Paromomycin for Individuals With Uncomplicated Cutaneous Leishmaniasis

• Status: No longer available
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

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.

Details

• Lead Sponsor: U.S. Army Medical Research and Development Command; U.S. Army Medical Research and Materiel Command
• Treatments: Gentamicins; Paromomycin

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