A Study to Learn How Well Nifurtimox Works and How Safe it is in Children Aged 0 to 17 Years With Chagas' Disease, an Inflammatory, Infectious Disease Caused by the Parasite Trypanosoma Cruzi
NCT ID: NCT02625974
Last Updated: 2024-08-19
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
330 participants
INTERVENTIONAL
2016-01-27
2021-08-10
Brief Summary
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Chagas'disease is an inflammatory, infectious disease caused by the parasite Trypanosoma cruzi. This parasite is mainly spread by insects called triatomine bug. If Chagas' disease is left untreated, it can later cause serious heart and digestive problems.
The study treatment nifurtimox has been used for more than 50 years to treat Chagas' disease. When used early after infection, it kills the parasite. In people who have long-term Chagas' disease, it's no longer possible to kill the parasite. However, nifurtimox may help slow the progression of the disease and its most serious complications.
Nifurtimox was developed for use in adults only, but has also been used in children (off-label) for over 40 years. Currently it is available for doctors to give to adults and to children. However, there are not enough data about nifurtimox in children.
The main purpose of this study is to learn how well nifurtimox works in children aged 8 months to less than 18 years with Chagas' disease. To answer this, the researchers will compare the amount of antibodies against the parasite Trypanosoma cruzi in the serum (fluid from blood without the clotting factors) between children treated with nifurtimox for 60 days with untreated children from the past (control group):
* 12 months and
* 4 years after the end of treatment. The data for the control group will come from 2 previous studies conducted in children.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Nifurtimox 60 days / Arm 1
Nifurtimox tablets administered three times daily for 60 days (Days 1 - 60, active nifurtimox treatment)
Nifurtimox (Lampit, BAYA2502)
For pediatric participants with body weight ≤ 40 kg: dosage 10 to 20 mg/kg/day in three divided doses.
For pediatric participants with body weight \> 40 kg: 8 - 10 mg/kg/day in three divided doses.
60 days or 30 days of nifurtimox treatment
Nifurtimox 30 days / Arm 2
Nifurtimox tablets administered three times daily for 30 days, followed by placebo administered three times daily for 30 days (Days 1 - 30, active nifurtimox treatment; Days 31 - 60, placebo)
Nifurtimox (Lampit, BAYA2502)
For pediatric participants with body weight ≤ 40 kg: dosage 10 to 20 mg/kg/day in three divided doses.
For pediatric participants with body weight \> 40 kg: 8 - 10 mg/kg/day in three divided doses.
60 days or 30 days of nifurtimox treatment
Placebo
Matching placebo
Interventions
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Nifurtimox (Lampit, BAYA2502)
For pediatric participants with body weight ≤ 40 kg: dosage 10 to 20 mg/kg/day in three divided doses.
For pediatric participants with body weight \> 40 kg: 8 - 10 mg/kg/day in three divided doses.
60 days or 30 days of nifurtimox treatment
Placebo
Matching placebo
Eligibility Criteria
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Inclusion Criteria
* Male and female pediatric subjects aged 0 days to younger than 18 years
* Chagas' disease diagnosed/ confirmed for a) Subjects \< 8 months of age at randomization must demonstrate direct observation of Trypanosoma cruzi by concentration test; b) Subjects ≥ 8 months to \< 18 years of age at randomization must demonstrate a positive conventional ELISA result for both recombinant ELISA and total purified antigen ELISA
Part 2:
\- Male and female subjects who were randomized and received at least one dose of their assigned 60- or 30-day regimen of nifurtimox treatment
Exclusion Criteria
* Subjects aged 0 to 27 days who, at birth, were pre-term, weighed less than 2500 g, or had a maximum Apgar score \< 7 at 5 minutes
* Known evidence of Chagas' disease-related cardiomyopathy/ Chagas' heart disease
* Known evidence of Chagas' disease-related gastrointestinal dysfunction (e.g. megaoesophagus, megacolon, or both) or Chagas' digestive disease
* Serious manifestations of acute Chagas' disease, including myocarditis, meningoencephalitis, or pneumonitis
* Known evidence of Chagas' disease-related damage to the peripheral nervous system or peripheral neuropathy
* Clinically significant psychiatric disorder (e.g. moderate to severe depression, severe anxiety, or psychosis) or epilepsy
* Subjects with contraindications/ warnings to nifurtimox administration, or with conditions that may increase the risk of the undesirable effects of nifurtimox
* Subjects who have had previous treatment with trypanocidal agents or an accepted indication for antiparasitic therapy (e.g. reactivation of Chagas' infection due to immunosuppression by several diseases or treatment with steroids)
* Subjects living in housing conditions where there is no active or effective vector control to Trypanosoma cruzi reinfection as determined by Ministry of Health guidelines in each country
Part 2:
* Subjects with acute or chronic health conditions or congenital disorders which, in the opinion of the investigator, would make them unsuitable for participation in the clinical study
* Subjects living in housing conditions where there is no active or effective vector-control to Trypanosoma cruzi reinfection as determined by Ministry of Health guideline of the respective country
* Subjects with clinical manifestations of Chagas' disease-related gastrointestinal dysfunction or serious manifestations of acute Chagas' disease
* Immuno-compromised subjects (e.g. with human immunodeficiency virus or treated with immunosuppressive drugs)
17 Years
ALL
No
Sponsors
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Bayer
INDUSTRY
Responsible Party
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Principal Investigators
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Bayer Study Director
Role: STUDY_DIRECTOR
Bayer
Locations
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La Plata, Buenos Aires, Argentina
Buenos Aires, Ciudad Auton. de Buenos Aires, Argentina
Buenos Aires, Ciudad Auton. de Buenos Aires, Argentina
Buenos Aires, Ciudad Auton. de Buenos Aires, Argentina
Buenos Aires, Ciudad Auton. de Buenos Aires, Argentina
San Salvador de Jujuy, Jujuy Province, Argentina
Posadas, Misiones Province, Argentina
Rosario, Santa Fe Province, Argentina
Corrientes, , Argentina
Formosa, , Argentina
La Rioja, , Argentina
Mendoza, , Argentina
Mendoza, , Argentina
Salta, , Argentina
Salta, , Argentina
San Juan, , Argentina
San Miguel de Tucumán, , Argentina
Santiago del Estero, , Argentina
Cochabamba, , Bolivia
Punata, , Bolivia
Tarija, , Bolivia
Soledad, Atlántico, Colombia
Yopal, Casanare Department, Colombia
Santa Marta, Magdalena Department, Colombia
Floridablabca, Santander Department, Colombia
Countries
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References
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Sosa Estani S, Segura EL, Ruiz AM, Velazquez E, Porcel BM, Yampotis C. Efficacy of chemotherapy with benznidazole in children in the indeterminate phase of Chagas' disease. Am J Trop Med Hyg. 1998 Oct;59(4):526-9. doi: 10.4269/ajtmh.1998.59.526.
de Andrade AL, Zicker F, de Oliveira RM, Almeida Silva S, Luquetti A, Travassos LR, Almeida IC, de Andrade SS, de Andrade JG, Martelli CM. Randomised trial of efficacy of benznidazole in treatment of early Trypanosoma cruzi infection. Lancet. 1996 Nov 23;348(9039):1407-13. doi: 10.1016/s0140-6736(96)04128-1.
Altcheh J, Castro L, Dib JC, Grossmann U, Huang E, Moscatelli G, Pinto Rocha JJ, Ramirez TE; CHICO Study Group. Prospective, historically controlled study to evaluate the efficacy and safety of a new paediatric formulation of nifurtimox in children aged 0 to 17 years with Chagas disease one year after treatment (CHICO). PLoS Negl Trop Dis. 2021 Jan 7;15(1):e0008912. doi: 10.1371/journal.pntd.0008912. eCollection 2021 Jan.
Rivero R, Esteva MI, Huang E, Colmegna L, Altcheh J, Grossmann U, Ruiz AM; CHICO and CHICO SECURE Study Groups. ELISA F29 -A therapeutic efficacy biomarker in Chagas disease: Evaluation in pediatric patients treated with nifurtimox and followed for 4 years post-treatment. PLoS Negl Trop Dis. 2023 Jun 23;17(6):e0011440. doi: 10.1371/journal.pntd.0011440. eCollection 2023 Jun.
Altcheh J, Sierra V, Ramirez T, Pinto Rocha JJ, Grossmann U, Huang E, Moscatelli G, Ding O. Efficacy and Safety of Nifurtimox in Pediatric Patients with Chagas Disease: Results at 4-Year Follow-Up in a Prospective, Historically Controlled Study (CHICO SECURE). Antimicrob Agents Chemother. 2023 Apr 18;67(4):e0119322. doi: 10.1128/aac.01193-22. Epub 2023 Mar 28.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Related Links
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Click here to find information about studies related to Bayer Healthcare products conducted in Europe
Click here to find results for studies related to Bayer products.
Other Identifiers
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2022-001504-17
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
16027
Identifier Type: -
Identifier Source: org_study_id
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