Ignite Creation Date:
2024-05-06 @ 8:18 PM
Last Modification Date:
2024-10-26 @ 3:25 PM
Study NCT ID:
NCT06339710
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-07-15
First Post:
2024-02-15
Brief Title:
Short Benznidazole Regimen for Chronic Phase Chagas Disease Patients
Sponsor:
Evandro Chagas Institute of Clinical Research
Organization:
Evandro Chagas Institute of Clinical Research
Study Overview
Official Title:
Double Blind Phase III RandomizedSafety and Efficacy Non-inferiority Trial to Evaluate Two Short Benznidazole Regimens for the Treatment of Adults in the Chronic Phase of Chagas Disease in Its Indeterminate and Mild Cardiac Forms in Bolivia and Colombia
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
Benlatino
Brief Summary:
Multicentric study on Chagas disease that seeks to evaluate a new treatment regimen using the drug benznidazole Currently existing treatment regimens are long and have frequent side effects which leads to a high dropout rate among patients The research proposes testing two shorter benznidazole regimens to see if they are as effective as standard treatment but with fewer side effects
The study will have 672 participants and will be carried out in four locations Bolivia and Colombia The objective is to analyze the efficacy and safety of new treatment regimens evaluating the parasitological response in comparison with standard treatment In addition an economic assessment will be carried out to analyze direct and indirect costs including procedures associated with the management of adverse events
The study will have 672 participants and will be carried out in four locations Bolivia and Colombia The objective is to analyze the efficacy and safety of new treatment regimens evaluating the parasitological response in comparison with standard treatment In addition an economic assessment will be carried out to analyze direct and indirect costs including procedures associated with the management of adverse events
Detailed Description:
Chagas disease is a major cause of heart disease morbidity and premature loss of life in the Americas Eliminating the Trypanosoma cruzi parasite using antitrypanosomal drugs has shown to produce cure in children halt future congenital transmission and reduce morbidity from the disease However the current treatment regimens are lengthy 60 days and entail frequent side effects causing about 20 of patients to drop out of treatment and discouraging others from starting Recent research found that a reduced treatment of benznidazole still has adequate efficacy with few side effects
In this international multicenter double-blind phase III placebo-controlled study 672 participants will be randomly assigned to receive the standard-dose of benznidazole 300 mg daily for 8 weeks or the short experimental regimens benznidazole 300 mg daily for the first 2 weeks plus placebo for the last 6 weeks or benznidazole 300 mg daily for the first 4 weeks plus placebo for the last 4 weeks Efficacy will be assessed considering a non-inferiority design and through the detection of parasite deoxyribonucleic acid DNA through molecular biology Polymerase Chain Reaction - PCR Meanwhile safety will be evaluated through a superiority design with the aim to find the new regimen as effective as the standard one but superior in terms of safety An intention-to-treat analysis will be performed and statistical significance will be set at 0025 for the non-inferiority outcome positive PCR and 005 for the superiority outcome
The study population will be adult participants 18 years or older with chronic Chagas disease in its indeterminate or mild cardiac forms with a positive diagnosis from two serological assays The trial will be conducted in four sites two in Bolivia and two in Colombia The primary endpoint will be parasitological response determined as sustained negative qualitative PCR at 24 months after treatment The proportion of participants with positive qualitative PCR will be measured at 1 4 6 8 12 18 and 24 months from end of treatment The frequency of adverse events leading to treatment discontinuation will be compared An economic evaluation will be conducted assessing the direct and indirect costs including procedures associated with the management of adverse events
In this international multicenter double-blind phase III placebo-controlled study 672 participants will be randomly assigned to receive the standard-dose of benznidazole 300 mg daily for 8 weeks or the short experimental regimens benznidazole 300 mg daily for the first 2 weeks plus placebo for the last 6 weeks or benznidazole 300 mg daily for the first 4 weeks plus placebo for the last 4 weeks Efficacy will be assessed considering a non-inferiority design and through the detection of parasite deoxyribonucleic acid DNA through molecular biology Polymerase Chain Reaction - PCR Meanwhile safety will be evaluated through a superiority design with the aim to find the new regimen as effective as the standard one but superior in terms of safety An intention-to-treat analysis will be performed and statistical significance will be set at 0025 for the non-inferiority outcome positive PCR and 005 for the superiority outcome
The study population will be adult participants 18 years or older with chronic Chagas disease in its indeterminate or mild cardiac forms with a positive diagnosis from two serological assays The trial will be conducted in four sites two in Bolivia and two in Colombia The primary endpoint will be parasitological response determined as sustained negative qualitative PCR at 24 months after treatment The proportion of participants with positive qualitative PCR will be measured at 1 4 6 8 12 18 and 24 months from end of treatment The frequency of adverse events leading to treatment discontinuation will be compared An economic evaluation will be conducted assessing the direct and indirect costs including procedures associated with the management of adverse events
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None