Clinical Trial: Efficacy and Safety Study of Drugs for Treatment of Visceral Leishmaniasis in Brazil

Study Status: Terminated
Recruit Status: Terminated
Study Type: Interventional

Official Title: Multicentric Efficacy and Safety Study of Antileishmanial Drugs for Treatment of Visceral Leishmaniasis in Brazil

Brief Summary: This study is aimed to compare the efficacy and safety of medications currently used in Brazil for treatment of visceral leishmaniasis. The investigators will compare the effects of meglumine antimoniate, two formulations of amphotericin B: deoxycholate and liposomal, and a combination of meglumine plus the liposomal amphotericin B formulation. The study is designed to demonstrate the difference in efficacy measured as cure rate at six months after treatment and the safety profile based on the adverse event rate observed with each intervention.

Detailed Summary:

Visceral leishmaniasis is a relevant public health problem in Brazil with approximately 3500 cases registered every year. Eight percent lethality rate has been observed during the past decade in spite of free of charge availability of antileishmanial drugs supplied by the public health system.

The present study was designed as a phase IV, multicentric, open label, active controlled clinical trial targeted to visceral leishmaniasis adult and pediatric cases.

The current drugs approved for visceral leishmaniasis treatment in Brazil will be compared in four treatment groups: meglumine antimoniate, amphotericin B deoxycholate, liposomal amphotericin B and a combination of single dose of liposomal amphotericin B plus meglumine antimoniate. Meglumine antimoniate treated patients will constitute the active control group.

Drugs will be compared based on the cure rate observed after six months follow-up.

The study arm submitted to treatment with Amphotericin B deoxycholate was suspended in September 2012.


Sponsor: University of Brasilia

Current Primary Outcome: Cure rate [ Time Frame: 6 month ]

Complete remission of clinical signs and symptoms, three months after treatment plus normal hematological lab evaluation and no relapse at sixth month follow-up.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Improvement rate [ Time Frame: 30 days ]
    Fever disappearing, stable or improving hematological lab abnormalities plus any spleen size reduction.
  • Relapse rate [ Time Frame: (6 months post treatment) After treatment until the sixth month of follow-up ]
    Reappearing of signs and symptoms after any improvement observed after treatment, during the six months follow-up period.
  • Serious adverse events rate [ Time Frame: During (day one) and within the six months follow-up ]
    Rate of adverse events defined as conditions which fulfilled any of the following: results in death, is life threatening, requires inpatient hospitalization or prolongs hospitalization, results in persistent or significant disability/incapacity, causes a congenital anomaly or birth defect or it is considered as a important medical event for the responsible clinician.
  • Adverse event rate and intensity [ Time Frame: During (day one) treatment and within the six months follow-up ]
    Cumulative rate of any adverse event, including clinical, laboratory and electrocardiographic abnormalities observed within the treatment and follow-up periods. All adverse events will be graded using an adapted ACTG 0-4 scale.


Original Secondary Outcome:

  • Improvement rate [ Time Frame: 30 days ]
    Fever desapearing, stable or improving hematological lab abnormalities plus any spleen size reduction.
  • Relapse rate [ Time Frame: After treatment until the sixth month of follow-up ]
    Reappearing of signs and symptoms after any improvement observed after treatment, during the six months follow-up period.
  • Serious adverse events rate [ Time Frame: During and withing the six months follow-up ]
    Rate of adverse events defined as conditions which fulfilled any of the following: results in death, is life threatening, requires inpatient hospitalization or prolongs hospitalization, results in persistent or significant disability/incapacity, causes a congenital anomaly or birth defect or it is considered as a important medical event for the responsible clinician.
  • Adverse event rate and intensity [ Time Frame: During treatment and within the six months follow-up ]
    Cummulative rate of any adverse event, including clinical, laboratory and electrocardigraphic abnormalities observed within the treatment and follow-up periods. All adverse events will be graded using an adapted ACTG 0-4 scale.


Information By: University of Brasilia

Dates:
Date Received: March 7, 2011
Date Started: February 2011
Date Completion:
Last Updated: January 20, 2016
Last Verified: January 2016