Introduction and enrollment summary

This document provides an automated summary of data entered from ELICIT. It is generated from a dataset built from the MuSIC server and is updated several times each week. These data lag the actual collected data by roughly one week (for the primary forms) and in some cases longer (e.g. for labs that have a longer turnaround time). Also, because data quality is being monitored, with corrections made and missing data added, there can be some variance in the data from day to day even if new subjects have not been added.

As of today, inital assessment data from 1205 children have been entered (this includes 17 children who were ultimately not eligible)

The number of children with initial assessment data entered by week since enrollment began is as follows:

Eligibility

Of the 17 children who were not eligible, 3 did not consent to participation, 7 expected to move from the study area, 1 had a mother with age < 18, 2 were from a multiple pregnancy, 2 children were not healthy at the time of assessment, 0 had a child weight less than 1.5kg, 2 children were older than 14 days of age, 0 were not eligible for other reasons, and 0 already had a child enrolled in ELICIT. Additionally, 43 children did not remain in the study. 8 of these were due to death.

This leaves 1145 children in the study at present.

Baseline characteristics by randomization arm

Group 1 (n = 288) Group 2 (n = 290) Group 3 (n = 288) Group 4 (n = 279)
child age (days) 6 +/- 3.5 5.8 +/- 3.7 6 +/- 3.7 6 +/- 3.7
# male sex (%) 151 (52.4%) 150 (51.7%) 147 (51%) 139 (49.8%)
# born in hospital (%) 160 (55.6%) 158 (54.5%) 140 (48.6%) 140 (50.2%)
Median family income med:30000 (min: 4000, max: 6e+05) med:30000 (min: 5000, max: 4e+05) med:30000 (min: 5000, max: 360000) med:30000 (min: 1500, max: 3e+05)
Mother with >= 7 years of education (%) 227/282 (80.5%) 204/284 (71.8%) 212/285 (74.4%) 204/276 (73.9%)
Birth order med:3 (min: 1 max: 12) med:4 (min: 1 max: 12) med:4 (min: 1 max: 12) med:3 (min: 1 max: 12)
# Iraqw 222/282 (78.7%) 237/284 (83.5%) 228/285 (80%) 220/276 (79.7%)
# w/ improved sanitation (%) 38/282 (13.5%) 25/284 (8.8%) 26/285 (9.1%) 34/276 (12.3%)
# w/ improved drinking water (%) 187/282 (66.3%) 190/284 (66.9%) 191/285 (67%) 179/276 (64.9%)
# treating water (%) 39/282 (13.8%) 27/284 (9.5%) 35/285 (12.3%) 29/276 (10.5%)
# w/ water > 10 minute walk away (%) 232/282 (82.3%) 228/284 (80.3%) 234/285 (82.1%) 219/276 (79.3%)
# w/ electricity (%) 101/282 (35.8%) 103/284 (36.3%) 94/285 (33%) 87/276 (31.5%)
# w/ mattress (%) 177/282 (62.8%) 158/284 (55.6%) 154/285 (54%) 152/276 (55.1%)
# w/ table (%) 139/282 (49.3%) 115/284 (40.5%) 109/285 (38.2%) 106/276 (38.4%)
# w/ bench (%) 249/282 (88.3%) 243/284 (85.6%) 230/285 (80.7%) 232/276 (84.1%)
# w/ separate kitchen (%) 184/282 (65.2%) 174/284 (61.3%) 179/285 (62.8%) 164/276 (59.4%)
# w/ refrigerator (%) 5/282 (1.8%) 2/284 (0.7%) 2/285 (0.7%) 5/276 (1.8%)
# w/ television (%) 19/282 (6.7%) 19/284 (6.7%) 23/285 (8.1%) 15/276 (5.4%)
# w/ mobile phone (%) 234/282 (83%) 246/284 (86.6%) 234/285 (82.1%) 227/276 (82.2%)
# w/ family bank account (%) 21/282 (7.4%) 21/284 (7.4%) 10/285 (3.5%) 13/276 (4.7%)
# own agricultural land (%) 271/282 (96.1%) 274/284 (96.5%) 277/285 (97.2%) 266/276 (96.4%)
maternal age (years) 27.9 +/- 7.1 27.7 +/- 6.7 27.8 +/- 6.1 27.6 +/- 6.6
enrollment length (cm) 49.2 +/- 2 min:42.2 max: 59 48.6 +/- 3.3 min:5.7 max: 56 48.9 +/- 3.3 min:5 max: 55 49.1 +/- 2.1 min:38 max: 57
enrollment weight (kg) 3.1 +/- 0.5 min:1.8 max: 4.6 3.1 +/- 0.5 min:1.9 max: 6.6 3.1 +/- 0.5 min:1.6 max: 4.4 3.2 +/- 0.5 min:1.6 max: 5.7
enrollment head circumference (cm) 34.7 +/- 1.3 min:31 max: 38.2 34.6 +/- 1.3 min:30 max: 38.4 34.8 +/- 1.4 min:28.3 max: 38.5 34.8 +/- 1.3 min:31.5 max: 40

Illness, healthcare accessed, and antibiotic use

Healthcare accessed in last week by child age and nicotinamide assignment

Healthcare accessed in last week by child age and antibiotic assignment

Illness in the last week by child age and nicotinamide treatment assignment:

Illness in the last week by child age and antibiotic treatment assignment:

Antibiotic use in the last week by child age and nicotinamide treatment assignment:

Antibiotic use in the last week by child age and antibiotic treatment assignment:

Adverse events in mothers

To date, there have been 419 adverse events in mothers (223 in NIC-A and 196 in NIC-B). There have been 26 serious adverse events(14 in NIC-A and 12 in NIC-B) and 0 adverse events deemed related or possibily related to study medications (0 in NIC-A and 0 in NIC-B).

Serious adverse event categories in mothers by nicotinamide arm:

NIC-A NIC-B
Any Serious AE 14 (6.3%) 12 (6.1%)
ALRI 0 3
diarrhea 4 3
DVT 1 0
Lab abnormality 1 0
Other 4 4
Partial intestinal obstruction 2 0
Sepsis 2 2

The “other” serious AEs for NIC-A were as follows: EPILEPSY, ACUTE ASTHMATIC ATTACK, 1. UNSPECIFIED RESPIRATORY ILLNESS, UNSPECIFIED ILLNESS

The “other” serious AEs for NIC-B were as follows: POSTPARTUM PRE ECLAMPSIA, SCHIZOAFFECTIVE DISORDER, SUSPECTED ORGANOPHOSPHATE POISONING, SEIZURE DISORDER

Adverse events in children

By Nicotinamide arm:

To date, there have been 1799 adverse events in children (903 in NIC-A and 896 in NIC-B). There have been 132 serious adverse events(60 in NIC-A and 72 in NIC-B) and 0 adverse events deemed related or possibily related to study medications (0 in NIC-A and 0 in NIC-B).

All adeverse events by nicotinimide arm for children six months and older

NIC-A NIC-B
ALRI 74 88
diarrhea 85 114
Dysentery 0 1
Ear infection 2 2
fever 5 0
Lab abnormality 20 13
Ophthamalogical illness 5 8
Other 7 8
Skin rash/infection 11 8
URTI 14 11
Vomitting 0 2

The “other” AEs for NIC-A were as follows: UNSPECIFIED ILLNESS, UNSPECIFIED ILLNESS, UNSPECIFIED ILLNESS., UNSPECIFIED ENT ILLNESS, UNSPECIFIED ILLNESS, UNSPECIFIED ILLNESS, UNSPECIFIED SKIN DISEASE.

The “other” AEs for NIC-B were as follows: UNSPECIFIED ILLNESS, UNSPECIFIED ILLNESS, UNSPECIFIED ILLNESS, UNSPECIFIED ILLNESS., ALRTI, UNSPECIFIED ILLNESS, UNSPECIFIED ILLNESS, AURI

Serious adverse events by nicotinamide arm for children older than six months

NIC-A NIC-B
Any Serious AE 12 (5.4%) 20 (7.8%)
ALRI 2 3
diarrhea 8 14
Dysentery 0 1
Lab abnormality 0 1
URTI 2 1

The “other” serious AEs for NIC-A were as follows:

The “other” serious AEs for NIC-B were as follows:

Serious adverse events by nicotinamide arm for children less than 6 months old

NIC-A NIC-B
Any Serious AE 48 (7.1%) 52 (8.1%)
ALRI 25 20
diarrhea 11 15
Jaundice 0 1
Lab abnormality 3 0
Sepsis 6 10
Skin rash/infection 0 1
URTI 3 4
UTI 0 1

The “other” serious AEs for NIC-A were as follows:

The “other” serious AEs for NIC-B were as follows:

By antibiotic arm

To date, there have been 478 adverse events in children 6 months and older, (242 in ANTI-A and 236 in ANTI-B). There have been 32 serious adverse events(14 in ANTI-A and 18 in ANTI-B) and 0 adverse events deemed related or possibily related to study medications (0 in ANTI-A and 0 in ANTI-B).

All adverse events for children older than 6 months

ANTI-A ANTI-B
ALRI 86 76
diarrhea 98 101
Dysentery 1 0
Ear infection 2 2
fever 5 0
Lab abnormality 12 21
Ophthamalogical illness 6 7
Other 6 9
Skin rash/infection 11 8
URTI 13 12
Vomitting 2 0

The “other” AEs for ANTI-A were as follows: UNSPECIFIED ILLNESS., UNSPECIFIED ENT ILLNESS, UNSPECIFIED ILLNESS, ALRTI, UNSPECIFIED SKIN DISEASE., UNSPECIFIED ILLNESS

The “other” AEs fo ANTI-B were as follows: UNSPECIFIED ILLNESS, UNSPECIFIED ILLNESS, UNSPECIFIED ILLNESS, UNSPECIFIED ILLNESS, UNSPECIFIED ILLNESS, UNSPECIFIED ILLNESS., UNSPECIFIED ILLNESS, UNSPECIFIED ILLNESS, AURI

Serious adverse events for children older than 6 months

ANTI-A ANTI-B
Any Serious AE 14 (5.8%) 18 (7.6%)
ALRI 3 2
diarrhea 8 14
Dysentery 1 0
Lab abnormality 0 1
URTI 2 1

The “other” serious AEs for ANTI-A were as follows:

The “other” serious AEs fo ANTI-B were as follows:

All serious adverse events for children older than 6 months by randomization arm

1 2 3 4
Any Serious AE 6 (5.7%) 6 (5.1%) 8 (5.8%) 12 (10.2%)
ALRI 2 0 1 2
diarrhea 2 6 6 8
Dysentery 0 0 1 0
Lab abnormality 0 0 0 1
URTI 2 0 0 1

All serious adverse events for children of all ages by randomization arm

1 2 3 4
Any Serious AE 29 (6.7%) 31 (6.6%) 38 (8.1%) 34 (7.9%)
ALRI 16 11 16 7
diarrhea 7 12 15 14
Dysentery 0 0 1 0
Jaundice 0 0 0 1
Lab abnormality 2 1 0 1
Sepsis 2 4 4 6
Skin rash/infection 0 0 1 0
URTI 2 3 1 4
UTI 0 0 0 1

All adverse events for children older than 6 months by randomization arm

1 2 3 4
Any AE 105 118 137 118
ALRI 37 37 49 39
diarrhea 38 47 60 54
Dysentery 0 0 1 0
Ear infection 0 2 2 0
fever 5 0 0 0
Lab abnormality 8 12 4 9
Ophthamalogical illness 0 5 6 2
Other 4 3 2 6
Skin rash/infection 6 5 5 3
URTI 7 7 6 5
Vomitting 0 0 2 0

All adverse events for children of all ages by randomization arm

1 2 3 4
Any AE 434 469 467 429
ALRI 204 207 221 178
diarrhea 109 136 126 126
Dysentery 0 0 1 1
Ear infection 0 3 2 0
fever 11 12 4 7
Jaundice 0 0 0 1
Lab abnormality 12 16 9 12
Omphalitis 4 0 1 0
Ophthamalogical illness 9 13 14 8
Other 20 22 22 26
Sepsis 4 5 8 9
Skin rash/infection 22 15 19 14
URTI 39 39 37 42
UTI 0 1 1 5
Vomitting 0 0 2 0

Protocol deviations by nicotanmide arm

NIC-A NIC-B
Any protocol deviation 108 103
Inappropriate documentation of consent 0 1
Study medication given outside of time window 23 19
Study antimicrobials given prior to stool colelction 1 0
Incorrect does of study medication 6 6
Delay of AE/SAE reporting 7 15
Blood for safety labs at 2 months (first 100 participants) not obtained 70 61

Protocol deviations by antibiotic arm

ANTI-A ANTI-B
Any protocol deviation 105 106
Inappropriate documentation of consent 0 1
Study medication given outside of time window 21 21
Study antimicrobials given prior to stool colelction 0 1
Incorrect does of study medication 6 6
Delay of AE/SAE reporting 9 13
Blood for safety labs at 2 months (first 100 participants) not obtained 69 62

Protocol deviations by study arm

1 2 3 4
Any protocol deviation 47 61 58 45
Inappropriate documentation of consent 0 0 0 1
Study medication given outside of time window 9 14 12 7
Study antimicrobials given prior to stool colelction 0 1 0 0
Incorrect does of study medication 2 4 4 2
Delay of AE/SAE reporting 1 6 8 7
Blood for safety labs at 2 months (first 100 participants) not obtained 35 35 34 27

Compliance with study medications

Objective nicotanimide pill/packet compliance (based on pill/packet counting performed every 2 months starting at the 2 month visit):

Subjective nicotanimide pill compliance (based on maternal report of pills consumed in the previous 7 days at each monthly visit):