Table 3.
Visit schedule
| Selection visit (from − 3 months to day 0) |
Baseline visit (day 0) |
Treatment visit (day 7 ± 2) |
Treatment visit (day 15 ± 3) |
Treatment visit (day 28 ± 4) |
End of treatment visit (day 60 ± 7) |
Side effect visit (not scheduled) |
Follow-up visit (months 4, 6, and 8) |
Final visit (month 12) |
|
|---|---|---|---|---|---|---|---|---|---|
| Informed consent | x | ||||||||
| Demographic data | x | ||||||||
| Pathological background | x | ||||||||
| Toxic habits | x | ||||||||
| Chagas disease history | x | ||||||||
| Concomitant medication | x | x | x | x | x | x | x | x | x |
| Directed anamnesis | x | x | x | x | x | x | x | x | x |
| Physical examination | x | x | x | x | x | x | x | x | x |
| Pregnancy test | x | ||||||||
| Hematology | x | x | x | x | x | x | |||
| Biochemistry | x | x | x | x | x | x | |||
| HLA | x | ||||||||
| Chest x-ray | x | ||||||||
| EKG | x | ||||||||
| PK | x | x | x | ||||||
| Serology | x | x | |||||||
| PCR | x | x | x | x | x | x | x | ||
| Other complementary tests | x | ||||||||
| Adverse events | x | x | x | x | x | x | |||
| Randomization | x | ||||||||
| Study medication | x | x | x | x | x |
Abbreviations: EKG Electrocardiogram, HLA Human leukocyte antigen, PCR Polymerase chain reaction, PK Pharmacokinetics