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 weekly. These data lag the actual collected data by roughly two weeks (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, 71 children did not remain in the study. 12 of these were due to death.

This leaves 1117 children in the study at present.

Baseline characteristics by randomization arm

Group 1 (n = 285) Group 2 (n = 282) Group 3 (n = 278) Group 4 (n = 272)
child age (days) 6 +/- 3.5 5.8 +/- 3.7 5.9 +/- 3.6 6 +/- 3.7
# male sex (%) 150 (52.6%) 145 (51.4%) 143 (51.4%) 137 (50.4%)
# born in hospital (%) 159 (55.8%) 152 (53.9%) 134 (48.2%) 137 (50.4%)
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%) 199/282 (70.6%) 206/278 (74.1%) 201/272 (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 223/285 (78.2%) 232/282 (82.3%) 221/278 (79.5%) 219/272 (80.5%)
# w/ improved sanitation (%) 38/285 (13.3%) 24/282 (8.5%) 26/278 (9.4%) 33/272 (12.1%)
# w/ improved drinking water (%) 190/285 (66.7%) 185/282 (65.6%) 189/278 (68%) 178/272 (65.4%)
# treating water (%) 39/285 (13.7%) 28/282 (9.9%) 34/278 (12.2%) 28/272 (10.3%)
# w/ water > 10 minute walk away (%) 234/285 (82.1%) 224/282 (79.4%) 227/278 (81.7%) 216/272 (79.4%)
# w/ electricity (%) 101/285 (35.4%) 101/282 (35.8%) 92/278 (33.1%) 88/272 (32.4%)
# w/ mattress (%) 177/285 (62.1%) 155/282 (55%) 150/278 (54%) 153/272 (56.2%)
# w/ table (%) 140/285 (49.1%) 111/282 (39.4%) 108/278 (38.8%) 107/272 (39.3%)
# w/ bench (%) 249/285 (87.4%) 238/282 (84.4%) 225/278 (80.9%) 228/272 (83.8%)
# w/ separate kitchen (%) 186/285 (65.3%) 168/282 (59.6%) 176/278 (63.3%) 162/272 (59.6%)
# w/ refrigerator (%) 5/285 (1.8%) 2/282 (0.7%) 2/278 (0.7%) 5/272 (1.8%)
# w/ television (%) 19/285 (6.7%) 18/282 (6.4%) 21/278 (7.6%) 15/272 (5.5%)
# w/ mobile phone (%) 235/285 (82.5%) 240/282 (85.1%) 225/278 (80.9%) 226/272 (83.1%)
# w/ family bank account (%) 22/285 (7.7%) 20/282 (7.1%) 10/278 (3.6%) 13/272 (4.8%)
# own agricultural land (%) 272/285 (95.4%) 270/282 (95.7%) 269/278 (96.8%) 262/272 (96.3%)
maternal age (years) 28 +/- 7.1 27.7 +/- 6.7 27.8 +/- 6.1 27.7 +/- 6.6
enrollment length (cm) 49.2 +/- 2 min:42.2 max: 59 48.8 +/- 2.1 min:40 max: 57 49.1 +/- 2.1 min:41 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 474 adverse events in mothers (251 in NIC-A and 223 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 3558 adverse events in children (1765 in NIC-A and 1793 in NIC-B). There have been 205 serious adverse events(100 in NIC-A and 105 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
Acute watery diarrhea 21 31
ALRI 259 264
Constipation 4 0
diarrhea 402 428
Dysentery 5 8
Ear infection 14 8
fever 35 40
Fungal infection 3 4
Injury/Burn 6 19
Lab abnormality 76 55
Malnutrition 3 4
Omphalitis 0 1
Ophthamalogical illness 16 14
Other 16 23
Septicemia 0 2
Skin rash/infection 41 52
URTI 63 69
UTI 2 0
Vomitting 1 3

The “other” AEs for NIC-A were as follows: UNSPECIFIED ILLNESS, UNSPECIFIED ILLNESS, UNSPECIFIED ILLNESS., UNSPECIFIED ORAL INFECTION., UNSPECIFIED ENT ILLNESS, ARTI, UNSPECIFIED ILLNESS, ORAL TRUSH, UNSPECIFIED ORAL INFECTION., LARI, UNSPECIFIED ILLNESS, UNSPECIFIED ILLNESS, LOSS OF APPETITE, UNSPECIFIED SCALP TUMOR, UNSPECIFIED ILLNESS, SCORPION BITE

The “other” AEs for NIC-B were as follows: ADVERSE DRUG REACTION DUE TO OVERDOSE., UNSPECIFIED ORAL INFECTION, SCABIES, GATROENTERITIS , UNSPECIFIED ILLNESS., UNSPECIFIED ILLNESS, UNSPECIFIED ILLNESS, TONSILLITIS, UNSPECIFIED ILLNESS, UNSPECIFIED ILLNESS., UNSPECIFIED ILLNESS., USPECIFIED ILLNESS., LRI, ANIMAL BITE, UNSPECIFIED ILLNESS., UNSPECIFIED ILLNESS., LARI, UNSPECIFIED ILLNESS, UNSPECIFIED ILLNESS, UNSPECIFIED ILLNESS, UNSPECIFIED INFECTION ON THE THUMB., CHICKEN POX, UNSPECIFIED ILLNESS

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

NIC-A NIC-B
Any Serious AE 49 (5.1%) 51 (5%)
Acute watery diarrhea 0 2
ALRI 5 10
diarrhea 36 30
Dysentery 0 1
Injury/Burn 1 1
Lab abnormality 0 1
Malnutrition 3 2
Ophthamalogical illness 1 0
Other 1 1
Septicemia 0 1
URTI 2 2

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

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

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

NIC-A NIC-B
Any Serious AE 51 (6.4%) 54 (7%)
ALRI 27 19
diarrhea 10 18
Jaundice 0 1
Lab abnormality 3 0
Malnutrition 2 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 1992 adverse events in children 6 months and older, (1029 in ANTI-A and 963 in ANTI-B). There have been 100 serious adverse events(50 in ANTI-A and 50 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
Acute watery diarrhea 29 23
ALRI 281 242
Constipation 1 3
diarrhea 416 414
Dysentery 8 5
Ear infection 13 9
fever 38 37
Fungal infection 2 5
Injury/Burn 13 12
Lab abnormality 62 69
Malnutrition 6 1
Omphalitis 0 1
Ophthamalogical illness 18 12
Other 17 22
Septicemia 1 1
Skin rash/infection 50 43
URTI 72 60
UTI 1 1
Vomitting 1 3

The “other” AEs for ANTI-A were as follows: UNSPECIFIED ILLNESS., SCABIES, GATROENTERITIS , UNSPECIFIED ORAL INFECTION., UNSPECIFIED ENT ILLNESS, TONSILLITIS, UNSPECIFIED ILLNESS, LRI, UNSPECIFIED ILLNESS., LARI, LARI, UNSPECIFIED ILLNESS, UNSPECIFIED ILLNESS, LOSS OF APPETITE, UNSPECIFIED ILLNESS, UNSPECIFIED SCALP TUMOR, SCORPION BITE

The “other” AEs fo ANTI-B were as follows: UNSPECIFIED ILLNESS, UNSPECIFIED ILLNESS, ADVERSE DRUG REACTION DUE TO OVERDOSE., UNSPECIFIED ORAL INFECTION, UNSPECIFIED ILLNESS., UNSPECIFIED ILLNESS, UNSPECIFIED ILLNESS, UNSPECIFIED ILLNESS, UNSPECIFIED ILLNESS., UNSPECIFIED ILLNESS., ARTI, USPECIFIED ILLNESS., ANIMAL BITE, ORAL TRUSH, UNSPECIFIED ORAL INFECTION., UNSPECIFIED ILLNESS., UNSPECIFIED ILLNESS, UNSPECIFIED ILLNESS, UNSPECIFIED INFECTION ON THE THUMB., CHICKEN POX, UNSPECIFIED ILLNESS, UNSPECIFIED ILLNESS

Serious adverse events for children older than 6 months

ANTI-A ANTI-B
Any Serious AE 50 (4.9%) 50 (5.2%)
Acute watery diarrhea 1 1
ALRI 8 7
diarrhea 30 36
Dysentery 1 0
Injury/Burn 1 1
Lab abnormality 0 1
Malnutrition 5 0
Ophthamalogical illness 1 0
Other 1 1
Septicemia 0 1
URTI 2 2

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

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

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

1 2 3 4
Any Serious AE 28 (5.7%) 21 (4.4%) 22 (4.1%) 29 (6%)
Acute watery diarrhea 0 0 1 1
ALRI 4 1 4 6
diarrhea 17 19 13 17
Dysentery 0 0 1 0
Injury/Burn 1 0 0 1
Lab abnormality 0 0 0 1
Malnutrition 3 0 2 0
Ophthamalogical illness 1 0 0 0
Other 1 0 0 1
Septicemia 0 0 0 1
URTI 1 1 1 1

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

1 2 3 4
Any Serious AE 53 (6.1%) 47 (5.3%) 52 (5.6%) 53 (6.2%)
Acute watery diarrhea 0 0 1 1
ALRI 19 13 18 11
diarrhea 21 25 23 25
Dysentery 0 0 1 0
Injury/Burn 1 0 0 1
Jaundice 0 0 0 1
Lab abnormality 2 1 0 1
Malnutrition 5 0 2 0
Ophthamalogical illness 1 0 0 0
Other 1 0 0 1
Sepsis 2 4 4 6
Septicemia 0 0 0 1
Skin rash/infection 0 0 1 0
URTI 1 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 488 479 541 484
Acute watery diarrhea 12 9 17 14
ALRI 144 115 137 127
Constipation 1 3 0 0
diarrhea 180 222 236 192
Dysentery 3 2 5 3
Ear infection 8 6 5 3
fever 19 16 19 21
Fungal infection 1 2 1 3
Injury/Burn 6 0 7 12
Lab abnormality 34 42 28 27
Malnutrition 3 0 3 1
Omphalitis 0 0 0 1
Ophthamalogical illness 9 7 9 5
Other 9 7 8 15
Septicemia 0 0 1 1
Skin rash/infection 25 16 25 27
URTI 33 30 39 30
UTI 1 1 0 0
Vomitting 0 1 1 2

All adverse events for children of all ages by randomization arm

1 2 3 4
Any AE 876 889 936 857
Acute watery diarrhea 12 9 18 15
ALRI 336 312 332 283
Constipation 3 3 1 0
diarrhea 264 328 327 287
Dysentery 3 3 6 7
Ear infection 13 11 8 10
fever 25 29 24 28
Fungal infection 3 3 2 4
Injury/Burn 7 0 9 12
Jaundice 0 0 0 1
Lab abnormality 38 46 32 30
Malnutrition 5 0 3 1
Omphalitis 3 0 1 1
Ophthamalogical illness 19 16 17 14
Other 23 25 27 33
Sepsis 4 5 8 10
Septicemia 1 0 1 1
Skin rash/infection 46 30 45 42
URTI 70 66 71 69
UTI 1 2 2 6
Vomitting 0 1 2 3

Protocol deviations by nicotanmide arm

NIC-A NIC-B
Any protocol deviation 164 144
Inappropriate documentation of consent 0 1
Study medication given outside of time window 36 38
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 110 83

Protocol deviations by antibiotic arm

ANTI-A ANTI-B
Any protocol deviation 144 164
Inappropriate documentation of consent 0 1
Study medication given outside of time window 41 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 86 107

Protocol deviations by study arm

1 2 3 4
Any protocol deviation 72 92 72 72
Inappropriate documentation of consent 0 0 0 1
Study medication given outside of time window 18 18 23 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 48 62 38 45

Compliance with study medications

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