A Phase 2/3 interventional study of Oral tofacitinib and Parenteral meglumine antimoniate in Cutaneous Leishmaniasis, American, sponsored by Hospital Universitário Professor Edgard Santos. Not yet recruiting at 1 site in Brazil. Open to participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2023-08-25.
Sponsored by Hospital Universitário Professor Edgard Santos · Phase 2/3, Interventional, and Treatment
Phase 2/3 randomized and controlled clinical trial, which will evaluate the effectiveness of the association meglumine antimoniate (Glucantime) with tofacitinib in the cure of CL and the capacity of this association to reduce the time of cure of the disease.
STUDY AREA The southeastern region of the State of Bahia, Brazil, where the village of Corte de Pedra and adjacent towns are located, is one of the most important American Tegumentary Leishmaniasis (ATL) endemic area in Latin America. The Corte de Pedra Health Center, in the municipality of Tancredo Neves, is located 280km from Salvador and is a Reference Center for Diagnosis and Treatment of ATL. Yearly, more than 500 cases of patients with ATL are diagnosed and treated at this Center.
The Health Center was established in 1986 and clinical physicians, dermatologists, otorhinolaryngologists and immunologists from the Immunology Service of the Federal University of Bahia, the Gonçalo Moniz Institute (IGM) and the Federal University of Recôncavo Bahiano (UFRB) visit the area every two weeks. The Post also has the support of 4 trained health agents, all residents of the region. They assist patients, visit families, and participate in research activities.
STUDY DESIGN
A. Type of study:
This project is a phase 2/3 randomized and controlled clinical trial, which will evaluate the effectiveness of the association meglumine antimoniate (Glucantime) with tofacitinib in the cure of CL. the main objectives are: 1. To compare the cure rate of meglumine antimoniate associated with tofacitinib with meglumine antimoniate alone in the treatment of CL caused by L. braziliensis; 2. To determine whether combined treatment with meglumine antimoniate associated with tofacitinib reduces CL healing time.
B. Definition of cases:
Cutaneous Leishmaniasis: Presence of a typical ulcerated lesion on the skin, without evidence of mucosal involvement, with a positive skin test and disease duration between 30 and 90 days. The diagnosis will be made by identifying amastigotes in the histopathological study with immunohistochemistry and/or documentation of DNA for L.braziliensis by polymerase chain reaction (PCR).
C. Methodology:
The rate of cure or treatment failure is only defined on day 90 after starting therapy. We estimate that combining Glucantime with tofacitinib will increase the healing rate and reduce the healing time of CL. The present proposal is a proof of concept with the participation of patients with CL with disease duration between 30 and 90 days and with ulcer size between 10 and 60mm. Patients will be randomized, group 1 will receive Glucantime at a dose of 20mg/Kg/weight /day with a maximum dose of 1200mg intravenously for 20 days, and group 2 will be treated with Glucantime at the dose and time period described above associated with tofacitinib at a dose of 10mg/day for 30 days. Patients will be evaluated on day 0, day 30, day 60 and day 90 to determine the size and characteristics of the ulcers and the occurrence of wound healing.
Sample size calculation: Considering that healing of ulcers up to 60mm in diameter in patients with CL with Glucantime will occur in 50% of patients while the cure rate in patients receiving Glucantime combined with tofacitinib will be 90% with a power of 80% and P\< 0.05, 22 patients will be needed, 11 in each group.
Subjects will be allocated in the 2 study arms after randomization at www.randomization.com.
21 studies on the registry are indexed under Leishmaniasis, Mucocutaneous; 7 are open to participants now.
This study's planned enrollment of 22 is below the median of 49 across 16 interventional studies indexed under Leishmaniasis, Mucocutaneous.
Browse Leishmaniasis, Mucocutaneous studies →Hospital Universitário Professor Edgard Santos is the lead sponsor of 17 studies on the registry; 2 are open to participants now.
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The human immunodeficiency virus, which weakens the immune system.
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Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Eleven CL patients will receive meglumine antimoniate by EV route at 20mg/kg/day, for 20 days.
Drug: Parenteral meglumine antimoniate
Eleven CL patients will receive oral tofatinib (10mg daily for 30 days) associated to meglumine antimoniate by EV route at 20mg/kg/day, for 20 days.
Drug: Oral tofacitinib · Drug: Parenteral meglumine antimoniate
Association of tofacitinib and meglumine antimoniate
Meglumine antimoniate
Cure at 90 days
Healing will be defined by complete healing of the ulcer and re-epithelialization of the skin on day 90, in the absence of infiltrated borders. Failure will be defined as persistence of the ulcer at day 90 with ulcer healing occurring but persistent infiltration at the edges.
Time frame: 90 days
Cure at 180 days
Absence of relapse after 180 days
Time frame: 180 days
Time to cure
Time (in days) until complete healing of the ulcer and re-epithelialization of the skin in the absence of infiltrated borders.
Time frame: Days
Adverse events
Adverse events will be recorded and graded
Time frame: 45 dyas
Plan to share: No — There is not a plan to make IPD available.
No publications or documents are linked to this record.
Start is estimated for Oct 2023; primary completion for Oct 2024, 12 months later.
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This study is not yet recruiting, as verified in Aug 2023. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Tofacitinib
Leishmaniasis, Mucocutaneous →
Hospital Universitário Professor Edgard Santos