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Paromomycin for Individuals With Uncomplicated Cutaneous Leishmaniasis

Expanded access is currently available for this treatment.
Verified January 2017 by U.S. Army Medical Research and Materiel Command
Sponsor:
Information provided by (Responsible Party):
U.S. Army Medical Research and Materiel Command
ClinicalTrials.gov Identifier:
NCT01641796
First received: June 18, 2012
Last updated: January 17, 2017
Last verified: January 2017
  Purpose
This is an expanded access treatment protocol designed to provide a topical cream treatment option to military health care beneficiaries with parasitologically confirmed uncomplicated Cutaneous Leishmaniasis.

Condition Intervention
Leishmaniasis, Cutaneous Drug: Paromomycin

Study Type: Expanded Access     What is Expanded Access?
Official Title: Paromomycin Topical Cream Treatment Protocol for Individuals With Uncomplicated Cutaneous Leishmaniasis

Resource links provided by NLM:


Further study details as provided by U.S. Army Medical Research and Materiel Command:

Intervention Details:
    Drug: Paromomycin
    Paromomycin Topical Cream applied to all lesions once a day for 20 days
    Other Name: Paromomycin Topical Cream
Detailed Description:

When a military health care beneficiary presents at a Department of Defense Military Treatment Facility with a skin lesion clinically and epidemiologically consistent with suspicious Cutaneous Leishmaniasis (CL), routine diagnostic parasitology testing will be performed as standard of care, and if there is a positive diagnosis, the patient will be offered the option to participate in this treatment program and after providing written informed consent/assent., if eligible to participate, the patient will receive treatment with Paromomycin Topical Cream.

Eligible patients will receive Paromomycin Topical Cream applied topically to all CL lesions once daily for 20 days. The Day 1 application will be performed by or under the supervision of the site PI. The Day 2 application will be performed by the patient while being observed by the site PI or a designated medical staff member. The patient will be scheduled to return to an Medical Treatment Facility (MTF) weekly during treatment at Days 7 ± 2, 14 ± 2, and Day 20 + 4 days (the last day of treatment). During these visits, a member of the medical team will observe the application of the cream by the patient and will assist the patient, if necessary. In addition, the patient will be scheduled to return for a safety evaluation approximately 1 week after completing treatment. The patient will be instructed to contact the site PI or designee if any unusual adverse events (AEs) occur during treatment or in the week after completing treatment. The patient will be scheduled to return to the MTF on Day 90 (± 14 days) days after starting treatment to determine whether all CL lesions have healed (as per CL standard of care). Those patients who cannot return to an MTF will be contacted by phone.

If at any time after completing treatment the lesions get worse or appear to be infected, the patient will be instructed to go to an MTF for possible treatment of AEs or alternative treatments for CL.

  Eligibility

Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Criteria

Inclusion Criteria:

  • Male or female military health care beneficiary of any age.
  • Diagnosis of uncomplicated CL by having at least one lesion parasitologically confirmed 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) PCR assay performed either at the LDL, WRAIR or the Clinical Parasitology Service, CDC.
  • Ability to comprehend and willingness to sign informed consent or give assent
  • CL lesions in a location amenable to topical treatment
  • Patient is willing to forgo other treatments for CL while on treatment program
  • Females of childbearing potential must have a negative pregnancy test within 1 day of starting treatment and agree to use an acceptable method of birth control from start of treatment until 2 weeks after completing treatment

Exclusion Criteria:

  • Clinically significant concomitant disease that would preclude the patient from completing treatment in the opinion of the treating physician.
  • Clinical Evidence of mucosal involvement
  • Known allergy to aminoglycosides
  • Females who are pregnant or breastfeeding
  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: NCT01641796

Contacts
Contact: Naomi Aronson, MD 301-295-3621 naomi.aronson@usuhs.edu
Contact: Timothy Whitman, DO 301-295-6400 timothy.whitman@med.navy.mil

Locations
United States, Maryland
Walter Reed National Military Medical Center
Bethesda, Maryland, United States, 20814
Contact: Naomi Aronson, MD    301-295-3621    naomi.aronson@usuhs.edu   
Contact: Peter J Weina, MD    301-400-1239    peter.j.weina.mil@mail.mil   
Military Treatment Facilities
Multiple, Maryland, United States, 20814
Contact: Naomi Aronson, MD       usarmy.detrick.medcom-usammda.list.leishmania-tx-protocol@mail.mil   
Principal Investigator: Naomi Aronson, MD         
Sponsors and Collaborators
U.S. Army Medical Research and Materiel Command
Investigators
Principal Investigator: Naomi Aronson, MD Uniformed Services University of the Health Sciences
  More Information

Publications:
Responsible Party: U.S. Army Medical Research and Materiel Command
ClinicalTrials.gov Identifier: NCT01641796     History of Changes
Other Study ID Numbers: S-12-13
S-12-13/M-10337 ( Other Identifier: The Surgeon General Department of the Army )
Study First Received: June 18, 2012
Last Updated: January 17, 2017

Keywords provided by U.S. Army Medical Research and Materiel Command:
Cutaneous Leishmaniasis
CL
Lesion
Topical
Treatment
Cream
Expanded Access

Additional relevant MeSH terms:
Leishmaniasis
Leishmaniasis, Cutaneous
Euglenozoa Infections
Protozoan Infections
Parasitic Diseases
Skin Diseases, Parasitic
Skin Diseases, Infectious
Skin Diseases
Paromomycin
Amebicides
Antiprotozoal Agents
Antiparasitic Agents
Anti-Infective Agents
Anti-Bacterial Agents

ClinicalTrials.gov processed this record on August 16, 2017