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

PHASE3CompletedINTERVENTIONAL
Enrollment

330

Participants

Timeline

Start Date

January 27, 2016

Primary Completion Date

July 25, 2018

Study Completion Date

August 10, 2021

Conditions
Chagas Disease
Interventions
DRUG

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"

DRUG

Placebo

Matching placebo

Trial Locations (25)

0

Yopal

Santa Marta

1281

Buenos Aires

1900

La Plata

2000

Rosario

4000

San Miguel de Tucumán

4202

Santiago del Estero

4400

Salta

4600

San Salvador de Jujuy

5400

San Juan

5500

Mendoza

5535

Mendoza

681011

Floridablabca

C1270AAN

Buenos Aires

C1425AGP

Buenos Aires

C1425EFD

Buenos Aires

Unknown

Posadas

La Rioja

Cochabamba

Punata

Tarija

Soledad

W3400CBI

Corrientes

P3600HZL

Formosa

A4400ESE

Salta

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Bayer

INDUSTRY