Cutaneous LeishmaniasesPhase 2NCT02919605
Efficacy and Safety of Pentamidine (7mg/kg) for Patients With Cutaneous Leishmaniasis Caused by L. Guyanensis
A Phase 2 study testing Single dose of Pentamidine, Two doses of Pentamidine and Three doses of Pentamidine in people with Cutaneous Leishmaniases, run by Fundação de Medicina Tropical Dr. Heitor Vieira Dourado.
Trial summary
Introduction: Up to the present, have been few studies with pentamidine in the Americas; and there is no consensus regarding the dose used. Objectives: To evaluate the use of pentamidine in single dose, double and triplo in the treatment of cutaneous leishmaniasis. Read more about this study
- Who is it for?
- Ages 16 to 64 years
- Conditions the study is for
- Cutaneous Leishmaniases
- What is being tested?
- Single dose of Pentamidine, Two doses of Pentamidine and Three doses of Pentamidine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 159 participants
- Where
- No sites listed yet
- Study dates
- Jan 2014to Jan 2016
- Phase
- Phase 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 16 to 64 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Newly diagnosed cutaneous leishmaniasis (untreated) with localized lesions ( without maximum 6 injuries ) and Direct Examination positive : amastigotes display in tissue samples ;
- Age: 16-64 years;
- Sex: male and female patients to eligible ;
- Disease Clinical Evolution not longer than 3 months .
Who cannot join
- AST > 3 times the upper limit of normal;
- ALT > 3 times the upper limit of normal;
- Alkaline phosphatase > 3 times the upper limit of normal;
- Serum creatinine and urea > 1.5 times the upper limit of normality;
- Blood glucose above 110 mg / dl;
- Evidence of serious underlying disease ( heart , kidney , liver or lung);
Show all 10Show fewer
- protein and / or caloric severe malnutrition;
- Any uncompensated or uncontrolled condition like active tuberculosis, malignant disease , severe malaria , HIV, leprosy , systemic fungal disease (histoplasmosis, paracoccidioidomycosis) or any other infectious disease;
- Pregnant women or who are breastfeeding;
- Lack of ability or willingness to provide informed consent (patient and / or parent / legal representative); lack of availability for the visits or to comply with study procedures.
About this study
Official title: Efficacy and Safety of Single, Double and Triple Dose Pentamidine (7mg/kg) for Patients With Cutaneous Leishmaniasis Caused by L. Guyanensis: a Pilot Study
Introduction: Up to the present, have been few studies with pentamidine in the Americas; and there is no consensus regarding the dose used.
Objectives: To evaluate the use of pentamidine in single dose, double and triplo in the treatment of cutaneous leishmaniasis.
Methods: Clinical trial of phase II pilot study with 159 patients. Pentamidine will be used at a dose of 7 mg/kg, in three arms: single dose, double dose and triple dose. They will be also assessed the safety and adverse effects. The sic will be reviewed one, two and six months after the end of the treatments.
Read the detailed description
This is a phase II pilot study comprising 159 patients. The sample size was calculated for a study using a test of difference between proportion considering alpha and beta errors . With an estimated curing ratio of 80 % for group 3 Pentamidine applications 7 mg / kg group and the pentamidine at a dose of 7 mg / kg 58.1 % cure rate, with a significance level 95 % and a 80 % test power .
Clinical and laboratory workup: Full body skin examination will be performed. Ulcerated lesions will be measured and pictured before treatment. Follow-up measurements and pictures were also taken one week, one, two and six months after treatment. Species identification was made through polymerase chain reaction (PCR) as described elsewhere. Two months after treatment, additional smears will be obtained from lesions that were not completely healed and/or showed an increase of, at least, 50% of its original dimensions.
Other laboratory exams included complete blood count, sugar, AST, ALT, urea, creatinine and amylase blood levels, stool parasite examination, routine urine examination and rapid test for HIV.
Drug administration: PI (300mg) was diluted in 5 ml of saline solution and a single IM injection (7 mg/kg) was administered at the outpatient unit of the FMT-HVD.
Patients were given a carbohydrate enriched meal before treatment to prevent hypoglycemia and were kept at rest and under close clinical observation until one hour after medication. Rescue treatment with IV injections of antimonials (15 mg/kg every 20 days) was prescribed for those who fail to improve.
Therapeutic failure was defined as the persistence of clinical signs (onset of new lesions, >50% increase in the size of preexisting lesions) or laboratory findings (positive smears) two months after treatment or anytime during the follow-up period.
Adverse effects will be classified as mild (drug-related, well tolerated, with no need of prescription for symptomatic relief); moderate (drug-related, symptomatic prescription required) and severe (clinically detectable impairment of renal, hepatic or cardiac functions).
- Conditions
- Cutaneous Leishmaniases
- Being tested
- Single dose of Pentamidine, Two doses of Pentamidine, Three doses of Pentamidine
- Keywords
- Cutaneous Leishmaniasis, pentamidine isothionate, treatment
- Medical subject headings
- Leishmaniasis, Cutaneous
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Single dose of PentamidineDrug
Also called Pentamidine (7mg/kg) in a single application.
The patients will come to the hospital to take a single dose of the Pentamidine.
Two doses of PentamidineDrug
Also called Pentamidine (7mg/kg) in two weekly applications.
The patients will come to the hospital to take two doses of the Pentamidine, in interval of one week between them.
Three doses of PentamidineDrug
Also called Pentacarinat® (7mg/kg) in three weekly applications
The patients will come to the hospital to take three doses of the Pentamidine, in interval of one week between them.
| Study group | Role | What they receive |
|---|---|---|
| Single dose of Pentamidine | Experimental | Fifty three patients using Pentamidine at a dose of 7 mg/kg will be included, in a single dose. Receives: Drug: Single dose of Pentamidine |
| Two doses of Pentamidine | Experimental | Fifty three patients using Pentamidine at a dose of 7 mg/kg, in a weekly dose, during two weeks. Receives: Drug: Two doses of Pentamidine |
| Three doses of Pentamidine | Experimental | Fifty three patients using Pentamidine at a dose of 7 mg/kg, in a weekly dose, during three weeks. Receives: Drug: Three doses of Pentamidine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients with reduction in 50% in the diameters of the ulcers and lesions skin
Measured: Two months after the end of the treatment
Secondary outcomes (1)
Number of patients with complete healing in the diameters of the ulcers and lesions skin
Measured: Six months after the end of the treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2016 (estimated)
- Study startJan 2014
- Primary completionJan 2016
- Study completionJan 2016
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 Cutaneous LeishmaniasesStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 159 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fundação de Medicina Tropical Dr. Heitor Vieira Dourado
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Anette Talhari, Doctor, Principal investigator, Researcher
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02919605
- Sponsor's protocol ID
- CAAE - 0016.0.114.0000-10
- Status last verified
- Feb 2019
- First submitted
- 4 Mar 2016
- Last updated
- 15 Feb 2019
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Gadelha EPN, Ramasawmy R, da Costa Oliveira B, Morais Rocha N, de Oliveira Guerra JA, Allan Villa Rouco da Silva G, Gabrielle Ramos de Mesquita T, Chrusciak Talhari Cortez C, Chrusciak Talhari A. An open label randomized clinical trial comparing the safety and effectiveness of one, two or three weekly pentamidine isethionate doses (seven milligrams per kilogram) in the treatment of cutaneous leishmaniasis in the Amazon Region. PLoS Negl Trop Dis. 2018 Oct 31;12(10):e0006850. doi: 10.1371/journal.pntd.0006850. eCollection 2018 Oct.
PubMed 30379814
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Single, Double and Triple Dose Pentamidine (7mg/kg) for Patients With Cutaneous Leishmaniasis Caused by L. Guyanensis: a Pilot Study
- ClinicalTrials.gov ID
- NCT02919605
- Acronym / sponsor ID
- CAAE - 0016.0.114.0000-10
- Conditions
- Cutaneous Leishmaniases
- Keywords
- Cutaneous Leishmaniasis, pentamidine isothionate, treatment
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 159 participants (actual)
- Lead sponsor
- Fundação de Medicina Tropical Dr. Heitor Vieira DouradoUniversity, hospital or other
- Study start
- Jan 2014
- Primary completion
- Jan 2016 (actual)
- Study completion
- Jan 2016 (actual)
- First posted
- 29 Sep 2016 (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.
Introduction: Up to the present, have been few studies with pentamidine in the Americas; and there is no consensus regarding the dose used.
Objectives: To evaluate the use of pentamidine in single dose, double and triplo in the treatment of cutaneous leishmaniasis.
Methods: Clinical trial of phase II pilot study with 159 patients. Pentamidine will be used at a dose of 7 mg/kg, in three arms: single dose, double dose and triple dose. They will be also assessed the safety and adverse effects. The sic will be reviewed one, two and six months after the end of the treatments.
Detailed description
This is a phase II pilot study comprising 159 patients. The sample size was calculated for a study using a test of difference between proportion considering alpha and beta errors . With an estimated curing ratio of 80 % for group 3 Pentamidine applications 7 mg / kg group and the pentamidine at a dose of 7 mg / kg 58.1 % cure rate, with a significance level 95 % and a 80 % test power .
Clinical and laboratory workup: Full body skin examination will be performed. Ulcerated lesions will be measured and pictured before treatment. Follow-up measurements and pictures were also taken one week, one, two and six months after treatment. Species identification was made through polymerase chain reaction (PCR) as described elsewhere. Two months after treatment, additional smears will be obtained from lesions that were not completely healed and/or showed an increase of, at least, 50% of its original dimensions.
Other laboratory exams included complete blood count, sugar, AST, ALT, urea, creatinine and amylase blood levels, stool parasite examination, routine urine examination and rapid test for HIV.
Drug administration: PI (300mg) was diluted in 5 ml of saline solution and a single IM injection (7 mg/kg) was administered at the outpatient unit of the FMT-HVD.
Patients were given a carbohydrate enriched meal before treatment to prevent hypoglycemia and were kept at rest and under close clinical observation until one hour after medication. Rescue treatment with IV injections of antimonials (15 mg/kg every 20 days) was prescribed for those who fail to improve.
Therapeutic failure was defined as the persistence of clinical signs (onset of new lesions, >50% increase in the size of preexisting lesions) or laboratory findings (positive smears) two months after treatment or anytime during the follow-up period.
Adverse effects will be classified as mild (drug-related, well tolerated, with no need of prescription for symptomatic relief); moderate (drug-related, symptomatic prescription required) and severe (clinically detectable impairment of renal, hepatic or cardiac functions).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Single dose of Pentamidine | Experimental | Drug: Single dose of PentamidineFifty three patients using Pentamidine at a dose of 7 mg/kg will be included, in a single dose. |
| Two doses of Pentamidine | Experimental | Drug: Two doses of PentamidineFifty three patients using Pentamidine at a dose of 7 mg/kg, in a weekly dose, during two weeks. |
| Three doses of Pentamidine | Experimental | Drug: Three doses of PentamidineFifty three patients using Pentamidine at a dose of 7 mg/kg, in a weekly dose, during three weeks. |
Who may qualify
- Ages
- 16 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- Newly diagnosed cutaneous leishmaniasis (untreated) with localized lesions ( without maximum 6 injuries ) and Direct Examination positive : amastigotes display in tissue samples ;
- Age: 16-64 years;
- Sex: male and female patients to eligible ;
- Disease Clinical Evolution not longer than 3 months .
Key exclusion criteria (10 listed)
- AST > 3 times the upper limit of normal;
- ALT > 3 times the upper limit of normal;
- Alkaline phosphatase > 3 times the upper limit of normal;
- Serum creatinine and urea > 1.5 times the upper limit of normality;
- Blood glucose above 110 mg / dl;
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 |
|---|---|---|
| Single dose of PentamidineAlso: Pentamidine (7mg/kg) in a single application.The patients will come to the hospital to take a single dose of the Pentamidine. | Drug | Single dose of Pentamidine |
| Two doses of PentamidineAlso: Pentamidine (7mg/kg) in two weekly applications.The patients will come to the hospital to take two doses of the Pentamidine, in interval of one week between them. | Drug | Two doses of Pentamidine |
| Three doses of PentamidineAlso: Pentacarinat® (7mg/kg) in three weekly applicationsThe patients will come to the hospital to take three doses of the Pentamidine, in interval of one week between them. | Drug | Three doses of Pentamidine |
Primary outcome
Number of patients with reduction in 50% in the diameters of the ulcers and lesions skin
Time frame: Two months after the end of the treatment
1 secondary outcome
Number of patients with complete healing in the diameters of the ulcers and lesions skin
Time frame: Six months after the end of the 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 15 Feb 2019.
- Derived from this study: PubMed 30379814Gadelha EPN, Ramasawmy R, da Costa Oliveira B, Morais Rocha N, de Oliveira Guerra JA, Allan Villa Rouco da Silva G, Gabrielle Ramos de Mesquita T, Chrusciak Talhari Cortez C, Chrusciak Talhari A. An open label randomized clinical trial comparing the safety and effectiveness of one, two or three weekly pentamidine isethionate doses (seven milligrams per kilogram) in the treatment of cutaneous leishmaniasis in the Amazon Region. PLoS Negl Trop Dis. 2018 Oct 31;12(10):e0006850. doi: 10.1371/journal.pntd.0006850. eCollection 2018 Oct.
- Individual participant dataSharing planned: No
Related trials for Cutaneous Leishmaniases
RecruitingObservational study
Diagnosis and Treatment of Leishmania Infections
Kinetoplastid, Skin Diseases, Parasitic
Recruiting
Feasibility of Integrating Thermotherapy for Treatment of Cutaneous Leishmaniasis in Primary Health Care Setup
Cutaneous Leishmaniasis
Not yet recruiting
Immersive Technology Headsets to Reduce Procedural Pain and Anxiety: Feasibility and Effects in Cutaneous Leishmaniasis Patients in Pakistan
Cutaneous Leishmaniasis, Pain
RecruitingObservational study
Ex Vivo Immunogenicity Screening of Vaccine Candidate Antigen Combinations in Ethiopian Patients With Leishmaniasis
Leishmaniasis, Cutaneous, Leishmaniasis
Not yet recruitingPhase 2
Comparison of Intralesional Glucantime With and Without Fractional CO₂ Laser in Adults With Cutaneous Leishmaniasis
Cutaneous Leishminiasis
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.
Anette Talhari, Doctor principal investigator
Researcher
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Single dose of Pentamidine, Two doses of Pentamidine and Three doses of Pentamidine in people with Cutaneous Leishmaniases, run by Fundação de Medicina Tropical Dr. Heitor Vieira Dourado.
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 4 inclusion and 10 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 15 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
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 phase mean?
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?
Number of patients with reduction in 50% in the diameters of the ulcers and lesions skin (time frame: Two months after the end of the treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02919605, 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 Feb 2019.