Leishmaniasis, CutaneousNCT01641796
Paromomycin for Individuals With Uncomplicated Cutaneous Leishmaniasis
A study testing Paromomycin in people with Leishmaniasis, Cutaneous, run by U.S. Army Medical Research and Development Command at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Leishmaniasis, Cutaneous
- What is being tested?
- Paromomycin
- How many people
- Not given
- Where
- 2 sitesUnited States
- Study dates
- Start not givento not given
- Phase
- Expanded access
- 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 Any age
- All sexes
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Walter Reed National Military Medical Center
Bethesda, Maryland, 20814
Military Treatment Facilities
Multiple Locations, Maryland, 20814
About this study
Official title: Paromomycin Topical Cream Treatment Protocol for Individuals With Uncomplicated Cutaneous Leishmaniasis
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.
Read the 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.
- Conditions
- Leishmaniasis, Cutaneous
- Being tested
- Paromomycin
- Keywords
- Cutaneous Leishmaniasis, CL, Lesion, Topical, Treatment, Cream, Expanded Access
- Medical subject headings
- Leishmaniasis, Cutaneous
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ParomomycinDrug
Also called Paromomycin Topical Cream
Paromomycin Topical Cream applied to all lesions once a day for 20 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Leishmaniasis, CutaneousStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Expanded access
Sponsor and investigators
- Lead sponsor
- U.S. Army Medical Research and Development Command
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Naomi Aronson, MD, Principal investigator, Uniformed Services University of the Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01641796
- Sponsor's protocol ID
- S-12-13
- Other IDs
- S-12-13/M-10337
- Status last verified
- May 2020
- First submitted
- 18 Jun 2012
- Last updated
- 15 May 2020
- Results posted
- No
Publications
Grogl M, Schuster BG, Ellis WY, Berman JD. Successful topical treatment of murine cutaneous leishmaniasis with a combination of paromomycin (Aminosidine) and gentamicin. J Parasitol. 1999 Apr;85(2):354-9.
PubMed 10219319
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Paromomycin Topical Cream Treatment Protocol for Individuals With Uncomplicated Cutaneous Leishmaniasis
- ClinicalTrials.gov ID
- NCT01641796
- Acronym / sponsor ID
- S-12-13
- Conditions
- Leishmaniasis, Cutaneous
- Keywords
- Cutaneous Leishmaniasis, CL, Lesion, Topical, Treatment, Cream, Expanded Access
- Study type
- Expanded access
- Recruitment status
- No Longer Available
- Lead sponsor
- U.S. Army Medical Research and Development CommandUS federal agency
- First posted
- 17 Jul 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
Who may qualify
- Sex
- All
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ParomomycinAlso: Paromomycin Topical CreamParomomycin Topical Cream applied to all lesions once a day for 20 days | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 May 2020.
- Background: PubMed 10219319Grogl M, Schuster BG, Ellis WY, Berman JD. Successful topical treatment of murine cutaneous leishmaniasis with a combination of paromomycin (Aminosidine) and gentamicin. J Parasitol. 1999 Apr;85(2):354-9.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Naomi Aronson, MD principal investigator
Uniformed Services University of the Health Sciences
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Paromomycin in people with Leishmaniasis, Cutaneous, run by U.S. Army Medical Research and Development Command at 2 sites in United States.
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 6 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 15 May 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
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.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01641796, which also lists 1 linked publication.
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 15 May 2020.