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

This leaves 1121 children in the study at present.

Baseline characteristics by randomization arm

Group 1 (n = 285) Group 2 (n = 284) Group 3 (n = 279) Group 4 (n = 273)
child age (days) 6 +/- 3.5 5.8 +/- 3.7 6 +/- 3.7 6 +/- 3.7
# male sex (%) 150 (52.6%) 146 (51.4%) 144 (51.6%) 137 (50.2%)
# born in hospital (%) 159 (55.8%) 153 (53.9%) 134 (48%) 138 (50.5%)
Median family income med:30000 (min: 5000, max: 6e+05) med:30000 (min: 5000, max: 3e+05) med:30000 (min: 5000, max: 360000) med:30000 (min: 1500, max: 3e+05)
Mother with >= 7 years of education (%) 232/285 (81.4%) 200/284 (70.4%) 208/279 (74.6%) 202/273 (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 223/285 (78.2%) 234/284 (82.4%) 222/279 (79.6%) 219/273 (80.2%)
# w/ improved sanitation (%) 38/285 (13.3%) 24/284 (8.5%) 26/279 (9.3%) 33/273 (12.1%)
# w/ improved drinking water (%) 190/285 (66.7%) 187/284 (65.8%) 190/279 (68.1%) 179/273 (65.6%)
# treating water (%) 39/285 (13.7%) 28/284 (9.9%) 34/279 (12.2%) 28/273 (10.3%)
# w/ water > 10 minute walk away (%) 234/285 (82.1%) 226/284 (79.6%) 227/279 (81.4%) 217/273 (79.5%)
# w/ electricity (%) 101/285 (35.4%) 102/284 (35.9%) 92/279 (33%) 88/273 (32.2%)
# w/ mattress (%) 177/285 (62.1%) 157/284 (55.3%) 150/279 (53.8%) 153/273 (56%)
# w/ table (%) 140/285 (49.1%) 111/284 (39.1%) 107/279 (38.4%) 107/273 (39.2%)
# w/ bench (%) 249/285 (87.4%) 239/284 (84.2%) 225/279 (80.6%) 229/273 (83.9%)
# w/ separate kitchen (%) 186/285 (65.3%) 169/284 (59.5%) 175/279 (62.7%) 163/273 (59.7%)
# w/ refrigerator (%) 5/285 (1.8%) 2/284 (0.7%) 2/279 (0.7%) 5/273 (1.8%)
# w/ television (%) 19/285 (6.7%) 18/284 (6.3%) 21/279 (7.5%) 15/273 (5.5%)
# w/ mobile phone (%) 235/285 (82.5%) 242/284 (85.2%) 226/279 (81%) 227/273 (83.2%)
# w/ family bank account (%) 22/285 (7.7%) 20/284 (7%) 10/279 (3.6%) 13/273 (4.8%)
# own agricultural land (%) 272/285 (95.4%) 272/284 (95.8%) 270/279 (96.8%) 263/273 (96.3%)
maternal age (years) 28 +/- 7.1 27.7 +/- 6.7 27.7 +/- 6.1 27.7 +/- 6.6
enrollment length (cm) 49.2 +/- 2 min:42.2 max: 59 48.6 +/- 3.3 min:5.7 max: 56 48.9 +/- 3.4 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 472 adverse events in mothers (250 in NIC-A and 222 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 (5.6%) 12 (5.4%)
ALRI 0 3
diarrhea 4 2
DVT 1 0
Lab abnormality 1 0
Other 4 4
Partial intestinal obstruction 2 0
Sepsis 2 2
Septicemia 0 1

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 2674 adverse events in children (1330 in NIC-A and 1344 in NIC-B). There have been 169 serious adverse events(83 in NIC-A and 86 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 158 176
Constipation 4 0
diarrhea 222 242
Dysentery 3 7
Ear infection 12 7
fever 10 15
Fungal infection 2 3
Injury/Burn 2 5
Lab abnormality 46 35
Ophthamalogical illness 14 13
Other 11 23
Septicemia 0 2
Skin rash/infection 22 27
URTI 31 25
Vomitting 1 3

The “other” AEs for NIC-A were as follows: UNSPECIFIED ILLNESS, UNSPECIFIED ILLNESS, UNSPECIFIED ILLNESS., AuRI, UNSPECIFIED ENT ILLNESS, UNSPECIFIED ILLNESS, UNSPECIFIED ILLNESS, UNSPECIFIED ILLNESS, LOSS OF APPETITE, UNSPECIFIED ILLNESS, FIBRILE ILLNESS

The “other” AEs for NIC-B were as follows: ADVERSE DRUG REACTION DUE TO OVERDOSE., SCABIES, GATROENTERITIS , UNSPECIFIED ILLNESS., UNSPECIFIED ILLNESS, UNSPECIFIED ILLNESS, UNSPECIFIED ILLNESS, UNSPECIFIED ILLNESS., UNSPECIFIED ILLNESS., AWD, USPECIFIED ILLNESS., UNSPECIFIED GASTRIC ILLNESS(MALNUTRITION), UNSPECIFIED ILLNESS., UNSPECIFIED ILLNESS., AWD, UNSPECIFIED ILLNESS, UNSPECIFIED ILLNESS, AWD WITH SEVERE DEHYDRATION,, GASRTOENTERITIS, UNSPECIFIED ILLNESS, AWD, CHICKEN POX, UNSPECIFIED ILLNESS

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

NIC-A NIC-B
Any Serious AE 33 (6.1%) 33 (5.7%)
ALRI 4 7
diarrhea 25 19
Dysentery 0 1
Injury/Burn 1 0
Lab abnormality 0 1
Other 0 2
Septicemia 0 1
URTI 3 2

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

The “other” serious AEs for NIC-B were as follows: AWD WITH SEVERE DEHYDRATION,, CHICKEN POX

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

NIC-A NIC-B
Any Serious AE 50 (6.3%) 53 (7%)
ALRI 26 19
diarrhea 12 17
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 1121 adverse events in children 6 months and older, (579 in ANTI-A and 542 in ANTI-B). There have been 66 serious adverse events(30 in ANTI-A and 36 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 182 152
Constipation 1 3
diarrhea 234 230
Dysentery 6 4
Ear infection 11 8
fever 13 12
Fungal infection 2 3
Injury/Burn 5 2
Lab abnormality 38 43
Ophthamalogical illness 16 11
Other 14 20
Septicemia 1 1
Skin rash/infection 28 21
URTI 27 29
Vomitting 1 3

The “other” AEs for ANTI-A were as follows: UNSPECIFIED ILLNESS., SCABIES, GATROENTERITIS , UNSPECIFIED ENT ILLNESS, AWD, UNSPECIFIED ILLNESS, UNSPECIFIED GASTRIC ILLNESS(MALNUTRITION), UNSPECIFIED ILLNESS., UNSPECIFIED ILLNESS, UNSPECIFIED ILLNESS, LOSS OF APPETITE, GASRTOENTERITIS, UNSPECIFIED ILLNESS, AWD

The “other” AEs fo ANTI-B were as follows: UNSPECIFIED ILLNESS, UNSPECIFIED ILLNESS, ADVERSE DRUG REACTION DUE TO OVERDOSE., UNSPECIFIED ILLNESS., AuRI, UNSPECIFIED ILLNESS, UNSPECIFIED ILLNESS, UNSPECIFIED ILLNESS, UNSPECIFIED ILLNESS., UNSPECIFIED ILLNESS., USPECIFIED ILLNESS., UNSPECIFIED ILLNESS., UNSPECIFIED ILLNESS, AWD, UNSPECIFIED ILLNESS, AWD WITH SEVERE DEHYDRATION,, CHICKEN POX, UNSPECIFIED ILLNESS, UNSPECIFIED ILLNESS, FIBRILE ILLNESS

Serious adverse events for children older than 6 months

ANTI-A ANTI-B
Any Serious AE 30 (5.2%) 36 (6.6%)
ALRI 5 6
diarrhea 20 24
Dysentery 1 0
Injury/Burn 1 0
Lab abnormality 0 1
Other 0 2
Septicemia 0 1
URTI 3 2

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

The “other” serious AEs fo ANTI-B were as follows: AWD WITH SEVERE DEHYDRATION,, CHICKEN POX

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

1 2 3 4
Any Serious AE 17 (6.3%) 16 (5.9%) 13 (4.2%) 20 (7.4%)
ALRI 3 1 2 5
diarrhea 11 14 9 10
Dysentery 0 0 1 0
Injury/Burn 1 0 0 0
Lab abnormality 0 0 0 1
Other 0 0 0 2
Septicemia 0 0 0 1
URTI 2 1 1 1

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

1 2 3 4
Any Serious AE 41 (6.3%) 42 (6.2%) 42 (6%) 44 (6.9%)
ALRI 18 12 16 10
diarrhea 16 21 18 18
Dysentery 0 0 1 0
Injury/Burn 1 0 0 0
Jaundice 0 0 0 1
Lab abnormality 2 1 0 1
Other 0 0 0 2
Sepsis 2 4 4 6
Septicemia 0 0 0 1
Skin rash/infection 0 0 1 0
URTI 2 4 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 268 270 311 272
ALRI 88 70 94 82
Constipation 1 3 0 0
diarrhea 96 126 138 104
Dysentery 2 1 4 3
Ear infection 7 5 4 3
fever 8 2 5 10
Fungal infection 1 1 1 2
Injury/Burn 2 0 3 2
Lab abnormality 22 24 16 19
Ophthamalogical illness 7 7 9 4
Other 5 6 9 14
Septicemia 0 0 1 1
Skin rash/infection 13 9 15 12
URTI 16 15 11 14
Vomitting 0 1 1 2

All adverse events for children of all ages by randomization arm

1 2 3 4
Any AE 651 679 704 640
ALRI 280 268 289 237
Constipation 3 3 1 0
diarrhea 177 233 228 197
Dysentery 2 1 5 5
Ear infection 12 9 7 10
fever 14 14 10 17
Fungal infection 3 2 2 3
Injury/Burn 3 0 5 2
Jaundice 0 0 0 1
Lab abnormality 26 28 20 22
Omphalitis 3 0 1 0
Ophthamalogical illness 16 16 17 12
Other 20 24 29 33
Sepsis 4 5 8 10
Septicemia 1 0 1 1
Skin rash/infection 34 23 34 27
URTI 53 51 43 54
UTI 0 1 2 6
Vomitting 0 1 2 3

Protocol deviations by nicotanmide arm

NIC-A NIC-B
Any protocol deviation 152 138
Inappropriate documentation of consent 0 1
Study medication given outside of time window 34 36
Study antimicrobials given prior to stool colelction 4 1
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 100 79

Protocol deviations by antibiotic arm

ANTI-A ANTI-B
Any protocol deviation 135 155
Inappropriate documentation of consent 0 1
Study medication given outside of time window 37 33
Study antimicrobials given prior to stool colelction 3 2
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 81 98

Protocol deviations by study arm

1 2 3 4
Any protocol deviation 68 84 67 71
Inappropriate documentation of consent 0 0 0 1
Study medication given outside of time window 16 18 21 15
Study antimicrobials given prior to stool colelction 3 1 0 1
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 46 54 35 44

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):