Cutaneous Leishmaniasis Clinical Trial
Official title:
Phase III Clinical Trial for American Tegumentary Leishmaniasis: Comparison of Standard and Alternative Antimonial Dosage in Patients With American Cutaneous Leishmaniasis
Verified date | May 2018 |
Source | Oswaldo Cruz Foundation |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
"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.
Status | Completed |
Enrollment | 72 |
Est. completion date | December 2017 |
Est. primary completion date | April 2016 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 13 Years and older |
Eligibility |
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). |
Country | Name | City | State |
---|---|---|---|
Brazil | Oswaldo Cruz Foundation - IPEC/FIOCRUZ | Rio de Janeiro |
Lead Sponsor | Collaborator |
---|---|
Oswaldo Cruz Foundation | Conselho Nacional de Desenvolvimento Científico e Tecnológico, Rio de Janeiro State Research Supporting Foundation (FAPERJ) |
Brazil,
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
Sharquie KE. A new intralesional therapy of cutaneous leishmaniasis with hypertonic sodium chloride solution. J Dermatol. 1995 Oct;22(10):732-7. — View Citation
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. — View Citation
* Note: There are 18 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Effectiveness of meglumine antimoniate treatment | 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. | 6 years | |
Secondary | Safety of meglumine antimoniate treatment | 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. | 6 years |
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