Effects of Clindamycin and Ciprofloxacin administration on the emergence, prevalence and persistence of antibiotic-resistant bacteria in humans

• Conditions: 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.

• Registration Number: EUCTR2010-023889-52-SE
• Lead Sponsor: Karolinska Universitetssjukhuset

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2010-11-23
• Last Update Posted: 29 May 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 30

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.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified