Trial Outcomes & Findings for Study of the Nasal Decolonisation of Staphylococcus Aureus (SA) and the Safety and Tolerability of XF-73 Nasal Gel in Healthy Subjects (NCT NCT02282605)
NCT ID: NCT02282605
Last Updated: 2016-10-07
Results Overview
Anti-SA activity was assessed by the quantification of SA colonisation using the broth enriched (semi-quantitative culture) 0-6 point scale. Scores of negative and 0 were interpreted as absence of SA (Responder) and scores of 1 or greater were interpreted as presence of SA (Non-Responder).
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
60 participants
Primary outcome timeframe
The primary endpoint was 48 hours after the last dose (Day 4, 84 hours).
Results posted on
2016-10-07
Participant Flow
Persistent nasal SA carriage was defined by 3 separate, SA positive cultures from nasal swabs. The protocol allowed for dosing to commence before the results of the final swab on day -1 were available. Dosing was thus commenced in 3 subjects in the XF-73 2.0mg/g group but was withdrawn as the day -1 SA results were negative.
Participant milestones
| Measure |
XF-73 2.0 mg/g Nasal Gel
0.3mL (nominal 300 microgram) XF-73 nasal gel will be applied to each naris, twice daily for two days. Each dose will be 0.3mL per naris/0.6mL per dose delivering 0.6mg XF-73 per naris/1.2mg XF-73 per dose. Prior to each morning dose, subjects will use chlorhexidine gluconate 2% body and face cloths.
XF-73 nasal gel
Chlorhexidine gluconate 2% topical cloths
|
XF-73 0.5 mg/g Nasal Gel
0.3mL (nominal 300 microgram) XF-73 nasal gel will be applied to each naris twice daily for two days. Each dose will be 0.3mL per naris/0.6mL per dose delivering 0.15mg XF-73 per naris/0.3mg XF-73 per dose. Prior to each morning dose, subjects will use chlorhexidine gluconate 2% body and face cloths.
XF-73 nasal gel
Chlorhexidine gluconate 2% topical cloths
|
Placebo Nasal Gel
0.3mL nasal gel will be applied to each naris twice daily for two days. Prior to each morning dose, subjects will use chlorhexidine gluconate 2% body and face cloths.
Placebo nasal gel
Chlorhexidine gluconate 2% topical cloths
|
|---|---|---|---|
|
Overall Study
STARTED
|
27
|
12
|
24
|
|
Overall Study
COMPLETED
|
24
|
12
|
24
|
|
Overall Study
NOT COMPLETED
|
3
|
0
|
0
|
Reasons for withdrawal
| Measure |
XF-73 2.0 mg/g Nasal Gel
0.3mL (nominal 300 microgram) XF-73 nasal gel will be applied to each naris, twice daily for two days. Each dose will be 0.3mL per naris/0.6mL per dose delivering 0.6mg XF-73 per naris/1.2mg XF-73 per dose. Prior to each morning dose, subjects will use chlorhexidine gluconate 2% body and face cloths.
XF-73 nasal gel
Chlorhexidine gluconate 2% topical cloths
|
XF-73 0.5 mg/g Nasal Gel
0.3mL (nominal 300 microgram) XF-73 nasal gel will be applied to each naris twice daily for two days. Each dose will be 0.3mL per naris/0.6mL per dose delivering 0.15mg XF-73 per naris/0.3mg XF-73 per dose. Prior to each morning dose, subjects will use chlorhexidine gluconate 2% body and face cloths.
XF-73 nasal gel
Chlorhexidine gluconate 2% topical cloths
|
Placebo Nasal Gel
0.3mL nasal gel will be applied to each naris twice daily for two days. Prior to each morning dose, subjects will use chlorhexidine gluconate 2% body and face cloths.
Placebo nasal gel
Chlorhexidine gluconate 2% topical cloths
|
|---|---|---|---|
|
Overall Study
negative SA result on Day -1
|
3
|
0
|
0
|
Baseline Characteristics
Study of the Nasal Decolonisation of Staphylococcus Aureus (SA) and the Safety and Tolerability of XF-73 Nasal Gel in Healthy Subjects
Baseline characteristics by cohort
| Measure |
XF-73 2.0 mg/g Nasal Gel
n=27 Participants
0.3mL (nominal 300 microgram) XF-73 nasal gel will be applied to each naris, twice daily for two days. Each dose will be 0.3mL per naris/0.6mL per dose delivering 0.6mg XF-73 per naris/1.2mg XF-73 per dose. Prior to each morning dose, subjects will use chlorhexidine gluconate 2% body and face cloths.
XF-73 nasal gel
Chlorhexidine gluconate 2% topical cloths
|
XF-73 0.5 mg/g Nasal Gel
n=12 Participants
0.3mL (nominal 300 microgram) XF-73 nasal gel will be applied to each naris twice daily for two days. Each dose will be 0.3mL per naris/0.6mL per dose delivering 0.15mg XF-73 per naris/0.3mg XF-73 per dose. Prior to each morning dose, subjects will use chlorhexidine gluconate 2% body and face cloths.
XF-73 nasal gel
Chlorhexidine gluconate 2% topical cloths
|
Placebo Nasal Gel
n=24 Participants
0.3mL nasal gel will be applied to each naris twice daily for two days. Prior to each morning dose, subjects will use chlorhexidine gluconate 2% body and face cloths.
Placebo nasal gel
Chlorhexidine gluconate 2% topical cloths
|
Total
n=63 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
34.7 years
STANDARD_DEVIATION 12.4 • n=5 Participants
|
38.0 years
STANDARD_DEVIATION 12.8 • n=7 Participants
|
39.0 years
STANDARD_DEVIATION 12.5 • n=5 Participants
|
37.0 years
STANDARD_DEVIATION 11.5 • n=4 Participants
|
|
Sex: Female, Male
Female
|
12 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
20 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
15 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
43 Participants
n=4 Participants
|
|
Region of Enrollment
United Kingdom
|
27 participants
n=5 Participants
|
12 participants
n=7 Participants
|
24 participants
n=5 Participants
|
63 participants
n=4 Participants
|
PRIMARY outcome
Timeframe: The primary endpoint was 48 hours after the last dose (Day 4, 84 hours).Population: Exploratory comparisons between active groups versus placebo of the number of Responder subjects were performed using a one-sided Fisher's exact test at 5% significance level.
Anti-SA activity was assessed by the quantification of SA colonisation using the broth enriched (semi-quantitative culture) 0-6 point scale. Scores of negative and 0 were interpreted as absence of SA (Responder) and scores of 1 or greater were interpreted as presence of SA (Non-Responder).
Outcome measures
| Measure |
XF-73 2.0 mg/g Nasal Gel
n=27 Participants
0.3mL (nominal 300 microgram) XF-73 nasal gel will be applied to each naris, twice daily for two days. Each dose will be 0.3mL per naris/0.6mL per dose delivering 0.6mg XF-73 per naris/1.2mg XF-73 per dose. Prior to each morning dose, subjects will use chlorhexidine gluconate 2% body and face cloths.
XF-73 nasal gel
Chlorhexidine gluconate 2% topical cloths
|
XF-73 0.5 mg/g Nasal Gel
n=12 Participants
0.3mL (nominal 300 microgram) XF-73 nasal gel will be applied to each naris twice daily for two days. Each dose will be 0.3mL per naris/0.6mL per dose delivering 0.15mg XF-73 per naris/0.3mg XF-73 per dose. Prior to each morning dose, subjects will use chlorhexidine gluconate 2% body and face cloths.
XF-73 nasal gel
Chlorhexidine gluconate 2% topical cloths
|
Placebo Nasal Gel
n=24 Participants
0.3mL nasal gel will be applied to each naris twice daily for two days. Prior to each morning dose, subjects will use chlorhexidine gluconate 2% body and face cloths.
Placebo nasal gel
Chlorhexidine gluconate 2% topical cloths
|
|---|---|---|---|
|
Apparent Eradication of Nasal SA After the Last Dose of XF-73 Based on Semi-quantitative SA Scores From a Broth Enrichment Method.
|
3 participants
|
1 participants
|
4 participants
|
SECONDARY outcome
Timeframe: Time-points: Day 1(12 hours), Day 2 (24 hours), Day 3 (12 hours after last dose), Day 7 and Day 14.Population: Exploratory comparisons between active groups versus placebo of the percentage of Responder subjects were performed using a one-sided Fisher's exact test at 5% significance level.
Anti-SA activity was assessed by the quantification of SA colonisation using the broth enriched (semi-quantitative culture) 0-6 point scale. Scores of negative and 0 were interpreted as absence of SA (Responder) and scores of 1 or greater were interpreted as presence of SA (Non-Responder).
Outcome measures
| Measure |
XF-73 2.0 mg/g Nasal Gel
n=27 Participants
0.3mL (nominal 300 microgram) XF-73 nasal gel will be applied to each naris, twice daily for two days. Each dose will be 0.3mL per naris/0.6mL per dose delivering 0.6mg XF-73 per naris/1.2mg XF-73 per dose. Prior to each morning dose, subjects will use chlorhexidine gluconate 2% body and face cloths.
XF-73 nasal gel
Chlorhexidine gluconate 2% topical cloths
|
XF-73 0.5 mg/g Nasal Gel
n=12 Participants
0.3mL (nominal 300 microgram) XF-73 nasal gel will be applied to each naris twice daily for two days. Each dose will be 0.3mL per naris/0.6mL per dose delivering 0.15mg XF-73 per naris/0.3mg XF-73 per dose. Prior to each morning dose, subjects will use chlorhexidine gluconate 2% body and face cloths.
XF-73 nasal gel
Chlorhexidine gluconate 2% topical cloths
|
Placebo Nasal Gel
n=24 Participants
0.3mL nasal gel will be applied to each naris twice daily for two days. Prior to each morning dose, subjects will use chlorhexidine gluconate 2% body and face cloths.
Placebo nasal gel
Chlorhexidine gluconate 2% topical cloths
|
|---|---|---|---|
|
Apparent Eradication of Nasal SA After the Last Dose of XF-73 Based on Semi-quantitative SA Scores From a Broth Enrichment Method.
Day 7
|
1 participants
|
0 participants
|
1 participants
|
|
Apparent Eradication of Nasal SA After the Last Dose of XF-73 Based on Semi-quantitative SA Scores From a Broth Enrichment Method.
Day 14
|
1 participants
|
0 participants
|
2 participants
|
|
Apparent Eradication of Nasal SA After the Last Dose of XF-73 Based on Semi-quantitative SA Scores From a Broth Enrichment Method.
Day 1 (12 hours)
|
2 participants
|
2 participants
|
6 participants
|
|
Apparent Eradication of Nasal SA After the Last Dose of XF-73 Based on Semi-quantitative SA Scores From a Broth Enrichment Method.
Day 2 (24 hours)
|
10 participants
|
3 participants
|
2 participants
|
|
Apparent Eradication of Nasal SA After the Last Dose of XF-73 Based on Semi-quantitative SA Scores From a Broth Enrichment Method.
Day 3 (12 hours after last dose)
|
9 participants
|
9 participants
|
6 participants
|
SECONDARY outcome
Timeframe: Day 1 (12 h), Day 2 (24 h) , Day 3 (12 hours after last dose),Day 4 (48 hours after last dose)The number of subjects with absence of SA from nasal swabs at the specified time-points..
Outcome measures
| Measure |
XF-73 2.0 mg/g Nasal Gel
n=27 Participants
0.3mL (nominal 300 microgram) XF-73 nasal gel will be applied to each naris, twice daily for two days. Each dose will be 0.3mL per naris/0.6mL per dose delivering 0.6mg XF-73 per naris/1.2mg XF-73 per dose. Prior to each morning dose, subjects will use chlorhexidine gluconate 2% body and face cloths.
XF-73 nasal gel
Chlorhexidine gluconate 2% topical cloths
|
XF-73 0.5 mg/g Nasal Gel
n=12 Participants
0.3mL (nominal 300 microgram) XF-73 nasal gel will be applied to each naris twice daily for two days. Each dose will be 0.3mL per naris/0.6mL per dose delivering 0.15mg XF-73 per naris/0.3mg XF-73 per dose. Prior to each morning dose, subjects will use chlorhexidine gluconate 2% body and face cloths.
XF-73 nasal gel
Chlorhexidine gluconate 2% topical cloths
|
Placebo Nasal Gel
n=24 Participants
0.3mL nasal gel will be applied to each naris twice daily for two days. Prior to each morning dose, subjects will use chlorhexidine gluconate 2% body and face cloths.
Placebo nasal gel
Chlorhexidine gluconate 2% topical cloths
|
|---|---|---|---|
|
Time-point at Which Clearance Was First Observed From Nasal Swabs Based on Semi-quantitative Score
Day 2 (24 hours)
|
8 participants
|
2 participants
|
1 participants
|
|
Time-point at Which Clearance Was First Observed From Nasal Swabs Based on Semi-quantitative Score
Day 3 (12 hours after last dose)
|
4 participants
|
5 participants
|
4 participants
|
|
Time-point at Which Clearance Was First Observed From Nasal Swabs Based on Semi-quantitative Score
Day 4 (48 hours after last dose)
|
0 participants
|
0 participants
|
1 participants
|
|
Time-point at Which Clearance Was First Observed From Nasal Swabs Based on Semi-quantitative Score
Day 1 (12 hours)
|
1 participants
|
2 participants
|
5 participants
|
SECONDARY outcome
Timeframe: 2 day treatment period; 2 day treatment period up to discharge; 2 day treatment period, discharge and follow-upPopulation: A comparison between treatment groups was performed separately for each AUC with an ANCOVA model with AUC as dependent variable, treatment as fixed effect and baseline SA (0 hours) as covariate. The AUC is a cumulative measure, comparison could be performed only within the same time period therefore data was normalised over time.
Anti-SA activity was assessed by the quantification of SA colonisation using the broth enriched (semi-quantitative culture) 0-6 point scale. Mean changes from baseline (0h) to each timepoint (Day 1,12 h; Day 2, 24 h: Day 3, 48h; Day 4, 84h; Day 7, 144h; Day 14, 312h) were calculated by treatment for the semi-quantitative SA scores. The AUC of the semi-quantitative SA scores were calculated for the two-day treatment period (AUC Day1- Day2); through the two day treatment period and up to discharge (AUC Day 1- Day4); and over the two-day treatment period, discharge and follow-up (AUC Day1- Day14). AUC was calculated by means of a trapezoidal rule using a standard algorithm. A higher AUC is indicative of a higher bacterial growth.
Outcome measures
| Measure |
XF-73 2.0 mg/g Nasal Gel
n=27 Participants
0.3mL (nominal 300 microgram) XF-73 nasal gel will be applied to each naris, twice daily for two days. Each dose will be 0.3mL per naris/0.6mL per dose delivering 0.6mg XF-73 per naris/1.2mg XF-73 per dose. Prior to each morning dose, subjects will use chlorhexidine gluconate 2% body and face cloths.
XF-73 nasal gel
Chlorhexidine gluconate 2% topical cloths
|
XF-73 0.5 mg/g Nasal Gel
n=12 Participants
0.3mL (nominal 300 microgram) XF-73 nasal gel will be applied to each naris twice daily for two days. Each dose will be 0.3mL per naris/0.6mL per dose delivering 0.15mg XF-73 per naris/0.3mg XF-73 per dose. Prior to each morning dose, subjects will use chlorhexidine gluconate 2% body and face cloths.
XF-73 nasal gel
Chlorhexidine gluconate 2% topical cloths
|
Placebo Nasal Gel
n=24 Participants
0.3mL nasal gel will be applied to each naris twice daily for two days. Prior to each morning dose, subjects will use chlorhexidine gluconate 2% body and face cloths.
Placebo nasal gel
Chlorhexidine gluconate 2% topical cloths
|
|---|---|---|---|
|
AUC of the Semi-quantitative SA Scores From Nasal Swabs
Treatment period
|
64.3 units on a scale
Standard Deviation 28.9
|
54.5 units on a scale
Standard Deviation 33.1
|
76.8 units on a scale
Standard Deviation 35.2
|
|
AUC of the Semi-quantitative SA Scores From Nasal Swabs
Treatment to follow-up
|
964.3 units on a scale
Standard Deviation 335.8
|
911.5 units on a scale
Standard Deviation 380.1
|
1041.0 units on a scale
Standard Deviation 414.4
|
|
AUC of the Semi-quantitative SA Scores From Nasal Swabs
Treatment to discharge
|
159.0 units on a scale
Standard Deviation 85.8
|
139.5 units on a scale
Standard Deviation 98.6
|
245.8 units on a scale
Standard Deviation 121.8
|
SECONDARY outcome
Timeframe: Assessed over the two day treatment period and follow-up at 7 and 14 days relative to the first dose.Outcome measures
| Measure |
XF-73 2.0 mg/g Nasal Gel
n=27 Participants
0.3mL (nominal 300 microgram) XF-73 nasal gel will be applied to each naris, twice daily for two days. Each dose will be 0.3mL per naris/0.6mL per dose delivering 0.6mg XF-73 per naris/1.2mg XF-73 per dose. Prior to each morning dose, subjects will use chlorhexidine gluconate 2% body and face cloths.
XF-73 nasal gel
Chlorhexidine gluconate 2% topical cloths
|
XF-73 0.5 mg/g Nasal Gel
n=12 Participants
0.3mL (nominal 300 microgram) XF-73 nasal gel will be applied to each naris twice daily for two days. Each dose will be 0.3mL per naris/0.6mL per dose delivering 0.15mg XF-73 per naris/0.3mg XF-73 per dose. Prior to each morning dose, subjects will use chlorhexidine gluconate 2% body and face cloths.
XF-73 nasal gel
Chlorhexidine gluconate 2% topical cloths
|
Placebo Nasal Gel
n=24 Participants
0.3mL nasal gel will be applied to each naris twice daily for two days. Prior to each morning dose, subjects will use chlorhexidine gluconate 2% body and face cloths.
Placebo nasal gel
Chlorhexidine gluconate 2% topical cloths
|
|---|---|---|---|
|
The Number of Participants With Changes in Vital Signs, ECG and Routine Haematology, Clinical Chemistry and Urinalysis Tests.
|
0 participants
|
0 participants
|
0 participants
|
Adverse Events
XF-73 2.0 mg/g Nasal Gel
Serious events: 0 serious events
Other events: 9 other events
Deaths: 0 deaths
XF-73 0.5 mg/g Nasal Gel
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Placebo Nasal Gel
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
XF-73 2.0 mg/g Nasal Gel
n=27 participants at risk
0.3mL (nominal 300 microgram) XF-73 nasal gel will be applied to each naris, twice daily for two days. Each dose will be 0.3mL per naris/0.6mL per dose delivering 0.6mg XF-73 per naris/1.2mg XF-73 per dose. Prior to each morning dose, subjects will use chlorhexidine gluconate 2% body and face cloths.
XF-73 nasal gel
Chlorhexidine gluconate 2% topical cloths
|
XF-73 0.5 mg/g Nasal Gel
n=12 participants at risk
0.3mL (nominal 300 microgram) XF-73 nasal gel will be applied to each naris twice daily for two days. Each dose will be 0.3mL per naris/0.6mL per dose delivering 0.15mg XF-73 per naris/0.3mg XF-73 per dose. Prior to each morning dose, subjects will use chlorhexidine gluconate 2% body and face cloths.
XF-73 nasal gel
Chlorhexidine gluconate 2% topical cloths
|
Placebo Nasal Gel
n=24 participants at risk
0.3mL nasal gel will be applied to each naris twice daily for two days. Prior to each morning dose, subjects will use chlorhexidine gluconate 2% body and face cloths.
Placebo nasal gel
Chlorhexidine gluconate 2% topical cloths
|
|---|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
rhinorrhoea
|
11.1%
3/27 • Number of events 3 • Screening, treatment days 1 and 2 and follow up on days 7 and 14.
|
8.3%
1/12 • Number of events 1 • Screening, treatment days 1 and 2 and follow up on days 7 and 14.
|
4.2%
1/24 • Number of events 1 • Screening, treatment days 1 and 2 and follow up on days 7 and 14.
|
|
Respiratory, thoracic and mediastinal disorders
rhinalgia
|
7.4%
2/27 • Number of events 2 • Screening, treatment days 1 and 2 and follow up on days 7 and 14.
|
0.00%
0/12 • Screening, treatment days 1 and 2 and follow up on days 7 and 14.
|
0.00%
0/24 • Screening, treatment days 1 and 2 and follow up on days 7 and 14.
|
|
Respiratory, thoracic and mediastinal disorders
oropharyngeal pain
|
3.7%
1/27 • Number of events 1 • Screening, treatment days 1 and 2 and follow up on days 7 and 14.
|
0.00%
0/12 • Screening, treatment days 1 and 2 and follow up on days 7 and 14.
|
0.00%
0/24 • Screening, treatment days 1 and 2 and follow up on days 7 and 14.
|
|
Nervous system disorders
headache
|
14.8%
4/27 • Number of events 5 • Screening, treatment days 1 and 2 and follow up on days 7 and 14.
|
0.00%
0/12 • Screening, treatment days 1 and 2 and follow up on days 7 and 14.
|
0.00%
0/24 • Screening, treatment days 1 and 2 and follow up on days 7 and 14.
|
|
Nervous system disorders
dizziness
|
0.00%
0/27 • Screening, treatment days 1 and 2 and follow up on days 7 and 14.
|
8.3%
1/12 • Number of events 1 • Screening, treatment days 1 and 2 and follow up on days 7 and 14.
|
0.00%
0/24 • Screening, treatment days 1 and 2 and follow up on days 7 and 14.
|
|
Infections and infestations
oral herpes
|
0.00%
0/27 • Screening, treatment days 1 and 2 and follow up on days 7 and 14.
|
8.3%
1/12 • Number of events 1 • Screening, treatment days 1 and 2 and follow up on days 7 and 14.
|
4.2%
1/24 • Number of events 1 • Screening, treatment days 1 and 2 and follow up on days 7 and 14.
|
|
Infections and infestations
rhinitis
|
0.00%
0/27 • Screening, treatment days 1 and 2 and follow up on days 7 and 14.
|
0.00%
0/12 • Screening, treatment days 1 and 2 and follow up on days 7 and 14.
|
4.2%
1/24 • Number of events 1 • Screening, treatment days 1 and 2 and follow up on days 7 and 14.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/27 • Screening, treatment days 1 and 2 and follow up on days 7 and 14.
|
0.00%
0/12 • Screening, treatment days 1 and 2 and follow up on days 7 and 14.
|
4.2%
1/24 • Number of events 1 • Screening, treatment days 1 and 2 and follow up on days 7 and 14.
|
|
Gastrointestinal disorders
nausea
|
0.00%
0/27 • Screening, treatment days 1 and 2 and follow up on days 7 and 14.
|
0.00%
0/12 • Screening, treatment days 1 and 2 and follow up on days 7 and 14.
|
4.2%
1/24 • Number of events 1 • Screening, treatment days 1 and 2 and follow up on days 7 and 14.
|
|
Metabolism and nutrition disorders
Gout
|
0.00%
0/27 • Screening, treatment days 1 and 2 and follow up on days 7 and 14.
|
0.00%
0/12 • Screening, treatment days 1 and 2 and follow up on days 7 and 14.
|
4.2%
1/24 • Number of events 1 • Screening, treatment days 1 and 2 and follow up on days 7 and 14.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: OTHER