We updated the design of this site on September 25th. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

Comparison of Standard and Alternative Antimonial Dosage in Patients With American Cutaneous Leishmaniasis

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01301924
First Posted: February 23, 2011
Last Update Posted: May 23, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
Rio de Janeiro State Research Supporting Foundation (FAPERJ)
Conselho Nacional de Desenvolvimento Científico e Tecnológico
Information provided by (Responsible Party):
ASchubach, Oswaldo Cruz Foundation
  Purpose
"Phase III Clinical Trial for American Tegumentary Leishmaniasis: Comparison of Standard and Alternative Antimonial Dosage in Patients With American Cutaneous Leishmaniasis " has begun in October 2008 at the Laboratory of Leishmaniasis Surveillance at Evandro Chagas Clinical Research Institute (IPEC), FIOCRUZ, aiming to compare efficacy and safety of the standard recommended schedule with an alternative dosage scheme of meglumine antimoniate in the treatment of American tegumentary leishmaniasis (ATL). It is a study with blind evaluation by the doctors and the responsible for statistical analysis. Patients diagnosed with ATL, eligible for the trial are randomly allocated into one of the schemes with meglumine antimoniate and monitored before, during and after it. There is no single regimen applicable to all forms of leishmaniasis around the world. Therapeutic regimens applied to treat people living in other geographic areas result in mixed outcomes. Ideally, the most appropriate regimens should be established for each endemic area, based on its efficacy, toxicity, difficulties of administration and cost. Given the problems and limitations of the use of pentavalent antimonials (Sb5+) at 20 mg Sb5+ / kg / day, less toxic alternative regimens, i.e. 5mg Sb5+/kg/day, deserve to be better evaluated. The treatment of ATL must heal skin lesions and prevent late mucosal lesion development. The indication of high doses of Sb5+ is based on the evidence that there could be induction of resistance with use of subdoses. However, clinical studies with extended follow-up in Rio de Janeiro have suggested that regular low doses (5mg Sb5+ / kg / day) may constitute an effective scheme, achieving cure rates similar to higher doses, with lower toxicity, ease of implementation and lower cost. Published studies on efficacy and safety of alternative dosage schemes with meglumine antimoniate failed to provide conclusive results so far, for various methodological biases. The need to compare the effectiveness and safety between the standard treatment scheme with meglumine antimoniate currently recommended in Brazil for the treatment of ATL and an alternative scheme with low doses of antimony is the motive for this study in Rio de Janeiro.

Condition Intervention Phase
Cutaneous Leishmaniasis Drug: Meglumine antimoniate Phase 2 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Care Provider)
Primary Purpose: Treatment
Official Title: Phase III Clinical Trial for American Tegumentary Leishmaniasis: Comparison of Standard and Alternative Antimonial Dosage in Patients With American Cutaneous Leishmaniasis

Resource links provided by NLM:


Further study details as provided by ASchubach, Oswaldo Cruz Foundation:

Primary Outcome Measures:
  • Effectiveness of meglumine antimoniate treatment [ Time Frame: 6 years ]
    To compare the effectiveness of meglumine antimoniate at a dose of 5 mg or 20 mg Sb5+ / kg / day in the treatment of patients with cutaneous leishmaniasis.


Secondary Outcome Measures:
  • Safety of meglumine antimoniate treatment [ Time Frame: 6 years ]
    To compare the safety of meglumine antimoniate at a dose of 5 mg or 20 mg Sb5+ / kg / day in the treatment of patients with cutaneous leishmaniasis.


Estimated Enrollment: 264
Study Start Date: October 2008
Estimated Study Completion Date: December 2017
Primary Completion Date: April 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: High dose
High dose: 20 days of 20 mg/kg/day meglumine antimoniate
Drug: Meglumine antimoniate

Meglumine antimoniate is stored and ministered under actual conditions employed by health services in Brazil. Each patient will be included in one of the treatment groups with meglumine antimoniate IM:

High dose: 20 days of 20 mg/kg/day antimoniate meglumine. Low dose: 30 days of 5 mg/kg/day antimoniate meglumine.

Other Names:
  • High dose
  • Low dose
Experimental: Low dose
Low dose: 30 days of 5 mg/kg/day meglumine antimoniate
Drug: Meglumine antimoniate

Meglumine antimoniate is stored and ministered under actual conditions employed by health services in Brazil. Each patient will be included in one of the treatment groups with meglumine antimoniate IM:

High dose: 20 days of 20 mg/kg/day antimoniate meglumine. Low dose: 30 days of 5 mg/kg/day antimoniate meglumine.

Other Names:
  • High dose
  • Low dose

  Show Detailed Description

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   13 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Eligibility Criteria.

Inclusion criteria:

  1. Cutaneous leishmaniasis with parasitological diagnosis by one or more of the following methods: direct examination (scraping or imprint), histopathology, culture, immunohistochemistry, or PCR.
  2. History of exposure in an endemic area of Rio de Janeiro
  3. Absence of prior treatment with meglumine antimoniate

Exclusion criteria:

  1. women who do not use contraceptives or do it inadequately
  2. pregnant
  3. under 13
  4. prior treatment with meglumine antimoniate
  5. use of immunosuppressive therapy (steroids, cancer chemotherapy) or medicines for tuberculosis or leprosy.
  6. presence of changes in baseline clinical adverse effect level equivalent to> G3
  7. presence of changes in baseline laboratory adverse effect level equivalent to> G2
  8. presence of baseline electrocardiographic changes equivalent to an adverse effect level> G4 and / or baseline QTc> 0.46 ms (equivalent to AS level G1).
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01301924


Locations
Brazil
Oswaldo Cruz Foundation - IPEC/FIOCRUZ
Rio de Janeiro, Brazil
Sponsors and Collaborators
Oswaldo Cruz Foundation
Rio de Janeiro State Research Supporting Foundation (FAPERJ)
Conselho Nacional de Desenvolvimento Científico e Tecnológico
Investigators
Study Director: Armando O. Schubach, MD, PhD IPEC/FIOCRUZ
  More Information

Additional Information:
Publications:
Antezana G, Zeballos R, Mendoza C, Lyevre P, Valda L, Cardenas F, Noriega I, Ugarte H, Dedet JP. Electrocardiographic alterations during treatment of mucocutaneous leishmaniasis with meglumine antimoniate and allopurinol. Trans R Soc Trop Med Hyg. 1992 Jan-Feb;86(1):31-3.
de Azeredo-Coutinho RB, Mendonça SC. An intermittent schedule is better than continuous regimen of antimonial therapy for cutaneous leishmaniasis in the municipality of Rio de Janeiro, Brazil. Rev Soc Bras Med Trop. 2002 Sep-Oct;35(5):477-81.
Chulay JD, Spencer HC, Mugambi M. Electrocardiographic changes during treatment of leishmaniasis with pentavalent antimony (sodium stibogluconate). Am J Trop Med Hyg. 1985 Jul;34(4):702-9.
Deps PD, Viana MC, Falqueto A, Dietze R. [Comparative assessment of the efficacy and toxicity of N-methyl-glucamine and BP88 sodium stibogluconate in the treatment of localized cutaneous leishmaniasis]. Rev Soc Bras Med Trop. 2000 Nov-Dec;33(6):535-43. Portuguese.
Hepburn NC, Nolan J, Fenn L, Herd RM, Neilson JM, Sutherland GR, Fox KA. Cardiac effects of sodium stibogluconate: myocardial, electrophysiological and biochemical studies. QJM. 1994 Aug;87(8):465-72.
Hepburn NC, Siddique I, Howie AF, Beckett GJ, Hayes PC. Hepatotoxicity of sodium stibogluconate therapy for American cutaneous leishmaniasis. Trans R Soc Trop Med Hyg. 1994 Jul-Aug;88(4):453-5.
Marzochi MC, Marzochi KB. Tegumentary and visceral leishmaniases in Brazil: emerging anthropozoonosis and possibilities for their control. Cad Saude Publica. 1994;10 Suppl 2:359-75. Epub 2004 Mar 19.
McBride MO, Linney M, Davidson RN, Weber JN. Pancreatic necrosis following treatment of leishmaniasis with sodium stibogluconate. Clin Infect Dis. 1995 Sep;21(3):710.
Oliveira Neto MP, Schubach A, Araujo ML, Pirmez C. High and low doses of antimony (Sbv) in American cutaneous leishmaniasis. A five years follow-up study of 15 patients. Mem Inst Oswaldo Cruz. 1996 Mar-Apr;91(2):207-9.
Oliveira-Neto MP, Schubach A, Mattos M, da Costa SC, Pirmez C. Intralesional therapy of American cutaneous leishmaniasis with pentavalent antimony in Rio de Janeiro, Brazil--an area of Leishmania (V.) braziliensis transmission. Int J Dermatol. 1997 Jun;36(6):463-8.
Oliveira-Neto MP, Schubach A, Mattos M, Goncalves-Costa SC, Pirmez C. A low-dose antimony treatment in 159 patients with American cutaneous leishmaniasis: extensive follow-up studies (up to 10 years). Am J Trop Med Hyg. 1997 Dec;57(6):651-5.
Oliveira-Neto MP, Schubach A, Mattos M, Gonçalves-Costa SC, Pirmez C. Treatment of American cutaneous leishmaniasis: a comparison between low dosage (5 mg/kg/day) and high dosage (20 mg/kg/day) antimony regimens. Pathol Biol (Paris). 1997 Jun;45(6):496-9.
Ribeiro AL, Drummond JB, Volpini AC, Andrade AC, Passos VM. Electrocardiographic changes during low-dose, short-term therapy of cutaneous leishmaniasis with the pentavalent antimonial meglumine. Braz J Med Biol Res. 1999 Mar;32(3):297-301.
Rodrigues ML, Costa RS, Souza CS, Foss NT, Roselino AM. Nephrotoxicity attributed to meglumine antimoniate (Glucantime) in the treatment of generalized cutaneous leishmaniasis. Rev Inst Med Trop Sao Paulo. 1999 Jan-Feb;41(1):33-7.
Sampaio RN, de Paula CD, Sampaio JH, Furtado Rde S, Leal PP, Rosa TT, Rodrigues ME, Veiga JP. [The evaluation of the tolerance and nephrotoxicity of pentavalent antimony administered in a dose of 40 mg Sb V/kg/day, 12/12 hr, for 30 days in the mucocutaneous form of leishmaniasis]. Rev Soc Bras Med Trop. 1997 Nov-Dec;30(6):457-63. Portuguese.
Schubach Ade O, Marzochi KB, Moreira JS, Schubach TM, Araújo ML, Vale AC, Passos SR, Marzochi MC. Retrospective study of 151 patients with cutaneous leishmaniasis treated with meglumine antimoniate. Rev Soc Bras Med Trop. 2005 May-Jun;38(3):213-7. Epub 2005 May 4.
Sharquie KE. A new intralesional therapy of cutaneous leishmaniasis with hypertonic sodium chloride solution. J Dermatol. 1995 Oct;22(10):732-7.
Veiga JP, Wolff ER, Sampaio RN, Marsden PD. Renal tubular dysfunction in patients with mucocutaneous leishmaniasis treated with pentavalent antimonials. Lancet. 1983 Sep 3;2(8349):569.

Responsible Party: ASchubach, Senior Researcher, Oswaldo Cruz Foundation
ClinicalTrials.gov Identifier: NCT01301924     History of Changes
Other Study ID Numbers: StdvsaltCL
First Submitted: February 20, 2011
First Posted: February 23, 2011
Last Update Posted: May 23, 2017
Last Verified: May 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by ASchubach, Oswaldo Cruz Foundation:
Leishmaniasis Cutaneous
Leishmania braziliensis
Meglumine Antimoniate
Treatment Effectiveness
Controlled Clinical Trials, Randomized

Additional relevant MeSH terms:
Leishmaniasis
Leishmaniasis, Cutaneous
Euglenozoa Infections
Protozoan Infections
Parasitic Diseases
Skin Diseases, Parasitic
Skin Diseases, Infectious
Skin Diseases
Meglumine antimoniate
Antiprotozoal Agents
Antiparasitic Agents
Anti-Infective Agents


To Top