Table 3.
Top five results from dose optimisation for children 3–11 months old in the MORDOR and CHAT trials, with age cut-off determination and tolerance limits 15–30 mg/kg
Study (n) | Age cut-off (months)† | Dose 1, younger group | Dose 2, older group | Within limits | Underdose | Overdose | |||
N | % | N | % | N | % | ||||
MORDOR (3713) | 3 | 120 mg (3 mL) | 160 mg (4 mL) | 3507 | 94.5 | 98 | 2.6 | 108 | 2.9 |
4 | 120 mg (3 mL) | 160 mg (4 mL) | 3500 | 94.3 | 132 | 3.6 | 81 | 2.2 | |
3 | 160 mg (4 mL) | 160 mg (4 mL) | 3470 | 93.5 | 83 | 2.2 | 160 | 4.3 | |
4 | 160 mg (4 mL) | 160 mg (4 mL) | 3470 | 93.5 | 83 | 2.2 | 160 | 4.3 | |
5 | 120 mg (3 mL) | 160 mg (4 mL) | 3470 | 93.5 | 194 | 5.2 | 49 | 1.3 | |
CHAT (5167) | 5 | 120 mg (3 mL) | 160 mg (4 mL) | 4839 | 93.7 | 186 | 3.6 | 142 | 2.7 |
4 | 120 mg (3 mL) | 160 mg (4 mL) | 4836 | 93.6 | 120 | 2.3 | 211 | 4.1 | |
6 | 120 mg (3 mL) | 160 mg (4 mL) | 4803 | 93.0 | 272 | 5.3 | 92 | 1.8 | |
3 | 120 mg (3 mL) | 160 mg (4 mL) | 4785 | 92.6 | 81 | 1.6 | 301 | 5.8 | |
7 | 120 mg (3 mL) | 160 mg (4 mL) | 4706 | 91.1 | 403 | 7.8 | 58 | 1.1 |
Result with highest accuracy is highlighted for each set of analyses.*
*Percentages may not sum to 100% due to rounding.
†Age cutoffs refer to the age at which the younger group ends. An age cut-off of 3 indicates a younger group of 3 months old and an older group of 4–11 months old, an age cut-off of 4 indicates a younger group of 3–4 months old and an older group of 5–11 months old, an age cut-off of 5 indicates a younger group of 3–5 months old and an older group of 6–11 months old.
CHAT, Child Health with Azithromycin Treatment; MORDOR, Macrolides Oraux pour le Réduire des Décès avec un Oeil sur la Résistance.