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, 50 children did not remain in the study. 10 of these were due to death.

This leaves 1138 children in the study at present.

Baseline characteristics by randomization arm

Group 1 (n = 288) Group 2 (n = 289) Group 3 (n = 284) Group 4 (n = 277)
child age (days) 6 +/- 3.5 5.8 +/- 3.7 6 +/- 3.7 6 +/- 3.7
# male sex (%) 151 (52.4%) 150 (51.9%) 145 (51.1%) 137 (49.5%)
# born in hospital (%) 160 (55.6%) 157 (54.3%) 138 (48.6%) 140 (50.5%)
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 (%) 232/288 (80.6%) 205/289 (70.9%) 210/284 (73.9%) 205/277 (74%)
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 226/288 (78.5%) 238/289 (82.4%) 226/284 (79.6%) 221/277 (79.8%)
# w/ improved sanitation (%) 39/288 (13.5%) 25/289 (8.7%) 27/284 (9.5%) 34/277 (12.3%)
# w/ improved drinking water (%) 191/288 (66.3%) 191/289 (66.1%) 191/284 (67.3%) 181/277 (65.3%)
# treating water (%) 40/288 (13.9%) 28/289 (9.7%) 35/284 (12.3%) 30/277 (10.8%)
# w/ water > 10 minute walk away (%) 236/288 (81.9%) 230/289 (79.6%) 232/284 (81.7%) 220/277 (79.4%)
# w/ electricity (%) 102/288 (35.4%) 104/289 (36%) 93/284 (32.7%) 88/277 (31.8%)
# w/ mattress (%) 180/288 (62.5%) 161/289 (55.7%) 153/284 (53.9%) 153/277 (55.2%)
# w/ table (%) 141/288 (49%) 115/289 (39.8%) 109/284 (38.4%) 107/277 (38.6%)
# w/ bench (%) 251/288 (87.2%) 244/289 (84.4%) 227/284 (79.9%) 233/277 (84.1%)
# w/ separate kitchen (%) 189/288 (65.6%) 174/289 (60.2%) 178/284 (62.7%) 165/277 (59.6%)
# w/ refrigerator (%) 5/288 (1.7%) 2/289 (0.7%) 2/284 (0.7%) 5/277 (1.8%)
# w/ television (%) 19/288 (6.6%) 19/289 (6.6%) 22/284 (7.7%) 15/277 (5.4%)
# w/ mobile phone (%) 237/288 (82.3%) 247/289 (85.5%) 231/284 (81.3%) 228/277 (82.3%)
# w/ family bank account (%) 22/288 (7.6%) 21/289 (7.3%) 10/284 (3.5%) 13/277 (4.7%)
# own agricultural land (%) 275/288 (95.5%) 275/289 (95.2%) 275/284 (96.8%) 267/277 (96.4%)
maternal age (years) 27.9 +/- 7.1 27.7 +/- 6.7 27.7 +/- 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 3.1 +/- 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 453 adverse events in mothers (237 in NIC-A and 216 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 (5.9%) 12 (5.6%)
ALRI 0 3
diarrhea 4 2
DVT 1 0
Lab abnormality 1 0
Other 4 5
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, 1. SUSPECTED ANGINA PECTORIS

Adverse events in children

By Nicotinamide arm:

To date, there have been 2034 adverse events in children (1008 in NIC-A and 1026 in NIC-B). There have been 139 serious adverse events(64 in NIC-A and 75 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 96 120
diarrhea 121 146
Dysentery 0 3
Ear infection 2 2
fever 6 3
Lab abnormality 19 15
Ophthamalogical illness 9 9
Other 12 24
Skin rash/infection 16 12
URTI 18 11
UTI 0 1
Vomitting 0 2

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

The “other” AEs for NIC-B were as follows: ADVERSE DRUG REACTION DUE TO OVERDOSE., UNSPECIFIED ILLNESS, UNSPECIFIED ILLNESS., INJURY ON THE ARM, UNSPECIFIED ILLNESS, NA, UNSPECIFIED ILLNESS, UNSPECIFIED ILLNESS, UNSPECIFIED ILLNESS., UNSPECIFIED ILLNESS., BURN WOUND , BURN WOUND, 1. AMOEBIOASIS, FUNGAL INFECTION, ALRTI, AURI, UNSPECIFIED ILLNESS., UNSPECIFIED ILLNESS., UNSPECIFIED ILLNESS, 1. SEPTICEMIA, UNSPECIFIED ILLNESS, UNSPECIFIED ILLNESS, AURI, AURI

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

NIC-A NIC-B
Any Serious AE 17 (5.7%) 25 (7.2%)
ALRI 3 4
diarrhea 12 16
Dysentery 0 1
Lab abnormality 0 1
Other 0 1
URTI 2 2

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

The “other” serious AEs for NIC-B were as follows: 1. SEPTICEMIA

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

NIC-A NIC-B
Any Serious AE 47 (6.6%) 50 (7.4%)
ALRI 25 19
diarrhea 10 14
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 647 adverse events in children 6 months and older, (337 in ANTI-A and 310 in ANTI-B). There have been 42 serious adverse events(18 in ANTI-A and 24 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 112 104
diarrhea 138 129
Dysentery 1 2
Ear infection 2 2
fever 8 1
Lab abnormality 13 21
Ophthamalogical illness 10 8
Other 15 21
Skin rash/infection 17 11
URTI 18 11
UTI 1 0
Vomitting 2 0

The “other” AEs for ANTI-A were as follows: UNSPECIFIED ILLNESS., INJURY ON THE ARM, NA, UNSPECIFIED ENT ILLNESS, AURI, BURN WOUND, UNSPECIFIED ILLNESS, ALRTI, AURI, UNSPECIFIED ILLNESS., ACUTE OTITIS MEDIA, UNSPECIFIED SKIN DISEASE., AURI, UNSPECIFIED ILLNESS, UNSPECIFIED ILLNESS

The “other” AEs fo ANTI-B were as follows: UNSPECIFIED ILLNESS, UNSPECIFIED ILLNESS, ADVERSE DRUG REACTION DUE TO OVERDOSE., UNSPECIFIED ILLNESS, UNSPECIFIED ILLNESS., AuRI, UNSPECIFIED ILLNESS, UNSPECIFIED ILLNESS, UNSPECIFIED ILLNESS, UNSPECIFIED ILLNESS., UNSPECIFIED ILLNESS., BURN WOUND , ACUTE OTITIS MEDIA, 1. AMOEBIOASIS, FUNGAL INFECTION, UNSPECIFIED ILLNESS., UNSPECIFIED ILLNESS, UNSPECIFIED ILLNESS, 1. SEPTICEMIA, AURI, AURI

Serious adverse events for children older than 6 months

ANTI-A ANTI-B
Any Serious AE 18 (5.3%) 24 (7.7%)
ALRI 3 4
diarrhea 11 17
Dysentery 1 0
Lab abnormality 0 1
Other 0 1
URTI 3 1

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

The “other” serious AEs fo ANTI-B were as follows: 1. SEPTICEMIA

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

1 2 3 4
Any Serious AE 8 (5.3%) 9 (6.1%) 10 (5.4%) 15 (9.3%)
ALRI 2 1 1 3
diarrhea 4 8 7 9
Dysentery 0 0 1 0
Lab abnormality 0 0 0 1
Other 0 0 0 1
URTI 2 0 1 1

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

1 2 3 4
Any Serious AE 31 (6.3%) 33 (6.4%) 38 (7.1%) 37 (7.6%)
ALRI 16 12 15 8
diarrhea 9 13 15 15
Dysentery 0 0 1 0
Jaundice 0 0 0 1
Lab abnormality 2 1 0 1
Other 0 0 0 1
Sepsis 2 4 4 6
Skin rash/infection 0 0 1 0
URTI 2 3 2 4
UTI 0 0 0 1

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

1 2 3 4
Any AE 151 148 186 162
ALRI 50 46 62 58
diarrhea 55 66 83 63
Dysentery 0 0 1 2
Ear infection 0 2 2 0
fever 6 0 2 1
Lab abnormality 8 11 5 10
Ophthamalogical illness 3 6 7 2
Other 7 5 8 16
Skin rash/infection 10 6 7 5
URTI 12 6 6 5
UTI 0 0 1 0
Vomitting 0 0 2 0

All adverse events for children of all ages by randomization arm

1 2 3 4
Any AE 493 515 538 488
ALRI 220 223 245 202
diarrhea 129 160 157 141
Dysentery 0 0 1 3
Ear infection 0 3 2 0
fever 12 12 5 7
Jaundice 0 0 0 1
Lab abnormality 12 15 9 13
Omphalitis 4 0 1 0
Ophthamalogical illness 12 15 15 9
Other 24 24 31 38
Sepsis 4 5 8 10
Skin rash/infection 30 17 22 16
URTI 46 40 37 43
UTI 0 1 3 5
Vomitting 0 0 2 0

Protocol deviations by nicotanmide arm

NIC-A NIC-B
Any protocol deviation 133 127
Inappropriate documentation of consent 0 1
Study medication given outside of time window 29 30
Study antimicrobials given prior to stool colelction 2 0
Incorrect does of study medication 6 6
Delay of AE/SAE reporting 7 14
Blood for safety labs at 2 months (first 100 participants) not obtained 88 75

Protocol deviations by antibiotic arm

ANTI-A ANTI-B
Any protocol deviation 122 138
Inappropriate documentation of consent 0 1
Study medication given outside of time window 28 31
Study antimicrobials given prior to stool colelction 1 1
Incorrect does of study medication 6 6
Delay of AE/SAE reporting 8 13
Blood for safety labs at 2 months (first 100 participants) not obtained 79 84

Protocol deviations by study arm

1 2 3 4
Any protocol deviation 58 75 64 63
Inappropriate documentation of consent 0 0 0 1
Study medication given outside of time window 12 17 16 14
Study antimicrobials given prior to stool colelction 1 1 0 0
Incorrect does of study medication 2 4 4 2
Delay of AE/SAE reporting 1 6 7 7
Blood for safety labs at 2 months (first 100 participants) not obtained 42 46 37 38

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):