Table 2.

Bacterial carriage in newborns and mothers Intent-to-treat analysis; nasopharyngeal swab and breast milk samples

	Day 0a				Day 3				Day 6b				Day 14				Day 28
P'bo (%)	AZI (%)	PR (95% CI)	p value	P'bo (%)	AZI (%)	PR (95% CI)	p value	P'bo (%)	AZI (%)	PR (95% CI)	p value	P'bo (%)	AZI (%)	PR (95% CI)	p value	P'bo (%)	AZI (%)	PR (95% CI)	p value
NPS newborn	n = 416	n = 417			n = 396	n = 386			n = 387	n = 378			n = 381	n = 372			n = 374	n = 359
GBS	1.7	0.7	0.44 (0.11–1.68)	0.341	10.4	0.8	0.08 (0.02–0.24)	<0.001	5.4	1.1	0.20 (0.07–0.56)	0.001	4.7	0.8	0.17 (0.05–0.57)	0.001	3.2	0.6	0.17 (0.04–0.77)	0.012
Streptococcus pneumoniae	0.2	0.2	1.02 (0.06–16.3)	1.000	1.3	0.8	0.62 (0.15–2.56)	0.725	4.1	0.8	0.19 (0.06–0.65)	0.004	19.7	8.1	0.41 (0.28–0.61)	<0.001	37.2	24.8	0.67 (0.53–0.83)	<0.001
Staphylococcus aureus	3.6	1.5	0.41 (0.16–1.04)	0.075	57.6	25.4	0.44 (0.36–0.53)	<0.001	63.3	27.5	0.43 (0.36–0.52)	<0.001	44.1	23.1	0.52 (0.42–0.65)	<0.001	35.3	25.6	0.73 (0.58–0.91)	0.005
Any bacteria	5.5	2.2	0.40 (0.19–0.85)	0.018	62.1	26.2	0.42 (0.35–0.51)	<0.001	65.1	28.3	0.43 (0.36–0.52)	<0.001	57.7	29.6	0.51 (0.43–0.61)	<0.001	60.4	45.7	0.76 (0.66–0.87)	<0.001
NPS mother	n = 415	n = 414			n = 402	n = 400			n = 397	n = 395			n = 390	n = 390			n = 386	n = 381
GBS	0.5	0.7	1.50 (0.25–8.95)	0.686	0.2	0	NA	NA	0	0	NA	NA	0	0	NA	NA	0.5	0.3	0.51 (0.05–5.56)	1
S. pneumoniae	17.1	15.9	0.93 (0.69–1.27)	0.709	17.9	1.0	0.06 (0.02–1.15)	<0.001	16.1	1.3	0.08 (0.03–0.19)	<0.001	22.3	3.1	0.14 (0.08–0.25)	<0.001	23.8	4.2	0.18 (0.11–0.29)	<0.001
S. aureus	19.3	18.6	0.96 (0.73–1.28)	0.859	25.4	8.3	0.33 (0.23–0.47)	<0.001	27.2	7.8	0.29 (0.20–0.42)	<0.001	26.2	10.5	0.40 (0.29–0.56)	<0.001	26.9	15.2	0.57 (0.42–0.75)	<0.001
Any bacteria	34.5	32.6	0.95 (0.78–1.15)	0.607	40.0	9.3	0.23 (0.17–0.32)	<0.001	40.3	9.1	0.23 (0.16–0.32)	<0.001	43.8	12.8	0.29 (0.22–0.39)	<0.001	45.6	19.4	0.43 (0.34–0.54)	<0.001
Breast milk	n = 0	n = 0			n = 399	n = 394			n = 397	n = 385			n = 387	n = 388			n = 384	n = 381
GBS	—	—	—	—	6.8	0.8	0.11 (0.33–0.37)	<0.001	7.6	1.8	0.23 (0.10–0.53)	<0.001	6.5	0.8	0.12 (0.04–0.39)	<0.001	1.6	0.0	NA	0.031
S. pneumoniae	—	—	—	—	0.5	0	NA	NA	0	0	NA	NA	0.8	0.0	NA	0.124	0.0	0.0	NA	NA
S. aureus	—	—	—	—	15.5	7.1	0.46 (0.30–0.70)	<0.001	16.4	8.1	0.49 (0.33–0.74)	<0.001	12.4	8.0	0.64 (0.42–0.99)	0.044	10.4	5.0	0.48 (0.28–0.81)	0.006
Any bacteria	—	—	—	—	21.6	7.9	0.37 (0.25–0.54)	<0.001	21.9	9.6	0.44 (0.31–0.63)	<0.001	17.3	8.8	0.51 (0.33–0.75)	<0.001	11.7	5.0	0.43 (0.25–0.71)	0.001
Vaginal swabs	n = 415	n = 414			n = 0	n = 0			n = 396	n = 386			n = 0	n = 0			n = 0	n = 0
GBS	15.9	18.1	1.14 (0.84–1.54)	0.407	—	—	—	—	13.6	4.6	0.4 (0.20–0.56)	<0.001	—	—	—	—	—	—	—	—
S. pneumoniae	0	0	NA	NA	—	—	—	—	0	0	NA	NA	—	—	—	—	—	—	—	—
S. aureus	16.6	12.3	0.74 (0.53–1.04)	0.093	—	—	—	—	14.1	8.9	0.63 (0.42–0.94)	0.026	—	—	—	—	—	—	—	—
Any bacteria	28.9	25.1	0.87 (0.69–1.09)	0.241	—	—	—	—	24.2	13.2	0.55 (0.40–0.74)	<0.001	—	—	—	—	—	—	—	—

Abbreviations: AZI, azithromycin; GBS, group B streptococci; NPS, nasopharyngeal swab; P'bo– placebo; PR, Prevalence Ratio.

^aAt day 0, nasopharyngeal and vaginal swabs in mothers were collected before the intervention and nasopharyngeal swabs in newborns after the intervention.

^bVaginal swabs were collected at day 8–10 instead.