Clinical Study

Safety of a New Chewable Formulation of Mebendazole for Preventive Chemotherapy Interventions to Treat Young Children in Countries with Moderate-to-High Prevalence of Soil Transmitted Helminth Infections

Table 1

Patient demographics and baseline characteristics.

2–5 years6–10 yearsTotal
( )( )( )

Sex, (%)
 Boys132 (49)74 (59)206 (52)
 Girls139 (51)51 (41)190 (48)
Race, (%)
 White3 (1)1 (1)4 (1)
 Black or African 267 (99)124 (99)391 (99)
 Not reported1 (0.4)01 (0.3)
Age (yrs)
 Mean (SD)3.5 (1.07)7 (1.19)4.6 (1.94)
Baseline BMI (kg/m2)
268125393
 Mean (SD)14.5 (1.99)14.5 (1.97)14.5 (1.98)
Subgroup egg counts, (%)
 Not donea31 (11)13 (10)44 (11)
 No infectionb124 (46)33 (26)157 (40)
 Lightc109 (40)72 (58)181 (46)
 Moderated7 (3)7 (6)14 (3)
A. lumbricoides egg count, (%)
 No infectionb226 (83)102 (82)328 (83)
 Lightc10 (4)6 (5)16 (4)
 Moderated4 (1)4 (3)8 (2)
A. lumbricoides eggs per gram of fecese
 Mean (SD)249.2
(1805.36)
399.4
(2359.70)
297.0
(1996.27)
T. trichiura egg count, (%)
 No infectionb131 (48)40 (32)171 (43)
 Lightc105 (39)66 (53)171 (43)
 Moderated4 (1)6 (5)10 (2)
T. trichiura eggs per gram of fecese
 Mean (SD)143.3
(355.79)
244.7
(360.54)
175.6
(359.92)
Hookworm egg count, (%)
 No infectionb212 (78)83 (66)295 (74)
 Lightc28 (10)29 (23)57 (14)
Hookworm eggs per gram of fecese
 Mean (SD)43.0 (196.65)99.9 (264.28)61.1 (221.63)

BMI: body mass index.
aEgg count evaluation not conducted.
bNegative finding for egg count evaluation.
cEgg count evaluation finding is (A. lumbricoides (epg)): 1–4,999; (T. trichiura (epg)): 1–999; (Hookworms (epg)): 1–1,999.
dModerate: egg count evaluation finding is (A. lumbricoides (epg)): 5,000–49,999; (T. trichiura (epg)): 1,000–9,999; (Hookworms (epg)): 2,000–3,999.
eFor eggs per gram of feces, the number of children included were 2–5 years ; 6–10 years ; total .
For children infected with multiple parasites, the grouping is based on the most severe infection.