Paromomycin for Individuals With Uncomplicated Cutaneous Leishmaniasis
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01641796|
Expanded Access Status : Available
First Posted : July 17, 2012
Last Update Posted : October 12, 2017
|Condition or disease||Intervention/treatment|
|Leishmaniasis, Cutaneous||Drug: Paromomycin|
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.
|Study Type :||Expanded Access|
|Official Title:||Paromomycin Topical Cream Treatment Protocol for Individuals With Uncomplicated Cutaneous Leishmaniasis|
- Drug: Paromomycin
Paromomycin Topical Cream applied to all lesions once a day for 20 daysOther Name: Paromomycin Topical Cream
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01641796
|Contact: Naomi Aronson, MDemail@example.com|
|Contact: Timothy Whitman, DOfirstname.lastname@example.org|
|United States, Maryland|
|Walter Reed National Military Medical Center|
|Bethesda, Maryland, United States, 20814|
|Contact: Naomi Aronson, MD 301-295-3621 email@example.com|
|Contact: Peter J Weina, MD 301-400-1239 firstname.lastname@example.org|
|Military Treatment Facilities|
|Multiple Locations, Maryland, United States, 20814|
|Contact: Naomi Aronson, MD email@example.com|
|Principal Investigator: Naomi Aronson, MD|
|Principal Investigator:||Naomi Aronson, MD||Uniformed Services University of the Health Sciences|