E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
To assess the effect of ciprofloxacin and clindamycin administration on the proportions and types of cultivable antibiotic-resistant bacteria that emerge in the oropharynx, on the skin and in the intestinal tract of humans.
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MedDRA Classification |
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 assess the effect of ciprofloxacin and clindamycin administration on the proportions and types of cultivable antibiotic-resistant bacteria that emerge in the oropharynx, on the skin, anterior nares and in the intestinal tract of humans.
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E.2.2 | Secondary objectives of the trial |
To investigate the dynamics of resistance development by sampling on several occasions. To ascertain the effect of ciprofloxacin and clindamycin administration on the composition of the cultivable microbiota at a number of body sites. To determine the concentration of ciprofloxacin and clindamycin at relevant body sites. To obtain antibiotic-resistant isolates for analysis in other work packages. To obtain saliva and feces samples for 454 pyrosequencing.
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1. Signed an informed consent prior to any study related procedure. 2. Female or male subject, 18 to 40 years of age, inclusive. To avoid pregnancy, and the risk of not completing the study, females must use highly effective contraceptive methods (see section 7.5 for details). 3. Body mass index (weight [kg]/height2 [m]2) between 18 and 30 kg/m2 (inclusive), and body weight, not less than 45 kg. 4. Normal findings in the medical history and physical examination, unless the investigator consider an abnormality to be clinically irrelevant.
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E.4 | Principal exclusion criteria |
1. History of or current clinically significant medical illness that the investigator considers should exclude the subject or that could interfere with the interpretation of the study results. 2. History of multiple yearly incidents of infectious diseases treated with antibiotics (e.g. urinary tract infections, upper respiratory tract infections). 3. Clinically significant abnormal values for hematology, clinical chemistry or urinalysis, physical examination, vital signs or 12-lead electrocardiogram (ECG) at screening as deemed appropriate by the investigator 4. Pregnant or breast-feeding females or females planning a pregnancy during the study period. 5. Regular use of any prescription or nonprescription medication except contraceptives within the month preceding the baseline visit. 6. Regular use of ”probiotic” supplements. 7. Treatment with antimicrobial agents within the 3 months preceding the study. 8. History of, or a reason to believe a subject has a history of drug or alcohol abuse within the past 5 years. 9. Positive test for drugs of abuse at screening. 10. History of clinically significant allergies, requiring acute or chronic treatment (except seasonal allergic rhinitis) 11. Known allergy to the study drugs and any of the excipients of the formulation or any related substances. 12. Donated blood or blood products or had substantial loss of blood (more than 500 ml) within 1 month before baseline. Intention to donate blood or blood products during the treatment period or within 1 month after completion of the treatment period. 13. Positive test for human immunodeficiency virus (HIV) 1 and 2 antibodies, hepatitis B surface antigen (HBsAg), or hepatitis C antibodies 14. Participation in any other clinical trials during the preceding 3 months. 15. Preplanned surgery or procedures that would interfere with the conduct of the study 16. Employee of the investigator or study center, with direct involvement in the proposed study or other studies under the direction of that investigator or study center, as well as family members of the employees or the investigator.
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E.5 End points |
E.5.1 | Primary end point(s) |
Pharmacodynamics Assessment of the effects of ciprofloxacin and clindamycin administration on the proportions and types of cultivable antibiotic-resistant bacteria that emerge in saliva samples, fecal samples, skin samples and nasal samples.
Pharmacokinetics To determine the concentration of ciprofloxacin and clindamycin in saliva samples, fecal samples, skin samples and nasal samples.
Safety Adverse events, safety laboratory variables, physical examination, ECG and vital signs.
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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 | No |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | No |
E.6.6 | Pharmacokinetic | Yes |
E.6.7 | Pharmacodynamic | Yes |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
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 | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
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 | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | Yes |
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 | No |
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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The last visit of the last subject. |
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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 | 3 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 0 |
E.8.9.2 | In all countries concerned by the trial months | 0 |
E.8.9.2 | In all countries concerned by the trial days | 0 |