungus Disease
Intervention:  
Sponsor:   National Cancer Institute (NCI)
Completed - verified July 17, 2012

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