Cutaneous Leishmaniasis, AmericanPhase 1/2NCT06449040
Treatment of Cutaneous Leishmaniasis With Liposomal Amphotericin B in the Elderly
A Phase 1/2 study testing Liposomal amphotericin B (AmBisome®) in people with Cutaneous Leishmaniasis, American, run by Hospital Universitário Professor Edgard Santos at 1 site in Brazil.
Trial summary
A randomized controlled pilot trial with the aim of identifying the dose of liposomal amphotericin B associated with the highest cure rate in Cutaneous Leishmaniasis (CL). We selected 28 patients of both sexes, aged 60 years or older, diagnosed with CL and confirmed by detection of L. braziliensis DNA. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Cutaneous Leishmaniasis, American
- What is being tested?
- Liposomal amphotericin B (AmBisome®)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteBrazil
- Study dates
- 1 Mar 2019to 1 Sep 2023
- Phase
- Phase 1/2
- 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 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- CL clinical diagnosis (presence of an ulcer)
- CL confirmed by detection of amastigotes in pathology and/or positive PCR for L. braziliensis in tissue obtained from the ulcer border
- Presence of one to a maximum of three ulcers
- Ulcer size between 1 and 5 mm
- Ulcer evolution of 1 to 6 months
Who cannot join
- Previous CL treatment
- Renal or hepatic disease
- HIV co-infection.
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Corte de Pedra Health Post
Presidente Tancredo Neves, Estado de Bahia, 40000
About this study
Official title: Treatment of Cutaneous Leishmaniasis With Liposomal Amphotericin B in the Elderly: a Randomized Clinical Trial
A randomized controlled pilot trial with the aim of identifying the dose of liposomal amphotericin B associated with the highest cure rate in Cutaneous Leishmaniasis (CL). We selected 28 patients of both sexes, aged 60 years or older, diagnosed with CL and confirmed by detection of L. braziliensis DNA. The groups were treated with different total doses of medication: G1: 12 mg/kg; G2: 18mg/kg; G3: 24 mg/kg. Clinical and laboratory evaluations were carried out during the period of 180 days (D0, D15, D30, D60, D120, D150 and D180).
Read the detailed description
The study was carried out through a randomized and double-blind pilot clinical trial, with the inclusion of patients treated at the Corte de Pedra Health Center, endemic region for Cutaneous Leishmaniasis. Twenty-eight patients participated in the study, after accepting and signing the Free and Informed Consent Form they were randomized through the list generated electronically by the website www.randomization.com and allocated into three groups.
The groups were treated with liposomal amphotericin B (AmBisome®) with three different total doses: Group 1 (G1) total dose of 12 mg/kg (10 patients). Group 2 (G2): 18 mg/kg (9 patients). Group 3 (G3): 24 mg/kg (9 patients). The drug was used twice a week in a hospital outpatient setting. Clinical evaluations were performed before starting therapy (D0), and at D15, D30, D60, D120 and D180. Laboratory evaluations (hemogram, BUN, Creatinine, K, ALT, AST) were determined on D0, D15 and D30 or D60.
- Conditions
- Cutaneous Leishmaniasis, American
- Being tested
- Liposomal amphotericin B (AmBisome®)
- Keywords
- Cutaneous Leishmaniasis, Liposomal Amphotericn B, L. braziliensis, Elderly
- Medical subject headings
- Leishmaniasis, Mucocutaneous, Leishmaniasis, Cutaneous
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Liposomal amphotericin B (AmBisome®)Drug
Liposomal amphotericin B (AmBisome®) - intravenous use, twice a week until total dose is achieved
| Study group | Role | What they receive |
|---|---|---|
| Group Anfo12mg/kg | Active comparator | Liposomal amphotericin B (AmBisome®) - 3mg/kg twice a week; total dose of 12 mg/kg Receives: Drug: Liposomal amphotericin B (AmBisome®) |
| Group Anfo18mg/kg | Active comparator | Liposomal amphotericin B (AmBisome®) - 3mg/kg twice a week; total dose of 18 mg/kg Receives: Drug: Liposomal amphotericin B (AmBisome®) |
| Group Anfo24mg/kg | Active comparator | Liposomal amphotericin B (AmBisome®) - 3mg/kg twice a week; total dose of 24 mg/kg Receives: Drug: Liposomal amphotericin B (AmBisome®) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total initial cicatrization
Healing of the total ulcer area, without elevation of the ulcer edges upon clinical evaluation
Measured: 30 to 90 days after the first day of treatment
Secondary outcomes (2)
Total final cicatrization
Healing of the total ulcer area, without elevation of the ulcer edges upon clinical evaluation
Measured: 30 to 180 days after the first day of treatment
Time to cure
Number of days from the first day of treatment until total ulcer cicatrization
Measured: 30 to 180 days after the first day of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2024
- Study start1 Mar 2019
- Primary completion1 Sep 2021
- Study completion1 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cutaneous Leishmaniasis, AmericanStudies 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
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital Universitário Professor Edgard Santos
- Sponsor type
- University, hospital or other
- Collaborators
- Instituto Gonçalo Muniz FIOCRUZ BA
- Responsible party
- Principal investigator, Paulo Roberto Lima Machado, Hospital Universitário Professor Edgard Santos
- Investigators
- PAULO MACHADO, MD, PhD, Principal investigator, Federal University of Bahia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06449040
- Sponsor's protocol ID
- AmL Eld
- Status last verified
- Jun 2024
- First submitted
- 28 May 2024
- Last updated
- 7 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of Cutaneous Leishmaniasis With Liposomal Amphotericin B in the Elderly: a Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT06449040
- Acronym / sponsor ID
- AmL Eld
- Conditions
- Cutaneous Leishmaniasis, American
- Keywords
- Cutaneous Leishmaniasis, Liposomal Amphotericn B, L. braziliensis, Elderly
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Hospital Universitário Professor Edgard SantosUniversity, hospital or other
- Collaborators
- Instituto Gonçalo Muniz FIOCRUZ BA
- Study start
- 1 Mar 2019 (actual)
- Primary completion
- 1 Sep 2021 (actual)
- Study completion
- 1 Sep 2023 (actual)
- First posted
- 7 Jun 2024 (actual)
- 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.
A randomized controlled pilot trial with the aim of identifying the dose of liposomal amphotericin B associated with the highest cure rate in Cutaneous Leishmaniasis (CL). We selected 28 patients of both sexes, aged 60 years or older, diagnosed with CL and confirmed by detection of L. braziliensis DNA. The groups were treated with different total doses of medication: G1: 12 mg/kg; G2: 18mg/kg; G3: 24 mg/kg. Clinical and laboratory evaluations were carried out during the period of 180 days (D0, D15, D30, D60, D120, D150 and D180).
Detailed description
The study was carried out through a randomized and double-blind pilot clinical trial, with the inclusion of patients treated at the Corte de Pedra Health Center, endemic region for Cutaneous Leishmaniasis. Twenty-eight patients participated in the study, after accepting and signing the Free and Informed Consent Form they were randomized through the list generated electronically by the website www.randomization.com and allocated into three groups.
The groups were treated with liposomal amphotericin B (AmBisome®) with three different total doses: Group 1 (G1) total dose of 12 mg/kg (10 patients). Group 2 (G2): 18 mg/kg (9 patients). Group 3 (G3): 24 mg/kg (9 patients). The drug was used twice a week in a hospital outpatient setting. Clinical evaluations were performed before starting therapy (D0), and at D15, D30, D60, D120 and D180. Laboratory evaluations (hemogram, BUN, Creatinine, K, ALT, AST) were determined on D0, D15 and D30 or D60.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group Anfo12mg/kg | Active comparator | Drug: Liposomal amphotericin B (AmBisome®)Liposomal amphotericin B (AmBisome®) - 3mg/kg twice a week; total dose of 12 mg/kg |
| Group Anfo18mg/kg | Active comparator | Drug: Liposomal amphotericin B (AmBisome®)Liposomal amphotericin B (AmBisome®) - 3mg/kg twice a week; total dose of 18 mg/kg |
| Group Anfo24mg/kg | Active comparator | Drug: Liposomal amphotericin B (AmBisome®)Liposomal amphotericin B (AmBisome®) - 3mg/kg twice a week; total dose of 24 mg/kg |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- CL clinical diagnosis (presence of an ulcer)
- CL confirmed by detection of amastigotes in pathology and/or positive PCR for L. braziliensis in tissue obtained from the ulcer border
- Presence of one to a maximum of three ulcers
- Ulcer size between 1 and 5 mm
- Ulcer evolution of 1 to 6 months
Key exclusion criteria (3 listed)
- Previous CL treatment
- Renal or hepatic disease
- HIV co-infection.
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 |
|---|---|---|
| Liposomal amphotericin B (AmBisome®)Liposomal amphotericin B (AmBisome®) - intravenous use, twice a week until total dose is achieved | Drug | Group Anfo12mg/kg, Group Anfo18mg/kg, Group Anfo24mg/kg |
Primary outcome
Total initial cicatrization
Time frame: 30 to 90 days after the first day of treatment
Healing of the total ulcer area, without elevation of the ulcer edges upon clinical evaluation
2 secondary outcomes
Total final cicatrization
Time frame: 30 to 180 days after the first day of treatment
Time to cure
Time frame: 30 to 180 days after the first day of treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jun 2024.
- Individual participant dataSharing planned: No
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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.
PAULO MACHADO, MD, PhD principal investigator
Federal University of Bahia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Liposomal amphotericin B (AmBisome®) in people with Cutaneous Leishmaniasis, American, run by Hospital Universitário Professor Edgard Santos at 1 site in Brazil.
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 5 inclusion and 3 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: finished, as of the sponsor's last update on 7 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. 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.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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.
What does the primary outcome measure?
Total initial cicatrization (time frame: 30 to 90 days after the first day of treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 7 Jun 2024.