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 1097 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, 36 children dropped out of the study. 2 died.

This leaves 1041 children in the study at present.

Baseline characteristics by randomization arm

Group 1 (n = 260) Group 2 (n = 266) Group 3 (n = 260) Group 4 (n = 257)
child age (days) 5.9 +/- 7.1 5.7 +/- 6.7 5.9 +/- 6.2 5.7 +/- 6.6
# male sex (%) 133 (51.2%) 137 (51.5%) 138 (53.1%) 130 (50.6%)
# born in hospital (%) 145 (55.8%) 143 (53.8%) 126 (48.5%) 123 (47.9%)
Median family income med:30000 (min: 4000, max: 5e+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 (%) 200/251 (79.7%) 178/253 (70.4%) 190/256 (74.2%) 188/254 (74%)
Birth order med:3 (min: 1 max: 12) med:4 (min: 1 max: 12) med:4 (min: 1 max: 12) med:3.5 (min: 1 max: 12)
# Iraqw 197/251 (78.5%) 211/253 (83.4%) 203/256 (79.3%) 202/254 (79.5%)
# w/ improved sanitation (%) 27/251 (10.8%) 15/253 (5.9%) 19/256 (7.4%) 27/254 (10.6%)
# w/ improved drinking water (%) 165/251 (65.7%) 167/253 (66%) 173/256 (67.6%) 167/254 (65.7%)
# treating water (%) 37/251 (14.7%) 23/253 (9.1%) 29/256 (11.3%) 30/254 (11.8%)
# w/ water > 10 minute walk away (%) 206/251 (82.1%) 204/253 (80.6%) 211/256 (82.4%) 203/254 (79.9%)
# w/ electricity (%) 86/251 (34.3%) 91/253 (36%) 78/256 (30.5%) 75/254 (29.5%)
# w/ mattress (%) 156/251 (62.2%) 140/253 (55.3%) 132/256 (51.6%) 139/254 (54.7%)
# w/ table (%) 119/251 (47.4%) 102/253 (40.3%) 91/256 (35.5%) 95/254 (37.4%)
# w/ bench (%) 221/251 (88%) 214/253 (84.6%) 205/256 (80.1%) 214/254 (84.3%)
# w/ separate kitchen (%) 159/251 (63.3%) 149/253 (58.9%) 160/256 (62.5%) 150/254 (59.1%)
# w/ refrigerator (%) 3/251 (1.2%) 2/253 (0.8%) 2/256 (0.8%) 5/254 (2%)
# w/ television (%) 17/251 (6.8%) 17/253 (6.7%) 21/256 (8.2%) 15/254 (5.9%)
# w/ mobile phone (%) 206/251 (82.1%) 217/253 (85.8%) 206/256 (80.5%) 211/254 (83.1%)
# w/ family bank account (%) 19/251 (7.6%) 19/253 (7.5%) 7/256 (2.7%) 13/254 (5.1%)
# own agricultural land (%) 240/251 (95.6%) 244/253 (96.4%) 248/256 (96.9%) 244/254 (96.1%)
maternal age (years) 27.8 +/- 7.1 27.8 +/- 6.7 27.8 +/- 6.2 27.6 +/- 6.6
enrollment length (cm) 49.2 +/- 2.1 min:42.2 max: 59 48.6 +/- 3.4 min:5.7 max: 56 48.9 +/- 3.5 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 34.5 +/- 1.4 min:30 max: 38.4 34.8 +/- 1.4 min:28.3 max: 38.5 34.7 +/- 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 358 adverse events in mothers (190 in NIC-A and 168 in NIC-B). There have been 28 serious adverse events(16 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 16 (8.4%) 12 (7.1%)
ALRI 1 1
diarrhea 6 2
DVT 2 0
Lab abnormality 1 3
Other 2 4
Partial intestinal obstruction 2 0
Sepsis 2 2

The “other” serious AEs for NIC-A were as follows: EPILEPSY, ACUTE ASTHMATIC ATTACK 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 1429 adverse events in children (721 in NIC-A and 708 in NIC-B). There have been 114 serious adverse events(54 in NIC-A and 60 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 events by nicotinamide arm for children less than 6 months and younger

NIC-A NIC-B
Any Serious AE 46 (7.7%) 52 (9.1%)
ALRI 18 21
diarrhea 3 1
Jaundice 0 1
Lab abnormality 8 5
Other 1 4
Sepsis 8 12
URTI 8 8

The “other” serious AEs for NIC-A were as follows: ASTHMATIC ATTACK The “other” serious AEs for NIC-B were as follows: ABSCESS ON THE RIGHT BREAST, CONGENITAL CYST, SYMPTOMATIC UTI, 1. BRONCHILITIS

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

NIC-A NIC-B
Any Serious AE 8 (6.6%) 8 (5.8%)
ALRI 4 3
diarrhea 1 3
Lab abnormality 2 1
URTI 1 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 260 adverse events in children 6 months and older, (132 in ANTI-A and 128 in ANTI-B). There have been 16 serious adverse events(6 in ANTI-A and 10 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 64 58
diarrhea 23 21
fever 6 0
Lab abnormality 12 20
Other 12 19
Skin rash/infection 1 1
URTI 12 9
VOMITING 2 0

The “other” AEs for ANTI-A were as follows: UNSPECIFIED ILLNESS., UNSPECIFIED OPHTHALMOLOGICAL ILLNESS, EAR INFECTION., SHIGELOSIS, EYE INFECTION, UNSPECIFIED DERMATOLOGICAL ILLNESS, UNSPECIFIED DERMATOLOGICAL ILLNESS, UNSPECIFIED OPTHALMOLOGICAL ILLNESS, UNSPECIFIED ILLNESS, UNSPECIFIED DERMATOLOGICAL ILLNESS, UNSPECIFIED OPHTHEMOLOGICAL ILLNESS, EAR INFECTION

The “other” AEs fo ANTI-B were as follows: UNSPECIFIED EAR INFECTION., UNSPECIFIED ILLNESS, UNSPECIFIED ILLNESS, UNSPECIFIED ILLNESS, UNSPECIFIED OPHTHALMOLOGICAL ILLNESS, 1. HYPONATREMIA, UNSPECIFIED DERMATOLOGICAL ILLNESS, UNSPECIFIED ILLNESS, ABSCESS, HYPONATREMIA, UNSPECIFIED OPHTHALMOLOGICAL ILLNESS, UNSPECIFIED ILLNESS., PAST AURICULAR ABSCESS., HYPONATREMIA, HYPONATREMIA, UNSPECIFIED DERMATOLOGICAL ILLNESS., UNSPECIFIED OPHTHALMOLOGICAL ILLNESS, UNSPECIFIED DISORDER OF THE EYE, UNSPECIFIED AURICULAR ILLNESS

Serious adverse events for children older than 6 months

ANTI-A ANTI-B
Any Serious AE 6 (4.5%) 10 (7.8%)
ALRI 3 4
diarrhea 2 2
Lab abnormality 0 3
URTI 1 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 4 (7.1%) 4 (6.2%) 2 (2.6%) 6 (9.5%)
ALRI 3 1 0 3
diarrhea 0 1 2 1
Lab abnormality 0 2 0 1
URTI 1 0 0 1

Protocol deviations by nicotanmide arm

NIC-A NIC-B
Any protocol deviation 84 75
Inappropriate documentation of consent 0 1
Study medication given outside of time window 16 14
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 53 38

Protocol deviations by antibiotic arm

ANTI-A ANTI-B
Any protocol deviation 72 87
Inappropriate documentation of consent 0 1
Study medication given outside of time window 16 14
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 41 50

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):

Subjective nicotinimide packet compliance based on maternal report of the number of packets missed in the last 7 days