Trial Outcomes & Findings for Innate Immunity and Respiratory Syncytial Virus (RSV) Infection in Children (NCT NCT00593918)
NCT ID: NCT00593918
Last Updated: 2015-10-20
Results Overview
IL-2 measured from nasal lavage samples by Luminex multiplex assay
Recruitment status
COMPLETED
Target enrollment
91 participants
Primary outcome timeframe
1-5 days during acute illness (not after day 5 of illness)
Results posted on
2015-10-20
Participant Flow
Study details planned during the first 4 months of the study. Recruitment period began during the RSV seasons from November to May each year from 2003-2008 in medical clinics.
Patients were enrolled if they met the enrollment criteria
Participant milestones
| Measure |
Toll-like Receptor 4 GG Genotype
Toll-like Receptor 4 (TLR4) -2026/GG gentoype hypothesized to be associated with less inflammation during Respiratory syncytial virus (RSV) infection
|
Toll-like Receptor 4 AG/AA Genotypes
Toll-like Receptor 4 (TLR4) -2026/AG and AA control genotypes hypothesized to be associated with more inflammation during Respiratory syncytial virus (RSV) infection
|
|---|---|---|
|
Overall Study
STARTED
|
17
|
74
|
|
Overall Study
COMPLETED
|
12
|
50
|
|
Overall Study
NOT COMPLETED
|
5
|
24
|
Reasons for withdrawal
| Measure |
Toll-like Receptor 4 GG Genotype
Toll-like Receptor 4 (TLR4) -2026/GG gentoype hypothesized to be associated with less inflammation during Respiratory syncytial virus (RSV) infection
|
Toll-like Receptor 4 AG/AA Genotypes
Toll-like Receptor 4 (TLR4) -2026/AG and AA control genotypes hypothesized to be associated with more inflammation during Respiratory syncytial virus (RSV) infection
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
5
|
24
|
Baseline Characteristics
Innate Immunity and Respiratory Syncytial Virus (RSV) Infection in Children
Baseline characteristics by cohort
| Measure |
Toll-like Receptor 4 GG Genotype
n=17 Participants
Toll-like Receptor 4 (TLR4) -2026/GG gentoype hypothesized to be associated with less inflammation during Respiratory syncytial virus (RSV) infection
|
Toll-like Receptor 4 AG/AA Genotypes
n=74 Participants
Toll-like Receptor 4 (TLR4) -2026/AG and AA control genotypes hypothesized to be associated with more inflammation during Respiratory syncytial virus (RSV) infection
|
Total
n=91 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
17 Participants
n=5 Participants
|
74 Participants
n=7 Participants
|
91 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
0.78 years
STANDARD_DEVIATION 0.56 • n=5 Participants
|
0.82 years
STANDARD_DEVIATION 0.54 • n=7 Participants
|
0.82 years
STANDARD_DEVIATION 0.55 • n=5 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=5 Participants
|
32 Participants
n=7 Participants
|
39 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
10 Participants
n=5 Participants
|
42 Participants
n=7 Participants
|
52 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
17 participants
n=5 Participants
|
74 participants
n=7 Participants
|
91 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 1-5 days during acute illness (not after day 5 of illness)Population: Analysis was per protocol based on the number of children enrolled by genotype and completed nasal washes at first visit.
Interferon a2 was measured from nasal lavage samples by Luminex multiplex assay.
Outcome measures
| Measure |
Toll-like Receptor 4 GG Genotype
n=17 Participants
Toll-like Receptor 4 (TLR4) -2026/GG gentoype hypothesized to be associated with less inflammation during Respiratory syncytial virus (RSV) infection
|
Toll-like Receptor 4 AG/AA Genotypes
n=74 Participants
Toll-like Receptor 4 (TLR4) -2026/AG and AA control genotypes hypothesized to be associated with more inflammation during Respiratory syncytial virus (RSV) infection
|
|---|---|---|
|
Nasal Interferon (IFN)-a2
|
10 pg/ml
Standard Deviation 3
|
26 pg/ml
Standard Deviation 31
|
PRIMARY outcome
Timeframe: 1-5 days during acute illness (not after day 5 of illness)IL-2 measured from nasal lavage samples by Luminex multiplex assay
Outcome measures
| Measure |
Toll-like Receptor 4 GG Genotype
n=12 Participants
Toll-like Receptor 4 (TLR4) -2026/GG gentoype hypothesized to be associated with less inflammation during Respiratory syncytial virus (RSV) infection
|
Toll-like Receptor 4 AG/AA Genotypes
n=50 Participants
Toll-like Receptor 4 (TLR4) -2026/AG and AA control genotypes hypothesized to be associated with more inflammation during Respiratory syncytial virus (RSV) infection
|
|---|---|---|
|
Percentage of Participants With Detected Nasal Interferon (IL)-2 Cytokine Expression
|
0 Percentage of Participants
|
44 Percentage of Participants
|
Adverse Events
Toll-like Receptor 4 GG Genotype
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Toll-like Receptor 4 AG/AA Genotypes
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place