Table 1.
Summary of efficacy data from major clinical trials of benznidazole in
children with congenital Chagas infection

Reference

Age (years)

 Benznidazole  Nifurtimox

n

Dose (mg/kg/d)

Time (days)

 n  Dose (mg/kg/d) Time (days)

Russomando
1998

Congenital
<2

6 7-10 60  –  –  –
60

Blanco
2000

Congenital
<1

3
5
30
 –
29
 –
10

 Schijman
2003

Congenital
<2

16{ 5-8
60
 –
10-15
 –
60

 Chippaux
(IRD) 2008-2009

Congenital
<1

(control=non infected)

68
59
52

NT
5
7.5
 –
60
30
 –  –  –

 

Reference

Age (years)

Design*

 Follow-up (Months) Lost in FU (%)  Efficacy measures†
 Serologic test (% neg)  Parasitological test (% pos)

Russomando
1998

Congenital
<2

nC
nR
nB
24m
} 0%
 (EIA, IFI)
} 100%
(Hc, MH,PCR)
} 0%

Blanco
2000

Congenital
<1

C
nR
nB
24m
} 6%
(EIA, HAI, IFI)
} 94%
(MH)
} 0%

 Schijman
2003

Congenital
<2

C
nR
nB
36m
} 0%
(EIA, HAI)
} 87%
 (MH,PCR)
} 0%

 Chippaux
(IRD) 2008-2009

Congenital
<1

(control=non infected)

C
R
B

10m
0%
2%
4%
(EIA, IC)
100%
91%
90%
 (MH a 2m)
0%
0%
0%

* Design: C (controlled: control or comparative group), nC (not controlled); R (randomized), nR (not randomized); B (blinded), nB (not blinded)

† Efficacy endpoints: IHA (Indirect Hemagglutination Assay), IFA (Immunofluorescence Assay), EIA (Enzyme Immune Assay), IC (Immunochromatography), MH (Microhematocrit), HC (Hemoculture), PCR (Polymerase Chain Reaction),

Source: IRD 2009

In the recommended doses, adverse reactions to benznidazole are frequent, often occuring in 25 to 30% of patients. However, in general, the tolerabilitay is better in children than in adults.

 

Table 2.
Children tolerability of Benznidazole, Summary of studies results

Study

Year

n

Dosage

Results

Chippaux

2009

111 newborns

59 with 2.5 mg/kg twice daily for 60 days
52 with 7.5 mg/kg twice daily for 30 days

No adverse reactions

Russomando

1998

6 children

7 mg/kg per day, taken twice daily for 60 days

No adverse reactions

Streiger et al.

2004

64 children between 1 and 14

5mg/kg/day split in 2 dosese daily for 30 days

  • discontinuation in 2 patients
  • some adverse events: vomiting, generalized eythema with edema and pruritus.
  • No information about severitiy and frequency

 Altcheh et al.

2003-2007

107 children from 10 days to 19 years

5.9 mg/kg/day in2-3 doses daily for 60 days

  •  62 adverse effects in 44 children in 3 years
  • 80.6% mild, 16% moderate, 3.2% severe