Cutaneous Leishmaniasis Clinical Trial
Official title:
Therapeutic Gain of Adding the Immunomodulator Pentoxifylline to the Treatment of Cutaneous Leishmaniasis
The purpose of this study is to determine whether adding pentoxifylline to treatment of American cutaneous leishmaniasis with meglumine antimoniate increases the rate and speed of clinical response without diminishing safety, and to identify immune correlates of the healing response.
Failure of first line therapies for cutaneous leishmaniasis is a public health issue. Since
pathogenesis of dermal leishmaniasis is mediated by the immune and inflammatory responses,
resolution of disease and control of infection are intimately linked to the host response.
Several investigations have substantiated "proof of principal" for the therapeutic gain of
co-adjuvant immunotherapy. This study will evaluate the efficacy and safety of using
pentoxifylline (PTX) as a co-adjuvant in the treatment of cutaneous leishmaniasis with
meglumine antimoniate in a randomized, double-blind, controlled trial. One arm will receive
meglumine antimoniate and PTX and the other arm will receive meglumine antimoniate plus
placebo. Efficacy will be assessed at the end of the treatment, and 5, 7, 13 and 26 weeks
after initiation of treatment. Efficacy will be measured as the proportion of patients with
definitive cure at 26 weeks after initiation of treatment, and time to healing. Safety will
be assessed at the end of treatment with respect to the frequency and severity of adverse
events.
Blood samples will be taken to evaluate the effects of PTX invitro and ex vivo on cells of
the immune system. Proliferation and secretion of cytokines relevant to the immune and
inflammatory responses by peripheral blood mononuclear cells will be measured before and
after treatment. Likewise, macrophages will be differentiated from peripheral blood
monocytes and infected with a strain of L. panamensis transfected with the luciferase (luc)
gene. The investigators will measure the capacity of patient macrophages to kill parasites
before and after treatment using a luminometric assay of viable parasite burden.
Additionally, the investigators will measure the expression of inducible nitric oxide
synthase, an enzyme that is necessary for nitric oxide production, one of the main
leishmanicidal mechanisms used by macrophages. The investigators postulate that the use of
the co-adjuvant with antimonials will increase the therapeutic response and that indicators
predictive of a healing response can be identified by this prospective analysis of the
immune response and therapeutic outcome.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT01988909 -
WR 279,396 for the Treatment of Cutaneous Leishmaniasis
|
Phase 2 | |
Enrolling by invitation |
NCT00737386 -
Frequency of Parasite Infection in Hyraxes and Sandflies During Outbreak of Leishmania Tropica Epidemic in The West Bank
|
N/A | |
Enrolling by invitation |
NCT00840359 -
Study of the Efficacy of Daylight Activated Photodynamic Therapy in the Treatment of Cutaneous Leishmaniasis
|
Phase 2 | |
Completed |
NCT00233545 -
Miltefosine to Treat Cutaneous Leishmaniasis in Bolivia
|
Phase 2 | |
Completed |
NCT01462500 -
Pharmacokinetics of Miltefosine in Children and Adults
|
Phase 4 | |
Completed |
NCT01011309 -
A Study of the Efficacy and Safety of the LEISH-F2 + MPL-SE Vaccine for Treatment of Cutaneous Leishmaniasis
|
Phase 2 | |
Completed |
NCT01301924 -
Comparison of Standard and Alternative Antimonial Dosage in Patients With American Cutaneous Leishmaniasis
|
Phase 2/Phase 3 | |
Not yet recruiting |
NCT02281669 -
Prospective Observational Study of Intralesional Treatment With Pentostam in Cutaneous Leishmaniasis Israeli Patients
|
N/A | |
Completed |
NCT01790659 -
Phase 3 Study of Walter Reed (WR) 279,396 and Paromomycin Alone for the Treatment of Cutaneous Leishmaniasis in Panama
|
Phase 3 | |
Completed |
NCT01050907 -
Miltefosine to Treat Mucocutaneous Leishmaniasis
|
Phase 2 | |
Completed |
NCT04340128 -
Efficacy of Intra-lesional Injections of Glucantime Once a Week or Twice a Week in the Treatment of Anthroponotic Cutaneous Leishmaniasis (ACL)
|
Phase 3 | |
Terminated |
NCT00317629 -
Controlled Nitric Oxide Releasing Patch Versus Meglumine Antimoniate in the Treatment of Cutaneous Leishmaniasis
|
Phase 3 | |
Completed |
NCT00351520 -
Efficacy Trial on Oral Miltefosine in Comparison With Glucantime in the Treatment of ACL Caused by L. Tropica
|
Phase 3 | |
Completed |
NCT01381055 -
Antimony Plus Pentoxifylline in Cutaneous Leishmaniasis
|
Phase 2/Phase 3 | |
Completed |
NCT01050777 -
Efficacy of Topical Liposomal Form of Drugs in Cutaneous Leishmaniasis
|
Phase 0 | |
Completed |
NCT01380314 -
Oral Miltefosine Plus Topical Imiquimod to Treat Cutaneous Leishmaniasis
|
Phase 2 | |
Terminated |
NCT01380301 -
Treatment of Cutaneous Leishmaniasis With a Combination of Miltefosine and Antimony
|
Phase 2 | |
Completed |
NCT00703924 -
Topical Treatment of Cutaneous Leishmaniasis With WR 279,396: A Phase 2 Study in the Old World
|
Phase 2 | |
Completed |
NCT00344084 -
Surveillance for Leishmaniasis Skin Lesions in Mali
|
||
Completed |
NCT03023111 -
Miltefosine and GM-CSF in Cutaneous Leishmaniasis
|
Phase 3 |