Table 1.
Participant Characteristics at Study Enrollment by Randomization Arm (N = 6692)
| Characteristic | Overall (N = 6692) | Azithromycin (n = 3347) | Placebo (n = 3345) | |||
|---|---|---|---|---|---|---|
| Enrollment site | ||||||
| Bangladesh (Jun 2017–Jan 2019) | 998 | (14.9%) | 500 | (14.9%) | 498 | (14.9%) |
| India (Sep 2017–May 2019) | 998 | (14.9%) | 501 | (15.0%) | 497 | (14.9%) |
| Kenya (Dec 2017–Jul 2019) | 1014 | (15.2%) | 502 | (15.0%) | 512 | (15.3%) |
| Malawi (Jan 2018–Jul 2019) | 691 | (10.3%) | 343 | (10.3%) | 348 | (10.4%) |
| Mali (Sep 2017–Jun 2019) | 1000 | (14.9%) | 498 | (14.9%) | 502 | (15.0%) |
| Pakistan (Sep 2017–Mar 2019) | 995 | (14.9%) | 498 | (14.9%) | 497 | (14.9%) |
| Tanzania (Sep 2017–Jul 2019) | 996 | (14.9%) | 505 | (15.1%) | 491 | (14.7%) |
| Child age | ||||||
| 2–5 mo | 967 | (14.5%) | 473 | (14.1%) | 494 | (14.8%) |
| 6–11 mo | 2799 | (41.8%) | 1408 | (42.1%) | 1391 | (41.6%) |
| 12–23 mo | 2926 | (43.7%) | 1466 | (43.8%) | 1460 | (43.6%) |
| Male sex | 3604 | (53.9%) | 1800 | (53.8%) | 1804 | (53.9%) |
| Duration of diarrhea prior to presentation, d, median (IQR) | 2 | (1–3) | 2 | (1–3) | 2 | (1–3) |
| No. of unusually loose or watery stools in last 24 h, median (IQR) | 6 | (5–9) | 6 | (5–9) | 6 | (5–9) |
| Dehydration status | ||||||
| None | 3053 | (45.6%) | 1545 | (46.2%) | 1508 | (45.1%) |
| Some | 3285 | (49.1%) | 1638 | (48.9%%) | 1647 | (49.2%) |
| Severe | 354 | (5.3%) | 164 | (4.9%) | 190 | (5.7%) |
| LAZ, median (IQR) | −1.4 | (−2.4 to −0.6) | −1.4 | (−2.3 to −0.6) | −1.4 | (−2.4 to −0.6) |
| Stuntinga | ||||||
| None | 4491 | (67.1%) | 2257 | (67.4%) | 2234 | (66.8%) |
| Moderate | 1209 | (18.1%) | 593 | (17.7%) | 616 | (18.4%) |
| Severe | 992 | (14.8%) | 497 | (14.9%) | 495 | (14.8%) |
| MUAC, cm, median (IQR) | 12.9 | (12.3–13.9) | 12.9 | (12.3–13.9) | 12.9 | (12.3–13.9) |
| WLZb, median (IQR) | −1.34 | (−2.1 to −0.4) | −1.4 | (−2.2 to −0.4) | −1.3 | (−2.1 to −0.4) |
| Wastingc | ||||||
| None | 3589 | (53.6%) | 1761 | (52.6%) | 1828 | (54.7%) |
| Moderate | 3103 | (46.4%) | 1586 | (47.4%) | 1517 | (45.4%) |
| No. of children <5 y of age in household, median (IQR) | 1 | (1–2) | 1 | (1–2) | 1 | (1–2) |
| Wealth quintile | ||||||
| Lowest | 864 | (12.9%) | 443 | (13.2%) | 421 | (12.6%) |
| Second | 1092 | (16.3%) | 546 | (16.3%) | 546 | (16.3%) |
| Middle | 1071 | (16.0%) | 552 | (16.5%) | 519 | (15.5%) |
| Fourth | 1779 | (26.6%) | 839 | (25.1%) | 940 | (28.1%) |
| Highest | 1886 | (28.2%) | 967 | (28.9%) | 919 | (27.5%) |
| Fecal sample type | ||||||
| Whole stool | 4094 | (61.2%) | 2025 | (60.5%) | 2069 | (61.9%) |
| Rectal swab | 2598 | (38.8%) | 1322 | (39.5%) | 1276 | (38.2%) |
Data are presented as No. (%) unless otherwise indicated.
Abbreviations: IQR, interquartile range; LAZ, length-for-age z-score; MUAC, mid-upper arm circumference; WLZ, weight-for-length z-score.
aNo stunting defined as LAZ ≥ −2; moderate stunting defined as −3 ≤ LAZ < −2; severe stunting defined as LAZ < −3.
bThree participants missing WLZ at enrollment.
cNo wasting defined as MUAC ≥12.5 cm (if ≥6 months) or WLZ ≥ −2; moderate wasting defined as 11.5 cm ≤ MUAC <12.5 cm (if ≥6 mo) or −2 < WLZ < −3. Three participants missing WLZ at enrollment.