E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Nasal carriage of Staphylococcus aures (including MRSA) |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 12 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10067910 |
E.1.2 | Term | Staphylococcal colonisation |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
• To determine the efficacy of HT61 (1%) gel at two dose frequencies as determined by nasal decolonisation of Staphylococcus aureus in comparison with vehicle alone. |
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E.2.2 | Secondary objectives of the trial |
• To determine the efficacy of HT61 (1%) gel at two dose frequencies as determined by nasal decolonisation of Staphylococcus aureus in comparison with 2% mupirocin. • To determined the rate of reduction of colony forming units of nasal Staphylococcus aureus. • To determine the rate of relapse. • To determined the safety and tolerability of HT61 (1%) gel at two dose frequencies as determined by nasal decolonisation of Staphylococcus aureus in comparison with vehicle alone and 2% mupirocin • To determine the pharmacokinetic profile of HT61 (1%) gel.
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1. Male or female between 18 to 85 years inclusive. 2. Judged healthy from a medical history, routine laboratory investigations, vital signs and ECGs. 3. Capable of giving informed consent. 4. Able to understand, willing and likely to fully comply with study procedures and restrictions. 5. Able to attend all visits and complete the study. 6. Male or female subjects who are using a medically acceptable method of contraception or of non-childbearing potential (i.e., surgically sterile-bilateral tubal ligation or removal of both ovaries and/or uterus at least 6 months prior to dosing or naturally postmenopausal for at least one year with a Screening FSH level ≥ 40 mIU/L). A negative serum pregnancy test is required at Screening for females. Female subjects Female subjects of childbearing potential must use medically acceptable methods of contraception from the time of the first administration of the study medication until 3 months following administration of the last application of study medication. Acceptable methods include: • Oral contraceptives (combination oestrogen/progesterone pills), injectable progesterone or sub-dermal implants and a barrier method {condom or occlusive cap (diaphragm or cervical/vault caps) used with spermicidal foam/gel/film/cream/suppository}: • A documented placement of an intrauterine device (IUD) or intrauterine system (IUS) and the use of a barrier method {condom or occlusive cap (diaphragm or cervical/vault caps) used with spermicidal foam/gel/film/cream/suppository}; • Medically prescribed topically-applied transdermal contraceptive patch and a barrier method {condom or occlusive cap (diaphragm or cervical/vault caps) used with spermicidal foam/gel/film/cream/suppository}; • Documented tubal ligation (female sterilisation). In addition, a barrier method {condom or occlu-sive cap (diaphragm or cervical/vault caps) used with spermicidal foam/gel/film/cream/suppository} should also be used; • Double barrier method: Condom and occlusive cap (diaphragm or cervical/vault caps) with spermicidal foam/gel/film/cream/suppository; • Abstinence. Male subjects Male subjects must use medically acceptable methods of contraception if their female partners are pregnant from the time of the first administration of the study medication until 3 months following administration of the last application of study medication. Acceptable methods include: • Condom • If the subject has undergone surgical sterilisation (vasectomy with documentation of azoosper-mia) a condom with spermicidal foam/gel/film/cream/suppository should also be used. • Use acceptable methods of contraception if the male subject’s partner could become pregnant from the time of the first administration of study medication until 3 months following administration of the last application of study medication. The acceptable methods of contraception are as follows: • Condom and occlusive cap (diaphragm or cervical/vault caps) with spermicidal foam/gel/film/cream/suppository; • Surgical sterilisation (vasectomy with documentation of azoospermia) and a barrier method {condom or occlusive cap (diaphragm or cervical/vault caps) used with spermicidal foam/gel/film/cream/suppository}; • The female partner uses oral contraceptives (combination estrogen/progesterone pills), in-jectable progesterone or subdermal implants and a barrier method {condom or occlusive cap (diaphragm or cervical/vault caps) used with spermicidal foam/gel/film/cream/suppository}; • Medically prescribed topically-applied transdermal contraceptive patch and a barrier method {condom or occlusive cap (diaphragm or cervical/vault caps) used with spermicidal foam/gel/film/cream/suppository}; • The female partner has undergone documented tubal ligation (female sterilisation). In addition, a barrier method {condom or occlusive cap (diaphragm or cervical/vault caps) used with spermi-cidal foam/gel/film/cream/suppository} should also be used; • The female partner has undergone documented placement of an intrauterine device (IUD) or in-trauterine system (IUS) and the use of a barrier method {condom or occlusive cap (diaphragm or cervical/vault caps) used with spermicidal foam/gel/film/cream/suppository}; • Abstinence 7. Microbial diagnosis of nasal carriage of Staphylococcus aureus. 8. Treatment area amenable to topical treatment, i.e. anterior nares should be free of any obstructions and tissue damage
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E.4 | Principal exclusion criteria |
1. Any allergic reactions to mupirocin or glycine ester. 2. Any clinically significant skin or other condition or disorder which may affect the conduct or outcome of the study. 3. Clinical significant signs of infected skin diseases, e.g. infected Eczema 4. Carriage of either methicillin sensitive or resistant Staphylococcus aureas in the throat or skin/wound lesion. 5. Abnormal pathology of nasal passages. 6. Any clinically significant allergy or drug intolerance 7. Active hay fever, on-going cold/flu symptoms, including rhinitis. 8. Use of antibiotics for 4 weeks prior to the study drug application or use of concomitant systemic or topical antibiotics. 9. Any medical history or renal insufficiency or hepatic disorder. 10. Any history of history of pet ownership. 11. Are living with children under the age of 10. 12. History or signs or symptoms of any cancer. 13. Participation in a study with an investigational drug within 90 days prior to study drug application on Day 1. 14. History of regular alcohol consumption exceeding an average weekly intake of alcohol greater than 21 units. One unit is equivalent to a half-pint of beer or one measure of spirits or one glass of wine. 15. Subjects with known or suspected immunodeficiency. 16. Systemic treatment with immunosuppressive drugs e.g. cyclosporine, azathioprine or oral corticosteroids within 4 weeks prior to baseline visit. 17. Subjects who have received treatment with any non–marketed drug substance (i.e. an agent which has not yet been made available for clinical use following registration) within 4 weeks prior to baseline visit. 18. History or presence of clinically significant haematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, respiratory, psychiatric, or neurological disease. 19. A positive HIV 1 & 2 antibodies, Hepatitis B surface antigen, and/or Hepatitis C antibody result. 20. Blood donation or blood loss of more than 600 ml within 90 days prior to dosing on Day 1. 21. Known or suspected drug abuse.
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E.5 End points |
E.5.1 | Primary end point(s) |
• To determine the efficacy of HT61 (1%) gel at two dose frequencies as determined by nasal decolonisation of Staphylococcus aureus in comparison with vehicle alone. |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | Yes |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | Information not present in EudraCT |
E.7.1.2 | Bioequivalence study | Information not present in EudraCT |
E.7.1.3 | Other | Information not present in EudraCT |
E.7.1.3.1 | Other trial type description |
A study to determine the efficacy of HT61 |
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E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | Yes |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.4.1 | Number of sites anticipated in Member State concerned | 1 |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 1 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | 0 |