Table 2

Clinical and parasitological responses

Intention-to-treat analysis

Modified ITT analysis

NTZ

Placebo

NTZ

Placebo

Number of children

30

30

26

26

Primary endpoints

Proportion achieving well clinical response (number, %)

14 (47)

12 (40)

11 (42)

8 (31)

Time to well clinical response(days)

11.4 (7.2)

7.9 (4.8)

12.2 (9.6)

13.8 (9.7)

Secondary endpoints

Parasitological eradication (number, %)

10 (33)

12 (40)

7 (27)

9 (35)

Time to parasite eradication (days)

8.7 (7.0)

11.7 (9.0)

8.0 (6.3)

13.8 (9.5)

Time to combined clinical and parasitological response

19.1 (11.5)

20.3 (10.1)

12.7 (8.4)

14.2 (7.8)

Mortality (deaths by 4 weeks)

11 (37)

6 (20)

10 (38)

6 (23)

Rate of reduction in stool frequency (expressed as change per day during treatment) (mean, SD)

-0.21 (0.34)

-0.16 (0.25)

-

-

Nutritional response (change in weight over 4 weeks, kg) (mean, SD)

0.8 (1.0)

1.2 (0.9)

1.3 (0.8)

1.6 (0.8)

- not analysed; ITT, intention-to-treat. Rate of change in diarrhoea frequency was only analysed on a strict ITT basis. Statistical testing using the t test or Fisher's exact test showed no significant differences between NTZ and placebo groups.

Amadi et al. BMC Infectious Diseases 2009 9:195   doi:10.1186/1471-2334-9-195