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Gram-positive, Skin InfectionsPhase 2NCT01223222

A Study to Evaluate Safety, Tolerability and Efficacy of Lytixar™ (LTX-109) on Uncomplicated, Gram-positive, Skin Infection

A Phase 2 study testing LTX-109 in people with Gram-positive, Skin Infections and Mild Eczema/Dermatoses, run by Lytix Biopharma AS at 4 sites in Hungary.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The purpose of this study is to evaluate the safety and tolerability of Lytixar™ applied topically to uncomplicated skin infections. Three dose levels of Lytixar™ (1%, 2% and 5%) versus placebo will be tested. Read more about this study

Who is it for?
Ages 18 to 65 years
What is being tested?
LTX-109
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
24 participants
Where
4 sitesHungary
Study dates
Sep 2010to Feb 2011
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Male and female patients between the ages of 18 and 65, inclusive.
  • Diagnosis of uncomplicated, Gram-positive, skin infection. This may include patients with mild eczema/dermatoses such as atopic dermatitis.
  • Gram-positive organisms determined at Baseline (Day 1) which in the opinion of the investigator are causative for infection of the lesion(s).
  • Candidate for treatment with topical antibacterial therapy:
  • area to be treated ≤100 cm2
  • SIRS score of at least 8 for the area of study medication application
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  • Female patients of child bearing potential and male patients with female partners of child-bearing potential must be willing to use an adequate barrier form of contraception, (i.e., diaphragm or condom with spermicidal agent) prior to entry into the study and for two weeks following the completion of all follow-up procedures. Hormonal contraception or hormonal IUDs alone are not considered to be acceptable forms of contraception.
  • Provision of signed and dated written informed consent by the patient.
  • Patient's medical condition is stable, with no other clinically significant abnormalities as determined by the investigator.
  • Patients must be able to understand the written patient information and the consent form, and be willing to return to the study site for follow up visits, comply with requirements, instructions and restrictions of the study as listed in the informed consent form.

Who cannot join

  • Moderate to Severe dermatoses including but not limited to psoriasis, atopic dermatitis or eczema.
  • Secondarily-infected animal/human bite, puncture wound or abscess.
  • Chronic ulcerative lesions.
  • Bacterial skin infection which, due to the area, depth or severity, in the opinion of the investigator, cannot be appropriately treated by a topical antibiotic.
  • More than one type of infected lesion.
  • Surgical intervention is required for treatment of the infection prior to enrolment in the study, or such intervention is likely to be required during the course of the study.
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  • Application of any topical pharmaceutical agent (including but not limited to, corticosteroids, antibacterials, antiseptics or antifungal agents) directly to the infected wound/lesion(s), within 72 hours prior to study entry.
  • Systemic signs or symptoms of infection (such as fever).
  • Treatment for one or more days with a systemic antibacterial agent within 72 hours of study entry.
  • Ongoing treatment with systemic corticosteroids at a dose of >0.125mg/kg per day of prednisone (or the equivalent).
  • Known, pre-existing or serious underlying disease that could be imminently life-threatening.
  • Pregnancy or ongoing lactation.
  • Participation in any study using an investigational drug or device during the previous 30 days prior to entering the study.
  • Significant ongoing or history of drug or alcohol abuse which in the opinion of the investigator makes the patient unsuitable for enrolment.
  • Known allergic reactions or hypersensitivity of significant severity in general and specifically to any component of the study medication.
  • Current or history of significant hepatic, renal, endocrine, cardiac, nervous, psychiatric, gastrointestinal, pulmonary, haematological, or metabolic disorder that is not in a stable condition. Malignancy <5 years since last treatment (resolved basal cell carcinoma is permitted).
  • Current or history of any significant disease or condition known to interfere with the absorption, distribution, metabolism or excretion of drugs.
  • Other unspecified reasons that, in the opinion of the investigator make the Patient unsuitable for enrolment.

Trial locations and contacts

4 sites in 1 country.

Hungary4 sites

  • Debreceni Egyetem Orvos-és Egészségtudományi

    Debrecen, 4032

  • Miskolci Semmelweis Ignác Egészegügyi Központ és

    Miskolc, 3529

  • Pécsi Tudományegyetem általános Orvostudom´nyi Centum

    Pécs, 7624

  • Szeged Univesrity Hospital

    Szeged, 6720

Other trials in Hungary

About this study

Official title: A Randomised, Double-blind, Placebo-controlled, Phase IIa Pilot Study to Evaluate the Safety, Tolerability and Efficacy of Lytixar™ (LTX-109) in Patients With Uncomplicated, Gram-positive, Skin Infection

The purpose of this study is to evaluate the safety and tolerability of Lytixar™ applied topically to uncomplicated skin infections.

Three dose levels of Lytixar™ (1%, 2% and 5%) versus placebo will be tested.

Read the detailed description

Treatment of uncomplicated, Gram-positive, skin infection may include application of antiseptics and desiccants, but most importantly topical antibiotics. Guidance on the use of antimicrobial therapies has been published, poor prescribing practices still exist which facilitate the development of bacterial strains resistant to available therapy. The issue of antimicrobial resistance is particularly important for Gram-positive cocci such as Staphylococcus aureus and Streptococcus pyogenes. Methicillin-resistant Staphylococcus aureus (MRSA) has been a problem for many years in the hospital setting, more recently community acquired MRSA (CA-MRSA) has emerged posing additional challenges to physicians managing skin infection. The medicinal product under development, Lytixar™, is a synthetic antimicrobial peptidomimetic agent with a membrane lysing mode of action. Lytixar™ has demonstrated activity against several Gram-positive and Gram-negative bacteria in vitro. The compound appears to be equally effective against antibiotic-resistant species such as methicillin resistant Staphylococcus aureus (MRSA), vancomycin resistant Enterococci (VRE) and multi-resistant Pseudomonas isolates. The novel membrane lysing mode of action may result in a lower propensity to the development of resistance and to date Lytixar™ demonstrates no in vitro target-specific cross-resistance with other classes of antibiotics.

Being tested
LTX-109
Keywords
Uncomplicated skin infections, Impetigo, Gram-negative, Diagnosis of uncomplicated, Gram-positive, skin infection. This may include patients with mild eczema/dermatoses such as atopic dermatitis., Gram-positive organisms which in the opinion of the investigator are causative for infection of the lesion(s),
Medical subject headings
Cellulitis, Skin Diseases, Dermatitis, Atopic, Impetigo

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • LTX-109Drug

    Topical administration. 3 times daily. 5 days.

Study groups in NCT01223222
Study groupRoleWhat they receive
1% Lytixar™Placebo comparator6 subjects will be treated with Lytixar™ and 2 will be treated with vehicle (placebo).
Receives: Drug: LTX-109
2% Lytixar™Active comparator6 subjects will be treated with Lytixar™ and 2 will be treated with vehicle (placebo).
Receives: Drug: LTX-109
5% Lytixar™Active comparator6 subjects will be treated with Lytixar™ and 2 will be treated with vehicle (placebo).
Receives: Drug: LTX-109

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. To determine the safety and local tolerability of topically administered Lytixar™ in patients with uncomplicated, Gram-positive, skin infection.

    Tolerability and safety will be measured at Day 3, the end of treatment visit Day 7 and follow-up visits Day 14, and 21.

    Measured: After topical treatment 3 times per day 5 days

Secondary outcomes (1)

  1. To assess the clinical and microbiological response to Lytixar™ in patients with uncomplicated, Gram-positive, skin infection. And to determine the extent of systemic absorption of Lytixar™.

    Clinical outcome, changes in the Skin Infection Rating Scale (SIRS) scores from Baseline, and Bacteriological success, recurrence, failure or evaluability will be assessed at Day 3, end of treatment visit Day 7 and follow-up visits Day 14 and 21.

    Measured: Topical treatment 3 times daily for 5 days.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Oct 2010 (estimated)
  2. Study startSep 2010
  3. Primary completionFeb 2011
  4. Study completionFeb 2011

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Single group
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
24 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01223222
Sponsor's protocol ID
C10-109-03
Status last verified
Feb 2011
First submitted
14 Oct 2010
Last updated
16 Feb 2011
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing LTX-109 in people with Gram-positive, Skin Infections and Mild Eczema/Dermatoses, run by Lytix Biopharma AS at 4 sites in Hungary.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 16 Feb 2011. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in Hungary. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

To determine the safety and local tolerability of topically administered Lytixar™ in patients with uncomplicated, Gram-positive, skin infection. (time frame: After topical treatment 3 times per day 5 days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01223222.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Feb 2011.

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