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Study to determine the efficacy, safety and tolerability of two concentrations of XF-73 nasal gel in combination with body and face washing with chlorhexidine gluconate cloths in eradicating nasal carriage of Staphylococcus aureus.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| XF-73 2.0 mg/g nasal gel | Experimental | 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. |
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| XF-73 0.5 mg/g nasal gel | Experimental | 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. |
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| Placebo nasal gel | Placebo Comparator | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| XF-73 nasal gel | Drug |
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| Placebo nasal gel |
| Measure | Description | Time Frame |
|---|---|---|
| Apparent Eradication of Nasal SA After the Last Dose of XF-73 Based on Semi-quantitative SA Scores From a Broth Enrichment Method. | 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). | The primary endpoint was 48 hours after the last dose (Day 4, 84 hours). |
| Measure | Description | Time Frame |
|---|---|---|
| Apparent Eradication of Nasal SA After the Last Dose of XF-73 Based on Semi-quantitative SA Scores From a Broth Enrichment Method. | 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). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ian Mr Hayter, BSc | Destiny Pharma Plc | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Quintiles Drug Research Unit | London | SE11 1YR | United Kingdom |
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.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Drug |
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| Chlorhexidine gluconate 2% topical cloths | Other |
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| Time-points: Day 1(12 hours), Day 2 (24 hours), Day 3 (12 hours after last dose), Day 7 and Day 14. |
| Time-point at Which Clearance Was First Observed From Nasal Swabs Based on Semi-quantitative Score | The number of subjects with absence of SA from nasal swabs at the specified time-points.. | Day 1 (12 h), Day 2 (24 h) , Day 3 (12 hours after last dose),Day 4 (48 hours after last dose) |
| AUC of the Semi-quantitative SA Scores From Nasal Swabs | 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. | 2 day treatment period; 2 day treatment period up to discharge; 2 day treatment period, discharge and follow-up |
| The Number of Participants With Changes in Vital Signs, ECG and Routine Haematology, Clinical Chemistry and Urinalysis Tests. | Assessed over the two day treatment period and follow-up at 7 and 14 days relative to the first dose. |
| FG001 | 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 |
| FG002 | 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 |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| BG001 | 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 |
| BG002 | 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 |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
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| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
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| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| Primary | Apparent Eradication of Nasal SA After the Last Dose of XF-73 Based on Semi-quantitative SA Scores From a Broth Enrichment Method. | 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). | 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. | Posted | Number | participants | The primary endpoint was 48 hours after the last dose (Day 4, 84 hours). |
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| Secondary | Apparent Eradication of Nasal SA After the Last Dose of XF-73 Based on Semi-quantitative SA Scores From a Broth Enrichment Method. | 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). | 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. | Posted | Number | participants | Time-points: Day 1(12 hours), Day 2 (24 hours), Day 3 (12 hours after last dose), Day 7 and Day 14. |
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| Secondary | Time-point at Which Clearance Was First Observed From Nasal Swabs Based on Semi-quantitative Score | The number of subjects with absence of SA from nasal swabs at the specified time-points.. | Posted | Number | participants | Day 1 (12 h), Day 2 (24 h) , Day 3 (12 hours after last dose),Day 4 (48 hours after last dose) |
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| Secondary | AUC of the Semi-quantitative SA Scores From Nasal Swabs | 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. | 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. | Posted | Mean | Standard Deviation | units on a scale | 2 day treatment period; 2 day treatment period up to discharge; 2 day treatment period, discharge and follow-up |
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| Secondary | The Number of Participants With Changes in Vital Signs, ECG and Routine Haematology, Clinical Chemistry and Urinalysis Tests. | Posted | Number | participants | Assessed over the two day treatment period and follow-up at 7 and 14 days relative to the first dose. |
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Screening, treatment days 1 and 2 and follow up on days 7 and 14.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 | 0 | 27 | 9 | 27 | ||
| EG001 | 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 | 0 | 12 | 2 | 12 | ||
| EG002 | 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 | 0 | 24 | 5 | 24 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| rhinorrhoea | Respiratory, thoracic and mediastinal disorders | MedDRA 17.1 | Systematic Assessment |
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| rhinalgia | Respiratory, thoracic and mediastinal disorders | MedDRA 17.1 | Non-systematic Assessment |
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| oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 17.1 | Non-systematic Assessment |
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| headache | Nervous system disorders | MedDRA 17.1 | Non-systematic Assessment |
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| dizziness | Nervous system disorders | MedDRA 17.1 | Non-systematic Assessment |
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| oral herpes | Infections and infestations | MedDRA 17.1 | Non-systematic Assessment |
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| rhinitis | Infections and infestations | MedDRA 17.1 | Non-systematic Assessment |
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| Diarrhoea | Gastrointestinal disorders | MedDRA 17.1 | Non-systematic Assessment |
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| nausea | Gastrointestinal disorders | MedDRA 17.1 | Non-systematic Assessment |
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| Gout | Metabolism and nutrition disorders | MedDRA 17.1 | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Director of Projects | Destiny Pharma | +44 (0) 1273 704440 | medinfo@destinypharma.com |
| ID | Term |
|---|---|
| D013203 | Staphylococcal Infections |
| ID | Term |
|---|---|
| D016908 | Gram-Positive Bacterial Infections |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
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| ID | Term |
|---|---|
| C010882 | chlorhexidine gluconate |
| D013784 | Textiles |
| ID | Term |
|---|---|
| D008420 | Manufactured Materials |
| D013676 | Technology, Industry, and Agriculture |
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| Male |
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| No |
| Superiority or Other |
| OG002 | 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 |
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| OG001 | 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 |
| OG002 | 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 |
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