A randomised, open-labelled, multiple dose study of HT61 formulations applied to the anterior nares plus chlorhexidine body and hair washes in subjects with nasal carriage of Staphylococcus aureus - Multiple doses of HT61 formulations in Staph aureus carriers
- Conditions
- MedDRA version: 13Level: LLTClassification code 10067914Term: Staphylococcal colonisationasal carriage of Staphylococcus aureus (including MRSA)
- Registration Number
- EUCTR2010-021193-11-GB
- Lead Sponsor
- Helperby Thearapeutics Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 33
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 =40mlU/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 three 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 three 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 prescrib
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.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To determine the rate of reduction of colony forming units of nasal Staphylococcus aureus;Secondary Objective: To determine the safety and tolerability of HT61<br><br>To identify the optimum formulation of HT61 for the decolonisation of Staphylococcus aureus from the nose <br><br>To determine the rate of decolonisation Staphylococcus aureus at 30 days<br><br>To determine the pharmacokinetic profile of HT61;Primary end point(s): To compare the effectiveness of HT61 in cream or gel or ointment form as determined by nasal decolonisation of Staphylococcus aureus.
- Secondary Outcome Measures
Name Time Method