WR 279,396 for the Treatment of Cutaneous Leishmaniasis (PAGELEC)

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2013 by Assistance Publique - Hôpitaux de Paris
Sponsor:
Collaborator:
U.S. Army Medical Research and Materiel Command
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier:
NCT01988909
First received: November 14, 2013
Last updated: June 13, 2014
Last verified: November 2013
  Purpose

The objectives of the study are to evaluate the safety and efficacy of open label treatment with WR 279,396 (topical paromomycin & gentamicin) in patients with non-complicated, non-severe cutaneous leishmaniasis (CL).


Condition Intervention Phase
Cutaneous Leishmaniasis
Drug: WR 279,396
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: An Open-Label Study to Examine the Safety and Efficacy, of WR 279,396 (Paromomycin + Gentamicin Topical Cream) for the Treatment of Cutaneous Leishmaniasis in France

Resource links provided by NLM:


Further study details as provided by Assistance Publique - Hôpitaux de Paris:

Primary Outcome Measures:
  • final clinical cure rate for the index lesion: initial clinical cure [ Time Frame: Day 42 or day 100 ] [ Designated as safety issue: No ]
    Initial clinical cure: 100% reepithelialization (ie, a 0 x 0 length x width measurement) of the lesion at the nominal Day 42 evaluation, or initial clinical improvement followed >50% reepithelialization by Day 100


Secondary Outcome Measures:
  • final clinical cure rate for the index lesion: Relapse [ Time Frame: day 42 or day 100 ] [ Designated as safety issue: No ]
    Relapse is defined as a 10 percent or greater increase in the area of ulceration of the index lesion or a shift from 100% to < 100% re-epithelialization of the index lesion at nominal Day 100 for those patients that had 100% re-epithelialization of the index lesion at nominal Day 42 or before


Estimated Enrollment: 30
Study Start Date: June 2014
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: WR 279,396
All patients with the same Study drug: WR 279,396 (Topical Paromomycin and Gentamicin Cream)
Drug: WR 279,396
Paromomycin + Gentamicin Topical Cream

Detailed Description:

Patients with suspected CL will be screened up to a 14 day period for eligibility including parasitology for confirmation of ulcerative CL. Recruitment will primarily be from patients exposed to leishmaniasis. A target enrollment of 30 patients will receive WR 279,396 (15% paromomycin + 0.5% gentamicin topical cream) once daily for 20 days.

The index lesion and all other ulcerated lesions will be assessed for clinical response by measurement of the length and width of area of ulceration. A lesion will be considered to be completely cured if 100% re-epithelialization is observed. Non-ulcerated lesions will also be measured to monitor the total area of exposure of lesions to study drug and will be evaluated for cure.

  Eligibility

Ages Eligible for Study:   2 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

To be eligible for the study, patients must:

  1. Be male or females ages 2 to 80 years of age, inclusive.
  2. Have non-complicated, non-severe CL.
  3. Be able to give written informed consent or by their legal representative.
  4. Have a diagnosis of CL in at least one lesion by at least one of the following methods: 1) positive culture for promastigotes; 2) microscopic identification of amastigotes in stained lesion tissue and/or 3) by positive polymerase chain reaction (PCR). Patients who have a prior diagnosis of CL within 30 days of the start of treatment are eligible without a confirmatory test during screening.
  5. Have at least one ulcerative lesion ≥ 1 cm and < 5 cm, that meets the criteria for an index lesion.
  6. Be willing to forego other forms of treatments for CL including other investigational treatment during the study.
  7. In the opinion of the investigator, be capable of understanding (or their legal representative) and complying with the protocol.
  8. Expect to be located in the area of the clinical site for at least the duration of the screening, 20-day treatment period, and for the followup visits at Days 28 +/- 2 days, 42 +/- 7 days and 100 +/- 14 days.
  9. If female and of child-bearing potential, have a negative serum or urine pregnancy test during screening and agree to use an acceptable method of birth control during the treatment phase and for 1 month after treatment is completed.

Exclusion Criteria:

Also, to be eligible for the study, patients must not:

  1. Have a prior diagnosis of leishmaniasis where all lesions had healed.
  2. Have only a single lesion whose characteristics include any of the following: verrucous or nodular lesion (non-ulcerative), lesion <1 cm in its greatest diameter, lesion in a location that in the opinion of the Investigator is difficult to maintain application of study drug topically.
  3. Have a lesion due to leishmania that involves the mucosa or palate.
  4. Have signs and symptoms of disseminated disease.
  5. Be a female who is breast-feeding.
  6. Have an active malignancy or history of solid, metastatic or hematologic malignancy with the exception of basal or squamous cell carcinoma of the skin that has been removed.
  7. Have significant organ abnormality, chronic disease such as diabetes, severe hearing loss, evidence of renal or hepatic dysfunction, myasthenia gravis, parkinsonism, impairment of the eighth cranial nerve or clinically significant levels of creatinine, AST, or ALT in the judgment of the investigator.
  8. Have received treatment for leishmaniasis (except mercurochrome or local antiseptics) including any medication with pentavalent antimony including sodium stibogluconate (Pentostam), meglumine antimoniate (Glucantime); amphotericin B (including liposomal amphotericin B and amphotericin B deoxycholate); WR 279,396; or other medications containing paromomycin (administered parenterally or topically) within 56 days of starting study treatments, or methylbenzethonium chloride (MBCL); or local or systemic antibiotics of the following families (penicillin, betalactamics, cyclines, synergistin, macrolides, lincosamides, fusidic acid, mupirocin) within 8 days of starting study treatments.
  9. Have history of known or suspected hypersensitivity or idiosyncratic reactions to aminoglycosides.
  10. Have any other topical disease/condition which would interfere with the objectives of this study.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01988909

Contacts
Contact: Pierre Buffet, MD,PhD pierre.buffet@psl.aphp.fr

Locations
France
Groupe Hospitalier Pitié-Salpêtrière Recruiting
Paris, France, 75013
Contact: Pierre Buffet, MD, PhD         
Principal Investigator: Pierre Buffet, MD, PhD         
Centre d'investigations cliniques- Hopital Robert Debré Recruiting
Paris, France, 75019
Contact: Emmanuelle Bourrat, MD         
Sub-Investigator: Emmanuelle Bourrat, MD         
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
U.S. Army Medical Research and Materiel Command
Investigators
Principal Investigator: Pierre Buffet, MD, PhD Assistance Publique - Hôpitaux de Paris
  More Information

No publications provided

Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT01988909     History of Changes
Other Study ID Numbers: P080705
Study First Received: November 14, 2013
Last Updated: June 13, 2014
Health Authority: France: Ministry of Health

Keywords provided by Assistance Publique - Hôpitaux de Paris:
Cutaneous leishmaniasis
Paromomycin + Gentamicin Topical Cream
Safety
Efficacy

Additional relevant MeSH terms:
Leishmaniasis
Leishmaniasis, Cutaneous
Euglenozoa Infections
Protozoan Infections
Parasitic Diseases
Skin Diseases, Parasitic
Skin Diseases, Infectious
Skin Diseases
Gentamicins
Paromomycin
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Protein Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Amebicides
Antiprotozoal Agents
Antiparasitic Agents

ClinicalTrials.gov processed this record on September 16, 2014