Trial Outcomes & Findings for Standardized Treatment of Pulmonary Exacerbations II (NCT NCT02781610)

NCT ID: NCT02781610

Last Updated: 2021-05-19

Results Overview

Absolute change in FEV1 % predicted from baseline/visit 1 (start of IV antibiotic treatment) to last study visit/visit 3 (14 days after the end of IV antibiotic treatment).

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 982 participants
• Primary outcome timeframe: Start of IV antibiotic treatment to 14 days after the end of IV antibiotic treatment
• Results posted on: 2021-05-19

Participant Flow

Participant milestones

Measure	ERR-10 ERR treatment duration - 10 Day Standard of care IV antibiotic(s) will be selected by the treating physician. Duration of treatment is the assigned intervention. Standard of care IV antibiotic(s): IV antibiotics will be selected by the treating physician following standard of care. Duration of treatment is the assigned intervention.	ERR-14 ERR treatment duration - 14 Day Standard of care IV antibiotic(s) will be selected by the treating physician. Duration of treatment is the assigned intervention. Standard of care IV antibiotic(s): IV antibiotics will be selected by the treating physician following standard of care. Duration of treatment is the assigned intervention.	NERR-14 NERR treatment duration - 14 Day Standard of care IV antibiotic(s) will be selected by the treating physician. Duration of treatment is the assigned intervention. Standard of care IV antibiotic(s): IV antibiotics will be selected by the treating physician following standard of care. Duration of treatment is the assigned intervention.	NERR-21 NERR treatment duration - 21 Day Standard of care IV antibiotic(s) will be selected by the treating physician. Duration of treatment is the assigned intervention. Standard of care IV antibiotic(s): IV antibiotics will be selected by the treating physician following standard of care. Duration of treatment is the assigned intervention.
Overall Study STARTED	140	137	353	352
Overall Study COMPLETED	134	130	336	323
Overall Study NOT COMPLETED	6	7	17	29

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Standardized Treatment of Pulmonary Exacerbations II

Baseline characteristics by cohort

Measure	ERR-10 n=107 Participants ERR treatment duration - 10 Day Standard of care IV antibiotic(s) will be selected by the treating physician. Duration of treatment is the assigned intervention. Standard of care IV antibiotic(s): IV antibiotics will be selected by the treating physician following standard of care. Duration of treatment is the assigned intervention.	ERR-14 n=107 Participants ERR treatment duration - 14 Day Standard of care IV antibiotic(s) will be selected by the treating physician. Duration of treatment is the assigned intervention. Standard of care IV antibiotic(s): IV antibiotics will be selected by the treating physician following standard of care. Duration of treatment is the assigned intervention.	NERR-14 n=353 Participants NERR treatment duration - 14 Day Standard of care IV antibiotic(s) will be selected by the treating physician. Duration of treatment is the assigned intervention. Standard of care IV antibiotic(s): IV antibiotics will be selected by the treating physician following standard of care. Duration of treatment is the assigned intervention.	NERR-21 n=352 Participants NERR treatment duration - 21 Day Standard of care IV antibiotic(s) will be selected by the treating physician. Duration of treatment is the assigned intervention. Standard of care IV antibiotic(s): IV antibiotics will be selected by the treating physician following standard of care. Duration of treatment is the assigned intervention.	Total n=919 Participants Total of all reporting groups
Age, Continuous	26.6 years STANDARD_DEVIATION 6.34 • n=5 Participants	27.1 years STANDARD_DEVIATION 8.89 • n=7 Participants	31.8 years STANDARD_DEVIATION 10.52 • n=5 Participants	31.5 years STANDARD_DEVIATION 9.63 • n=4 Participants	30.6 years STANDARD_DEVIATION 9.79 • n=21 Participants
Sex: Female, Male Female	46 Participants n=5 Participants	53 Participants n=7 Participants	192 Participants n=5 Participants	171 Participants n=4 Participants	462 Participants n=21 Participants
Sex: Female, Male Male	61 Participants n=5 Participants	54 Participants n=7 Participants	161 Participants n=5 Participants	181 Participants n=4 Participants	457 Participants n=21 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	8 Participants n=5 Participants	9 Participants n=7 Participants	26 Participants n=5 Participants	20 Participants n=4 Participants	63 Participants n=21 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	99 Participants n=5 Participants	98 Participants n=7 Participants	327 Participants n=5 Participants	332 Participants n=4 Participants	856 Participants n=21 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	3 Participants n=5 Participants	1 Participants n=4 Participants	4 Participants n=21 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	2 Participants n=4 Participants	3 Participants n=21 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Race (NIH/OMB) Black or African American	5 Participants n=5 Participants	3 Participants n=7 Participants	7 Participants n=5 Participants	17 Participants n=4 Participants	32 Participants n=21 Participants
Race (NIH/OMB) White	98 Participants n=5 Participants	100 Participants n=7 Participants	335 Participants n=5 Participants	322 Participants n=4 Participants	855 Participants n=21 Participants
Race (NIH/OMB) More than one race	2 Participants n=5 Participants	2 Participants n=7 Participants	5 Participants n=5 Participants	4 Participants n=4 Participants	13 Participants n=21 Participants
Race (NIH/OMB) Unknown or Not Reported	2 Participants n=5 Participants	2 Participants n=7 Participants	2 Participants n=5 Participants	6 Participants n=4 Participants	12 Participants n=21 Participants
Cystic Fibrosis (CF) Genotype Delta F508 Homozygous	46 Participants n=5 Participants	55 Participants n=7 Participants	171 Participants n=5 Participants	174 Participants n=4 Participants	446 Participants n=21 Participants
Cystic Fibrosis (CF) Genotype Delta F508 Heterozygous	45 Participants n=5 Participants	40 Participants n=7 Participants	127 Participants n=5 Participants	135 Participants n=4 Participants	347 Participants n=21 Participants
Cystic Fibrosis (CF) Genotype Other/Unknown	16 Participants n=5 Participants	12 Participants n=7 Participants	55 Participants n=5 Participants	43 Participants n=4 Participants	126 Participants n=21 Participants
Forced Expiratory Volume in 1 second (FEV1)	1.9 liters STANDARD_DEVIATION 0.80 • n=5 Participants	1.8 liters STANDARD_DEVIATION 0.83 • n=7 Participants	1.8 liters STANDARD_DEVIATION 0.83 • n=5 Participants	1.8 liters STANDARD_DEVIATION 0.76 • n=4 Participants	1.8 liters STANDARD_DEVIATION 0.80 • n=21 Participants
FEV1 (% Predicted) Distribution <50%	60 Participants n=5 Participants	61 Participants n=7 Participants	192 Participants n=5 Participants	194 Participants n=4 Participants	507 Participants n=21 Participants
FEV1 (% Predicted) Distribution >=50%	47 Participants n=5 Participants	46 Participants n=7 Participants	161 Participants n=5 Participants	158 Participants n=4 Participants	412 Participants n=21 Participants
History of PEx in last year 0 - 1	43 Participants n=5 Participants	45 Participants n=7 Participants	145 Participants n=5 Participants	144 Participants n=4 Participants	377 Participants n=21 Participants
History of PEx in last year >=2	64 Participants n=5 Participants	62 Participants n=7 Participants	208 Participants n=5 Participants	208 Participants n=4 Participants	542 Participants n=21 Participants
IV Antibiotic Treatment Location Prior to Randomization Any Nights in Hospital	92 Participants n=5 Participants	90 Participants n=7 Participants	265 Participants n=5 Participants	266 Participants n=4 Participants	713 Participants n=21 Participants
IV Antibiotic Treatment Location Prior to Randomization All at Home	15 Participants n=5 Participants	17 Participants n=7 Participants	88 Participants n=5 Participants	86 Participants n=4 Participants	206 Participants n=21 Participants
Systemic Corticosteroid Use Yes	13 Participants n=5 Participants	10 Participants n=7 Participants	23 Participants n=5 Participants	41 Participants n=4 Participants	87 Participants n=21 Participants
Systemic Corticosteroid Use No	94 Participants n=5 Participants	97 Participants n=7 Participants	330 Participants n=5 Participants	311 Participants n=4 Participants	832 Participants n=21 Participants

PRIMARY outcome

Timeframe: Start of IV antibiotic treatment to 14 days after the end of IV antibiotic treatment

Population: Includes only participants within the ERR treatment group and per-protocol population, with FEV1 measurements at baseline and last study visit.

Absolute change in FEV1 % predicted from baseline/visit 1 (start of IV antibiotic treatment) to last study visit/visit 3 (14 days after the end of IV antibiotic treatment).

Outcome measures

Measure	ERR-10 n=107 Participants ERR treatment duration - 10 Day Standard of care IV antibiotic(s) will be selected by the treating physician. Duration of treatment is the assigned intervention. Standard of care IV antibiotic(s): IV antibiotics will be selected by the treating physician following standard of care. Duration of treatment is the assigned intervention.	ERR-14 n=107 Participants ERR treatment duration - 14 Day Standard of care IV antibiotic(s) will be selected by the treating physician. Duration of treatment is the assigned intervention. Standard of care IV antibiotic(s): IV antibiotics will be selected by the treating physician following standard of care. Duration of treatment is the assigned intervention.
Absolute Change in FEV1 % Predicted From Visit 1 to Visit 3 Between ERR-10 Day and ERR-14 Day	13.30 percentage change Standard Deviation 9.65	13.83 percentage change Standard Deviation 9.94

PRIMARY outcome

Timeframe: Start of IV antibiotic treatment to14 days after the end of IV antibiotic treatment

Population: Includes only participants within the NERR treatment group and intent-to-treat population, with FEV1 measurements at baseline and last study visit.

Absolute change in FEV1 % predicted from baseline/visit 1 (start of IV antibiotic treatment) to last study visit/visit 3 (14 days after the end of IV antibiotic treatment).

Outcome measures

Measure	ERR-10 n=331 Participants ERR treatment duration - 10 Day Standard of care IV antibiotic(s) will be selected by the treating physician. Duration of treatment is the assigned intervention. Standard of care IV antibiotic(s): IV antibiotics will be selected by the treating physician following standard of care. Duration of treatment is the assigned intervention.	ERR-14 n=322 Participants ERR treatment duration - 14 Day Standard of care IV antibiotic(s) will be selected by the treating physician. Duration of treatment is the assigned intervention. Standard of care IV antibiotic(s): IV antibiotics will be selected by the treating physician following standard of care. Duration of treatment is the assigned intervention.
Absolute Change in FEV1 % Predicted From Visit 1 to Visit 3 Between NERR-14 Day and NERR-21	3.60 percentage change Standard Deviation 8.22	3.53 percentage change Standard Deviation 7.13

SECONDARY outcome

Timeframe: Start of IV antibiotic treatment to14 days after the end of IV antibiotic treatment

Population: Includes only participants within the ERR treatment group and per-protocol (PP) population, with CRISS measurements at baseline and last study visit.

Absolute change in respiratory symptoms, as measured by the the Cystic Fibrosis Respiratory Symptoms Diary-Chronic Respiratory Infection Symptom Severity Score (CFRSD-CRISS), from baseline/visit 1 (start of IV antibiotic treatment) to last study visit/visit 3 (14 days after the end of IV antibiotic treatment). The Diary asks a participant to state the extent of their 8 respiratory symptoms: difficulty breathing, feverishness, tiredness, chills or sweats, coughing, coughing up mucus, tightness in the chest and wheezing. Each respiratory symptom is assigned a score from 0-4 based on the response, with zero corresponding to the absence of the symptom and four corresponding to symptom being present 'a great deal' or 'extremely'. A summed score (range from 0-24) is calculated for each participant and converted to a final score with a range of 0 to 100, where the lowest scores indicate improvement of symptoms.

Outcome measures

Measure	ERR-10 n=106 Participants ERR treatment duration - 10 Day Standard of care IV antibiotic(s) will be selected by the treating physician. Duration of treatment is the assigned intervention. Standard of care IV antibiotic(s): IV antibiotics will be selected by the treating physician following standard of care. Duration of treatment is the assigned intervention.	ERR-14 n=107 Participants ERR treatment duration - 14 Day Standard of care IV antibiotic(s) will be selected by the treating physician. Duration of treatment is the assigned intervention. Standard of care IV antibiotic(s): IV antibiotics will be selected by the treating physician following standard of care. Duration of treatment is the assigned intervention.
Change in CRISS From Visit 1 to Visit 3 Between ERR-10 Day and ERR-14 Day	-24.2 score on a scale Standard Deviation 13.21	-25.3 score on a scale Standard Deviation 12.89

SECONDARY outcome

Timeframe: Start of IV antibiotic treatment to14 days after the end of IV antibiotic treatment

Population: Includes only participants within the NERR treatment group and intent-to-treat (ITT) population, with CRISS measurements at baseline and last study visit.

Absolute change in respiratory symptoms, as measured by the the Cystic Fibrosis Respiratory Symptoms Diary-Chronic Respiratory Infection Symptom Severity Score (CFRSD-CRISS), from baseline/visit 1 (start of IV antibiotic treatment) to last study visit/visit 3 (14 days after the end of IV antibiotic treatment). The Diary asks a participant to state the extent of their 8 respiratory symptoms: difficulty breathing, feverishness, tiredness, chills or sweats, coughing, coughing up mucus, tightness in the chest and wheezing. Each respiratory symptom is assigned a score from 0-4 based on the response, with zero corresponding to the absence of the symptom and four corresponding to symptom being present 'a great deal' or 'extremely'. A summed score (range from 0-24) is calculated for each participant and converted to a final score with a range of 0 to 100, where the lowest scores indicate improvement of symptoms.

Outcome measures

Measure	ERR-10 n=335 Participants ERR treatment duration - 10 Day Standard of care IV antibiotic(s) will be selected by the treating physician. Duration of treatment is the assigned intervention. Standard of care IV antibiotic(s): IV antibiotics will be selected by the treating physician following standard of care. Duration of treatment is the assigned intervention.	ERR-14 n=322 Participants ERR treatment duration - 14 Day Standard of care IV antibiotic(s) will be selected by the treating physician. Duration of treatment is the assigned intervention. Standard of care IV antibiotic(s): IV antibiotics will be selected by the treating physician following standard of care. Duration of treatment is the assigned intervention.
Change in CRISS From Visit 1 to Visit 3 Between NERR-14 Day and NERR-21 Day	-15.1 score on a scale Standard Deviation 13.74	-16.7 score on a scale Standard Deviation 14.15

SECONDARY outcome

Timeframe: Start of IV antibiotic treatment to14 days after the end of IV antibiotic treatment

Population: Includes only participants within the ERR treatment group and per-protocol (PP) population, with weight measurements at baseline and last study visit.

Absolute change in weight (kg) from baseline/visit 1 (start of IV antibiotic treatment) to last study visit/visit 3 (14 days after the end of IV antibiotic treatment).

Outcome measures

Measure	ERR-10 n=107 Participants ERR treatment duration - 10 Day Standard of care IV antibiotic(s) will be selected by the treating physician. Duration of treatment is the assigned intervention. Standard of care IV antibiotic(s): IV antibiotics will be selected by the treating physician following standard of care. Duration of treatment is the assigned intervention.	ERR-14 n=106 Participants ERR treatment duration - 14 Day Standard of care IV antibiotic(s) will be selected by the treating physician. Duration of treatment is the assigned intervention. Standard of care IV antibiotic(s): IV antibiotics will be selected by the treating physician following standard of care. Duration of treatment is the assigned intervention.
Change in Weight From Visit 1 to Visit 3 Between ERR-10 Day and ERR-14 Day	1.7 kg Standard Deviation 2.18	1.5 kg Standard Deviation 2.21

SECONDARY outcome

Timeframe: Start of IV antibiotic treatment to14 days after the end of IV antibiotic treatment

Population: Includes only participants within the NERR treatment group and intent-to-treat (ITT) population, with weight measurements at baseline and last study visit.

Absolute change in weight (kg) from baseline/visit 1 (start of IV antibiotic treatment) to last study visit/visit 3 (14 days after the end of IV antibiotic treatment).

Outcome measures

Measure	ERR-10 n=333 Participants ERR treatment duration - 10 Day Standard of care IV antibiotic(s) will be selected by the treating physician. Duration of treatment is the assigned intervention. Standard of care IV antibiotic(s): IV antibiotics will be selected by the treating physician following standard of care. Duration of treatment is the assigned intervention.	ERR-14 n=320 Participants ERR treatment duration - 14 Day Standard of care IV antibiotic(s) will be selected by the treating physician. Duration of treatment is the assigned intervention. Standard of care IV antibiotic(s): IV antibiotics will be selected by the treating physician following standard of care. Duration of treatment is the assigned intervention.
Change in Weight From Visit 1 to Visit 3 Between NERR-14 Day and NERR-21 Day	0.5 kg Standard Deviation 2.16	0.8 kg Standard Deviation 2.07

Adverse Events

ERR-10

Serious events: 4 serious events

Other events: 8 other events

Deaths: 0 deaths

ERR-14

Serious events: 1 serious events

Other events: 4 other events

Deaths: 0 deaths

NERR-14

Serious events: 19 serious events

Other events: 4 other events

Deaths: 0 deaths

NERR-21

Serious events: 19 serious events

Other events: 4 other events

Deaths: 0 deaths

Serious adverse events

Measure	ERR-10 n=140 participants at risk ERR treatment duration - 10 Day Standard of care IV antibiotic(s) will be selected by the treating physician. Duration of treatment is the assigned intervention. Standard of care IV antibiotic(s): IV antibiotics will be selected by the treating physician following standard of care. Duration of treatment is the assigned intervention.	ERR-14 n=137 participants at risk ERR treatment duration - 14 Day Standard of care IV antibiotic(s) will be selected by the treating physician. Duration of treatment is the assigned intervention. Standard of care IV antibiotic(s): IV antibiotics will be selected by the treating physician following standard of care. Duration of treatment is the assigned intervention.	NERR-14 n=353 participants at risk NERR treatment duration - 14 Day Standard of care IV antibiotic(s) will be selected by the treating physician. Duration of treatment is the assigned intervention. Standard of care IV antibiotic(s): IV antibiotics will be selected by the treating physician following standard of care. Duration of treatment is the assigned intervention.	NERR-21 n=352 participants at risk NERR treatment duration - 21 Day Standard of care IV antibiotic(s) will be selected by the treating physician. Duration of treatment is the assigned intervention. Standard of care IV antibiotic(s): IV antibiotics will be selected by the treating physician following standard of care. Duration of treatment is the assigned intervention.
Infections and infestations Pneumonia	0.00% 0/140 • For Serious Adverse Events (SAEs): Informed consent to final study visit (14 days after the end of IV antibiotic treatment). For all Other (Not Including Serious) AEs: Randomization to final study visit. Final study visit is Day 25 for ERR-10 arm, Day 29 for ERR-14 arm and NERR-14 arm, and Day 36 for NERR-21 arm.	0.00% 0/137 • For Serious Adverse Events (SAEs): Informed consent to final study visit (14 days after the end of IV antibiotic treatment). For all Other (Not Including Serious) AEs: Randomization to final study visit. Final study visit is Day 25 for ERR-10 arm, Day 29 for ERR-14 arm and NERR-14 arm, and Day 36 for NERR-21 arm.	0.00% 0/353 • For Serious Adverse Events (SAEs): Informed consent to final study visit (14 days after the end of IV antibiotic treatment). For all Other (Not Including Serious) AEs: Randomization to final study visit. Final study visit is Day 25 for ERR-10 arm, Day 29 for ERR-14 arm and NERR-14 arm, and Day 36 for NERR-21 arm.	0.28% 1/352 • Number of events 1 • For Serious Adverse Events (SAEs): Informed consent to final study visit (14 days after the end of IV antibiotic treatment). For all Other (Not Including Serious) AEs: Randomization to final study visit. Final study visit is Day 25 for ERR-10 arm, Day 29 for ERR-14 arm and NERR-14 arm, and Day 36 for NERR-21 arm.
Infections and infestations Infective pulmonary exacerbation of cystic fibrosis	0.71% 1/140 • Number of events 1 • For Serious Adverse Events (SAEs): Informed consent to final study visit (14 days after the end of IV antibiotic treatment). For all Other (Not Including Serious) AEs: Randomization to final study visit. Final study visit is Day 25 for ERR-10 arm, Day 29 for ERR-14 arm and NERR-14 arm, and Day 36 for NERR-21 arm.	0.73% 1/137 • Number of events 1 • For Serious Adverse Events (SAEs): Informed consent to final study visit (14 days after the end of IV antibiotic treatment). For all Other (Not Including Serious) AEs: Randomization to final study visit. Final study visit is Day 25 for ERR-10 arm, Day 29 for ERR-14 arm and NERR-14 arm, and Day 36 for NERR-21 arm.	2.5% 9/353 • Number of events 9 • For Serious Adverse Events (SAEs): Informed consent to final study visit (14 days after the end of IV antibiotic treatment). For all Other (Not Including Serious) AEs: Randomization to final study visit. Final study visit is Day 25 for ERR-10 arm, Day 29 for ERR-14 arm and NERR-14 arm, and Day 36 for NERR-21 arm.	2.6% 9/352 • Number of events 10 • For Serious Adverse Events (SAEs): Informed consent to final study visit (14 days after the end of IV antibiotic treatment). For all Other (Not Including Serious) AEs: Randomization to final study visit. Final study visit is Day 25 for ERR-10 arm, Day 29 for ERR-14 arm and NERR-14 arm, and Day 36 for NERR-21 arm.
Infections and infestations Influenza	0.00% 0/140 • For Serious Adverse Events (SAEs): Informed consent to final study visit (14 days after the end of IV antibiotic treatment). For all Other (Not Including Serious) AEs: Randomization to final study visit. Final study visit is Day 25 for ERR-10 arm, Day 29 for ERR-14 arm and NERR-14 arm, and Day 36 for NERR-21 arm.	0.00% 0/137 • For Serious Adverse Events (SAEs): Informed consent to final study visit (14 days after the end of IV antibiotic treatment). For all Other (Not Including Serious) AEs: Randomization to final study visit. Final study visit is Day 25 for ERR-10 arm, Day 29 for ERR-14 arm and NERR-14 arm, and Day 36 for NERR-21 arm.	0.00% 0/353 • For Serious Adverse Events (SAEs): Informed consent to final study visit (14 days after the end of IV antibiotic treatment). For all Other (Not Including Serious) AEs: Randomization to final study visit. Final study visit is Day 25 for ERR-10 arm, Day 29 for ERR-14 arm and NERR-14 arm, and Day 36 for NERR-21 arm.	0.28% 1/352 • Number of events 1 • For Serious Adverse Events (SAEs): Informed consent to final study visit (14 days after the end of IV antibiotic treatment). For all Other (Not Including Serious) AEs: Randomization to final study visit. Final study visit is Day 25 for ERR-10 arm, Day 29 for ERR-14 arm and NERR-14 arm, and Day 36 for NERR-21 arm.
Blood and lymphatic system disorders Haemolytic anaemia	0.00% 0/140 • For Serious Adverse Events (SAEs): Informed consent to final study visit (14 days after the end of IV antibiotic treatment). For all Other (Not Including Serious) AEs: Randomization to final study visit. Final study visit is Day 25 for ERR-10 arm, Day 29 for ERR-14 arm and NERR-14 arm, and Day 36 for NERR-21 arm.	0.00% 0/137 • For Serious Adverse Events (SAEs): Informed consent to final study visit (14 days after the end of IV antibiotic treatment). For all Other (Not Including Serious) AEs: Randomization to final study visit. Final study visit is Day 25 for ERR-10 arm, Day 29 for ERR-14 arm and NERR-14 arm, and Day 36 for NERR-21 arm.	0.28% 1/353 • Number of events 1 • For Serious Adverse Events (SAEs): Informed consent to final study visit (14 days after the end of IV antibiotic treatment). For all Other (Not Including Serious) AEs: Randomization to final study visit. Final study visit is Day 25 for ERR-10 arm, Day 29 for ERR-14 arm and NERR-14 arm, and Day 36 for NERR-21 arm.	0.00% 0/352 • For Serious Adverse Events (SAEs): Informed consent to final study visit (14 days after the end of IV antibiotic treatment). For all Other (Not Including Serious) AEs: Randomization to final study visit. Final study visit is Day 25 for ERR-10 arm, Day 29 for ERR-14 arm and NERR-14 arm, and Day 36 for NERR-21 arm.
Cardiac disorders Palpitations	0.00% 0/140 • For Serious Adverse Events (SAEs): Informed consent to final study visit (14 days after the end of IV antibiotic treatment). For all Other (Not Including Serious) AEs: Randomization to final study visit. Final study visit is Day 25 for ERR-10 arm, Day 29 for ERR-14 arm and NERR-14 arm, and Day 36 for NERR-21 arm.	0.00% 0/137 • For Serious Adverse Events (SAEs): Informed consent to final study visit (14 days after the end of IV antibiotic treatment). For all Other (Not Including Serious) AEs: Randomization to final study visit. Final study visit is Day 25 for ERR-10 arm, Day 29 for ERR-14 arm and NERR-14 arm, and Day 36 for NERR-21 arm.	0.28% 1/353 • Number of events 1 • For Serious Adverse Events (SAEs): Informed consent to final study visit (14 days after the end of IV antibiotic treatment). For all Other (Not Including Serious) AEs: Randomization to final study visit. Final study visit is Day 25 for ERR-10 arm, Day 29 for ERR-14 arm and NERR-14 arm, and Day 36 for NERR-21 arm.	0.00% 0/352 • For Serious Adverse Events (SAEs): Informed consent to final study visit (14 days after the end of IV antibiotic treatment). For all Other (Not Including Serious) AEs: Randomization to final study visit. Final study visit is Day 25 for ERR-10 arm, Day 29 for ERR-14 arm and NERR-14 arm, and Day 36 for NERR-21 arm.
Gastrointestinal disorders Distal intestinal obstruction syndrome	0.71% 1/140 • Number of events 1 • For Serious Adverse Events (SAEs): Informed consent to final study visit (14 days after the end of IV antibiotic treatment). For all Other (Not Including Serious) AEs: Randomization to final study visit. Final study visit is Day 25 for ERR-10 arm, Day 29 for ERR-14 arm and NERR-14 arm, and Day 36 for NERR-21 arm.	0.00% 0/137 • For Serious Adverse Events (SAEs): Informed consent to final study visit (14 days after the end of IV antibiotic treatment). For all Other (Not Including Serious) AEs: Randomization to final study visit. Final study visit is Day 25 for ERR-10 arm, Day 29 for ERR-14 arm and NERR-14 arm, and Day 36 for NERR-21 arm.	0.00% 0/353 • For Serious Adverse Events (SAEs): Informed consent to final study visit (14 days after the end of IV antibiotic treatment). For all Other (Not Including Serious) AEs: Randomization to final study visit. Final study visit is Day 25 for ERR-10 arm, Day 29 for ERR-14 arm and NERR-14 arm, and Day 36 for NERR-21 arm.	0.28% 1/352 • Number of events 1 • For Serious Adverse Events (SAEs): Informed consent to final study visit (14 days after the end of IV antibiotic treatment). For all Other (Not Including Serious) AEs: Randomization to final study visit. Final study visit is Day 25 for ERR-10 arm, Day 29 for ERR-14 arm and NERR-14 arm, and Day 36 for NERR-21 arm.
Gastrointestinal disorders Gastrointestinal haemorrhage	0.00% 0/140 • For Serious Adverse Events (SAEs): Informed consent to final study visit (14 days after the end of IV antibiotic treatment). For all Other (Not Including Serious) AEs: Randomization to final study visit. Final study visit is Day 25 for ERR-10 arm, Day 29 for ERR-14 arm and NERR-14 arm, and Day 36 for NERR-21 arm.	0.00% 0/137 • For Serious Adverse Events (SAEs): Informed consent to final study visit (14 days after the end of IV antibiotic treatment). For all Other (Not Including Serious) AEs: Randomization to final study visit. Final study visit is Day 25 for ERR-10 arm, Day 29 for ERR-14 arm and NERR-14 arm, and Day 36 for NERR-21 arm.	0.28% 1/353 • Number of events 1 • For Serious Adverse Events (SAEs): Informed consent to final study visit (14 days after the end of IV antibiotic treatment). For all Other (Not Including Serious) AEs: Randomization to final study visit. Final study visit is Day 25 for ERR-10 arm, Day 29 for ERR-14 arm and NERR-14 arm, and Day 36 for NERR-21 arm.	0.00% 0/352 • For Serious Adverse Events (SAEs): Informed consent to final study visit (14 days after the end of IV antibiotic treatment). For all Other (Not Including Serious) AEs: Randomization to final study visit. Final study visit is Day 25 for ERR-10 arm, Day 29 for ERR-14 arm and NERR-14 arm, and Day 36 for NERR-21 arm.
Gastrointestinal disorders Small intestinal obstruction	0.00% 0/140 • For Serious Adverse Events (SAEs): Informed consent to final study visit (14 days after the end of IV antibiotic treatment). For all Other (Not Including Serious) AEs: Randomization to final study visit. Final study visit is Day 25 for ERR-10 arm, Day 29 for ERR-14 arm and NERR-14 arm, and Day 36 for NERR-21 arm.	0.00% 0/137 • For Serious Adverse Events (SAEs): Informed consent to final study visit (14 days after the end of IV antibiotic treatment). For all Other (Not Including Serious) AEs: Randomization to final study visit. Final study visit is Day 25 for ERR-10 arm, Day 29 for ERR-14 arm and NERR-14 arm, and Day 36 for NERR-21 arm.	0.00% 0/353 • For Serious Adverse Events (SAEs): Informed consent to final study visit (14 days after the end of IV antibiotic treatment). For all Other (Not Including Serious) AEs: Randomization to final study visit. Final study visit is Day 25 for ERR-10 arm, Day 29 for ERR-14 arm and NERR-14 arm, and Day 36 for NERR-21 arm.	0.28% 1/352 • Number of events 1 • For Serious Adverse Events (SAEs): Informed consent to final study visit (14 days after the end of IV antibiotic treatment). For all Other (Not Including Serious) AEs: Randomization to final study visit. Final study visit is Day 25 for ERR-10 arm, Day 29 for ERR-14 arm and NERR-14 arm, and Day 36 for NERR-21 arm.
General disorders Fatigue	0.00% 0/140 • For Serious Adverse Events (SAEs): Informed consent to final study visit (14 days after the end of IV antibiotic treatment). For all Other (Not Including Serious) AEs: Randomization to final study visit. Final study visit is Day 25 for ERR-10 arm, Day 29 for ERR-14 arm and NERR-14 arm, and Day 36 for NERR-21 arm.	0.00% 0/137 • For Serious Adverse Events (SAEs): Informed consent to final study visit (14 days after the end of IV antibiotic treatment). For all Other (Not Including Serious) AEs: Randomization to final study visit. Final study visit is Day 25 for ERR-10 arm, Day 29 for ERR-14 arm and NERR-14 arm, and Day 36 for NERR-21 arm.	0.28% 1/353 • Number of events 1 • For Serious Adverse Events (SAEs): Informed consent to final study visit (14 days after the end of IV antibiotic treatment). For all Other (Not Including Serious) AEs: Randomization to final study visit. Final study visit is Day 25 for ERR-10 arm, Day 29 for ERR-14 arm and NERR-14 arm, and Day 36 for NERR-21 arm.	0.00% 0/352 • For Serious Adverse Events (SAEs): Informed consent to final study visit (14 days after the end of IV antibiotic treatment). For all Other (Not Including Serious) AEs: Randomization to final study visit. Final study visit is Day 25 for ERR-10 arm, Day 29 for ERR-14 arm and NERR-14 arm, and Day 36 for NERR-21 arm.
General disorders Pyrexia	0.00% 0/140 • For Serious Adverse Events (SAEs): Informed consent to final study visit (14 days after the end of IV antibiotic treatment). For all Other (Not Including Serious) AEs: Randomization to final study visit. Final study visit is Day 25 for ERR-10 arm, Day 29 for ERR-14 arm and NERR-14 arm, and Day 36 for NERR-21 arm.	0.00% 0/137 • For Serious Adverse Events (SAEs): Informed consent to final study visit (14 days after the end of IV antibiotic treatment). For all Other (Not Including Serious) AEs: Randomization to final study visit. Final study visit is Day 25 for ERR-10 arm, Day 29 for ERR-14 arm and NERR-14 arm, and Day 36 for NERR-21 arm.	0.00% 0/353 • For Serious Adverse Events (SAEs): Informed consent to final study visit (14 days after the end of IV antibiotic treatment). For all Other (Not Including Serious) AEs: Randomization to final study visit. Final study visit is Day 25 for ERR-10 arm, Day 29 for ERR-14 arm and NERR-14 arm, and Day 36 for NERR-21 arm.	0.57% 2/352 • Number of events 2 • For Serious Adverse Events (SAEs): Informed consent to final study visit (14 days after the end of IV antibiotic treatment). For all Other (Not Including Serious) AEs: Randomization to final study visit. Final study visit is Day 25 for ERR-10 arm, Day 29 for ERR-14 arm and NERR-14 arm, and Day 36 for NERR-21 arm.
Infections and infestations Appendicitis	0.00% 0/140 • For Serious Adverse Events (SAEs): Informed consent to final study visit (14 days after the end of IV antibiotic treatment). For all Other (Not Including Serious) AEs: Randomization to final study visit. Final study visit is Day 25 for ERR-10 arm, Day 29 for ERR-14 arm and NERR-14 arm, and Day 36 for NERR-21 arm.	0.00% 0/137 • For Serious Adverse Events (SAEs): Informed consent to final study visit (14 days after the end of IV antibiotic treatment). For all Other (Not Including Serious) AEs: Randomization to final study visit. Final study visit is Day 25 for ERR-10 arm, Day 29 for ERR-14 arm and NERR-14 arm, and Day 36 for NERR-21 arm.	0.28% 1/353 • Number of events 1 • For Serious Adverse Events (SAEs): Informed consent to final study visit (14 days after the end of IV antibiotic treatment). For all Other (Not Including Serious) AEs: Randomization to final study visit. Final study visit is Day 25 for ERR-10 arm, Day 29 for ERR-14 arm and NERR-14 arm, and Day 36 for NERR-21 arm.	0.28% 1/352 • Number of events 1 • For Serious Adverse Events (SAEs): Informed consent to final study visit (14 days after the end of IV antibiotic treatment). For all Other (Not Including Serious) AEs: Randomization to final study visit. Final study visit is Day 25 for ERR-10 arm, Day 29 for ERR-14 arm and NERR-14 arm, and Day 36 for NERR-21 arm.
Infections and infestations Gastrointestinal viral infection	0.00% 0/140 • For Serious Adverse Events (SAEs): Informed consent to final study visit (14 days after the end of IV antibiotic treatment). For all Other (Not Including Serious) AEs: Randomization to final study visit. Final study visit is Day 25 for ERR-10 arm, Day 29 for ERR-14 arm and NERR-14 arm, and Day 36 for NERR-21 arm.	0.00% 0/137 • For Serious Adverse Events (SAEs): Informed consent to final study visit (14 days after the end of IV antibiotic treatment). For all Other (Not Including Serious) AEs: Randomization to final study visit. Final study visit is Day 25 for ERR-10 arm, Day 29 for ERR-14 arm and NERR-14 arm, and Day 36 for NERR-21 arm.	0.00% 0/353 • For Serious Adverse Events (SAEs): Informed consent to final study visit (14 days after the end of IV antibiotic treatment). For all Other (Not Including Serious) AEs: Randomization to final study visit. Final study visit is Day 25 for ERR-10 arm, Day 29 for ERR-14 arm and NERR-14 arm, and Day 36 for NERR-21 arm.	0.28% 1/352 • Number of events 1 • For Serious Adverse Events (SAEs): Informed consent to final study visit (14 days after the end of IV antibiotic treatment). For all Other (Not Including Serious) AEs: Randomization to final study visit. Final study visit is Day 25 for ERR-10 arm, Day 29 for ERR-14 arm and NERR-14 arm, and Day 36 for NERR-21 arm.
Musculoskeletal and connective tissue disorders Back pain	0.00% 0/140 • For Serious Adverse Events (SAEs): Informed consent to final study visit (14 days after the end of IV antibiotic treatment). For all Other (Not Including Serious) AEs: Randomization to final study visit. Final study visit is Day 25 for ERR-10 arm, Day 29 for ERR-14 arm and NERR-14 arm, and Day 36 for NERR-21 arm.	0.00% 0/137 • For Serious Adverse Events (SAEs): Informed consent to final study visit (14 days after the end of IV antibiotic treatment). For all Other (Not Including Serious) AEs: Randomization to final study visit. Final study visit is Day 25 for ERR-10 arm, Day 29 for ERR-14 arm and NERR-14 arm, and Day 36 for NERR-21 arm.	0.00% 0/353 • For Serious Adverse Events (SAEs): Informed consent to final study visit (14 days after the end of IV antibiotic treatment). For all Other (Not Including Serious) AEs: Randomization to final study visit. Final study visit is Day 25 for ERR-10 arm, Day 29 for ERR-14 arm and NERR-14 arm, and Day 36 for NERR-21 arm.	0.28% 1/352 • Number of events 1 • For Serious Adverse Events (SAEs): Informed consent to final study visit (14 days after the end of IV antibiotic treatment). For all Other (Not Including Serious) AEs: Randomization to final study visit. Final study visit is Day 25 for ERR-10 arm, Day 29 for ERR-14 arm and NERR-14 arm, and Day 36 for NERR-21 arm.
Nervous system disorders Cerebrovascular accident	0.00% 0/140 • For Serious Adverse Events (SAEs): Informed consent to final study visit (14 days after the end of IV antibiotic treatment). For all Other (Not Including Serious) AEs: Randomization to final study visit. Final study visit is Day 25 for ERR-10 arm, Day 29 for ERR-14 arm and NERR-14 arm, and Day 36 for NERR-21 arm.	0.00% 0/137 • For Serious Adverse Events (SAEs): Informed consent to final study visit (14 days after the end of IV antibiotic treatment). For all Other (Not Including Serious) AEs: Randomization to final study visit. Final study visit is Day 25 for ERR-10 arm, Day 29 for ERR-14 arm and NERR-14 arm, and Day 36 for NERR-21 arm.	0.28% 1/353 • Number of events 1 • For Serious Adverse Events (SAEs): Informed consent to final study visit (14 days after the end of IV antibiotic treatment). For all Other (Not Including Serious) AEs: Randomization to final study visit. Final study visit is Day 25 for ERR-10 arm, Day 29 for ERR-14 arm and NERR-14 arm, and Day 36 for NERR-21 arm.	0.00% 0/352 • For Serious Adverse Events (SAEs): Informed consent to final study visit (14 days after the end of IV antibiotic treatment). For all Other (Not Including Serious) AEs: Randomization to final study visit. Final study visit is Day 25 for ERR-10 arm, Day 29 for ERR-14 arm and NERR-14 arm, and Day 36 for NERR-21 arm.
Psychiatric disorders Panic attack	0.00% 0/140 • For Serious Adverse Events (SAEs): Informed consent to final study visit (14 days after the end of IV antibiotic treatment). For all Other (Not Including Serious) AEs: Randomization to final study visit. Final study visit is Day 25 for ERR-10 arm, Day 29 for ERR-14 arm and NERR-14 arm, and Day 36 for NERR-21 arm.	0.00% 0/137 • For Serious Adverse Events (SAEs): Informed consent to final study visit (14 days after the end of IV antibiotic treatment). For all Other (Not Including Serious) AEs: Randomization to final study visit. Final study visit is Day 25 for ERR-10 arm, Day 29 for ERR-14 arm and NERR-14 arm, and Day 36 for NERR-21 arm.	0.00% 0/353 • For Serious Adverse Events (SAEs): Informed consent to final study visit (14 days after the end of IV antibiotic treatment). For all Other (Not Including Serious) AEs: Randomization to final study visit. Final study visit is Day 25 for ERR-10 arm, Day 29 for ERR-14 arm and NERR-14 arm, and Day 36 for NERR-21 arm.	0.28% 1/352 • Number of events 1 • For Serious Adverse Events (SAEs): Informed consent to final study visit (14 days after the end of IV antibiotic treatment). For all Other (Not Including Serious) AEs: Randomization to final study visit. Final study visit is Day 25 for ERR-10 arm, Day 29 for ERR-14 arm and NERR-14 arm, and Day 36 for NERR-21 arm.
Renal and urinary disorders Acute kidney injury	0.00% 0/140 • For Serious Adverse Events (SAEs): Informed consent to final study visit (14 days after the end of IV antibiotic treatment). For all Other (Not Including Serious) AEs: Randomization to final study visit. Final study visit is Day 25 for ERR-10 arm, Day 29 for ERR-14 arm and NERR-14 arm, and Day 36 for NERR-21 arm.	0.00% 0/137 • For Serious Adverse Events (SAEs): Informed consent to final study visit (14 days after the end of IV antibiotic treatment). For all Other (Not Including Serious) AEs: Randomization to final study visit. Final study visit is Day 25 for ERR-10 arm, Day 29 for ERR-14 arm and NERR-14 arm, and Day 36 for NERR-21 arm.	0.57% 2/353 • Number of events 2 • For Serious Adverse Events (SAEs): Informed consent to final study visit (14 days after the end of IV antibiotic treatment). For all Other (Not Including Serious) AEs: Randomization to final study visit. Final study visit is Day 25 for ERR-10 arm, Day 29 for ERR-14 arm and NERR-14 arm, and Day 36 for NERR-21 arm.	0.85% 3/352 • Number of events 3 • For Serious Adverse Events (SAEs): Informed consent to final study visit (14 days after the end of IV antibiotic treatment). For all Other (Not Including Serious) AEs: Randomization to final study visit. Final study visit is Day 25 for ERR-10 arm, Day 29 for ERR-14 arm and NERR-14 arm, and Day 36 for NERR-21 arm.
Renal and urinary disorders Nephrolithiasis	0.71% 1/140 • Number of events 1 • For Serious Adverse Events (SAEs): Informed consent to final study visit (14 days after the end of IV antibiotic treatment). For all Other (Not Including Serious) AEs: Randomization to final study visit. Final study visit is Day 25 for ERR-10 arm, Day 29 for ERR-14 arm and NERR-14 arm, and Day 36 for NERR-21 arm.	0.00% 0/137 • For Serious Adverse Events (SAEs): Informed consent to final study visit (14 days after the end of IV antibiotic treatment). For all Other (Not Including Serious) AEs: Randomization to final study visit. Final study visit is Day 25 for ERR-10 arm, Day 29 for ERR-14 arm and NERR-14 arm, and Day 36 for NERR-21 arm.	0.00% 0/353 • For Serious Adverse Events (SAEs): Informed consent to final study visit (14 days after the end of IV antibiotic treatment). For all Other (Not Including Serious) AEs: Randomization to final study visit. Final study visit is Day 25 for ERR-10 arm, Day 29 for ERR-14 arm and NERR-14 arm, and Day 36 for NERR-21 arm.	0.00% 0/352 • For Serious Adverse Events (SAEs): Informed consent to final study visit (14 days after the end of IV antibiotic treatment). For all Other (Not Including Serious) AEs: Randomization to final study visit. Final study visit is Day 25 for ERR-10 arm, Day 29 for ERR-14 arm and NERR-14 arm, and Day 36 for NERR-21 arm.
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.00% 0/140 • For Serious Adverse Events (SAEs): Informed consent to final study visit (14 days after the end of IV antibiotic treatment). For all Other (Not Including Serious) AEs: Randomization to final study visit. Final study visit is Day 25 for ERR-10 arm, Day 29 for ERR-14 arm and NERR-14 arm, and Day 36 for NERR-21 arm.	0.00% 0/137 • For Serious Adverse Events (SAEs): Informed consent to final study visit (14 days after the end of IV antibiotic treatment). For all Other (Not Including Serious) AEs: Randomization to final study visit. Final study visit is Day 25 for ERR-10 arm, Day 29 for ERR-14 arm and NERR-14 arm, and Day 36 for NERR-21 arm.	0.28% 1/353 • Number of events 1 • For Serious Adverse Events (SAEs): Informed consent to final study visit (14 days after the end of IV antibiotic treatment). For all Other (Not Including Serious) AEs: Randomization to final study visit. Final study visit is Day 25 for ERR-10 arm, Day 29 for ERR-14 arm and NERR-14 arm, and Day 36 for NERR-21 arm.	0.00% 0/352 • For Serious Adverse Events (SAEs): Informed consent to final study visit (14 days after the end of IV antibiotic treatment). For all Other (Not Including Serious) AEs: Randomization to final study visit. Final study visit is Day 25 for ERR-10 arm, Day 29 for ERR-14 arm and NERR-14 arm, and Day 36 for NERR-21 arm.
Respiratory, thoracic and mediastinal disorders Haemoptysis	0.71% 1/140 • Number of events 1 • For Serious Adverse Events (SAEs): Informed consent to final study visit (14 days after the end of IV antibiotic treatment). For all Other (Not Including Serious) AEs: Randomization to final study visit. Final study visit is Day 25 for ERR-10 arm, Day 29 for ERR-14 arm and NERR-14 arm, and Day 36 for NERR-21 arm.	0.00% 0/137 • For Serious Adverse Events (SAEs): Informed consent to final study visit (14 days after the end of IV antibiotic treatment). For all Other (Not Including Serious) AEs: Randomization to final study visit. Final study visit is Day 25 for ERR-10 arm, Day 29 for ERR-14 arm and NERR-14 arm, and Day 36 for NERR-21 arm.	0.85% 3/353 • Number of events 3 • For Serious Adverse Events (SAEs): Informed consent to final study visit (14 days after the end of IV antibiotic treatment). For all Other (Not Including Serious) AEs: Randomization to final study visit. Final study visit is Day 25 for ERR-10 arm, Day 29 for ERR-14 arm and NERR-14 arm, and Day 36 for NERR-21 arm.	0.00% 0/352 • For Serious Adverse Events (SAEs): Informed consent to final study visit (14 days after the end of IV antibiotic treatment). For all Other (Not Including Serious) AEs: Randomization to final study visit. Final study visit is Day 25 for ERR-10 arm, Day 29 for ERR-14 arm and NERR-14 arm, and Day 36 for NERR-21 arm.
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	0.00% 0/140 • For Serious Adverse Events (SAEs): Informed consent to final study visit (14 days after the end of IV antibiotic treatment). For all Other (Not Including Serious) AEs: Randomization to final study visit. Final study visit is Day 25 for ERR-10 arm, Day 29 for ERR-14 arm and NERR-14 arm, and Day 36 for NERR-21 arm.	0.00% 0/137 • For Serious Adverse Events (SAEs): Informed consent to final study visit (14 days after the end of IV antibiotic treatment). For all Other (Not Including Serious) AEs: Randomization to final study visit. Final study visit is Day 25 for ERR-10 arm, Day 29 for ERR-14 arm and NERR-14 arm, and Day 36 for NERR-21 arm.	0.00% 0/353 • For Serious Adverse Events (SAEs): Informed consent to final study visit (14 days after the end of IV antibiotic treatment). For all Other (Not Including Serious) AEs: Randomization to final study visit. Final study visit is Day 25 for ERR-10 arm, Day 29 for ERR-14 arm and NERR-14 arm, and Day 36 for NERR-21 arm.	0.85% 3/352 • Number of events 3 • For Serious Adverse Events (SAEs): Informed consent to final study visit (14 days after the end of IV antibiotic treatment). For all Other (Not Including Serious) AEs: Randomization to final study visit. Final study visit is Day 25 for ERR-10 arm, Day 29 for ERR-14 arm and NERR-14 arm, and Day 36 for NERR-21 arm.

Other adverse events

Measure	ERR-10 n=140 participants at risk ERR treatment duration - 10 Day Standard of care IV antibiotic(s) will be selected by the treating physician. Duration of treatment is the assigned intervention. Standard of care IV antibiotic(s): IV antibiotics will be selected by the treating physician following standard of care. Duration of treatment is the assigned intervention.	ERR-14 n=137 participants at risk ERR treatment duration - 14 Day Standard of care IV antibiotic(s) will be selected by the treating physician. Duration of treatment is the assigned intervention. Standard of care IV antibiotic(s): IV antibiotics will be selected by the treating physician following standard of care. Duration of treatment is the assigned intervention.	NERR-14 n=353 participants at risk NERR treatment duration - 14 Day Standard of care IV antibiotic(s) will be selected by the treating physician. Duration of treatment is the assigned intervention. Standard of care IV antibiotic(s): IV antibiotics will be selected by the treating physician following standard of care. Duration of treatment is the assigned intervention.	NERR-21 n=352 participants at risk NERR treatment duration - 21 Day Standard of care IV antibiotic(s) will be selected by the treating physician. Duration of treatment is the assigned intervention. Standard of care IV antibiotic(s): IV antibiotics will be selected by the treating physician following standard of care. Duration of treatment is the assigned intervention.
Infections and infestations Infective pulmonary exacerbation of cystic fibrosis	5.7% 8/140 • Number of events 8 • For Serious Adverse Events (SAEs): Informed consent to final study visit (14 days after the end of IV antibiotic treatment). For all Other (Not Including Serious) AEs: Randomization to final study visit. Final study visit is Day 25 for ERR-10 arm, Day 29 for ERR-14 arm and NERR-14 arm, and Day 36 for NERR-21 arm.	2.9% 4/137 • Number of events 4 • For Serious Adverse Events (SAEs): Informed consent to final study visit (14 days after the end of IV antibiotic treatment). For all Other (Not Including Serious) AEs: Randomization to final study visit. Final study visit is Day 25 for ERR-10 arm, Day 29 for ERR-14 arm and NERR-14 arm, and Day 36 for NERR-21 arm.	1.1% 4/353 • Number of events 4 • For Serious Adverse Events (SAEs): Informed consent to final study visit (14 days after the end of IV antibiotic treatment). For all Other (Not Including Serious) AEs: Randomization to final study visit. Final study visit is Day 25 for ERR-10 arm, Day 29 for ERR-14 arm and NERR-14 arm, and Day 36 for NERR-21 arm.	1.1% 4/352 • Number of events 4 • For Serious Adverse Events (SAEs): Informed consent to final study visit (14 days after the end of IV antibiotic treatment). For all Other (Not Including Serious) AEs: Randomization to final study visit. Final study visit is Day 25 for ERR-10 arm, Day 29 for ERR-14 arm and NERR-14 arm, and Day 36 for NERR-21 arm.

Additional Information

Michelle Skalland (Biostatistician)

Seattle Children's

Phone: 206-884-7519

Email: michelle.skalland@seattlechildrens.org

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place