Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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Recruitment Status
COMPLETED
Clinical Phase
PHASE2
Total Enrollment
450 participants
Study Classification
INTERVENTIONAL
Study Start Date
2019-12-18
Study Completion Date
2024-05-31
Brief Summary
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Chagas disease (CD) is an endemic zoonotic disease with a significant global impact. Current approved treatments for CD (benznidazole (BZN) and nifurtimox (NFX)) were developed in the 1970s with regimens and dosing intervals derived from decades-old patient series and with very limited direct comparisons. Treatment recommendations vary significantly from country to country and the comparative evidence-base with the current treatment regimens is limited.
The reported efficacy of both drugs in patients with T. cruzi infection is variable and depends on the disease stage, the drug dose, the age of patients, and the infecting T. cruzi strain or genotype. Due to a therapeutic failure of at least 20% after 12 months in chronic patients and the high rate of adverse events, together with the recent data that suggest that we may be overdosing patients, we propose to test new dosing regimens of these two old compounds.
Hypotheses:
* Lowering the frequency of drug dosing of BZN and NFX, the plasma drug levels of the drugs within the therapeutic range will be maintained.
* The duration of treatment with BZN or NFX may be related to the effectiveness of these drugs.
* Blood levels of the proposed biomarkers will significantly diminish or became negative after a relatively short interval after treatment.
The reported efficacy of both drugs in patients with T. cruzi infection is variable and depends on the disease stage, the drug dose, the age of patients, and the infecting T. cruzi strain or genotype. Due to a therapeutic failure of at least 20% after 12 months in chronic patients and the high rate of adverse events, together with the recent data that suggest that we may be overdosing patients, we propose to test new dosing regimens of these two old compounds.
Hypotheses:
* Lowering the frequency of drug dosing of BZN and NFX, the plasma drug levels of the drugs within the therapeutic range will be maintained.
* The duration of treatment with BZN or NFX may be related to the effectiveness of these drugs.
* Blood levels of the proposed biomarkers will significantly diminish or became negative after a relatively short interval after treatment.
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Detailed Description
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Chagas disease (CD) is an endemic zoonotic disease caused by the protozoan parasite, T. cruzi. It affects 8-10 million people in Latin America and is a worldwide public health issue due to migratory flows. CD has a significant economic impact. Recently, a study showed that the global costs for CD are US$7-19 billion per year, similar or even higher to those of other important diseases such as rotavirus infection or cervical cancer. Treatment of chronic CD (CCD) has been hampered, unlike other illnesses, by the paramount importance given to the autoimmune theory of the disease that prevailed for many years. As a result, several generations of health professionals were trained in the belief that CCD had no treatment. As a consequence, currently, most (\>99%) chronically infected people are still not treated with specific antiparasitic drugs, and the research and development for new, more effective drugs was overlooked for many years, until very recently. Nowadays, the key role of the parasite persistence in the pathophysiology of CD is recognized, as well as the need for specific treatment.
Current approved specific treatments for CD include nifurtimox (NFX) and benznidazole (BZN) and the recommended dosing regimens are 5 mg/Kg/day divided into two doses (2.5 mg/Kg b.i.d) given for 60 days for BZN, and 8 mg/Kg divided into three equal daily doses (2.7 mg/Kg t.i.d.) given for 90 days for NFX. The efficacy of both drugs in patients with T. cruzi infection is highly variable and depends on the disease stage, the drug dose, the age of patients, and the infecting T. cruzi strain or genotype. Moreover, the high rate of adverse events hampers their standard use in the field. Recent studies show that at the current doses of both drugs, more than 70% of patients suffer mild/moderate reactions and around 10-27% experience serious ones, forcing patients to stop the treatment and take appropriate medications for the adverse events. Data on the pharmacokinetics (PK) of BZN and NFX are limited and there are no recent data on PK of NFX in adults with chronic CD. Moreover, due to a lack of early BMKs of therapeutic efficacy, the true efficacy of these drugs remains unknown. Seroconversion using conventional serology (CS) is often long-term (\~10-20 years) or incomplete, and a reduction in T. cruzi-specific antibody titers often takes many years, rendering the evaluation of response to treatment insensitive and lengthy, and therefore impractical in clinical settings. The need for new, safer, and more efficacious drugs against T. cruzi as well as early BMKS of therapeutic efficacy are the major challenges in the treatment of CD, particularly in chronic adults.
With this project, the investigators aim to achieve specific knowledge about the safety and efficacy of new dosing regimens for BZN and NFX. The proposed new regimens for these drugs are based on recent data that suggest that with half of the dosing frequency the levels of BZN can be maintained in the therapeutic range of this drug, which could conceivably reduce the appearance of adverse events while maintaining antiparasitic efficacy. At the same time, the investigators plan to evaluate whether the drug efficacy will be maintained if the investigators reduce the length of treatment with BZN or NFX to 30 days. Furthermore, the investigators also plan to evaluate whether the efficacy of the treatment with BZN or NFX is improved by increasing its duration to 90 days and to evaluate novel potential BMKs of response to specific treatment and eventual parasitological cure in CCD patients. The information obtained in this study would also allow for better-designed clinical trials with drug combinations, in which NFX and BZN will have a central role.
The results will be disseminated via publications in peer-reviewed journals, conferences, and reports to the NIH, FDA, and participating institutions. The investigators of this study are aware of and have agreed to abide by the principles for sharing research resources as described by NIH in "Principles and Guidelines for Recipients of NIH Research Grants and Contracts on Obtaining and Disseminating Biomedical Research Programs." Accordingly, resources developed in this study will be available to the scientific community as soon as the intellectual property of these resources and/or research tools have been protected or disclosed in publications. In the event that a specific research tool is requested from the TESEO investigators and is available, it will be shared with members of the scientific community. Data sharing not applicable as no datasets have been generated and/or analysed for this study yet. However, once the datasets resulting from this study are available, they will be disseminated via publications in peer-reviewed journals, national and international conferences, and reports to the NIH, FDA, and participating institutions.
Current approved specific treatments for CD include nifurtimox (NFX) and benznidazole (BZN) and the recommended dosing regimens are 5 mg/Kg/day divided into two doses (2.5 mg/Kg b.i.d) given for 60 days for BZN, and 8 mg/Kg divided into three equal daily doses (2.7 mg/Kg t.i.d.) given for 90 days for NFX. The efficacy of both drugs in patients with T. cruzi infection is highly variable and depends on the disease stage, the drug dose, the age of patients, and the infecting T. cruzi strain or genotype. Moreover, the high rate of adverse events hampers their standard use in the field. Recent studies show that at the current doses of both drugs, more than 70% of patients suffer mild/moderate reactions and around 10-27% experience serious ones, forcing patients to stop the treatment and take appropriate medications for the adverse events. Data on the pharmacokinetics (PK) of BZN and NFX are limited and there are no recent data on PK of NFX in adults with chronic CD. Moreover, due to a lack of early BMKs of therapeutic efficacy, the true efficacy of these drugs remains unknown. Seroconversion using conventional serology (CS) is often long-term (\~10-20 years) or incomplete, and a reduction in T. cruzi-specific antibody titers often takes many years, rendering the evaluation of response to treatment insensitive and lengthy, and therefore impractical in clinical settings. The need for new, safer, and more efficacious drugs against T. cruzi as well as early BMKS of therapeutic efficacy are the major challenges in the treatment of CD, particularly in chronic adults.
With this project, the investigators aim to achieve specific knowledge about the safety and efficacy of new dosing regimens for BZN and NFX. The proposed new regimens for these drugs are based on recent data that suggest that with half of the dosing frequency the levels of BZN can be maintained in the therapeutic range of this drug, which could conceivably reduce the appearance of adverse events while maintaining antiparasitic efficacy. At the same time, the investigators plan to evaluate whether the drug efficacy will be maintained if the investigators reduce the length of treatment with BZN or NFX to 30 days. Furthermore, the investigators also plan to evaluate whether the efficacy of the treatment with BZN or NFX is improved by increasing its duration to 90 days and to evaluate novel potential BMKs of response to specific treatment and eventual parasitological cure in CCD patients. The information obtained in this study would also allow for better-designed clinical trials with drug combinations, in which NFX and BZN will have a central role.
The results will be disseminated via publications in peer-reviewed journals, conferences, and reports to the NIH, FDA, and participating institutions. The investigators of this study are aware of and have agreed to abide by the principles for sharing research resources as described by NIH in "Principles and Guidelines for Recipients of NIH Research Grants and Contracts on Obtaining and Disseminating Biomedical Research Programs." Accordingly, resources developed in this study will be available to the scientific community as soon as the intellectual property of these resources and/or research tools have been protected or disclosed in publications. In the event that a specific research tool is requested from the TESEO investigators and is available, it will be shared with members of the scientific community. Data sharing not applicable as no datasets have been generated and/or analysed for this study yet. However, once the datasets resulting from this study are available, they will be disseminated via publications in peer-reviewed journals, national and international conferences, and reports to the NIH, FDA, and participating institutions.
Conditions
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Trypanosoma Cruzi Infection
Chagas Disease
Study Design
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Allocation Method
RANDOMIZED
Intervention Model
PARALLEL
Three of 6 parallel groups will receive one of three different oral benznidazole (BZN) dosing regimens and the other three will receive one of the three different nifurtimox (NFX) regimens.
Primary Study Purpose
TREATMENT
Blinding Strategy
NONE
Study Groups
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BZN-60
150 mg twice a day for 60 days.
Group Type
EXPERIMENTAL
Benznidazole
Intervention Type
DRUG
50 mg and 100 mg tablet taken orally
BZN-30
150 mg once a day for 30 days.
Group Type
EXPERIMENTAL
Benznidazole
Intervention Type
DRUG
50 mg and 100 mg tablet taken orally
BZN-90
150 mg once a day for 90 days.
Group Type
EXPERIMENTAL
Benznidazole
Intervention Type
DRUG
50 mg and 100 mg tablet taken orally
NFX-60
240 mg twice a day for 60 days.
Group Type
EXPERIMENTAL
Nifurtimox
Intervention Type
DRUG
120 mg tablet taken orally
NFX-30
240 mg twice a day for 30 days.
Group Type
EXPERIMENTAL
Nifurtimox
Intervention Type
DRUG
120 mg tablet taken orally
NFX-90
240 mg once a day for 90 days.
Group Type
EXPERIMENTAL
Nifurtimox
Intervention Type
DRUG
120 mg tablet taken orally
Interventions
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Benznidazole
50 mg and 100 mg tablet taken orally
Intervention Type
DRUG
Nifurtimox
120 mg tablet taken orally
Intervention Type
DRUG
Other Intervention Names
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P01CA02
Abarax
Radanil
Rochagan
Lampit
P01CC01
QP51AC01
Eligibility Criteria
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Inclusion Criteria
1. Adults, 18-50 years.
2. Weight: 88-198 pounds (40-90 Kg).
3. Individuals diagnosed as being infected with T. cruzi by conventional serology (two positive tests with different antigens) with at least one positive qualitative RT-PCR assay out of three during the screening.
4. Patient classified as being in the indeterminate form (without clinical manifestations) or early cardiac form (Kushnir 1) of chronic Chagas disease.
5. Signed informed consent form (ICF).
2. Weight: 88-198 pounds (40-90 Kg).
3. Individuals diagnosed as being infected with T. cruzi by conventional serology (two positive tests with different antigens) with at least one positive qualitative RT-PCR assay out of three during the screening.
4. Patient classified as being in the indeterminate form (without clinical manifestations) or early cardiac form (Kushnir 1) of chronic Chagas disease.
5. Signed informed consent form (ICF).
Exclusion Criteria
1. Clinical signs of dilated cardiomyopathy (dyspnea, legs' edema, syncope, pulmonary crackles). Patients with an EKG showing the following characteristics: sinus tachycardia or atrial fibrillation, ventricular arrhythmias, left atrial enlargement, left bundle-branch block (LBBB) accompanied by right axis deviation (RAD), and/or patients with Calculation of Fridericia's corrected QT interval (QTcF) \> 450ms, a formula for calculating the QT interval on an electrocardiogram (ECG).
2. History of Chagas disease treatment with BZN or NFX or any triazole drug(s) in the last five years.
3. Clinical signs and/or symptoms of digestive form of Chagas disease, which is characterized by the presence of two or more of the following criteria \*:
1. Excessive exertion in at least 25% of bowel movements
2. Hard stools in at least 25% of stools (type 1-2 of Bristol)
3. Feeling of incomplete evacuation in at least 25% of bowel movements
4. Feeling of obstruction or anorectal block in at least 25% of bowel movements
5. Manual maneuvers to facilitate defecation in at least 25% of bowel movements
6. Less than 3 complete spontaneous stools per week
* Criteria must be met for at least the last three months and symptoms must have been started for at least six months before diagnosis.
4. Hypersensitivity to the active substances (BZN or NFX) or to the excipient.
5. Previous diagnosis of porphyria.
6. Any other acute or chronic health conditions that in the opinion of the PI, may interfere with the efficacy and/or safety evaluation of the study drug.
7. Formal contraindication to BZN or NFX.
8. Any concomitant or anticipated use of drugs that are contraindicated with the use of BZN or NFX.
9. Individuals currently known to abuse alcohol and/or drugs. Furthermore, if throughout the course of the study the team becomes aware that a participant is using drugs/alcohol that participant will be excluded from the treatment but will continue with the follow-up visits. The study manual outlines how abuse and dependence will be measured for this study.
10. Pregnancy. Females of childbearing potential will be required to complete a pregnancy test prior to enrollment and throughout the course of treatment.
11. Women in reproductive age must have a negative serum pregnancy test at screening, must not be breastfeeding, and consistently use and/or have partner consistently use a highly effective contraceptive method during the entire treatment phase of the trial.
12. Transaminases (alanine aminotransferase-ALT and aspartate aminotransferase- AST). AST must be within the normal range, within an acceptable margin of 25% above the upper limit of normality for both, according to the insert of the biochemical kit being used in this study.
13. Creatinine must be within an acceptable range, within an acceptable margin of 10% above the upper limit of normality, according to the insert of the biochemical kit being used. The normal ranges of transaminases (ALT and AST) and creatinine are defined by the inserts of the commercial biochemical kits selected to be used in the present study. All treatment centers (Chagas Platforms in Cochabamba, Sucre, and Tarija) are going to use the same biochemical kits. The participating clinical laboratories at the Platforms (in Cochabamba, Sucre, and Tarija) will use the Common Terminology Criteria for Adverse Events (CTCAE, v.5.0; ttps://ctep.cancer.gov/protocoldevelopment/electronic\_applications/docs/ctcae\_v5\_quick\_reference\_5x7.pdf).
14. Total bilirubin must be within the normal range, within an acceptable margin of 15% above the upper limit of normality for both sexes, according to the insert of the biochemical kit being used in this study.
2. History of Chagas disease treatment with BZN or NFX or any triazole drug(s) in the last five years.
3. Clinical signs and/or symptoms of digestive form of Chagas disease, which is characterized by the presence of two or more of the following criteria \*:
1. Excessive exertion in at least 25% of bowel movements
2. Hard stools in at least 25% of stools (type 1-2 of Bristol)
3. Feeling of incomplete evacuation in at least 25% of bowel movements
4. Feeling of obstruction or anorectal block in at least 25% of bowel movements
5. Manual maneuvers to facilitate defecation in at least 25% of bowel movements
6. Less than 3 complete spontaneous stools per week
* Criteria must be met for at least the last three months and symptoms must have been started for at least six months before diagnosis.
4. Hypersensitivity to the active substances (BZN or NFX) or to the excipient.
5. Previous diagnosis of porphyria.
6. Any other acute or chronic health conditions that in the opinion of the PI, may interfere with the efficacy and/or safety evaluation of the study drug.
7. Formal contraindication to BZN or NFX.
8. Any concomitant or anticipated use of drugs that are contraindicated with the use of BZN or NFX.
9. Individuals currently known to abuse alcohol and/or drugs. Furthermore, if throughout the course of the study the team becomes aware that a participant is using drugs/alcohol that participant will be excluded from the treatment but will continue with the follow-up visits. The study manual outlines how abuse and dependence will be measured for this study.
10. Pregnancy. Females of childbearing potential will be required to complete a pregnancy test prior to enrollment and throughout the course of treatment.
11. Women in reproductive age must have a negative serum pregnancy test at screening, must not be breastfeeding, and consistently use and/or have partner consistently use a highly effective contraceptive method during the entire treatment phase of the trial.
12. Transaminases (alanine aminotransferase-ALT and aspartate aminotransferase- AST). AST must be within the normal range, within an acceptable margin of 25% above the upper limit of normality for both, according to the insert of the biochemical kit being used in this study.
13. Creatinine must be within an acceptable range, within an acceptable margin of 10% above the upper limit of normality, according to the insert of the biochemical kit being used. The normal ranges of transaminases (ALT and AST) and creatinine are defined by the inserts of the commercial biochemical kits selected to be used in the present study. All treatment centers (Chagas Platforms in Cochabamba, Sucre, and Tarija) are going to use the same biochemical kits. The participating clinical laboratories at the Platforms (in Cochabamba, Sucre, and Tarija) will use the Common Terminology Criteria for Adverse Events (CTCAE, v.5.0; ttps://ctep.cancer.gov/protocoldevelopment/electronic\_applications/docs/ctcae\_v5\_quick\_reference\_5x7.pdf).
14. Total bilirubin must be within the normal range, within an acceptable margin of 15% above the upper limit of normality for both sexes, according to the insert of the biochemical kit being used in this study.
Minimum Eligible Age
18 Years
Maximum Eligible Age
50 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
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Fundación Ciencia y Estudios Aplicados para el Desarrollo en Salud y Medio Ambiente (CEADES)
UNKNOWN
Sponsor Role
collaborator
Barcelona Institute for Global Health
OTHER
Sponsor Role
collaborator
Institute of Parasitology and Biomedicine Lopez Neyra
UNKNOWN
Sponsor Role
collaborator
U.S. Food and Drug Administration (FDA)
UNKNOWN
Sponsor Role
collaborator
Drugs for Neglected Diseases
OTHER
Sponsor Role
collaborator
Mundo Sano Foundation
OTHER
Sponsor Role
collaborator
National Institute of Allergy and Infectious Diseases (NIAID)
NIH
Sponsor Role
collaborator
University of Texas, El Paso
OTHER
Sponsor Role
lead
Responsible Party
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Igor C Almeida, D.Sc.
Professor
Responsibility Role
PRINCIPAL_INVESTIGATOR
Principal Investigators
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Igor C Almeida, D.Sc.
Role: PRINCIPAL_INVESTIGATOR
The University of Texas at El Paso (UTEP)
Faustino Torrico, M.D., Ph.D
Role: PRINCIPAL_INVESTIGATOR
Fundación Ciencia y Estudios Aplicados para el Desarrollo en Salud y Medio Ambiente (CEADES)
Joaquim Gascon, M.D., Ph.D
Role: PRINCIPAL_INVESTIGATOR
Barcelona Institute for Global Health
Locations
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Platform for the Comprehensive Care of Patients with Chagas Disease
Cochabamba, Cercado, Bolivia
Site Status
Platform for the Comprehensive Care of Patients with Chagas Disease
Tarija, Cercado, Bolivia
Site Status
Platform for the Comprehensive Care of Patients with Chagas Disease
Sucre, , Bolivia
Site Status
Countries
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Bolivia
References
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Bern C, Montgomery SP, Herwaldt BL, Rassi A Jr, Marin-Neto JA, Dantas RO, Maguire JH, Acquatella H, Morillo C, Kirchhoff LV, Gilman RH, Reyes PA, Salvatella R, Moore AC. Evaluation and treatment of chagas disease in the United States: a systematic review. JAMA. 2007 Nov 14;298(18):2171-81. doi: 10.1001/jama.298.18.2171.
Reference Type
BACKGROUND
Bustamante JM, Tarleton RL. Potential new clinical therapies for Chagas disease. Expert Rev Clin Pharmacol. 2014 May;7(3):317-25. doi: 10.1586/17512433.2014.909282. Epub 2014 Apr 9.
Reference Type
BACKGROUND
Carod-Artal FJ, Gascon J. Chagas disease and stroke. Lancet Neurol. 2010 May;9(5):533-42. doi: 10.1016/S1474-4422(10)70042-9.
Reference Type
BACKGROUND
Gascon J, Vilasanjuan R, Lucas A. The need for global collaboration to tackle hidden public health crisis of Chagas disease. Expert Rev Anti Infect Ther. 2014 Apr;12(4):393-5. doi: 10.1586/14787210.2014.896194. Epub 2014 Mar 3.
Reference Type
BACKGROUND
Jackson Y, Alirol E, Getaz L, Wolff H, Combescure C, Chappuis F. Tolerance and safety of nifurtimox in patients with chronic chagas disease. Clin Infect Dis. 2010 Nov 15;51(10):e69-75. doi: 10.1086/656917. Epub 2010 Oct 8.
Reference Type
BACKGROUND
Kierszenbaum F. Chagas' disease and the autoimmunity hypothesis. Clin Microbiol Rev. 1999 Apr;12(2):210-23. doi: 10.1128/CMR.12.2.210.
Reference Type
BACKGROUND
Lee BY, Bacon KM, Bottazzi ME, Hotez PJ. Global economic burden of Chagas disease: a computational simulation model. Lancet Infect Dis. 2013 Apr;13(4):342-8. doi: 10.1016/S1473-3099(13)70002-1. Epub 2013 Feb 8.
Reference Type
BACKGROUND
Pinazo MJ, Thomas MC, Bua J, Perrone A, Schijman AG, Viotti RJ, Ramsey JM, Ribeiro I, Sosa-Estani S, Lopez MC, Gascon J. Biological markers for evaluating therapeutic efficacy in Chagas disease, a systematic review. Expert Rev Anti Infect Ther. 2014 Apr;12(4):479-96. doi: 10.1586/14787210.2014.899150.
Reference Type
BACKGROUND
Perez-Molina JA, Sojo-Dorado J, Norman F, Monge-Maillo B, Diaz-Menendez M, Albajar-Vinas P, Lopez-Velez R. Nifurtimox therapy for Chagas disease does not cause hypersensitivity reactions in patients with such previous adverse reactions during benznidazole treatment. Acta Trop. 2013 Aug;127(2):101-4. doi: 10.1016/j.actatropica.2013.04.003. Epub 2013 Apr 11.
Reference Type
BACKGROUND
Rassi A Jr, Rassi A, Marin-Neto JA. Chagas disease. Lancet. 2010 Apr 17;375(9723):1388-402. doi: 10.1016/S0140-6736(10)60061-X.
Reference Type
BACKGROUND
Regueiro A, Garcia-Alvarez A, Sitges M, Ortiz-Perez JT, De Caralt MT, Pinazo MJ, Posada E, Heras M, Gascon J, Sanz G. Myocardial involvement in Chagas disease: insights from cardiac magnetic resonance. Int J Cardiol. 2013 Apr 30;165(1):107-12. doi: 10.1016/j.ijcard.2011.07.089. Epub 2011 Sep 9.
Reference Type
BACKGROUND
Soy D, Aldasoro E, Guerrero L, Posada E, Serret N, Mejia T, Urbina JA, Gascon J. Population pharmacokinetics of benznidazole in adult patients with Chagas disease. Antimicrob Agents Chemother. 2015;59(6):3342-9. doi: 10.1128/AAC.05018-14. Epub 2015 Mar 30.
Reference Type
BACKGROUND
Tarleton RL. Parasite persistence in the aetiology of Chagas disease. Int J Parasitol. 2001 May 1;31(5-6):550-4. doi: 10.1016/s0020-7519(01)00158-8.
Reference Type
BACKGROUND
Tarleton RL, Reithinger R, Urbina JA, Kitron U, Gurtler RE. The challenges of Chagas Disease-- grim outlook or glimmer of hope. PLoS Med. 2007 Dec;4(12):e332. doi: 10.1371/journal.pmed.0040332.
Reference Type
BACKGROUND
Urbina JA, Docampo R. Specific chemotherapy of Chagas disease: controversies and advances. Trends Parasitol. 2003 Nov;19(11):495-501. doi: 10.1016/j.pt.2003.09.001. No abstract available.
Reference Type
BACKGROUND
Viotti R, Vigliano C, Lococo B, Alvarez MG, Petti M, Bertocchi G, Armenti A. Side effects of benznidazole as treatment in chronic Chagas disease: fears and realities. Expert Rev Anti Infect Ther. 2009 Mar;7(2):157-63. doi: 10.1586/14787210.7.2.157.
Reference Type
BACKGROUND
Viotti R, Alarcon de Noya B, Araujo-Jorge T, Grijalva MJ, Guhl F, Lopez MC, Ramsey JM, Ribeiro I, Schijman AG, Sosa-Estani S, Torrico F, Gascon J; Latin American Network for Chagas Disease, NHEPACHA. Towards a paradigm shift in the treatment of chronic Chagas disease. Antimicrob Agents Chemother. 2014;58(2):635-9. doi: 10.1128/AAC.01662-13. Epub 2013 Nov 18.
Reference Type
BACKGROUND
Zhang L, Tarleton RL. Parasite persistence correlates with disease severity and localization in chronic Chagas' disease. J Infect Dis. 1999 Aug;180(2):480-6. doi: 10.1086/314889.
Reference Type
BACKGROUND
Schelldorfer, J., Meier, L., and Buhlmann, P. (2014). GLMMLasso: An algorithm for high-dimensional generalized linear mixed models using l1-penalization. J Comput Graph Stat 23, 460-477.
Reference Type
BACKGROUND
Alonso-Vega C, Urbina JA, Sanz S, Pinazo MJ, Pinto JJ, Gonzalez VR, Rojas G, Ortiz L, Garcia W, Lozano D, Soy D, Maldonado RA, Nagarkatti R, Debrabant A, Schijman A, Thomas MC, Lopez MC, Michael K, Ribeiro I, Gascon J, Torrico F, Almeida IC. New chemotherapy regimens and biomarkers for Chagas disease: the rationale and design of the TESEO study, an open-label, randomised, prospective, phase-2 clinical trial in the Plurinational State of Bolivia. BMJ Open. 2021 Dec 31;11(12):e052897. doi: 10.1136/bmjopen-2021-052897.
Reference Type
DERIVED
Provided Documents
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Document Type: Informed Consent Form
Other Identifiers
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743474
Identifier Type: -
Identifier Source: org_study_id
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Diagnostic Tools for Human African Trypanosomiasis Elimination and Clinical Trials: WP3 Post Elimination Monitoring
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COMPLETED
NA
Clinical Study to Assess the Tolerability, Feasibility and Effectiveness of Nifurtimox and Eflornithine (NECT) for the Treatment of Trypanosoma Brucei Gambiense Human African Trypanosomiasis (HAT) in the Meningo-encephalitic Phase
NCT00906880
COMPLETED
PHASE4
An Open Label Dose Finding Safety and Efficacy in Children and Infants Infected With Schistosomiasis (S.Mansoni)
NCT02806232
COMPLETED
PHASE2
Monitoring Schistosome Hybrids Under Under Praziquantel Pressure
NCT04635553
UNKNOWN
The Effect of Praziquantel Treatment on Schistosoma Mansoni Morbidity and re-Infection Along Lake Victoria, Uganda
NCT00215267
COMPLETED
NA
Schistosoma Haematobium Infections and Praziquantel
NCT01558336
COMPLETED
PHASE3
Hantavirus Transmission in Households in Chile
NCT00533767
TERMINATED
Safety and Tolerability Study of Acoziborole in g-HAT Seropositive Subjects
NCT05256017
COMPLETED
PHASE2/PHASE3
Monitoring Drug Efficacy and Anthelmintic Resistance in Soil-transmitted Helminth Programs
NCT04177654
COMPLETED
Burden of Schistosomiasis and Soil-transmitted Helminth Infections in Schoolchildren in Banfora, Burkina Faso
NCT06973200
COMPLETED
Health Benefits of Repeated Treatment in Pediatric Schistosomiasis
NCT01424410
COMPLETED
L-PZQ ODT in Schistosoma Infected Children
NCT03845140
COMPLETED
PHASE3
Possible Efficacy and Safety of Mebendazole in Patients With Ulcerative Colitis Treated With Mesalamine
NCT06335160
RECRUITING
NA
Taenia Solium Elimination Versus Control: What is the Best Way Forward for Sub-Saharan Africa?
NCT02612896
COMPLETED
NA
RVF and Other Emerging Infectious Diseases in East and Central Africa
NCT05139524
RECRUITING
Evaluation, Treatment and Monitoring of Patients With a Known or Suspected Parasitic Infection
NCT00001645
RECRUITING
Schistosomiasis in Women of Reproductive Age in Burkina Faso: Implications for Control
NCT00463632
COMPLETED
Efficacy - Safety of Eflornithine-Nifurtimox Combination Versus Eflornithine to Treat Human African Trypanosomiasis
NCT00146627
COMPLETED
PHASE3