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, 78 children did not remain in the study. 12 of these were due to death.

This leaves 1110 children in the study at present.

Baseline characteristics by randomization arm

Group 1 (n = 283) Group 2 (n = 280) Group 3 (n = 276) Group 4 (n = 271)
child age (days) 6 +/- 3.5 5.9 +/- 3.7 5.9 +/- 3.6 6 +/- 3.7
# male sex (%) 148 (52.3%) 144 (51.4%) 142 (51.4%) 137 (50.6%)
# born in hospital (%) 157 (55.5%) 150 (53.6%) 133 (48.2%) 137 (50.6%)
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 (%) 230/283 (81.3%) 197/280 (70.4%) 204/276 (73.9%) 200/271 (73.8%)
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 221/283 (78.1%) 230/280 (82.1%) 219/276 (79.3%) 218/271 (80.4%)
# w/ improved sanitation (%) 37/283 (13.1%) 23/280 (8.2%) 25/276 (9.1%) 33/271 (12.2%)
# w/ improved drinking water (%) 189/283 (66.8%) 183/280 (65.4%) 188/276 (68.1%) 178/271 (65.7%)
# treating water (%) 39/283 (13.8%) 27/280 (9.6%) 32/276 (11.6%) 28/271 (10.3%)
# w/ water > 10 minute walk away (%) 232/283 (82%) 224/280 (80%) 226/276 (81.9%) 215/271 (79.3%)
# w/ electricity (%) 101/283 (35.7%) 99/280 (35.4%) 91/276 (33%) 88/271 (32.5%)
# w/ mattress (%) 175/283 (61.8%) 153/280 (54.6%) 149/276 (54%) 153/271 (56.5%)
# w/ table (%) 139/283 (49.1%) 109/280 (38.9%) 107/276 (38.8%) 107/271 (39.5%)
# w/ bench (%) 247/283 (87.3%) 236/280 (84.3%) 224/276 (81.2%) 228/271 (84.1%)
# w/ separate kitchen (%) 184/283 (65%) 166/280 (59.3%) 174/276 (63%) 162/271 (59.8%)
# w/ refrigerator (%) 5/283 (1.8%) 2/280 (0.7%) 2/276 (0.7%) 5/271 (1.8%)
# w/ television (%) 19/283 (6.7%) 17/280 (6.1%) 20/276 (7.2%) 15/271 (5.5%)
# w/ mobile phone (%) 233/283 (82.3%) 238/280 (85%) 223/276 (80.8%) 226/271 (83.4%)
# w/ family bank account (%) 22/283 (7.8%) 19/280 (6.8%) 9/276 (3.3%) 13/271 (4.8%)
# own agricultural land (%) 270/283 (95.4%) 268/280 (95.7%) 267/276 (96.7%) 261/271 (96.3%)
maternal age (years) 28 +/- 7.1 27.8 +/- 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 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 4077 adverse events in children (2039 in NIC-A and 2038 in NIC-B). There have been 252 serious adverse events(123 in NIC-A and 129 in NIC-B) and 0 adverse events deemed related or possibily related to study medications (0 in NIC-A and 0 in NIC-B).

Of the 12 that died, 6 were in Nic-A, and 6 were in Nic-B.

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

NIC-A NIC-B
Acute watery diarrhea 84 89
ALRI 337 350
Constipation 4 0
diarrhea 426 442
Dysentery 5 8
Ear infection 16 11
fever 45 47
Fungal infection 5 5
Injury/Burn 15 29
Lab abnormality 115 74
Malnutrition 5 6
Omphalitis 1 1
Ophthamalogical illness 19 15
Other 21 27
Septicemia 0 2
Skin rash/infection 54 66
URTI 87 97
UTI 5 1
Vomitting 1 3

The “other” AEs for NIC-A were as follows: UNSPECIFIED ILLNESS, UNSPECIFIED ILLNESS, UNSPECIFIED ILLNESS., UNSPECIFIED ORAL INFECTION., THROMBOCTOPENIA, ABNORMAL BUN LEVEL, UNSPECIFIED ENT ILLNESS, ARTI, UNSPECIFIED ILLNESS, UNSPECIFIED ILLNESS., ORAL TRUSH, UNSPECIFIED ORAL INFECTION., UNSPECIFIED ORAL INFECTION., TONSILLITIS, UNSPECIFIED ILLNESS, UNSPECIFIED ILLNESS, LOSS OF APPETITE, NA, 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, VAGINAL CANDIDIASIS , TONSILLITIS, UNSPECIFIED ILLNESS, UNSPECIFIED ILLNESS., UNSPECIFIED ILLNESS., TINEA CAPITAS WITH BACTERIAL SUPER INFECTION., UNSPECIFIED ILLNESS, USPECIFIED ILLNESS., LRI, ANIMAL BITE, UNSPECIFIED ILLNESS., UNSPECIFIED ILLNESS., ANIMAL BITE, UNSPECIFIED ILLNESS, UNSPECIFIED ILLNESS, UNSPECIFIED ILLNESS, UNSPECIFIED INFECTION ON THE THUMB., CHICKEN POX, UNSPECIFIED NECK SWELLING., UNSPECIFIED ILLNESS

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

NIC-A NIC-B
Any Serious AE 74 (5.9%) 75 (5.9%)
Acute watery diarrhea 1 2
ALRI 12 22
diarrhea 46 38
Dysentery 0 1
fever 1 1
Injury/Burn 1 1
Lab abnormality 1 2
Malnutrition 5 3
Omphalitis 1 0
Ophthamalogical illness 1 0
Other 1 1
Septicemia 0 1
Skin rash/infection 0 1
URTI 4 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 49 (6.2%) 54 (7.1%)
Acute watery diarrhea 3 4
ALRI 26 19
diarrhea 7 14
Jaundice 0 1
Lab abnormality 2 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 2518 adverse events in children 6 months and older, (1304 in ANTI-A and 1214 in ANTI-B). There have been 149 serious adverse events(78 in ANTI-A and 71 in ANTI-B) and 0 adverse events deemed related or possibily related to study medications (0 in ANTI-A and 0 in ANTI-B).

Of the 12 that died, 7 were in Anti-A, and 5 were in Anti-B.

All adverse events for children older than 6 months

ANTI-A ANTI-B
Acute watery diarrhea 109 64
ALRI 361 326
Constipation 1 3
diarrhea 436 432
Dysentery 8 5
Ear infection 16 11
fever 47 45
Fungal infection 5 5
Injury/Burn 24 20
Lab abnormality 91 98
Malnutrition 7 4
Omphalitis 1 1
Ophthamalogical illness 18 16
Other 17 31
Septicemia 1 1
Skin rash/infection 64 56
URTI 94 90
UTI 3 3
Vomitting 1 3

The “other” AEs for ANTI-A were as follows: UNSPECIFIED ILLNESS., SCABIES, GATROENTERITIS , UNSPECIFIED ORAL INFECTION., ABNORMAL BUN LEVEL, UNSPECIFIED ENT ILLNESS, TONSILLITIS, TINEA CAPITAS WITH BACTERIAL SUPER INFECTION., UNSPECIFIED ILLNESS, LRI, UNSPECIFIED ILLNESS., 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., THROMBOCTOPENIA, UNSPECIFIED ILLNESS, UNSPECIFIED ILLNESS, VAGINAL CANDIDIASIS , UNSPECIFIED ILLNESS, UNSPECIFIED ILLNESS., UNSPECIFIED ILLNESS., ARTI, UNSPECIFIED ILLNESS., UNSPECIFIED ILLNESS, USPECIFIED ILLNESS., ANIMAL BITE, ORAL TRUSH, UNSPECIFIED ORAL INFECTION., UNSPECIFIED ORAL INFECTION., UNSPECIFIED ILLNESS., TONSILLITIS, UNSPECIFIED ILLNESS, ANIMAL BITE, UNSPECIFIED ILLNESS, NA, UNSPECIFIED INFECTION ON THE THUMB., CHICKEN POX, UNSPECIFIED NECK SWELLING., UNSPECIFIED ILLNESS, UNSPECIFIED ILLNESS

Serious adverse events for children older than 6 months

ANTI-A ANTI-B
Any Serious AE 78 (6%) 71 (5.8%)
Acute watery diarrhea 1 2
ALRI 18 16
diarrhea 43 41
Dysentery 1 0
fever 1 1
Injury/Burn 1 1
Lab abnormality 2 1
Malnutrition 5 3
Omphalitis 1 0
Ophthamalogical illness 1 0
Other 1 1
Septicemia 0 1
Skin rash/infection 0 1
URTI 3 3

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 41 (6.5%) 33 (5.4%) 37 (5.5%) 38 (6.3%)
Acute watery diarrhea 1 0 0 2
ALRI 6 6 12 10
diarrhea 24 22 19 19
Dysentery 0 0 1 0
fever 0 1 1 0
Injury/Burn 1 0 0 1
Lab abnormality 1 0 1 1
Malnutrition 3 2 2 1
Omphalitis 1 0 0 0
Ophthamalogical illness 1 0 0 0
Other 1 0 0 1
Septicemia 0 0 0 1
Skin rash/infection 0 0 0 1
URTI 2 2 1 1

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

1 2 3 4
Any Serious AE 65 (6.4%) 58 (5.7%) 67 (6.3%) 62 (6.4%)
Acute watery diarrhea 3 1 3 3
ALRI 21 17 26 15
diarrhea 26 27 26 26
Dysentery 0 0 1 0
fever 0 1 1 0
Injury/Burn 1 0 0 1
Jaundice 0 0 0 1
Lab abnormality 2 1 1 1
Malnutrition 5 2 2 1
Omphalitis 1 0 0 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 1
URTI 2 5 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 634 611 670 603
Acute watery diarrhea 50 34 59 30
ALRI 178 159 183 167
Constipation 1 3 0 0
diarrhea 197 229 239 203
Dysentery 3 2 5 3
Ear infection 10 6 6 5
fever 24 21 23 24
Fungal infection 3 2 2 3
Injury/Burn 10 5 14 15
Lab abnormality 56 59 35 39
Malnutrition 3 2 4 2
Omphalitis 1 0 0 1
Ophthamalogical illness 9 10 9 6
Other 9 12 8 19
Septicemia 0 0 1 1
Skin rash/infection 34 20 30 36
URTI 43 44 51 46
UTI 3 2 0 1
Vomitting 0 1 1 2

All adverse events for children of all ages by randomization arm

1 2 3 4
Any AE 1020 1019 1062 976
Acute watery diarrhea 65 57 74 44
ALRI 370 355 376 323
Constipation 3 3 1 0
diarrhea 265 311 315 285
Dysentery 3 3 6 7
Ear infection 15 11 9 12
fever 30 34 28 31
Fungal infection 5 3 3 4
Injury/Burn 11 5 16 15
Jaundice 0 0 0 1
Lab abnormality 59 63 39 42
Malnutrition 5 2 4 2
Omphalitis 4 0 1 1
Ophthamalogical illness 19 19 17 15
Other 23 30 27 37
Sepsis 4 5 8 10
Septicemia 1 0 1 1
Skin rash/infection 55 34 50 51
URTI 80 80 83 85
UTI 3 3 2 7
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):